INMETRO Ordinance #200

Machine Translated by Google
Federal Public Service

MINISTRY OF ECONOMY
NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY-INMETRO
ORDINANCE No. 200, OF APRIL 29, 2021
Approves the General Product Certification Requirements

(RGCP) – Consolidated.
THE PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY -

INMETRO, in the exercise of the authority granted to it by articles 4, § 2, of Law No. 5,966, of December 11, 1973,
and 3, items I and IV, of Law No. 9,933, of December 20, 1999, combined with the provisions of articles 18, item V,
of Annex I to Decree No. 6,275, of November 28, 2007, and 105, item V, of the Annex to Ordinance No. 2, of January
4, 2017, of the then Ministry of Industry, Foreign Trade and Services, considering what is determined by Decree No.
10,139, of November 28, 2019, and what is contained in SEI Process No. 0052600.011940/2020-11, resolves:
Subject matter and scope of application
Art.1º The consolidation of the General Product Certification Requirements (RGCP) is hereby approved,
set out in the annex to this Ordinance.
Art. 2 The General Product Certification Requirements – RGCP establish the common requirements that must
be used in assessing the conformity of products that use the Certification Mechanism.
Art. 3º The Conformity Assessment Requirements to be prepared for each object must contain only specific
requirements, complementary to the General Product Certification Requirements, respecting the specificities of the
object to be certified.
§1º The object-specific Conformity Assessment Requirements must define the corresponding requirements and follow the same
structure of items and subitems as presented in this RGCP.
§2º The provisions contained in the Requirements now approved may, exceptionally, be
changed, through the Conformity Assessment Requirements prepared in compliance with the specificities of the
object to be assessed.
Deadlines and transitional provisions
Art. 4º Conformity Assessment Requirements that do not use the RGCP will be gradually adapted as they
undergo improvement.
§1º Regardless of the provisions of the caput, the requirements related to the items “Certification Request”,
“Certificate Issuance”, “Certificate of Conformity”, “Activities Performed by OCP accredited by a member of the IAF
MLA”, “Certification Transfer”, “Certification Termination”, “Conformity Identification Seal”, “Authorization for Use of
the Conformity Identification Seal”, “Responsibility and Obligations”, “Market Monitoring”, “Penalties”, “Reports”,
“Annex B – Certification Transfer” apply to all Conformity Assessment Requirements – RAC approved up to the
publication of this Ordinance, not yet covered by the RGCP -
exclusively in cases of omission, and Annex C.

Fl. 2 of Ordinance No. 200/ Presi, of 04/29/2021
§2º Regardless of the provisions of the caput, the Quality Management System Audit, when provided for in the
Conformity Assessment Requirements – RAC approved up to the publication of this Ordinance, must be conducted
based on the current edition of the ISO 9001 standard (and its translations) or ABNT NBR ISO 9001 standard, preserving
the auditable requirements provided for in the specific RAC of the object and respecting the requirements correlation
matrix published by the standardizing body.
§3º The requirement of the previous version, without correlation with the version, must be excluded from the audit.
current standard.
Art. 5 All certification processes covered by the situation provided for in the paragraphs of art. 4 must be adapted
by the OCPs from the maintenance or recertification following the publication of this Ordinance, provided that these do
not occur in a period of less than 6 (six) months, when they may still meet the conditions defined in the specific RAC of
the object.
Revocation clause
Art. 6º The following Inmetro Ordinances are hereby revoked on the effective date of this Ordinance:
I - No. 118, of March 6, 2015, published in the Official Gazette of the Union of March 9, 2015, section 1, page 76;
II – No. 250, of June 3, 2016, published in the Official Gazette of the Union on June 7, 2016, section 1, page 44;
III – No. 252, of June 3, 2016, published in the Official Gazette of the Union on June 7, 2016, section 1, page 45
to 47; and
IV – No. 176, of June 28, 2017, published in the Official Gazette of the Union on July 5, 2017; section 1, page 59.
Validity
Art. 7 This Ordinance shall come into force on June 1, 2021, as determined by art. 4 of Decree No. 10,139 of 2019.
MARCOS HELENO GUERSON JUNIOR

President
ANNEX TO INMETRO ORDINANCE Nº 200/2021
GENERAL PRODUCT CERTIFICATION REQUIREMENTS - RGCP
1. OBJECTIVE
This document establishes the General Product Certification Requirements common to all Conformity Assessment Requirements
that use the Product Certification mechanism.
Particularities will be expressed in the object-specific Conformity Assessment Requirements.
Note: The term “product” in this RGCP applies to a product, service or process. The terms “manufacturing unit” and “production process” also
apply to the location where the product, process or service is produced, just as the term “manufacturer” applies to the provider of the service
or process.
1.1 Grouping for certification purposes
The grouping for the purposes of object certification will comply with the criteria established by the RAC
specific.
2. ACRONYMS
ABNT Brazilian Association of Technical Standards

Cgcre General Coordination of Accreditation
Dconf Conformity Assessment Directorate
IAAC Interamerican Accreditation Cooperation
IAF International Accreditation Forum
IEC International Electrotechnical Commission
ILAC International Laboratory Accreditation Cooperation
Inmetro National Institute of Metrology, Quality and Technology
ISO International Organization for Standardization
MLA Multilateral Recognition Arrangement
MoU Memorandum of Understanding
NBR Brazilian Standard
OCP Product Certification Body
OCS Quality Management System Certification Body
RAC Conformity Assessment Requirements
RGCP General Product Certification Requirements
QMS Quality Management System
3. DOCUMENTS
3.1 REFERENCE DOCUMENTS
ABNT NBR ISO/IEC Standard Conformity Assessment – Vocabulary and General Principles.
17000
ABNT NBR ISO/IEC Standard General Requirements for Testing and Calibration Laboratory Competence.
17025
ABNT NBR ISO 9001:2015 Standard Quality Management Systems – Requirements.
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ABNT NBR ISO/IEC Standard Conformity assessment - Fundamentals for product certification and
17067:2015 product certification scheme guidelines.
3.2 COMPLEMENTARY DOCUMENTS
Inmetro Ordinance No. 274 Approves the Regulation for the Use of Inmetro Brands, Symbols,
of 2014, or replacement. Seals and Labels.
Inmetro Ordinance No. 248, Approves the Inmetro Conformity Assessment Vocabulary with terms
of 2015, or replacement. and definitions commonly used by Inmetro's Conformity Assessment
Directorate.
4. DEFINITIONS
In the RACs established by Inmetro that use the Certification mechanism, the definitions contained in the Inmetro
Ordinance that approves the Inmetro Vocabulary for Conformity Assessment are applied. Other definitions will be
described in the specific RAC for the object.
5. COMPLIANCE ASSESSMENT MECHANISM
The Conformity Assessment Mechanism addressed in this document is Certification.
6. STEPS OF COMPLIANCE ASSESSMENT
The conformity assessment process consists of several stages. Each stage will follow a sequence of procedures,
in accordance with the Certification Model(s) adopted.
6.1 Definition of the Certification Model(s) used
The Certification Models will be explained in the specific RAC for the object under evaluation, among those
defined in the Inmetro Conformity Assessment Vocabulary.
The specific RAC may include more than one Certification Model.
6.1.1 Certification Model Steps
Each model consists of a sequence of steps described in Table 1. These steps must be included in the RAC,
separately for each model, when the specific RAC includes more than one Certification Model.
Table 1: Certification Model Steps

MODELS
STEPS OF THE PRODUCT CERTIFICATION PROCESS
1a 1b 2 3 4 5 6
Certification Request XXXXXXX
Analysis of the Request and Compliance of XXXXXXX
Documentation
Initial Audit of the Management System
Initial Assessment
Quality and Process Assessment XX
Productive
Initial Test Plan XXXXXX
Issuance of Certificate of Conformity XXXXXXX
2
System Maintenance Audit

Quality Management and Assessment XX
Evaluation of Production Process
Maintenance XXXX
Maintenance Test Plan
Maintenance Confirmation XXXXX
Evaluation of XXXXX
Recertification Assessment
Recertification
6.2 Initial Assessment
This item describes the steps of the process that aim to certify the object's compliance.
6.2.1 Certification Request
6.2.1.1 Certification must be requested exclusively by the Supplier, and must follow the provisions of this RGCP
and the specific RAC for the object to be evaluated.
6.2.1.2 The start of the certification process is subject to a formal statement from the Supplier requesting
certification, which must be made directly to one of the Product Certification Bodies accredited and/or designated
by Inmetro, of its choice, which must be legally established in the country, for the product under evaluation,
accompanied by the delivery of documentation, meeting the following requirements:
a) Identification of the model subject to certification, when certification is by model, referencing its technical
description and including the list of all brands sold;
b) List of model(s) that make up the family subject to certification, complying with the family formation rules
established in the specific RAC, when the certification is by family,
referencing its technical description(s) and including a list of all brands sold;
c) List of the scope(s) of service for which certification is being requested, in the case of service certification;
d) Photographic documentation of the object: external and internal photos of all sides, detailing labels, logos,
notices, inputs, outputs, activation buttons, when applicable;
e) Descriptive report covering the design of the object in its construction and functional details, and the list of its
critical components, including its suppliers and possible existing certifications, translated into Portuguese, when in
a language other than English or Spanish;
f) User manual with instructions in Portuguese;
g) Design or final artwork of packaging (primary, secondary and/or tertiary), when applicable (if packaging exists);
h) Choice of Certification Model, among those mentioned in the specific RAC of the object;
i) Information on the corporate name, address and CNPJ of the Supplier requesting certification, as well as
presentation of the articles of association, or other instrument of incorporation, which proves its status as a
Supplier;
j) Contact person, telephone number and email address of the Supplier requesting certification;
k) Identification of the manufacturer with full address, including the manufacturing unit(s) to be certified, located in
another country, when applicable;
l) Information on outsourced activities/processes that may affect the conformity of the product subject to certification;
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m) Documentation proving compliance with item 7 of this document (Treatment of

Complaints) for all brands sold, in all locations, owned by the certification applicant or directly outsourced by the
applicant, where the Complaints Handling activity is carried out;
n) Documents relating to the manufacturer's Quality Management System, applicable to the object to be certified,
in the case of certification by models 5 and 6, as provided for in tables 2 and 3, of item 6.2.3.1, even if they
necessarily come to be audited by the OCP, as provided for in this document;
o) Valid certificate issued based on the current edition of the ISO 9001 Standard or ABNT NBR ISO 9001 Standard,
which covers the production process of the object of certification, if any;
p) Identification of the certification batch, in the case of Model 1b, including quantities and manufacturing batch(es)
of the model(s) to be certified;
q) Import License (LI or LPCO), or, in the absence thereof, Import Declaration (DI or DUIMP),
in the case of Model 1b, when dealing with imported products;
r) Other documents required for the application process, described in the specific RAC; and
s) Documentation proving the classification as a micro and small enterprise - MPE, of the manufacturer, applicant
for certification, when applicable.
Note 1: If the brand(s) referred to in a) and b) is/are not owned by the Supplier requesting certification, the Supplier
must have authorization to use the same. It will be up to the OCP to verify the legal qualification of the authorization
instrument and the constitutive act of the owner(s) of the brand(s).
Note 2: The photos mentioned in d) must have a minimum resolution of 800 x 600 dpi.
Note 3: It is up to the OCP to evaluate the relationship of the components considered critical mentioned in e), and
may include others.
Note 4: The User Manual, mentioned in f), is understood to mean information about the product relating to:
instructions for assembly, installation, disassembly, uninstallation, handling, operation, cleaning, maintenance,
warnings and other information relevant to the user.
Note 5: The documentation referred to in item “m” is exempt from presentation if the OCP chooses to carry out the
audit provided for in the Note to subitem 7.3.
6.2.1.3 When, due to the characteristics of the product, the user manual is not applicable, the OCP must validate
and record this information in the certification process.
6.2.1.4 If the Supplier requesting certification is an integrator, packer and/or distributor that makes changes to the
packaging of the already certified product or that changes the form of presentation for marketing of the product in
relation to the original certification process, the certification request must follow the requirements defined in Annex
B of this RGCP.
6.2.2 Analysis of the Request and Documentation Compliance
6.2.2.1 The OCP, upon receiving the specified documentation, must open a process for granting the Certificate of
Conformity and carry out an analysis regarding the relevance of the request, in addition to an assessment of the
conformity of the documentation forwarded by the Supplier requesting the certification.
6.2.2.2 If non-conformity is identified in the documentation received, this must be formally forwarded to the Supplier
requesting certification for correction and due formalization with the OCP, in order to demonstrate the implementation
of the same for new analysis.
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6.2.2.3 If any of the documents mentioned in 6.2.1 are not presented in their final form by the Supplier requesting certification, when
delivering the documentation, and provided that this fact does not interfere with the other stages of the Initial Assessment process,
this fact must be made explicit by the OCP and the certification will only be concluded when all documents are in their final form and
duly approved by the OCP.
6.2.3 Initial Audit of the Quality Management System and Assessment of the Production Process
The QMS audit must be carried out whenever the chosen certification model so defines, regardless of whether the manufacturer or
service provider has a Quality Management System certified based on the ISO 9001 Standard or ABNT NBR ISO 9001 Standard.
According to the adopted model, the OCP evaluates the QMS documents and records and conducts an audit at the service provider's
or manufacturing unit's premises, with the aim of verifying the conformity of the production process, including facilities and personnel
training. The QMS audit must seek objective demonstration that the production process is systematized and monitored effectively,
providing evidence of compliance with the product requirements established in the RAC. In this way, the QMS requirements are
complementary to the requirements defined in the specific RAC of the object.
Records of compliance with these requirements must be obtained consistently.
The date of the audit visit must be scheduled in mutual agreement with the Supplier requesting certification.
6.2.3.1 The QMS assessment must be carried out by the OCP based on the scope of the certification process and in accordance
with the requirements of ISO 9001 or ABNT NBR ISO 9001, with the minimum requirements defined in Tables 2 and 3 below:
Table 2: Minimum QMS verification requirements for manufacturers or service providers with valid certification in accordance
with ISO 9001:2015 or ABNT NBR ISO 9001:2015
Resources 7.1.5.1 / 7.1.5.2
Documented information 7.5.2 / 7.5.3
Operational planning and control 8.1
Requirements for products and services 8.2.1
Control of externally provided processes, products and services 8.4.1 / 8.4.2 / 8.4.3
Production and service provision 8.5.1 / 8.5.2 / 8.5.3 / 8.5.4/ 8.5.5
Release of products and services 8.6
Control of non-conforming outputs 8.7
Monitoring, measurement, analysis and evaluation 9.1.1
Non-conformity and corrective action 10.2.1 / 10.2.2
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Table 3: Minimum QMS verification requirements for manufacturers and service providers without certification in ISO
9001:2015 or ABNT NBR ISO 9001:2015
Resources 7.1.5.1 / 7.1.5.2 / 7.1.3
Competence 7.2
Awareness 7.3
Documented information 7.5.2 / 7.5.3
Operational planning and control 8.1
Requirements for products and services 8.2.1
Production and service provision 8.5.1 / 8.5.2 / 8.5.3 / 8.5.4/ 8.5.5
Monitoring, measurement, analysis and evaluation 9.1.1 / 9.1.2 / 9.1.3 (a), (f)
Internal audit 9.2.1 / 9.2.2
Critical analysis by management 9.3.1 / 9.3.2 / 9.3.3
6.2.3.2 Even upon presentation of a valid certificate, according to the current edition of the ISO 9001 Standard or ABNT NBR ISO
9001 Standard, issued by an OCS accredited by Inmetro or a member of the IAF MLA, for the respective accreditation scope, the
OCP must carry out the initial audit of the QMS at the manufacturing unit or service provider during the initial assessment stage, in
accordance with Table 2 of this RGCP, with the aim of verifying the conformity of the production process.
Note: Certificates issued by a foreign OCS must be accompanied by a sworn translation into Portuguese when issued in a language
other than English or Spanish. Other documents relating to the Management System that are in a language other than English or
Spanish must be translated into Portuguese.
6.2.3.3 During the audit, the Supplier requesting certification must make available to the OCP all documents corresponding to the
certification of the Quality Management System based on the current edition of the ISO 9001 Standard or ABNT NBR ISO 9001
Standard and present records of the production process clearly identifying the object of certification. The OCP must analyze the
relevant documentation to ensure that the requirements described in Table 2 of item 6.2.3.1 have been met.
6.2.3.4 After the audit, the OCP must issue a report, recording its results, using this RGCP and the specific RAC of the object as a
reference.
6.2.3.5 The audit report must be signed by at least the audit team, and a copy must be made available to the Supplier requesting
certification.
6.2.3.6 Any change in the production process must be reported to the OCP and may imply, if it impacts the product's conformity, a
new audit.
6.2.3.7 In the case of certification based on prototypes, it is the responsibility of the OCP, during the audit, to ensure
that the product produced on a large scale corresponds to the prototype tested.
6.2.4 Initial Test Plan
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The initial tests must prove that the object of the conformity assessment meets the requirements defined in the normative basis.
The OCP is responsible for preparing the test plan, which must contain, at a minimum, the initial tests to be performed, a clear
definition of the test methods, number of samples and the acceptance/rejection criteria for these tests. In the case of certification by
family, the test plan must also be prepared in such a way as to include, at a minimum, the models that contain the greatest number
of requirements pre-established by the reference normative base. The OCP is responsible for carrying out a critical analysis of the
laboratory's test reports, comparing them with the previously established test plan.
The OCP must require that laboratories report the measurement uncertainties used in their test reports.
Test reports issued before the start of the certification process will not be accepted, unless clearly defined in the object-specific RAC.
Any change in critical component(s) must be reported to the OCP and will result in new tests being carried out.
6.2.4.1 Definition of the Tests to be Performed
The tests, their methods and acceptance/rejection criteria must be defined in the object's specific RAC and must be carried out in
accordance with the requirements pre-established by the normative basis.
The body of the test report must include the complete identification of the model of the object to be certified, so that the test report is
clearly traced to the sample collected.
The OCP is responsible for assessing whether the data contained in the descriptive report and in the product design or specification
are in compliance with the technical identification of the model in the test report presented.
6.2.4.2 Sampling Definition
The OCP is responsible for selecting and sealing samples of the object to be certified. The collection of samples for sending to the
laboratory must be agreed between the Supplier requesting certification and the OCP. The number of samples, acceptance/rejection
criteria and exceptional cases must be included in the specific RAC for the object. Table 4 presents an example of sample collection
applicable to Models 1a, 2, 3, 4 and 5.
When selecting and sealing samples, the OCP must prepare a sampling report, detailing the date, location, storage conditions,
sample identification (model/brand, manufacturing batch and manufacturing date, quantities sampled, etc.).
The Sampling Plan does not apply when the specific RAC for the object allows the acceptance of reports prior to the start of
certification.
When applicable, additional parts, components or parts of the product complementary to the sample(s) must be sealed, identified and
sent to the laboratory together with the product.
The tests on the counter-sample and witness samples must necessarily be carried out in the same laboratory where the test on the
test sample was carried out.
In the case of certification model 1b, the selection and sealing of samples must take place on national territory, and counter-proof and
witness sampling does not apply.
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Table 4: Presentation model of sample sizes required for initial tests
SAMPLE SIZE
CRITERIA OF
ESSAYS REGULATORY BASIS OF PROOF AGAINST WITNESS ACCEPTANCE /
PROOF REJECTION
(test name) (corresponding item (number of (number of (number of units of (criteria for
from the base units units sample acceptance/
normative) of the product) of the product) product) rejection)
6.2.4.2.1 If the test tests are approved, the sample is considered approved. If non-conformity is found in the test
sample, the test(s) must be repeated on the counter-test and witness samples.
a) If non-compliance is found in the counter-test, the sample is considered to have failed;
b) If the counter-test does not show any non-conformity, the control sample must be tested;
c) If the witness shows non-compliance, the sample is considered to have failed;
d) If the witness does not show any non-conformity, the sample is considered approved.
6.2.4.2.1.1 The specific RAC of the object will be responsible for defining the need to repeat all tests provided for
in the normative basis on the counter-test and witness samples.
6.2.4.2.2 At the discretion of the Supplier requesting certification, upon formalization to the OCP, the counter-test
and witness samples will not necessarily need to be tested. In this case, there may be no dispute regarding the
results obtained in the test sample.
6.2.4.2.3 Prototypes may be sent directly to the laboratory. In this case, the initial sample will consist only of the
product sample, dispensing with the counter-sample and witness.
6.2.4.2.4 It is the OCP's responsibility to ensure that the prototype tested is the product that will be mass-produced.
If the OCP finds any discrepancy between the tested prototype and the mass-produced product, or even the design
of the object, if it deems it pertinent, it must conduct new tests, in accordance with the test plan, on new samples.
6.2.4.2.5 If the batch fails the certifications conducted using model 1b, it cannot be released for sale and the
supplier must arrange for its destruction or return to the country of origin (in the case of import) with documentation
proving the measure that was taken.
6.2.4.3 Laboratory Definition
6.2.4.3.1 The OCP must adopt testing laboratories considering the order of priority defined below:
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1st Laboratory designated by Inmetro;

2nd 3rd party laboratory, national or foreign, accredited by Inmetro/Cgcre or signatory of the ILAC or IAAC
mutual recognition agreements, in all tests provided for in the specific RAC of the object;
3rd First-party laboratory, national or foreign, accredited by Inmetro/Cgcre or signatory of the ILAC or IAAC
mutual recognition agreements, in all tests provided for in the specific RAC of the object;
4th 3rd party laboratory, national or foreign, accredited by Inmetro/Cgcre or signatory of the ILAC or IAAC
mutual recognition agreements, in part (above 70% of the total) of the tests provided for in the specific RAC
of the object;
5th 1st party laboratory, national or foreign, accredited by Inmetro/Cgcre or signatory of the ILAC or IAAC
mutual recognition agreements, in part (above 70% of the total) of the tests provided for in the specific RAC
of the object;
mutual recognition agreements, in part (below 70% of the total) of the tests provided for in the specific RAC
of the object or accredited in the same test class and same area of activity of the test(s) provided for in the
specific RAC, but for another object;
mutual recognition agreements, below 70% of the total tests provided for in the specific RAC of the object or
accredited in the same test class and same area of activity of the test(s) provided for in the specific RAC, but
for another object;
mutual recognition agreements, in another scope;
mutual recognition agreements, in another scope;
10th 3rd party laboratory, national or foreign, not accredited;
11th 1st party laboratory, national or foreign, not accredited.
Note 1: The designation of a laboratory will be given, exceptionally, based on criteria defined by Inmetro,
through the publication of a specific Ordinance in the Official Gazette of the Union.
Note 2: The third-party laboratory accredited for part of the tests provided for in the specific RAC of the object
may, in situations authorized by Inmetro/Cgcre, subcontract third-party laboratory(ies) accredited for part or all
of the tests provided for in the specific RAC of the object, to perform the test(s) for which it is not accredited. In
this condition, it shall be considered in the same selection position as the third-party laboratory accredited by
Inmetro/Cgcre or signatory of the ILAC or IAAC mutual recognition agreements, for all of the tests provided for
in the specific RAC of the object. The Test Report must be issued in full by the laboratory that sought the
subcontracting and must contain the identification of the tests and respective subcontracted laboratory(ies). In
this case, the Certification Body, as the entity responsible for the certification process, must analyze and
approve the use of the subcontracted laboratory.
6.2.4.3.2 For the purposes of using the aforementioned order of priority, any of the following hypotheses must
be considered:
a) Non-existence of the laboratory defined in the previous priority;
b) When the laboratory defined in the previous priority does not make the test budget available within a
maximum of 10 (ten) business days of the request made by the OCP or cannot meet, within a maximum of 30
(thirty) calendar days, counted from the date of acceptance by the OCP, the deadline for starting the tests
provided for in the Conformity Assessment Requirements (RAC) or cannot perform them within a maximum of
one and a half times the regular time for the tests provided for in the normative basis;
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c) When the OCP shows that the price of the tests carried out, plus the costs arising from the assessment/
monitoring by the OCP, compared to that defined in the previous priority is at least 50% lower.
Note 1: The OCP must record, through supporting documents, updated at each stage of maintenance/
recertification, the reasons that led it to select the adopted laboratory, by model or by certified family. When
using the cost criterion provided for in 6.2.4.3.2 c) for selecting a 1st party laboratory, the internal cost
spreadsheet (calculation report) that results in the price charged for each test must be presented.
Note 2: Depending on the specificities of the product, at the time of preparation of the specific RAC or in its
implementation phase, Inmetro may authorize, through Ordinance, the use of accredited first-party laboratories,
as an alternative to accredited third-party laboratories.
Note 3: If there is only a third-party laboratory accredited in the specific scope abroad, but there is a first-party
laboratory fully accredited in the specific scope in the country, this may be used.
Note 4: When toxicity tests are provided for in the specific RAC for the object, the OCP may, as an alternative
to accreditation, select a testing laboratory recognized by Inmetro/Cgcre for the Principles of Good Laboratory
Practices-GLP, within the scope of the Mutual Acceptance of Data System of the Organization for Economic
Cooperation and Development - OECD.
6.2.4.3.3 In the case of using a laboratory accredited by a signatory to the ILAC or IAAC mutual recognition
agreements, it is the responsibility of the OCP to observe and document the equivalence of the test method
and parameters.
6.2.4.3.4 In any case of use of a first-party laboratory accredited in the specific scope, fully or partially, the OCP
must monitor and record the execution of all tests. This monitoring consists of, at least, following the stages of
sample selection and preparation and the subsequent collection of results.
6.2.4.3.5 In any case of use of a 1st or 3rd party laboratory accredited for another testing scope, the OCP must,
after recognizing and registering the laboratory's capabilities and infrastructure (including equipment), monitor
and record the execution of all tests. This monitoring consists of, at least, following the stages of sample
selection and preparation, start of tests and subsequent collection of results.
6.2.4.3.6 In any case of use of a non-accredited 1st or 3rd party laboratory, the OCP must, after evaluating and
recording all the requirements set out in Annex A of this document, monitor and record the execution of all
stages of all tests. The evaluation carried out by the OCP must be done by an OCP professional who has a
training record of at least 16 hours/class, in the current ABNT NBR ISO IEC 17025 Standard, in addition to
formal proof of experience and specific technical knowledge regarding the tests to be evaluated.
6.2.4.3.7 The definition of the laboratory must be made by mutual agreement between the OCP and the
Supplier requesting certification, provided that the provisions of 6.2.4.3 are respected.
6.2.5 Treatment of non-conformities in the Initial Assessment stage

6.2.5.1 If any non-conformity is identified in the Initial Assessment stage, the Supplier requesting certification
must send to the OCP, within a maximum period of 60 (sixty) calendar days, evidence of the implementation of
corrective actions for the non-conformity(ies) identified.
6.2.5.2 The critical analysis of the causes of non-conformities, as well as the proposal of corrective actions, are
the responsibility of the Supplier requesting certification.
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6.2.5.3 If the Supplier requesting certification does not comply with the established deadline, the Certification process must be
cancelled or interrupted, and may be restarted if the Supplier requesting certification and the OCP are interested.
6.2.5.4 New deadlines may be agreed upon, provided that they are formally requested by the Supplier requesting certification,
justified and considered relevant by the OCP. These deadlines also apply to non-conformities or pending issues identified during the
analysis of the request.
6.2.5.5 The OCP must evaluate the effectiveness of the corrective actions implemented, accepting them or not.
6.2.5.6 It is at the OCP's discretion whether it is necessary to conduct a new audit of the QMS and/or perform new tests to verify the
implementation of corrective actions.
6.2.5.7 The Supplier requesting certification must identify and segregate the non-compliant product(s) in separate areas, so that
there is no possibility of mixing with the compliant product and sending it to the market, and must keep a record of this action.
6.2.5.8 Objective evidence of the treatment of non-conformities is a requirement for issuing the Certificate of Conformity.
6.2.6 Issuance of Certificate of Conformity
6.2.6.1 Critical Analysis and Certification Decision
6.2.6.1.1 The OCP must designate at least one person to critically analyze the information and results related to the evaluation. The
critical analysis must be carried out by person(s) not involved in the evaluation process.
6.2.6.1.2 The critical analysis must include all information about documentation, audits, test results and treatment of nonconformities.
6.2.6.1.3 Recommendations for Certification based on critical analysis must be documented.
6.2.6.1.4 The OCP is responsible for decisions regarding Certification.
6.2.6.1.5 The Certification decision will be made by a person or group of people not involved in the assessment process.
6.2.6.1.6 The OCP must notify the Supplier requesting certification if it decides not to grant Certification, stating the reasons for the
decision.
6.2.6.1.7 Should the OCP choose to use a Certification Committee, there must be formal rules for its appointment, terms of reference
and operation.
6.2.6.1.7.1 Certification Committees must be free from any interests, commercial, financial and other pressures that may influence
their decisions.
6.2.6.1.7.2 The OCP is responsible for appointing and excluding members of the Certification Committees.
6.2.6.2 Issuance of Certificate
Once the requirements set out in this RGCP and in the specific RAC for the object have been met, the OCP issues an exclusive
Certificate of Conformity, with a different number, for each model or family that is the subject of the request.
6.2.6.2.1 If certification is by family, the certificate must list all models covered by the family.
6.2.6.2.2 If more than one page is required for the certificate, all pages must be numbered with reference to their own number and
the total number of pages, and each page must contain the certificate number and date of issue. The first page must state how many
pages make up the complete certificate. In this case, the certificate must contain the expression
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“Certificate of Conformity valid only accompanied by pages 01 to N” (mention the start and end pages of the certificate).
6.2.6.3 Certificate of Conformity
The validity of the Certificate of Conformity is defined in the specific RAC and must contain the following wording, in the case of
certification according to Models 2, 3, 4, 5 and 6: “The validity of this Certificate of Conformity is linked to the performance of
maintenance assessments and treatment of possible non-conformities in accordance with the OCP guidelines provided for in the
specific RAC. To verify the updated regularity status of this Certificate of Conformity, the Inmetro database of certified products and
services must be consulted”.
6.2.6.3.1 The Certificate of Conformity, as a formal instrument issued by the OCP, must contain at least:
a) Numbering of the certificate of conformity;
b) Corporate name, National Registry of Legal Entities (CNPJ), full address and, when applicable, trade name of the Supplier
requesting certification (certificate holder);
c) Company name, full address and, when applicable, trade name of the manufacturer;
d) Name, address, accreditation registration number and signature of the person responsible for the OCP;
e) Date of issue and date of validity (except Model 1a and 1b) of the Certificate of Conformity;
f) Certification model adopted;
g) Identification of the certified product model, in the case of certification by model, including the list of all brands sold;
h) Identification of the certified product family and all models covered, in the case of certification by family, including the list of all
brands sold;
i) Identification of manufacturing batch(es) (mandatory in the case of certification using Model 1b);
j) Identification of the Import License number (LI or LPCO) in the case of certification using Model 1b;
k) Scopes of service, when it comes to service certification;
l) RAC Ordinance based on which the certificate was issued (scope of certification) and its supplement(s), where applicable;
m) Numbering of the Bar Code of the models provided for in “g” or “h”, and all versions, when existing in the GTIN – Global Trade
Item Number standard;
n) Number and date of issue of the test report(s), as well as identification of the issuing laboratory; and
o) Date of the audit, applicable to Models 5 and 6.
Note 1: A certificate must be issued for each certified family, in the case of certification by family, or for each certified model, in the
case of certification by model.
Note 2: Any additional items required for issuing the Certificate of Conformity must be listed in the specific RAC.
Note 3: For the purposes of the provisions of paragraph l), the complementary ordinance(s) that amend(s) RAC requirements and
lead to scope adjustment with Inmetro/Cgcre must be considered.
6.2.6.3.2 The OCP must observe the additional criteria for issuing the certificate established in Annex C of this RGCP.
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6.3 Maintenance Assessment
After the Certificate of Conformity is granted, the Certification control is carried out by the OCP, to verify whether the technical-
organizational conditions that gave rise to the initial granting of the certification continue to be met.
The maintenance assessment must be scheduled by the OCP, according to the frequency and criteria established in the specific RAC
for the object in question. The deadlines must be counted from the date of issue of the certificate. All steps must be completed by the
deadlines defined in the specific RAC for the object.
Note 1: The frequency of maintenance audits and maintenance tests may be fixed or variable, as defined in the RAC.
Note 2: Variable frequency allows for an increase in the time interval between audits and/or maintenance tests. The increase in
spacing is solely linked to the non-identification of non-conformities. If non-conformities are found, the spacing is reduced, and a new
cycle is restarted. The opposite occurs when no non-conformities are identified. The RAC defines whether or not variable frequency
should be applied.
Note 3: The presence of non-conformities with subsequent treatment does not give rise to the application of the increase in the time
interval between two maintenance operations, as provided for in maintenance with variable frequency.
It is up to the OCP to formally request the certificate holder to inform any changes to the project, descriptive report or production
process.
In the case of certification by family, the inclusion of a new model in the certified family may be done, at any time, in the same
certificate, maintaining the original validity of the certificate issued, which must contain information on the date of inclusion of the new
model(s).
In cases where the same certificate holder wishes to certify a new family (in the case of certification by family) or a new model (in the
case of certification by model), the OCP must conduct a new certification process starting from 6.2. The QMS audit may be waived,
at the OCP's discretion, if the new families or models to be included come from the same production process that has already been
audited previously to certify other families or models from the same manufacturing unit. In this case, the OCP must record the reason
for waiving the QMS audit, documenting the correspondence of the requirements previously audited in the same production process.
6.3.1 Quality Management System Maintenance Audit and Production Process Assessment
6.3.1.1 The OCP must schedule periodic maintenance audits in the manufacturer's or service provider's production process, covering
at least the following steps:
a) verification of the originals of the documentation provided for in item 6.2.1, in particular as to their availability, organization and
recovery, and
b) analysis of records, especially those related to compliance with the requirements set out in Tables 2 and 3.
6.3.1.2 The date of the maintenance audit visit must be scheduled in mutual agreement with the Supplier requesting certification.
However, when explicitly defined by Inmetro/Dconf, the OCP must perform the maintenance audit or extraordinary audits without prior
notice.
6.3.1.3 If the supplier holding the certification presents a QMS Certificate within its validity period, the OCP may, under its analysis
and responsibility, choose not to evaluate the QMS provided for in this RGCP during the maintenance evaluation stage. The Certificate
must have been issued by a
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CAO accredited by Inmetro or member of the IAF MLA, for the scope of accreditation and according to the current edition of ISO
9001 Standard (and its translations) or ABNT NBR ISO 9001 Standard. The certification must be valid for the production process in
the manufacturing unit of the object to be certified. In this case, the supplier must make available to the CAO all documents
corresponding to this certification and present the records of the production process clearly identifying the object of certification.
The CAO must analyze the relevant documentation to ensure that the requirements described in Table 2, subitem 6.2.3.1 were met
for the QMS. 6.3.1.3.1 It is the supplier's responsibility to ensure that the Quality Management System, certified based on the
current edition of ISO 9001 Standard (and its translations) or ABNT NBR
ISO 9001 Standard, is executed and applied considering compliance with the specific Conformity Assessment Requirements of the
object.
6.3.2 Maintenance Test Plan
Maintenance tests must prove continued compliance, after the initial assessment, with the requirements set out in the specific RAC
for the object.
In the same way as in the Initial Assessment, the OCP is responsible for preparing the Test Plan, which must contain, at a minimum,
maintenance tests, test methods, sampling, acceptance/rejection criteria and periodicity, in accordance with what is established in
the specific RAC for the object.
The OCP must require that laboratories report the measurement uncertainties used in their test reports.
The Test Plan must be planned so that, during maintenance, there is rotation of models in the family, when certification is by family.
6.3.2.1 Definition of tests to be performed
The tests must comply with the criteria established in subitem 6.2.4.1 of this document.
6.3.2.2 Definition of maintenance sampling
The criteria established in subitem 6.2.4.2 of this document must be observed.
6.3.2.2.1 For certification models 2, 4 and 5, in the sample collection/purchase phase, for both national and imported products, to
carry out maintenance tests, the OCP must, mandatorily, collect/purchase them from the trade.
6.3.2.2.1.1 The shipping area of the manufacturing unit or distribution centers may be considered commerce, provided that the
product is already in the final packaging for sale to the consumer, in a condition to have the invoice issued.
6.3.2.2.1.1.1 Collection in the shipping area of the manufacturing unit or distribution centers may only be carried out by the OCP
without prior notice, and may not be carried out during the audit period in the case of certification model 5.
6.3.2.2.2 The collection for carrying out maintenance tests must be carried out by the OCP on samples that were manufactured
between the date of issue of the certificate and the first maintenance assessment. Afterwards, the collection must occur on samples
of the product manufactured in the interval between two sequential maintenances or between the last maintenance and recertification.
6.3.2.3 Laboratory definition
The guidelines described in subitem 6.2.4.3 of this document must be observed.
6.3.3 Treatment of non-conformities in the Maintenance Assessment stage
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6.3.3.1 If any non-conformity is identified during the maintenance assessment, the certificate holder is responsible for critically
analyzing the causes of the non-conformities, as well as proposing corrective actions.
6.3.3.2 The certificate holder must send the corrective action plan to the OCP within a maximum period of 15 (fifteen) calendar days,
which must have a maximum period of 60 (sixty) calendar days to demonstrate the implementation of corrective actions.
6.3.3.3 The certificate holder must take immediate control actions at the factory to prevent the model/family that failed the
maintenance test from being sent to the market.
6.3.3.4 The OCP must evaluate the effectiveness of the corrective actions proposed in the plan, as well as whether they were
implemented.
6.3.3.5 It is up to the OCP to assess the need to conduct a new audit to verify the implementation of corrective actions and/or the
performance of new tests.
6.3.3.6 Failure to submit the corrective action plan within the deadline set out in 6.3.3.2 or the identification of any non-conformity
without evidence of treatment will result in the immediate suspension of the Certificate of Conformity for the non-conforming model/
family. The OCP must notify the certificate holder in writing, informing that it may only resume the certification process when the non-
conformities found have been remedied.
6.3.3.6.1 In the case of certification by model, if the non-conformity demonstrated compromises other models already certified, the
suspension of certification may be extended to these models, at the discretion of the OCP.
6.3.3.6.2 In the case of certification by family, if non-compliance is evidenced in one of the models in the family, the suspension of
certification applies to all models that make up the family and may be extended to other families, at the discretion of the OCP.
6.3.3.7 The certificate holder must submit the corrective action plan within 15 (fifteen) calendar days from the suspension of its
certification. The certification becomes effective again when the corrective actions are considered effective by the OCP. The
effectiveness of the corrective actions must be confirmed by means of tests, audits and/or document analysis, at the discretion of
the OCP.
6.3.3.8 New deadlines may be agreed upon provided they are formally requested by the certificate holder, justified, and their
relevance is assessed by the OCP.
6.3.3.9 If the certificate holder does not meet the established deadlines, and provided that no new deadline has been agreed, the
certification will be cancelled.
6.3.3.10 In case of refusal by the certificate holder to implement corrective actions, the OCP must cancel the Certificate of Conformity
for the certified product model(s)/family(ies) and formally notify Inmetro.
6.3.3.11 In the event that the product cannot be collected as determined in subitem 6.3.2.2.1, the certificate must be suspended
until the end of its validity period.
6.3.3.12 In the event of non-conformity(ies) that may put the user's health or safety at risk, the OCP must suspend the Certificate of
Conformity, regardless of the deadlines provided for the proposal of corrective actions by the supplier holding the certification, for
the period necessary to correct the production process, respecting the limit of the certificate's validity.
6.3.4 Maintenance Confirmation
The OCP must issue confirmation of maintenance after critical analysis, covering information on documentation, audits, tests,
treatment of non-conformities, monitoring in
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market and complaints handling, observing the relevant requirements of subitem 6.2.6, that maintenance of compliance with the
requirements has been demonstrated.
Once the requirements set out in this RGCP and in the specific RAC for the product have been met, the OCP issues the document
called “Maintenance Confirmation”, formalizing that the certification is maintained.
6.3.4.1 The Maintenance Confirmation, as a formal instrument issued by the OCP, must contain at least:
a) Reference to the certificate of conformity being maintained;
b) Corporate name, National Registry of Legal Entities (CNPJ), full address and, when applicable, trade name of the certificate holder;
c) Name, address, accreditation registration number and signature of the person responsible for the OCP;
d) Date of issue of the Maintenance Confirmation;
e) Certification model adopted;
f) Identification of the certified model, in the case of certification by model, including the list of all brands sold;
g) Identification of the certified family and all models covered, in the case of certification by family, including the list of all brands sold;
h) Scopes of service, when it concerns service certification;
i) RAC Ordinance based on which the certificate was issued (certification scope) and its supplement(s), if any;
j) Bar Code Numbering of the models listed in “f” or “g”, and all versions, when existing in the GTIN – Global Trade Item Number
standard;
k) Number and date of issue of the maintenance test report(s), as well as identification of the issuing laboratory;
l) Date of the audit, applicable to Models 5 and 6;
m) Date of the next maintenance assessment, in the case of maintenance assessment with variable frequency, depending on whether
or not non-conformities were found in the audit and in the tests carried out in accordance with the specific RAC of the object.
Note: For the purposes of the provisions of paragraph k), the complementary ordinance(s) that change RAC requirements and give
rise to scope adjustment with Inmetro/Cgcre must be considered.
6.3.4.2 The OCP must observe the additional criteria for issuing the Maintenance Confirmation established in Annex C of this RGCP.
6.4 Recertification Assessment
The recertification assessment must be scheduled by the OCP, in accordance with the criteria established in subitem 6.2 of this
document and in the specific RAC of the object, except for the Non-Conformity Treatment stage, which must follow the provisions of
6.3.
If the specific RAC provides for maintenance assessment with variable frequency, the OCP must, upon recertification, continue with
the spacing practiced from the last assessment carried out, depending on whether or not there are non-conformities.
The collection for carrying out the tests must be carried out by the OCP on samples that were manufactured between the date of the
last maintenance and the date of recertification.
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The OCP, after critical analysis, covering information on documentation, audits, tests, treatment of non-conformities, market
monitoring and treatment of complaints, decides on recertification.
Once the requirements set out in this RGCP and the specific RAC for the product have been met, the OCP issues the new Certificate
of Conformity.
A certificate, with a distinct number, must be issued by the OCP for each model or for each family, at each recertification.
Note: Any additional items required for issuing the new Certificate of Conformity are described in the specific RAC for the object.
6.5 Special Cases
6.5.1 The certification of products subject to multiple certification (hybrid product) must consider all functions of use subject to
compulsory certification, that is, all functions subject to certification must be certified (initial assessment, maintenance and
recertification) simultaneously, even if conducted in different certification processes. If the certification process is conducted by a
single OCP, it must be accredited for both scopes subject to certification. Tests and test methods common to both regulations may
be performed only once.
The hybrid product must bear only one Conformity Identification Seal.
Note: For the purposes of this RGCP, a hybrid product is characterized as a single, non-decoupable product, designed to perform
the function of two or more products subject to compulsory certification.
6.5.2 If, after the certificate has been granted, an ordinance is published to improve the Conformity Assessment Requirements, with
the provision for revocation of the current RAC, the OCP must conduct a new certification process, with the issuance of a new
certificate. Certificates issued after the publication of the ordinance to improve the Conformity Assessment Requirements, still based
on the current RAC, will have their validity linked to the first adaptation period provided for in the most recently published ordinance.
6.5.2.1 The new certification process, based on the new published Requirements, must be initiated from 6.2 and completed by the deadline
for adaptation for manufacturing and import, defined in the new Ordinance.
6.5.2.2 After completion of the new certification process, the OCP must issue a new certificate, with a new number.
7. COMPLAINTS HANDLING
The complaints handling described in this document applies to the Supplier requesting certification and the OCP.
7.1 The complaints handling process must include:
a) A system for handling complaints, signed by the person formally designated for this purpose, which demonstrates that the Supplier
requesting certification and the OCP:
- They value and effectively deal with complaints submitted;
- They are aware of and undertake to comply with and be subject to the penalties provided for in the laws, specifically in
Law No. 8078/1990;
- Critically analyze the results, as well as take the necessary measures, based on the complaints received;
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- Define responsibilities regarding the handling of complaints;
- They undertake to respond to any complaint to Inmetro within 15 (fifteen) days

run; and
- They undertake to respond to the complainant regarding the receipt, treatment and
conclusion of the complaint, in accordance with internally established deadlines.
b) A system for handling complaints containing a record of each complaint, the treatment given and the current
stage;
c) The formal indication of a person or team, duly trained and with freedom to handle complaints; and
d) Telephone number or other means for handling complaints and complaint registration form, which includes a
code or protocol number provided to the consumer for follow-up.
7.2 The Supplier requesting certification and the OCP must also carry out an annual critical analysis of the
complaints received and evidence of the implementation of the corresponding corrective actions, as well as
opportunities for improvement, recording their results.
7.3 It is mandatory that, regardless of the certification model adopted, the OCP must audit all locations (owned by
the certification applicant or directly outsourced by the applicant) where the Complaints Handling activity is carried
out, to verify compliance with the requirements previously established, in the initial, maintenance and recertification
assessments, when applicable.
7.3.1 In cases where the certification applicant proves its status as a micro and small enterprise – MPE, the audit is
optional, and it is up to the OCP to carry it out.
8. ACTIVITIES PERFORMED BY OCP ACCREDITED BY MEMBER OF IAF MLA
8.1 Conformity assessment activities performed by a body accredited by an IAF MLA member may be accepted,
provided that all of the following conditions are met:
a) The organization must have an MoU with a Brazilian OCP accredited by Inmetro/Cgcre;
b) The organization must be accredited by the same international rules adopted by Inmetro, that is, accredited by a
signatory member of the IAF MLA, for the same or equivalent scope;
c) The activities carried out by the OCP must be equivalent to those regulated by Inmetro;
d) There is no restriction by the Regulatory Authority on the object submitted for certification.
8.2 The MoU will be subject to verification in the periodic accreditation assessments carried out by Inmetro/Cgcre
and must provide for, at least, the conditions below:
a) The parties must agree to keep the signatories informed about any change in their accreditation status in the
country of origin;
b) The parties must agree which documents in the certification process, issued in a language other than English or
Spanish, must be accompanied by a sworn translation into Portuguese;
c) The parties must make clear the activities that are covered by the MoU, such as audit, test plan, evaluation of
test reports, evaluation of audit report.
8.3 The body legally established in the country and accredited by Inmetro/Cgcre will be responsible for the
assessment and issuance of the certificate in accordance with Brazilian regulations, assuming all responsibilities for
the activities carried out abroad and resulting from this issuance, as if it had conducted them itself.
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8.4 Foreign organizations accredited by Inmetro/Cgcre in the specific scope may conduct certification processes within the scope of
the specific RAC for the object, provided that they are legally established in Brazil. In this case, all documentation of the certification
process must be available in Brazil and in Portuguese, observing the exceptions provided for in 6.2.1.2 “e” and in the note to subitem
6.2.3.2.
8.4.1 A foreign organization legally established in Brazil, accredited by Inmetro/Cgcre in the specific scope, is understood to be one
that has technically competent personnel, based in Brazil, has a physical structure in the national territory, demonstrates easy access
to the certification process and meets the legal documentation requirements required by Brazil for the incorporation of a company,
such as CNPJ and articles of association.
9. TRANSFER OF CERTIFICATION
9.1 The transfer of valid certificates, issued in accordance with the provisions of the specific RAC, from an issuing OCP to a receiving
OCP, is permitted and may be motivated by the issuing OCP or by the certificate holder.
9.2 The receiving OCP must be legally established in the country and accredited by Inmetro/Cgcre.
9.3 Each OCP must include in its contracts with its clients the availability to provide the necessary information to another OCP, upon
transfer of a certificate issued by it, still valid, and considering the provisions of 9.1 of this RGCP.
9.4 A qualified person from the receiving OCP shall conduct a critical analysis of the new client's certification process. This critical
analysis shall be conducted by examining documentation/records and/or visiting the manufacturer or service provider, and shall be
duly recorded. The critical analysis shall cover, at a minimum, the following aspects:
a) The process steps carried out to date and the situation at the current process stage
certification;
b) Test reports;
c) Plan of tests carried out, correlating with the family or model;
d) Reasons for the transfer request;
e) Validity of the certificate, with regard to authenticity and duration, covering the scope
object of transfer;
f) Validity of certification and situation of non-compliance(s) still pending correction(s).

This verification should preferably be carried out in conjunction with the issuing OCP, unless it has ceased its activities;
g) Report(s) of the last audit (certification, maintenance and recertification) and of the
extraordinary, and any non-compliance not yet remedied;
h) Complaint(s)/appeal(s) received and action(s) taken; and
i) The current stage of certification.
9.5 Suspended, cancelled or expired certificates cannot be accepted for transfer purposes.
9.6 If pending nonconformities or potential risks are identified in the prior critical analysis, or when there are doubts as to the
adequacy of the existing certification, the receiving OCP must, depending on the extent of the doubt:
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a) Not accept the transfer process and start a new certification process; or,
b) Accept the transfer process after demonstrating, through audit or testing, that the original certification can be maintained.
The decision regarding the required actions will depend on the nature and extent of the non-conformities found and must be
recorded and explained to the certificate holder.
9.7 If no pending nonconformities or potential risks are identified in the prior critical analysis, the receiving OCP must accept the
transfer of certification.
9.8 Once the transfer has been accepted, the receiving OCP will issue a new certificate, dated from the end of the critical analysis
and with the remaining validity period in relation to the original certificate, and considering all the items provided for in 6.2.6 of this
RGCP.
9.8.1 The new certificate of conformity issued must also mention that it refers to a certification transfer process, indicating the
issuing Body, the number of the transferred certificate and the date of transfer.
9.8.2 The issuing OCP shall only cancel the Certificate of Conformity when the receiving OCP issues the new Certificate of Conformity
with the remaining validity.
9.9 The next maintenance assessment or recertification must occur in accordance with the criteria established in the specific RAC
for the object and be carried out within the deadlines set out in the original certification process carried out by the issuing OCP.
9.10 The receiving OCP must maintain all documentation and records relating to the transfer of certification for the period
determined in its quality management system.
10. CERTIFICATION CLOSURE
Certification will be terminated in cases where the manufacturing/importation of products or service provision activities, compulsorily
certified, or at the option of the certificate holder in the case of voluntary certifications, ceases.
The OCP must ensure that objects certified prior to this decision comply with the object-specific RAC.
10.1 The OCP must schedule an extraordinary audit to verify and record the following requirements:
a) date of manufacture and size of the last batches of the certified object;
b) material available in stock;
c) quantity of finished product in stock and forecast for this batch to be distributed;
d) compliance with the requirements set out in the specific RAC for the object since the last monitoring audit;
e) routine tests carried out on the last batches produced;
f) stock of purchased stamps.
10.1.1 In the case of imported products, the closing audit must be carried out at the premises of the certification applicant to verify:
the date of the last import and size of the last imported batches; the quantity of finished product in stock (at the certification applicant
and/or importer) and the forecast for this batch to be distributed; compliance with the requirements set forth in the specific RAC for
the object since the last monitoring audit; routine tests carried out by the manufacturer on the last batches produced.
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10.2 When deemed necessary, the OCP may also schedule the collection of samples and the carrying out of
tests to assess the conformity of products in stock.
10.2.1 In the case of imported products, if there has been no import in the period between the initial certification
or last maintenance and the request for closure, as evidenced in the audit referred to in 10.1.1, tests to verify
the conformity of the products in stock at the importer are not applicable.
10.3 If the results of these tests show any non-conformity, the OCP, before considering the process closed,
requests the certificate holder to take the relevant action, defining the provisions and implementation deadlines.
10.4 In the event of non-compliant products occurring on the market, before considering the process closed,
and depending on the compromise that the identified non-compliance may impose on the use of the product, the
OCP must notify Inmetro of the cancellation of the certificate with the recommendation to withdraw the product
from the market.
10.5 From the end of compulsory certification, the product may no longer be manufactured or imported, and the
distribution and marketing of stock produced within the validity period of the certification is strictly permitted.
Likewise, the end of compulsory service certification implies the prohibition of the provision of services.
10.6 Once the above steps have been completed, the OCP must cancel the certificate, update the database of certified products and services
made available by Inmetro, and notify Inmetro/Dconf of the termination by issuing a document containing the information provided for in
subitem 10.1.
10.7 If the certificate holder does not allow the OCP to comply with requirements 10.1 to 10.5 above, the OCP
must cancel the certificate, update the database of certified products and services made available by Inmetro,
as well as notify Inmetro/Dconf of the termination, justifying the aforementioned impediment.
10.8 In the case of products subject to Object Registration, the supplier must request the change of its
registration to the “inactive” condition, in accordance with Inmetro Ordinance No. 258 of 2020, or a replacement,
after the certification termination process has been completed.
11. COMPLIANCE IDENTIFICATION SEAL
The purpose of the Conformity Identification Seal is to identify that the object of certification has been subjected
to the conformity assessment process and meets the requirements contained in this document and in its
respective RAC.
11.1 The model, characteristics, traceability and methods of affixing the Conformity Identification Seal will be
defined in the specific RAC of the object, in compliance with the provisions contained in Inmetro Ordinance No.
274 of 2014.
11.2 The Conformity Identification Seal may be printed on the Certificate of Conformity, marked or affixed to the
product and/or printed or affixed to the packaging, in accordance with the specific RAC of the object.
11.3 In the case of imported products, with the exception of those certified by Model 1b, the Conformity
Identification Seal must be marked or affixed to the product and/or printed or affixed to the packaging, in
accordance with the specific RAC of the object, before it enters the country.
12. AUTHORIZATION FOR USE OF THE COMPLIANCE IDENTIFICATION SEAL

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Authorization to use the Conformity Identification Seal is granted after all the requirements set out in this document
and in the specific RAC for the object have been met.
12.1 For certified products subject to Object Registration, authorization for the use of the Conformity Identification
Seal and the marketing of the product or provision of the service are subject to obtaining Object Registration.
12.2 In other cases, authorization is granted when the product complies with the criteria established in this
document and in the specific RAC for the object, with Registration by Inmetro being waived.
12.3 The authorization, whether for a product eligible for registration or not, will have its validity linked to the validity
of the certification and on the condition that it is not suspended or cancelled.
12.4 References to characteristics not included in the referenced normative base, contained in the instructions for
use or information to the user, cannot be associated with the Authorization for Use of the Conformity Identification
Seal or induce the user to believe that such characteristics are covered by the Certification process.
13. RESPONSIBILITIES AND OBLIGATIONS
13.1 Obligations of the Certificate Holder
13.1.1 Only provide services or produce, import and market products subject to certification that are in accordance with the specific
RAC of the object, which is evidenced through the Certificate of Conformity.
13.1.2 Comply with all conditions established in this document, in the specific RAC for the object in question, in the
legal provisions and in the contractual provisions relating to the authorization, regardless of their transcription.
13.1.3 Apply the Conformity Identification Seal to all certified products, in accordance with the criteria established
in this document and in the specific RAC for the object.
13.1.4 Comply with decisions relating to Certification taken by the OCP, appealing to Inmetro, in cases of complaints
and appeals, via the Inmetro Ombudsman.
13.1.5 Provide the OCP or its contractor, upon proof of this condition, with auditing and monitoring work, as well as
carrying out tests and other Certification activities provided for in this document and in the specific RAC for the
object.
13.1.6 Maintain the technical-organizational conditions that served as a basis for obtaining the certificate of
conformity, informing the OCP in advance of any modification that is intended to be made to the product for which
the said certificate was granted.
13.1.7 Immediately notify the OCP in the event of definitively ceasing the provision of the service or the manufacture
or import of the certified product.
13.1.8 Do not use the same coding (commercial name) for a certified product and a non-certified product.
13.1.9 Submit to Inmetro, for authorization, all promotional material that features the Conformity Identification Seal.
13.1.10 Reimburse the OCP for costs arising from market monitoring actions determined by Inmetro, as provided
for in item 14 of this RGCP.
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13.1.11 Notify Inmetro, within 48 hours, when identifying that the certified object placed on the market presents non-conformities that
put the health and safety of the consumer and the environment at risk.
13.1.12 Respond to notifications from Inmetro, within the established deadlines, requesting clarifications related to the investigation
processes of non-conformities detected in the certified object.
13.1.13 Provide Inmetro with all the information requested by it, regarding the certification process of the product subject to the RAC,
forwarding, when necessary and requested, supporting documents.
13.1.14 Present to the OCP the process that will be used to disseminate information, in a systematic manner, to all its customers,
about the adaptation period for the trade to make its products available without the Conformity Identification Seal, while this period
lasts.
13.1.15 Consider the deadlines given by the OCP, the testing laboratory and Inmetro to timely submit Maintenance and Recertification
Assessments.
13.1.16 Inform the OCP, at any time, of any change in the design, descriptive report or production process of the certified object.
13.1.17 In the event of cancellation of the OCP issuing the certificate, migrate to another OCP no later than the deadline for carrying
out the next maintenance or recertification, whichever occurs first.
13.2 OCP Obligations
13.2.1 Have qualified personnel, keeping records of qualifications and training actions, in order to be able to competently conduct the
entire certification process provided for in the specific RAC for the object.
13.2.2 Carry out product certification in accordance with the requirements established in this document and in the specific RAC for
the object, and must resolve any queries with Inmetro.
13.2.3 Feed and keep updated, within 5 (five) business days, the database of certified products and services provided by Inmetro,
with information related to the certificate, including issuance, scope adaptation, suspension and cancellation, also observing the
conditions established in Annex C of this RGCP.
13.2.4 Notify Inmetro/Dconf within 5 (five) business days of cases of suspension or cancellation of certification, exclusively by
electronic means, to the email docs.registro@inmetro.gov.br, for cases of objects subject to Object Registration with Inmetro, or to
the email divig@inmetro.gov.br, for cases involving objects not subject to Object Registration with Inmetro.
When the suspension or cancellation notice refers to an object whose Requirements

Conformity Assessment have been established by Inmetro by delegation of another regulator, the sending of the communication to
Inmetro/Dconf must be accompanied by evidence that the regulatory body was also notified.
13.2.4.1 The notice of suspension or cancellation of certification must contain, as a minimum:
a) number of the certificate of conformity to which the communication refers;
b) identification of the Scope and Inmetro Ordinance of the RAC (compulsory or voluntary) based on which
the certificate has been issued;
c) occurrence (suspension or cancellation);
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d) model (if certification by model) or product family (if certification by family) covered
by the occurrence;
e) reason for suspension or cancellation (inform the nature of the non-conformity, identification of the failure test,
identification of the compromised batch(es), as well as the need for withdrawal from the market);
e1) In cases of cancellation by transfer, inform the destination OCP and the date of transfer;
e2) In cases of cancellation due to cessation of manufacturing or import, inform the date of the last manufacture
or import of the product;
e3) In cases of cancellation of certification due to abandonment/breach of contract, this condition must be
expressly indicated;
e4) In cases of suspension revocation, which corrective action made such revocation possible;
f) date of the closing audit (in the case of cancellation due to closure);
g) date of suspension or cancellation or revocation of suspension;
h) signature of the OCP signatory.
Note 1: The email must be sent with the “subject” field filled in as follows:
Subject: “type of communication (cancellation or suspension)/Scope/RAC Inmetro Ordinance –

Reason"
Note 2: The reason must be indicated as described below:
Reason Description
I Suspension or cancellation due to failure in tests;
II Suspension or cancellation due to other types of non-conformities not related to
testing;
III Suspension or Cancellation due to abandonment/breach of contract (failure to

comply with the maintenance or recertification stage);
IV Cancellation by OCP transfer;
V Cancellation on request due to cessation of manufacturing/importation;
VI Cancellation due to adaptation to new RAC (expiration of the 1st adaptation
period).
13.2.5 Submit to Inmetro/Cgcre, for analysis and approval of use, the Memoranda of Understanding, within the scope of
this document and the specific RAC, established with other Certification Bodies.
13.2.6 Select, in common agreement with the Supplier requesting certification, the laboratory to be used in the certification
process, based on the requirements established in this document and the specific RAC for the object.
13.2.7 Collect, at any time and hour, as determined by Inmetro, in the face of duly substantiated suspicions or complaints,
samples on the market to carry out tests defined in the specific RAC for the object, following the sampling criteria provided
for, bearing the costs related to the collection and tests, in compliance with the provisions of item 14 of this RGCP.
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13.2.8 Have a Complaints Handling System as provided for in Chapter 7 of this RGCP.
13.2.9 Not have any outstanding debts with Inmetro.
13.2.10 Immediately notify Inmetro, within a maximum period of 48 hours, of any information about recalls, even if preliminary,
i.e., in the investigation phase, provided by companies that have their object certified.
13.2.11 Report to Inmetro/Cgcre the existence of non-conformity detected during an audit of the QMS carried out by a manufacturer
holding an ABNT NBR ISO 9001 or ISO 9001 certificate.
13.2.12 Formally communicate to its customers holding the Authorization for Use of the Conformity Identification Seal any changes
in technical standards and documents issued or recognized by Inmetro that may interfere with the requirements of this RGCP.
13.2.13 The interpretation of the results contained in the test reports issued by the laboratories is the sole responsibility of the OCP.
13.2.14 Require laboratories to report measurement uncertainties inherent in the tests performed.
13.2.15 If the OCP has its accreditation cancelled, it must:
a) Immediately inform your customers of your condition and instruct them in the transition process to another OCP that has active
accreditation, highlighting that certificates already issued will remain valid until the end of the maintenance or renewal periods,
whichever occurs first;
b) Make available, when requested, to Inmetro/Dconf all records and information relating to the certification processes carried out
by it;
c) Make available to its clients all records, certificates, reports and other documents relating to its certification process(es) to
support them when contracting another accredited OCP to continue its certification;
d) Inform Inmetro/Dconf of all actions carried out during the migration process of companies holding certificates with the aim of
avoiding damage to suppliers and consumers;
e) Facilitate the migration of the certification process to another OCP defined by the certification holder.
13.2.16 The canceled OCP cannot carry out maintenance or renewal activities for certificates issued for the Conformity Assessment
Programs established by Inmetro.
13.2.17 The suspended OCP must inform its clients of this condition and, while in this condition, it cannot carry out any initial
certification granting activity nor grant recertifications or extensions of space for current certifications. During the suspension
period, the OCP must carry out all activities related to the maintenance of current certificates, provided that there is no expansion
of their scope.
13.2.18 In the event of cancellation of accreditation by Cgcre/Inmetro, the OCP must cancel the certificates issued on the date of
completion of the migration to the receiving OCP or, if there is no migration, on the date of maintenance or renewal of the certificate
issued, whichever occurs first, as well as update the Prodcert System within 5 (five) days.
13.2.19 Make available, when requested, to Inmetro/Dconf all records and information relating to the certification processes carried
out by the OCP, within a maximum period of 5 (five) business days.
13.2.20 Plan maintenance and recertification activities in order to timely meet the compliance deadlines set out in the regulations
and their updates.
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14. MARKET MONITORING
Certified objects are subject to market monitoring through Inspection, Conformity Verification, Technical Inspection, among other
forms.
14.1 The certificate holder is responsible for replacing samples of the certified object withdrawn from the market by Inmetro or its
delegated bodies, for market monitoring purposes.
14.2 The certificate holder who has the certified object subject to monitoring in the market must provide Inmetro and OCP, when
requested or administratively notified, with all information about the Certification process and the internal production quality
control process, within a maximum period of 5 (five) business days.
14.3 If Inmetro identifies non-conformities in monitoring actions in the market, it will notify the certificate holder and the OCP,
establishing the need for measures and respective
deadlines.
14.4 Non-conformities identified through market monitoring may result in the application of penalties provided for in item 15 of
this RGCP.
14.5 If any non-conformity is found, considered by Inmetro to be systemic or a potential risk to the health and safety of the
consumer or the environment, Inmetro may order the withdrawal of the product from the market.
14.6 Whenever determined by Inmetro, in the event of a duly substantiated complaint, the OCP must receive the samples
collected by Inmetro in the market, at any time and for carrying out tests defined in the specific RAC, following the sampling
criteria provided for. The OCP must forward the samples to the accredited laboratory, defined in conjunction with Inmetro, bearing
the costs related to the tests and, at the end of these, send the test reports to Inmetro. Inmetro may determine that its technicians
monitor the tests performed.
14.7 The collection of samples may, exceptionally and when defined by Inmetro, be carried out by the OCP, which will arrange
for the delivery of the samples to the laboratory. In this case, the OCP will be responsible for the cost of collecting the samples
and sending them to the laboratory, in addition to the costs of the tests.
15. PENALTIES
Failure to comply with the requirements set out in the Ordinances, this document and the specific RAC will result in the suspension
or cancellation of the Certification.
16. COMPLAINTS, REPORTS AND SUGGESTIONS
The Inmetro Ombudsman's Office receives reports, complaints and suggestions through the following channels:
ÿ website: https://www.gov.br/inmetro/pt-br/canais_atendimento/ouvidoria
ÿ Telephone: 0800 285 18 18
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ANNEX A - REQUIREMENTS FOR THE EVALUATION OF NON-ACREDITED LABORATORIES

PRODUCT CERTIFICATION BODIES
1. CONFIDENTIALITY
The laboratory must have documented and implemented procedures to preserve the protection of confidentiality
and integrity of information, considering, at least:
a) Access to files, including computerized files;
b) Restricted access to the laboratory; and
c) The knowledge of laboratory personnel regarding the confidentiality of information.
2. ORGANIZATION
2.1 The laboratory must designate signatories to sign the test reports and have full technical responsibility for their
content.
2.2 The laboratory must have a technical manager and a deputy (whatever the title) with overall responsibility for
its technical operations.
2.3 Where the laboratory is a first party laboratory, the responsibilities of key personnel within the organisation who
have involvement or influence in the laboratory's testing should be defined, in order to identify potential conflicts of
interest.
2.3.1 Organizational arrangements should also be such that departments that have potential conflicts of interest,
such as production, commercial marketing or finance, do not adversely influence the laboratory's compliance with
the requirements of this Annex.
3. MANAGEMENT SYSTEM
3.1 All documents necessary for the correct performance of laboratory activities must be uniquely identified and
contain the date of issue, revision number and authorization for issue.
3.2 All documents necessary for the correct performance of laboratory activities must be up to date and accessible
to its personnel.
3.3 The laboratory must document the duties and responsibilities of the technical manager and technical personnel
involved in the tests, considering, at least, the responsibilities regarding:
a) Carrying out the tests;
b) Planning tests, evaluating results and issuing test reports;
c) The modification, development, characterization and validation of new test methods; and
d) To management activities.
3.4 The laboratory must have identification of authorized signatories (where this concept is appropriate).
3.5 The laboratory must have documented and implemented procedures to obtain traceability of measurements.
3.6 The laboratory must have formalized the scope of its services and arrangements to ensure that it has
appropriate facilities, personnel and resources.
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3.7 The laboratory must have documented and implemented procedures for handling test items.
3.8 The laboratory must have a list of equipment and reference standards used, including their respective
identification.
3.9 The laboratory must have documented and implemented procedures for feedback and corrective action
whenever non-conformities are detected in the tests.
3.10 The laboratory must report the measurement uncertainties inherent in the tests performed.
4. STAFF
4.1 The laboratory must have sufficient personnel with the necessary education, training, technical knowledge
and experience for the assigned functions.
4.2 The laboratory must have procedures for the use of technicians undergoing training, establishing supervision
records for them and creating mechanisms to ensure that their use does not harm the test results.
4.3 The laboratory must have and maintain up-to-date records of all its technical personnel involved in the tests.
These records must include the date of authorization, at least, for:
a) Carry out different types of sampling, when applicable;
b) Carry out different types of tests;
c) Sign the test reports; and
d) Operate different types of equipment.
5. ACCOMMODATIONS AND ENVIRONMENTAL CONDITIONS
5.1 Laboratory accommodations, testing areas, power sources, lighting and ventilation must enable the
appropriate performance of tests.
5.2 The laboratory must have facilities for effective monitoring, control and recording of environmental
conditions, whenever necessary.
5.3 The laboratory must maintain effective separation between neighboring areas when there are incompatible
activities.
5.4 The laboratory must have facilities that allow for safe testing, as well as the PPE required to protect its
personnel.
6. EQUIPMENT AND REFERENCE MATERIALS
6.1 The laboratory must have all the equipment, including the reference materials necessary for the correct
performance of the tests.
6.2 Before performing the test, the laboratory must check whether any item of equipment is showing suspicious
results. If this occurs, the equipment must be taken out of operation, identified as out of use, repaired and
demonstrated by calibration, verification or testing that it has returned to satisfactory operation before being put
back into use.
6.3 Each piece of equipment must be labeled, marked or identified to indicate the calibration status.
This calibration status should indicate the last and next calibration visibly.
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6.4 Each piece of equipment must have a record indicating, as a minimum:
a) Name of equipment;
b) Manufacturer's name, type identification, serial number or other specific identification;
c) Condition of receipt, where appropriate;
d) Copy of the manufacturer's instructions, where appropriate;
e) Dates and results of calibrations and/or verifications and date of the next calibration and/or verification;
f) details of maintenance carried out and planned for the future; and
g) History of each damage, modification or repair.
6.5 Each reference material shall be labeled or otherwise identified to indicate certification or standardization. The
label shall contain, as a minimum:
a) Name of reference material;
b) Responsible for certification or standardization (firm or person);
c) Composition, where appropriate; and
d) Expiration date.
6.5.1 For long-term reference materials, the laboratory must have a record containing the information indicated in
item 6.5.
7. TRACEABILITY OF MEASUREMENTS AND CALIBRATIONS
7.1 The laboratory must have an established program for the calibration, verification and maintenance of its
equipment, in order to ensure the use of calibrated and/or verified equipment, on the date of execution of the tests.
7.2 Calibration certificates for reference standards must be issued by:
a) National metrology laboratories mentioned in 7.2;
b) Calibration laboratories accredited by Inmetro/Cgcre;
c) Laboratories that are part of National Metrology Institutes in other countries, in the following cases:
- When traceability is obtained directly from an institution that holds the primary standard of associated magnitude,
or;
- When the institution participates in interlaboratory comparison programs, together with the
Inmetro/Cgcre, obtaining compatible results;
- Laboratories accredited by Accreditation Bodies in other countries, when there is a mutual recognition or
cooperation agreement between Inmetro/Cgcre and these bodies.
7.3 The certificates of the measuring and testing equipment of a testing laboratory must meet the requirements of
the previous item.
7.4 Reference standards maintained by the laboratory should be used only for calibrations unless it can be demonstrated that their
performance as a reference standard is not invalidated.
8. CALIBRATION AND TEST METHOD
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8.1 All instructions, standards and reference data pertinent to the work of the laboratory must be documented, kept up to date and
readily available to laboratory personnel.
8.2 The laboratory shall use documented procedures and appropriate statistical techniques for sample selection when performing
sampling as part of the test.
8.3 The laboratory shall subject calculations and data transfers to appropriate checks.
8.4 The laboratory must have procedures for the security prevention of computer record data.
9. HANDLING OF ITEMS
9.1 The laboratory must uniquely identify the items to be tested, so that there is no mistake, at any time, as to their identification.
9.2 The laboratory shall have documented procedures and adequate facilities to prevent deterioration or damage to the test item during
storage, handling and preparation of the test item.
10. RECORDS
10.1 The laboratory shall maintain a system of records appropriate to its particular circumstances and shall comply with applicable
regulations, including the recording of all original observations, calculations and resulting data, records and copies of test reports
for a period of at least four years.
10.2 Changes and/or errors in the records must be crossed out, without removing or making the previous writing or note illegible,
and the new note must be recorded next to the previous crossed out note, in a legible manner that does not allow for ambiguous
interpretation and must contain the signature or initials of the person responsible.
10.3 Test data records shall contain, as a minimum:
a) Identification of the laboratory;
b) Sample identification;
c) Identification of the equipment used;
d) Relevant environmental conditions;
e) Measurement result and its uncertainties, where appropriate; and
f) Date and signature of the personnel who carried out the work.
10.4 All computer or calculator printed records, graphs and the like shall be dated, initialed and attached to the measurement
records.
10.5 All records (technical and quality) must be maintained by the laboratory for security and confidentiality.
11. TEST REPORTS
11.1 The results of each test or series of tests performed by the laboratory must be reported accurately, clearly and objectively,
without ambiguity, in a test report and must include all information necessary for the interpretation of the test results, as required by
the method used.
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11.2 The laboratory must record all information necessary for repeating the test and these records must be available
to the customer.
11.3 Every test report shall include at least the following information:
a) Title;
b) Name and address of the laboratory;
c) Unique identification of the report;
d) Name and address of the customer;
e) Unambiguous description and identification of the item tested;
f) Characterization and condition of the item tested;
g) Date of receipt of the item and date of the test;
h) Reference to sampling procedures where relevant;
(i) Any deviations, additions or deletions from the test method and any other information relevant to a specific test,
such as environmental conditions;
j) Measurements, checks and resulting results, supported by tables, graphs, diagrams and photographs;
k) Statement of estimated uncertainty of the test result (where relevant);
l) Signature, title or equivalent identification of personnel responsible for the content of the report and date of issue;
m) Where applicable, a statement that the results refer only to the items tested;
n) Declaration that the report should only be reproduced in full and with the client's approval;
o) Item identification; and
p) Reference to the specification of the standard used.
12. SUPPORT SERVICES AND EXTERNAL SUPPLIES
12.1 The laboratory must maintain records regarding the acquisition of equipment, materials and services, including:
a) Purchase specification;
b) Receiving inspection;
c) Calibration or verification; and
d) Supplier registration.
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ANNEX B – CRITERIA FOR CERTIFICATION OF SETS OF CERTIFIED OBJECTS (KIT) OR

CERTIFICATION TRANSFER
1. OBJECTIVE
This Annex applies in the case of the integrator, packager and/or distributor who replaces or makes modifications to the
original packaging of the already certified product or who changes the form of presentation for marketing of the product
in relation to the original certification process, using or
taking advantage of the product's original certification for subsequent sale to the end consumer.
This annex does not apply to products that have already been certified and that, in addition to having their original
packaging altered, have had their characteristics modified, a condition that will give rise, when authorized by Inmetro, to
a new certification process.
Note 1: For simplicity of the text, integrators, packers and/or distributors who make modifications for repackaging or forming kits
already certified at the source will be referred to here as “packers”.
Note 2: The certification transfer process must be requested for each unit of operation of the packer.
2. DEFINITIONS
2.2.1 Kit Formation
Kit formation is characterized when the packer (assignee) integrates, in the same packaging, two or more already
certified products.
2.2.2 Fractionation
Operation characterized when the packer (assignee) performs a fractionation operation, starting from the bulk packaging
of the product, in addition to changing the display packaging.
3. STEPS OF COMPLIANCE ASSESSMENT
Packers who do not make any changes to the original packaging of already certified products, but who change the way
the product is presented for sale in new packaging will be subject to certification considering all the items below, with the
exception of the Test Plan provided for in this Annex.
Packers who make changes to the original packaging of an already certified product will be subject to certification
considering all the items described below. In this case, the final packaging must contain all mandatory markings provided
for in the specific RAC for the object.
In cases where two or more certified products are integrated into the same package, the OCP responsible for the
certification transfer process must be accredited for at least the scope of the main product. In cases where the products
are similar, and therefore the main product is not clear, the OCP responsible for the certification transfer process must
be accredited in at least one of the scopes that make up the kit.
For the purposes of marking on the packaging of kits containing certified products that have not had their original
packaging altered, the expression “CONTAINS PRODUCTS
REGISTERED WITH INMETRO”.
For kits containing certified products that have had their original packaging altered, the following possibilities are
considered:
a) The main product is clear: in this case, the new packaging must contain the Conformity Identification Seal of the
main product, with the kit's Registration number.
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b) The main product is not clear: in this case, the new packaging must contain the Conformity Identification Seal of the product
for which the OCP is accredited, with the kit's Registration number.
In both situations, the OCP must also evaluate item 7 of this RGCP – Complaints Handling.
3.1 Initial assessment
3.1.1 Request for Certification Repass
The request to be forwarded to the OCP must be accompanied by the following documentation:
a) Address of the packaging unit, Supplier requesting certification;
b) National Registry of Legal Entities – CNPJ, and the company's articles of association containing, in the object, the
description of their activities;
c) Documentation proving compliance with item 7 of the RGCP (Complaints Handling) for
all brands sold;
d) Description of the fractionated product or products that make up the kit;
e) Certified copy(ies) of the Certificate(s) of Conformity of the product submitted for fractionation or of the products that make up the
kit, within their validity period;
f) Private authorization for transfer of certification, signed by the holder(s) of the certificate(s)
of the products mentioned in e);
g) Photographic documentation of the product(s) listed in d): external and internal photos of all sides, detailing labels, logos, notices,
inputs, outputs, activation buttons, when applicable;
h) Design or final artwork of packaging (primary, secondary and/or tertiary);
i) User manual with instructions in Portuguese, when;
j) Authorization for the use of the brand(s), if the packer uses the certification brand(s)
original.
Note: In the event of the occurrence of the provisions of j), it will be up to the OCP to verify the legal qualification of the
authorization instrument and the constitutive act of the owner(s) of the brand(s).
Note: When the user manual is not applicable in the original certification, the OCP must validate and record this information in the
certification process.
3.1.1.1 In the case of a certification transfer process for imported products, it will be necessary to send a copy of the Import License
(LI), together with the certification transfer request.
3.1.1.2 The documents related in subitem 3.1.1 must have their authenticity proven by the OCP, in relation to the original documents.
3.1.2 Analysis of the Request and Documentation Compliance
3.1.2.1 Before starting the certification transfer process, the OCP must analyze the feasibility of fulfilling the request, as well as
verify the documentation submitted. If the request is considered unfeasible, the OCP must formally communicate the reason for the
unfeasibility of fulfilling the request and return all documentation submitted.
3.1.2.2 If any non-conformity is identified in the documentation received, it must be treated in accordance with subitem 6.2.2 of the
RGCP.
3.1.3 Initial Audit of the Management System
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3.1.3.1 After analyzing and approving the request and documentation, the OCP, by agreement with the packer
requesting the transfer of certification, must schedule the initial audit at the packer's unit, assessing in a
complementary manner the requirements of the Quality Management System applicable to the repackaging
processes, in accordance with Table 1, below:
Table 1: QMS verification requirements applicable to the packer based on ISO 9001:2015
or ABNT NBR ISO 9001:2015 Standard
Production and service provision 8.5.2 / 8.5.4
Note: This assessment must occur regardless of whether the packer has a certified quality management system.
3.1.3.2 If, during the audit, the OCP assesses the possibility that the original certified product may have its
compliance affected by the repackaging process, the product must be tested on the items provided for in the
object's RAC.
3.1.3.3 The OCP must issue an audit report, recording the results thereof, with reference to this Annex. The audit
report must be signed by the packer and the OCP. A copy of this report must be made available to the packer.
3.1.4 Initial Packaging Test Plan
The OCP must be responsible for preparing the Test Plan, which must, at a minimum, clearly define the sampling,
the initial tests to be carried out on the packaging of the product subject to the transfer and the acceptance/rejection
criteria for these tests.
If the OCP assesses that the original certified product had its compliance affected by the repackaging process, the
test plan must include all tests provided for the product in the object's RAC.
3.1.4.1 Definition of tests to be performed on the Packaging
3.1.4.1.1 Tests on the packaging must be carried out based on the specific RAC.
3.1.4.1.2 The testing laboratory must keep a photographic record of the evaluation.
3.1.4.2 Packaging Sampling Definition
3.1.4.2.1 For the transfer of certification, the OCP must establish the procedure for collecting samples (proof,
counterproof and witness) from the packaging subject to the transfer certification, in order to enable the tests
provided for in the specific RAC to be carried out.
3.1.4.2.2 The OCP is responsible for collecting samples to perform tests, in accordance with its procedures.
3.1.4.2.3 The OCP must sample all packaging models and forward them to the testing laboratory for analysis in
accordance with the provisions of the RAC.
3.1.4.2.4 The sample for the proof tests must be 2 (two) units of each model of the packaging subject to evaluation.
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3.1.4.2.5 To perform the counter-proof and witness tests, the same sample quantity defined in 3.1.4.2.4 must be repeated.
3.1.4.3 Definition of laboratories for Packaging Testing
Packaging tests must be carried out in laboratories in accordance with the requirements defined in this RGCP and in the specific
RAC.
Note: If the assessment of the packaging provided for in the object's RAC is limited to a visual assessment of the same (checking
markings, instructions and manual), this may be carried out by the OCP.
3.1.4.4 Acceptance and Rejection Criteria for Packaging
3.1.4.4.1 All tested units must demonstrate compliance with the requirements established in the specific RAC for the object.
3.1.4.4.2 If the test tests are approved, the sample is considered approved. If non-conformity is found in the test sample, all tests
must be repeated on the counter-test and witness samples.
a) If non-compliance is found in the counter-test, the sample is considered to have failed;
b) If the counter-test does not show any non-conformity, the control sample must be tested;
c) If the witness shows non-compliance, the sample is considered to have failed;
d) If the witness does not show any non-conformity, the sample is considered approved.
3.1.4.4.3 At the discretion of the Supplier requesting certification, upon formalization to the OCP, the counter-test and witness
samples will not necessarily need to be tested. In this case, there may be no dispute regarding the results obtained in the test sample.
3.1.4.4.4 In case of failure in the tests, the certification re-pass process will be cancelled.
3.1.5 Treatment of non-conformities in the Initial Assessment stage
If any non-conformity is identified in the initial assessment stage, it must be treated in accordance with subitem 6.2.5 of the RGCP.
3.1.6 Issuance of Certificate of Conformity
3.1.6.1 Once all the requirements set out in this Annex have been met, the OCP issues the Certificate of Conformity.
3.1.6.2 The Certificate of Conformity, as a formal instrument issued by the OCP, must contain, as a minimum:
a) Corporate name, full address, trade name and National Registry of Legal Entities (CNPJ) of the packager of the object of the
certification transfer;
b) Date of issue and validity of the Certificate of Conformity;
c) Name, accreditation registration number and signature of the person responsible for the OCP;
d) Certificate number(s), validity and name of the OCP of all products certified in the original process and included in the certification
transfer;
e) Model(s) of the product(s) that make up the kit or fractional packaging;
f) Number, date and identification of the issuer of the packaging test report(s) issued by the laboratory.
Note 1: The Certificate of Conformity must indicate, unequivocally, the operating unit of the packer to which it applies.
35
Note 2: When dealing with a kit, the product description on the certificate must be preceded by the term Kit.
When dealing with the fractionation of bulk product, the product description on the certificate must be preceded by
the term Fraction.
Note 3: The certificate must prominently display the expression Certification Transfer.
3.1.6.3 When the certificate issued is the result of the transfer of more than one original certification, its validity must
be equal to the shortest validity period among the certificates of the products that make up the packaging intended
for the end consumer. When the certificate issued is the result of the transfer of only one original certification, its
validity must be the remaining term in relation to the original certificate.
3.1.6.4 The Certificate must contain the following wording: “The validity of this Certificate is linked to the performance
of maintenance assessments and treatment of possible non-conformities in accordance with the OCP guidelines”.
3.1.6.5 For traceability purposes, the way in which the models are notated in the issued certificate must allow the
corresponding model of the certificate issued to be identified.
3.2 Maintenance Assessment
3.2.1 Maintenance Assessment Planning
3.2.1.1 After granting the Certificate of Conformity, the OCP must plan audits and maintenance tests on the
packaging, aiming to verify whether the technical-organizational conditions that originated the initial granting of the
certification are being maintained.
3.2.1.2 The frequency of the packaging machine maintenance assessment will be 12 (twelve) months.
3.2.1.3 The OCP responsible for the transfer certification must monitor the maintenance validity of each of the kit
components, since the maintenance validity of the certified kit will depend on the certification validity of each of its
components.
3.2.1.4 The OCP certifying the transfer must request that each of the OCPs responsible for certifying each of the
products that make up the kit or product with new packaging be notified in the event of suspension or cancellation
of the original certificate, so that it can take steps to certify the kit or product with new packaging. The reverse case
also applies, i.e., a suspension, recall or cancellation of the kit certificate must be notified to all OCPs of the original
products.
3.2.2 Maintenance Audit
The OCP must schedule maintenance audits in accordance with the provisions of subitem 3.1.3 of this Annex.
3.2.3 Packaging Maintenance Test Plan
The OCP must prepare the packaging maintenance test plan in accordance with the provisions of subitem 3.1.4 of this Annex.
To carry out maintenance tests, the OCP must collect/purchase them from the store, and for each new round of
tests, samples must be collected/purchased from different points of sale.
3.2.4 Treatment of non-conformities in the Maintenance Assessment stage
If any non-conformity is identified during the maintenance assessment stage, it must be treated in accordance with subitem 6.3.3 of
the RGCP.
3.2.5 Maintenance Confirmation
36
The OCP must issue confirmation of maintenance after critical analysis, including information on documentation, audits, tests,
treatment of non-conformities, market monitoring and treatment of complaints, observing the relevant requirements of subitem 3.1.6
of this Annex, that compliance with the requirements has been demonstrated.
The OCP must request the respective Maintenance Confirmation(s) from the original certification OCP for each product submitted to
fractionation or for the products that make up the kit.
Once the requirements set out in this Annex have been met, the OCP issues the document called “Maintenance Confirmation”,
formalizing that the certification is maintained.
3.2.5.1 The Maintenance Confirmation, as a formal instrument issued by the OCP, must contain at least:
a) Corporate name, full address, trade name and National Registry of Legal Entities (CNPJ) of the packager of the object of the
certification transfer;
b) Name, accreditation registration number and signature of the person responsible for the OCP;
c) Certificate number(s), validity and name of the OCP of all products certified in the original process and included in the certification
transfer;
d) Model(s) of the product(s) that make up the kit or fractional packaging;
e) Date of issue and validity of the Certificate of Conformity;
f) Number, date and identification of the issuer of the packaging test report(s) issued by the laboratory; and
g) Date of issue of the Maintenance Confirmation.
Note 1: The Certificate of Conformity must indicate unequivocally the packaging unit to which it applies.
Note 2: When dealing with a kit, the product description on the certificate must be preceded by the term Kit.
When dealing with fractionation of bulk product, the product description on the certificate must be preceded by the term Fraction.
3.3 Recertification Assessment
The recertification assessment must be scheduled by the OCP, in accordance with the criteria established in item 3.1 of this Annex.
3.3.1 Treatment of non-conformities in the Recertification Assessment stage
If any non-conformity is identified during the recertification assessment stage, it must be treated in accordance with subitem 6.3.3 of
the RGCP.
3.3.2 Confirmation of Recertification
Confirmation of recertification by the OCP is based on the decision taken after critical analysis, including information on documentation,
audits, tests, treatment of non-conformities and treatment of complaints, noting that compliance with the requirements has been
demonstrated.
Once the requirements established by this Annex have been met, the OCP issues the new Certificate of Conformity.
A certificate, with a distinct number, must be issued for each recertification.
Note: any additional items required for issuing the new Certificate of Conformity will be described in the RAC.
37
ANNEX TO INMETRO ORDINANCE No. 200/2021
ANNEX C – ADDITIONAL CRITERIA FOR ISSUING CERTIFICATES AND COMPLETING THEM

FROM THE BANK OF CERTIFIED PRODUCTS AND SERVICES - PRODCERT
C.1 The requirements of this Annex are applicable to all product certification processes, conducted based on Conformity
Assessment Requirements governed or not by the RGCP.
C.2 The certificate must identify the model with:
I - its commercial name, as identified in commerce, and commercial reference code(s) of the versions, when present on the product
and/or packaging;
II - related brand(s);
III - technical characteristics defined in the Conformity Assessment Requirements - RAC specific to the object, when applicable to
the product, namely:
a) product identification;
b) raw material;
c) dimensions;
d) textures and/or coatings;
e) parts and/or accessories; and
f) other construction characteristics provided for in the specific RAC for the object.
IV - GTIN (Global Trade Item Number) barcodes , when present on the product, for all versions of the certified models.
Note 1: For the purposes of the provisions of item I, the commercial designation of the model is understood to be the way in which
the product will be identified on the market.
Note 2: For the purposes of the provisions of item IV, in the case of imported products, the bar code of the country of origin is
accepted.
Note 3: If the original barcode is changed in Brazil, without violating the original packaging of the product, both codes, national and
foreign, must be informed on the certificate.
Note 4: In the case of products that are coupled, are part of or are sold together
with another product not subject to certification, the identification of the model in the certificate must consider the function of the
product that is certified, so as not to imply that the product/function not subject to certification is covered by the certificate.
C.3 Model versions of the product cannot appear on the certificate as models.
Note 1: In situations where the Conformity Assessment Requirements - RAC specific to the object do not define technical
characteristics of the model, it will be up to the OCP to distinguish the model from its version(s).
Note 2: The existence of a feature whose presence does not affect the version should be considered as a version.
any of the verifiable technical requirements provided for product evaluation, as established in the specific RAC of the object.
Note 3: The model notation on the certificate must allow identification of the information provided in the
item C.2, distinguishing each model from its versions.
Note 4: Examples of representation of the required notation form are presented in Tables 1 to 4 below.
38
C.4 The date of issue of the certificate is unique and corresponds to the date of its signature.
C.4.1 The validity of the certificate, defined in the specific RAC for the object, must be counted from the date of issue of the certificate.
C.4.2 Changes to the certificate, made between the date of issue and the end of validity, are
considered revisions and do not entail changes in the numbering or coding thereof.
C.4.3 Revisions must be evidenced and justified in the body of the certificate, with the date on which the change was made appearing
as the “revision date” and not as the date of issue.
C.4.4 The Maintenance Assessment does not give rise to the issuance of a new Certificate of Conformity, but rather the “Maintenance
Confirmation” document, as defined in this RGCP.
C.5 The same brand/model, from the same manufacturing unit, cannot appear in more than one active certificate, for the same
certification applicant.
C.6 Product Certification Bodies must complete the ProdCert in accordance with the Manual available at the website link https://
Operation
www4.inmetro.gov.br/sistemas/prodcert, respecting all
node of completing
the rules established for Inmetro, through
the system fields. of
C.6.1 ProdCert is intended for products and services certified exclusively based on mandatory or voluntary Conformity Assessment
Requirements established (published) by Inmetro. The responsibility for feeding the database, including its content, lies with the
accredited Conformity Assessment Bodies.
C.6.2 The information registered in ProdCert must accurately reflect the content of the certificate.
C.6.3 All information required for the certificate, which has corresponding fields in ProdCert, must be completed, including the fields
“Test Laboratory” and “Test Report Number”, which must be updated at each Certification Maintenance Stage.
C.6.4 In the event of there being more than one test report for the respective certification stage, the identification of the laboratories
and test report numbers must be separated by a slash (/) in each specific field required by the system.
C.6.5 In addition to the data of the certification applicant, the data of the product's manufacturing company, whether national or
foreign, must be filled in ProdCert, and the name and address of the manufacturer cannot be omitted.
C.6.6 The ProdCert fields, on the “Product Inclusion” screen, must be filled in considering the following criteria:
I – in the “Brand” field, the product brand must be entered, as described in the certificate;
II – in the “Model” field, the model – commercial name of the certificate must be entered; -, as described in
III – in the “Description” field, the technical description of the model and family must be entered, when applicable, as described in the
certificate.
C.6.7 The same brand/model can only be registered once in the ProdCert System, for the same active certificate and considering
the same manufacturing unit and the same applicant.
certification.
C.6.8 The inclusion of characters that are not part of the model description/designation defined by the supplier is not permitted.
C.6.9 Reviewing the certificate to include/exclude models in the family or changing the description does not result in the registration
of a new certificate in ProdCert.
39
C.6.9.1 Changes must be made to the originally registered certificate, in accordance with the provisions of subitems C.4.2 and C.4.3
of this Annex.
C.7. Compliance with the requirements set out in this Annex is mandatory for all Bodies, considering the certification of objects with
compliance assessed compulsorily or voluntarily by Inmetro.
Table 1
Certification by model* (when commercial reference code exists):
Mark Model (Designation) Description (Description Barcode

Model Commercial Model Technique)
in the way it is identified
node
business)
Daughter
Luxo Baby. Ref. com.: Wooden crib, lacquered, Enter all standard GTIN barcodes,
741147 (white), 1000x650mm, castor with lock (4). when available, for all versions.
741148 (yellow),
841147 (white with hood
and changing table),
841148 (yellow with hood
and changing table).
*Color and presence of accessories constitute, in the example, model versions. Brands and commercial names are fictitious.
Table 2
Certification by model* (when commercial reference code does not exist):
Mark Model (Commercial Description (Description Barcode

Name of the Model) Model Technique)
as it is identified in
the trade)
Sleep Happy Child. Colors Wooden crib, lacquered, Enter all standard GTIN barcodes,
white, blue and pink. 1000x650mm, castor with lock (4). when available, for all versions.
With or without hood and/
or changing table.
*Color and presence of accessories constitute, in the example, model versions. Brands and commercial names are fictitious.
40
Table 3
Certification by family* (when commercial reference code exists):
Mark Model (Commercial Name of Description (Description Barcode

the Model) Model Technique)
in the way trade is identified)
node
Bras Mix List. Ref.com: Disposable plastic cup, polypropylene, 120 mL, standard GTIN bars, when
96325 (50 units), 96321 white, striated. Provide all existing codes, of all versions.
(100 units).
Bras Smooth Mix. Ref.com: 56325 Disposable plastic cup, polypropylene, 120 mL, standard GTIN bars, when
(50 units), 56321 (100 units). colorless, smooth. Provide all existing codes, of all versions.
CopoBrax Mix Liso. Ref.com: 56326 (50 Disposable plastic cup, Enter all polypropylene codes, 120 mL, GTIN standard
units), 56322 (100 units). bars, when colorless, smooth.
existing, of all versions.
*Number of units in the sleeve constitutes, in the example, model version. Brands and commercial names are fictitious.
Table 4
Certification by family* (when commercial reference code does not exist):
Mark Model (Designation) Description (Description Barcode

Model Commercial Model Technique)
as it is
identified node
trade)
Bras Mix List. 50 or 100 units. Disposable plastic cup, polypropylene, 120 mL, standard GTIN bars, when
white, striated. Provide all existing codes, of all versions.
Bras Smooth Mix. 50 or 100 Disposable plastic cup, polypropylene, 120 mL, standard GTIN bars, when
units. colorless, smooth. Provide all existing codes, of all versions.
CopoBrax Mix Liso. 50 or 100 Disposable plastic cup, polypropylene, 120 mL, standard GTIN bars, when
units. colorless, smooth. Provide all existing codes, of all versions.
*Number of units in the sleeve constitutes, in the example, model version. Brands and commercial names are fictitious.
Note: A different table presentation format may be used as long as the information in the “Brand”, “Model” and “Description” fields
is arranged in such a way that the identification of each model and its versions is clear.
41

INMETRO Ordinance #200

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Federal Public Service

ORDINANCE No. 200, OF APRIL 29, 2021

Approves the General Product Certification Requirements

THE PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY -

Subject matter and scope of application

Deadlines and transitional provisions

exclusively in cases of omission, and Annex C.

Fl. 2 of Ordinance No. 200/ Presi, of 04/29/2021

MARCOS HELENO GUERSON JUNIOR

ANNEX TO INMETRO ORDINANCE Nº 200/2021

GENERAL PRODUCT CERTIFICATION REQUIREMENTS - RGCP

1.1 Grouping for certification purposes

ABNT Brazilian Association of Technical Standards

3.1 REFERENCE DOCUMENTS

ABNT NBR ISO 9001:2015 Standard Quality Management Systems – Requirements.

ANNEX TO INMETRO ORDINANCE Nº 200/2021

3.2 COMPLEMENTARY DOCUMENTS

5. COMPLIANCE ASSESSMENT MECHANISM

The Conformity Assessment Mechanism addressed in this document is Certification.

6. STEPS OF COMPLIANCE ASSESSMENT

6.1 Definition of the Certification Model(s) used

6.1.1 Certification Model Steps

Table 1: Certification Model Steps

ANNEX TO INMETRO ORDINANCE Nº 200/2021

System Maintenance Audit

6.2 Initial Assessment

6.2.1 Certification Request

f) User manual with instructions in Portuguese;

ANNEX TO INMETRO ORDINANCE Nº 200/2021

m) Documentation proving compliance with item 7 of this document (Treatment of

6.2.2 Analysis of the Request and Documentation Compliance

ANNEX TO INMETRO ORDINANCE Nº 200/2021

Records of compliance with these requirements must be obtained consistently.

Resources 7.1.5.1 / 7.1.5.2

Documented information 7.5.2 / 7.5.3

Operational planning and control 8.1

Requirements for products and services 8.2.1

Production and service provision 8.5.1 / 8.5.2 / 8.5.3 / 8.5.4/ 8.5.5

Release of products and services 8.6

Control of non-conforming outputs 8.7

Monitoring, measurement, analysis and evaluation 9.1.1

Non-conformity and corrective action 10.2.1 / 10.2.2

ANNEX TO INMETRO ORDINANCE Nº 200/2021

Resources 7.1.5.1 / 7.1.5.2 / 7.1.3

Documented information 7.5.2 / 7.5.3

Operational planning and control 8.1

Requirements for products and services 8.2.1

Production and service provision 8.5.1 / 8.5.2 / 8.5.3 / 8.5.4/ 8.5.5

Release of products and services 8.6

Control of non-conforming outputs 8.7

Internal audit 9.2.1 / 9.2.2

Critical analysis by management 9.3.1 / 9.3.2 / 9.3.3

Non-conformity and corrective action 10.2.1 / 10.2.2

ANNEX TO INMETRO ORDINANCE Nº 200/2021

6.2.4.1 Definition of the Tests to be Performed

6.2.4.2 Sampling Definition

ANNEX TO INMETRO ORDINANCE Nº 200/2021