CIG 021

Factory Inspection
Procedures

PERMANENT DOCUMENT CIG 021

Factory Inspection Procedures

Harmonised Requirements

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FACTORY INSPECTION PROCEDURES

HARMONISED REQUIREMENTS

1. Introduction

This document deals with the factory inspection procedures and tests which Manufacturers
are expected to provide and operate to ensure that all certified products are identical, within
accepted manufacturing tolerances, to the sample against which the product certification was
granted. This document should be taken to represent the minimum acceptable standard.
Compliance with these requirements will be checked during factory inspections.
Pre-Licence inspections shall be announced and arranged with the manufacturer in order
to assure that all persons involved can be available.
Routine inspections are normally un-announced. However in certain cases, it might be
necessary to meet the right contact person. In such circumstances, an inspection visit may
need to be pre-announced. On the other hand, due to a specific situation with a
Manufacturer, an inspection may need to be imperatively carried out un-announced.
It is the Certification Body who has to decide in this respect.
To verify that the conditions for the production of certified products are given to ensure that a
uniform manufacturing can be expected the inspection shall be always conducted and a
complete inspection report PD CIG 023) has to be issued even if there is no production of
certified products at the time of inspection.
All details about the testing, test equipment and calibration are equally important even if there
is no production or there are other products in production.
To verify that the conditions for the production of certified products are given to the effect that
a uniform manufacture can be expected, inspections are to be conducted even in cases
where certified products are not presently in production.

2. Definitions

The terms used in this document have the meanings defined in ISO 9001:2000 except for:

2.1 Factory Location/ Manufacturer's Premises

The location where the final assembly and/or testing of certified products normally takes
place and the Certification Mark is applied.

2.2 Manufacturer

Any manufacturing organisation or person (including subcontractors and outworkers)

responsible for the final assembly, testing and/or marking of products certified by an ECS
member Certification Body.

2.3 Subcontractor

Any manufacturing organisation undertaking the production of any sub-assembly in

accordance with the specific requirements of the Manufacturer of a certified product.

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2.4 Out-Worker

Any person who undertakes work at a place other than the factory location on component
parts supplied by the Manufacturer of the certified product.

2.5 Licence Holder

Any organisation or person who has entered into an agreement with the Certification Body for
the certification of the product.

2.6 Procedure

Specified way to carry out an activity or a process. Procedures can be documented or not.
When a procedure is documented, the term “documented procedure” is frequently used.

2.7 Calibration

Calibration is the process of establishing the relationship between the test and measuring
equipment and reference equipment according to the requirements as given in EN ISO/IEC
17025.
The reference equipment shall have a calibration traceable to (inter)national standards and
documented by a calibration certificate.
(Note: In general calibration is done by accredited laboratories).

2.8 Verification

Verification is the process of establishing the relationship between the test and measuring
equipment and reference equipment where the requirements as given in EN ISO/IEC 17025
are met only partially.
The reference equipment shall have a calibration traceable to (inter)national standards and
documented by a calibration certificate.
(Note: In general verification is done “In-House”).

3. General Arrangements

Factory locations of certified products shall be inspected once per year unless otherwise
indicated in document OD ECS 026 or similar document of individual ECS members’
certification schemes to ensure that the necessary routines and procedures are being
maintained at an acceptable standard. Should inspection prove to be unsatisfactory, the
certification of products may be suspended until such time as the complete production
process has again been found to be satisfactory. However, production under the certification
scheme may, in some cases, be allowed to continue whilst corrective action is taken,
provided adequate written assurances are given by the Licence Holder.
During routine inspections of a Manufacturer's premises/ factory location, sample(s) of
certified products and/or assemblies and components may be selected for re-examination
testing to verify compliance with the relevant standard.
Special inspections may be deemed necessary when a large number of unsatisfactory or
critical findings are found to the extent that conformity of the product with the standard may
be endangered.

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It is the responsibility of the Licence Holder to notify the Certification Body of any change of
factory location of the certified product.

4. Manufacturer's Responsibility

4.1 General Information

It is the Manufacturer's responsibility to ensure that the complete production process of the
certified products continuously complies with the ECS requirements as stated in this
document.
The manufacturer shall exercise adequate control (e.g. by inspection or otherwise) over all
subcontractors and out-workers preparing assemblies or parts which have a safety
implication.
At all stages in the production and control process non-conforming materials, parts and/or
products shall be clearly identified and/or segregated to prevent unauthorised use. The
process by which non-conforming products are to be handled shall be described in a
procedure.
The manufacturer shall maintain appropriate records to demonstrate conformance with the
ECS requirements. These records shall be made available to the Inspector. Records shall be
legible and identifiable to the product and/or test equipment involved and shall be kept for a
time which should be not less than the period between two inspection visits.
At least the following records shall be maintained as far as applicable:
Incoming inspection of components (including Certificates of Conformity)
– Routine Tests
– Product Verification Tests
– Functional checks of test and measuring equipment
– Calibration of test and measuring equipment
– Results of self assessment
– Customer complaints and corrective action
Note: Records stored on computer or microfilm are acceptable

4.2 Verification of purchased components and materials which have a safety implication
on the certified product (Incoming Inspection)

Manufacturers shall ensure that all purchased materials, components and subassemblies
comply with specified requirements. This shall be taken into account when selecting sources
of supply and may involve close liaison on a regular basis with suppliers to such an extent
that the Manufacturer relies on the suppliers’ control procedures. It is the responsibility of the
Manufacturer who undertakes final assembly to ensure that subassemblies completed by
subcontractors or out-workers meet the Quality Plans and/ or relevant safety requirements.
Materials, components and subassemblies which have a safety implication on the finished
product and which are purchased from or prepared by an outside supplier, shall be verified
as complying with the appropriate specification.
Note: Other materials and components may also need to be checked at Incoming Inspection. The
extent of these further checks will vary according to the nature of the item. The method by which the
manufacturer achieves these objectives is not prescribed. Procedures may be required to ensure
compliance with the specifications of components.

If a Manufacturer relies on Certificates of Conformity to underwrite the compliance of

components with their specifications, certificates shall clearly identify the products to which
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they refer, the quantity of items covered, the specification to which the products conform, the
production date and be signed or otherwise systematically issued and dated by the supplier's
inspector or authorised person.
Any non-conforming product, found during incoming inspection shall be clearly identified
and/or segregated in a controlled way to prevent unauthorised use.

4.3 Production Control, Inspection and Routine Tests

Production shall be inspected at appropriate stages of manufacture to ensure that piece-

parts, components, subassemblies, wiring runs, workmanship, etc. are in accordance with
the sample for which certification was granted. Quality Assurance and assembly personnel
shall be adequately briefed on their duties and have readily available up-to-date instructions,
photographs, drawings or samples on all those parts which have a bearing on the safety of
the finished product. The method of inspection adopted by a Manufacturer will obviously
depend on local circumstances and the type of product being manufactured Particular
attention shall be paid to those operations which, in themselves, have a critical bearing on
the safety of the product, for example: the dressing and routing of wiring, the correct location
of a safety controls, that connections are correctly made, clearances are adequate, nuts,
screws and connections are tight, there are no sharps edges that can damage wiring or harm
the user and that any earth bonding is satisfactory.
In addition to the above-mentioned inspections, routine tests may be required. These are line
tests performed on 100 % of the production and are normally carried out at the final stage of
manufacture. These tests shall include such functional tests as are deemed necessary to
ensure that the final product is operating safely. See Annex A for guidance. Normally no
further operations, except for marking and packing, may be carried out after these tests.
Note: In the absence of relevant standards by the Technical Committees covering the subject,
National Certification Bodies’ specifications apply.

It is required that there is evidence that the system of inspection and routine tests is planned
and ensures that the finished product complies with the standard to which it was originally
certified. Records of tests and inspections undertaken shall be maintained.
Any non-conforming product shall be clearly identified and segregated to prevent
unauthorised use, delivery or mixing with conforming products. There shall be a method or
procedure that ensures that repaired and reworked product are re-inspected to the same
requirements as applicable to new produced products.

4.4 Functional Check on Test and Measuring Equipment used for Safety Tests
(Dummy Test)

An operational or functional check shall be conducted at intervals which will allow previous
production to be re-tested if incorrect functioning of the test- and measuring equipment used
for safety (routine) tests is detected.
As a minimum daily checks are recommended at the end of the daily production, for lot
production taking less than a day a check before and after the lot has been produced is
recommended. The operational or functional check can be satisfied by subjecting the test
equipment to pre-determined fault conditions by a simulated failure (dummy). The simulated
failure shall represent the tripping limits used by the manufacturer during testing of the
certified product. The results of all these checks shall be recorded. Operators shall be
instructed on what action is to be taken if a functional test is found to be unsatisfactory. In all
cases subsequent corrective action taken shall be recorded.

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4.5 Products seen in Production during visit - Marking of products

The Certification Mark shall be applied according to the regulations of the Certification Body.
It is the Manufacturer's responsibility to ensure that the Certification Mark is applied only to
products that comply with the requirements.

4.6 Calibration of Safety Test and Measuring Equipment

Test and measuring equipment used for determining the safety of the products being
manufactured shall be calibrated or verified on a regular basis, preferably once per year,
depending on usage and the results of previous measurements. Records of
calibration/verification undertaken on the safety test- and measuring equipment and on
reference equipment owned by the manufacturer shall be kept. The records should include
equipment identification, location, calibration frequency, reference equipment, measured
values, deviation, results, signature and date. The calibration of the reference equipment
used for calibration/verification shall be traceable to National or International Standards. The
test- and measuring equipment shall be provided with a label indicating the next 'calibration
due' date or a similar method providing the same level of information.

4.7 Handling and Storage

Components, materials and sub-assemblies that have been accepted during incoming
inspection shall be properly identified and shall be stored in such a way (environmental
conditions; Electrostatic Discharge (ESD) safe; First In First Out (FIFO) principle) that no
damage and/or reduction of properties can occur.
Finished products shall be stored and handled in such a way as to ensure that they will
continue to comply with the applicable standards.

4.8 Product Verification Tests / Periodic Tests (PVT)

Note: Under the ENEC certification scheme these tests are described as periodic tests.

The tests are carried out by the manufacturer or on its behalf with at least the frequency
indicated and the test results shall be kept at disposal of the inspectors of the Certification
Body.
Product verification tests are in addition to the production line inspection and routine tests
and are performed on samples taken randomly from the production line.
In selecting samples for periodic tests preference should be given to products whose
characteristics are close to the limiting values and to tests relevant for safety considerations
according to the relevant standard.
These tests are performed according the paragraphs of the certification standard to
demonstrate continuous compliance with the certification standard. The tests may be carried
out at a location other than the Manufacturer’s premises, but records with the results shall be
available with the manufacturer and shall also include information about test and measuring
equipment used, including calibration. Product verification tests may be standardised or may
not be required for certain product categories, if the relevant Technical Committee so
decides. See Annex B for guidance.
Note: Unless decided otherwise by the relevant Technical Committee, National Certification Bodies’
specifications apply.

In cases where there are no certification body and/or certification scheme requirements it is
up to the Manufacturer to determine the need, nature and frequency of these tests and the
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sampling rate, taking into account the construction of the product, the nature of the standard,
the results of the original type tests, inspections and routine tests, the quality control and the
quantity of products manufactured. It is the responsibility of the Manufacturer to choose the
appropriate methods. Product verification tests need not to be identical to the type tests
specified in the relevant standard.
For the product verification tests a procedure shall be available. It is the Manufacturer's
responsibility to ensure that appropriate corrective actions are taken in the case that the
results of the product verification tests are found to be unsatisfactory. The actions to be taken
shall also be part of a procedure.
The Inspector or Certification Body's representative will check that the Manufacturer's
obligation is adequately fulfilled.

4.9 Void

4.10 Corrective actions in response to inspector’s evaluation

It is the Manufacturer's responsibility to take corrective action to any unsatisfactory finding

found during the factory inspection. The Certification Body shall be informed about the
corrective actions taken. Depending on the number and the seriousness of the findings the
Certification Body may decide to verify the implementation of the corrective actions during a
special inspection or during the next routine inspection.

4.11 Quality Management System

The Manufacturer is not required to have a certified Quality system. If the Manufacturer has a
Quality System certified by an accredited body according to EN ISO 9001 the inspector shall
verify if the production of the certified products is covered by the scope of the certificate and
if the relevant procedures cover the requirements of this document.
Note: Combined inspections/audits are permitted if the Quality System of the Manufacturer is audited
by the same organisation as the Body carrying out the subjected factory inspection.

4.12 Manufacturer’s self assessment of the manufacturing and control process of certified
products (formerly: Audits of the Quality System)

The Manufacturer shall regularly monitor all procedures used in the manufacturing- and
control process of certified products. This monitoring shall at least include verification that the
procedures, instructions and guidelines are up-to-date and properly applied by personnel
(including the keeping of records). Manufacturer’s procedures shall at least comply with the
requirements as given in this document. The results of the monitoring shall be recorded,
including corrective actions taken. Persons carrying out the monitoring shall preferably be
independent from the production process they are monitoring.

4.13 Void

4.14 Customer complaints

The Manufacturer shall record any technical complaint regarding the certified product. On a
regular basis the Manufacturer shall review whether the complaints received are related to
single errors or system errors. All decisions and corrective actions taken shall be recorded.
The originator of the complaint shall be informed about the handling and the result of the
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complaint.

4.15 Changes to Certified Products

Constructional changes which may affect compliance with the relevant standard shall be
notified, prior to its implementation on certified products, to the issuing Certification Body for
their (prior) approval. The process by which the Licence Holder handles changes to certified
products shall be described in a procedure and/or all personnel involved in the acceptance of
changes shall be aware how changes to certified products are communicated with the
Certification Body.
The Licence Holder is also responsible to inform any Manufacturer of certified products
regarding the details of the certified construction. Documents in which the certified
construction is specified (such as a parts list) shall be available at the Manufacturer’s
premises. It is to be assured that the Manufacturer shall not make changes to the certified
construction (including the application of alternative components) prior to permission of the
Licence Holder.

4.16 Selection and Shipping of Re-Examination Sample(s)

If required by the Certification Body the manufacturer shall assure that re-examination
samples can be selected by the inspector from the production line or from stock. If the re-
examination sample(s) are not transported by the inspector the manufacturer shall assure
that no modifications are made to the sample(s) selected and shall send the samples to the
Certification Body in accordance with the Certification Body’s requirements.

5. Factory Inspection Documents

Manufacturers should be made aware of the report forms and guidance documents used
during ECS Factory Inspections.

5.1 CIG 021: Factory Inspection Procedures - Harmonised Requirements

This document deals with the factory inspection procedures and tests which Manufacturers
are expected to provide and operate to ensure that all certified products are identical, within
accepted manufacturing tolerances, to the sample against which the product certification was
granted.
Annexes:
Annex A: Routine Tests
Annex B: Product Verification Tests / Periodic Tests (PVT)

5.2 CIG 022: Pre-licence Factory Inspection Questionnaire

Section A: To be completed by the Certification Body requesting the visit.

Section B: Before making the Pre-licence Inspection in the factory this section is to be
completed. Part B.1 is to be completed by the Licence Holder; part B.2 is to be
completed by the Manufacturer. The completion should be made in considerable
detail, particularly with reference to paragraphs B.1.4 (if the Licence Holder and
the Manufacturer are not the same) and B.2.5 and B.2.6 (where inspection and
test sampling rates and limits for test parameters are to be given in detail).

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5.3 CIG 023: Factory Inspection Report

This report is completed by the Inspector either during pre-licence inspections or during
routine inspections. Completion of this report during the pre-licence inspection will take into
account the previous information given in PD CIG 022 Section B and this will be compared
with the situation observed in the factory. The intention of completing this report during the
routine inspection is to verify that compliance with the test and quality assurance procedures
continues throughout the period for which the CCA Bodies' Certification is in force.

5.4 CIG 023 Appendix 1: Signature Page

This Appendix shall be used if the PD CIG 023 factory inspection report is completed
electronically and a hand written signature of the inspector and the contact person is
required.

5.5 CIG 023 Appendix 2: Additional Quality System Requirements

for ENEC Agreement

This Appendix is to be used only if all of the following conditions apply to the manufacturer:
– ENEC certified products are manufactured, and
– Compliance with EN ISO 9001 is required, and
There is no certificate, issued by an accredited Body, to demonstrate that the Quality
Management System complies with the requirements of EN ISO 9001

5.6 CIG 024: The Conduct of Factory Inspections

This document has been established in order to provide information and guidance to
Certification Bodies, Inspectors, Manufacturers and Licence Holders on how factory
inspections are conducted.

5.7 Current OSM/FIP Decisions

The inspector shall make reference to current OSM/FIP decisions, if relevant.

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Annex A

ROUTINE TESTS

Product Category Product examples Requirements for common

Certification Marks
The routine test requirements are
contained in the standards listed
below. Note also that there may
be additional requirements from
individual certification bodies.
Components Controls (EN 60730) EN 50344-1:2002
Switches EN 61058:2008 Annex R
Low voltage switchgear EN 60439:1999, Cl. 8.3
(EN 60439)
Plugs/ port. socket outlets IEC 60439-1:2008 incl. Annex A1
Low voltage switchgear EN 60947:2004, Cl. 8
(EN 60947) (EN 60947:2007 Cl. 8.1.3)
Other components CB requirements
Household Appliances All types EN 50106:1997+A1:1998
+A2:2001
Hand Held Motor Operated Hand held electrical tools EN 60144-1:1998 Annex E
Electric Tools Transportable electrical tools EN 60745:2006 Annex N
Battery Powered Tools All types EN 61029-1:2000 Annex ZA
EN 50260:2002 (Annex E)
Insulating and Safety- All types EN 61558-1:2005 (Annex L)
Insulating Transformers
Luminaries All types EN 60598-1:2004 (Annex Q)
Electronic Equipment Audio and video equipment EN 60065: 2002 (Annex N)
Laboratory equipment EN 61010-1:2001 Annex F
Other equipment CB requirements
Information Technology All types EN 50116:2006
Equipment incl. Electrical
Business Equipment
UPS (EN 62040-1-1: 2003) Operator access CB requirements
Restricted access CB requirements
Medical Equipment All types EN 60601:1990 incl. Am. 1,2,12
and 13 Cl. 4.1
(recommendations)
All within ENEC scheme All types For ENEC mark - PD ENEC 303

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Annex B

PRODUCT VERIFICATION TESTS / PERIODIC TESTS (PVT)

Product Category Product examples Requirements for common

Certification Marks
Note that there may be additional
requirements from individual
certification bodies.
Components All types Under consideration by the
relevant Technical Committee
Household Appliances All types None required
As determined by CLC/TC61
Handheld Motor Operated All types Under consideration by the
Tools relevant Technical Committee
Insulating and Safety- All types Under consideration by the
Insulating Transformers relevant Technical Committee
Luminaries All types Under consideration by the
relevant Technical Committee
Electronic Equipment All types Under consideration by the
relevant Technical Committee
Information Technology All types None required
Equipment As determined by CLC/TC74
including Electrical Business
Equipment
Medical Equipment All types Under consideration by the
relevant Technical Committee
Product category Product examples Requirements for other marks
All within ENEC scheme All types For ENEC mark - PD ENEC 303

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