Accreditation Procedure

PJLA offers third-party accreditation services to Conformity Assessment Bodies (CABs) (i.e.
Testing and/or Calibration Laboratories, Reference Material Producers, Field Sampling and
Measurement Organizations, Inspection Bodies and Proficiency Testing Providers). This
procedure outlines PJLA’s general accreditation process and criteria administered to conformity
assessments bodies. Additional SOP-1(s) may be available for specific programs which
shall be followed along with this procedure.

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1.0 INTRODUCTION

1.1 Perry Johnson Laboratory Accreditation, Inc. (PJLA) is a Michigan corporation

wholly owned by Perry Lawrence Johnson ("Stockholder"). Mr. Johnson has no
active management role in the operation of PJLA, and PJLA has no corporate
relationship to Mr. Johnson's other business enterprises.

1.2 PJLA services include assessment and accreditation of conformity assessment

body systems to international, national, regulatory or governmental standards or
program requirements.

2.0 SCOPE

2.1 This procedure covers the scope of the PJLA’s accreditation process. It
conforms to ISO/IEC 17011: 2017 and other national and/or international
standards as applicable. Accreditation criteria not covered in this procedure may
be found in specific accreditation procedural documents.

3.0 DEFINITIONS

3.1 Accreditation Body (PJLA): Authoritative Body that performs accreditation.

3.2 Accredited/Applicant Conformity Assessment Body (CAB): A body that

performs conformity assessment services that can be the object of accreditation.

3.3 Accreditation Certificate of Approval: A formal document or set of documents,

stating that accreditation has been granted for the defined scope

3.4 Assessment: Process undertaken by an accreditation body to assess the

competence of the CAB based on particular standard(s) and/or normative
documents and for a defined scope of accreditation.

3.5 Assessor: Person assigned by an accreditation body to perform, alone or as

part of an assessment team, an assessment of a CAB.

3.6 Preliminary Assessment (Preassessment): An informal assessment carried

out by PJLA to assess a CAB prior to the Initial Accreditation Assessment. The
objective of the preassessment is to identify system gaps so that corrective
actions can be implemented prior to the formal Accreditation Assessment.

3.7 Accreditation/Reassessment: Full System third-party attestation related to a

CAB conveying formal demonstration of its competence to carry out specific
conformity assessments tasks.

3.8 Surveillance Assessment: Set of activities, except reassessment, to monitor

the continued fulfillment by an accredited CAB of requirements for accreditation.

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3.9 Accreditation Symbol: A symbol issued by an accreditation body to be used by

accredited CAB to indicate their accreditation status.

3.10 Registry: Listing of accredited CABs.

4.0 REQUEST FOR ACCREDITATION

4.1 CABs initiate the accreditation process through verbal or written communication
of their interest in PJLA’s services. An application for accreditation is supplied to
the CAB (LF-1) along with additional accreditation system documentation and
information as necessary.

4.2 The applicant completes the (LF-1), which provides PJLA with the initial
information required to commence the accreditation process. This document
elicits from the applicant the following details, among others:

4.2.1 legal company name, address, contact information

4.2.2 description of testing/calibration/RMP/FSMO/Inspection/PTP
performed, including a description of activities performed at the
organization’s facility, customer locations, and in-house calibrations
performed as applicable;
4.2.3 description of equipment used;
4.2.4 description of methods used;
4.2.5 description of premises of facility, number of employees, traveling
employees and work shifts, and;
4.2.6 status of existing system.

4.3 If the (LF-1) is incomplete, it will be rejected and the CAB will be contacted for
further information. No quotation will be generated without having enough
information to determine the appropriate amount of time to spend at the facility,
including information in regard to the CAB’s structure and scope.

4.4 PJLA makes its services available to all CABs regardless of size, structure and
location unless the request is unfeasible to perform (i.e. PJLA does not provide
certain scope of activities, no resources are available within an economy,
government contract restrictions, and dangerous work zones).

4.5 On the basis of the information furnished by the applicant, PJLA provides a
quotation to cover the cost of the accreditation and subsequent surveillance
visits. The required number of assessment man-days is determined by
examining the number and types of activities being performed at fixed locations
and at customer locations, number of sites and number of technicians residing
within the CAB. At no such time, will an initial accreditation assessment be
quoted for less than 1.0 day on-site and .50 day off-site. The quotation may also

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include additional services such as preliminary assessments and on-site training
activities. Applicants are informed that quotations received are based on the
information as detailed in the application and is subject to change if inadequate
or incomplete information was provided.

4.6 Should the applicant wish to proceed, then the applicant signs and returns a copy
of the Agreement for Services bearing an original signature. The receipt by PJLA
of this document is taken as an instruction to proceed in accordance with the
agreement for services and associated procedures. At this stage, the applicant
also provides PJLA with the following:

4.6.1 Written confirmation of preferred dates for the preassessment (if

applicable) and initial accreditation assessment
4.6.2 Payment of the first installment per the Agreement for Services

4.7 If the requirements for accreditation change at any time needing retroactive
implementation, PJLA will ensure that the CAB is notified within a reasonable
timeframe in order for the CAB to successfully complete implementation.

4.8 PJLA reserves the right to amend said Agreement for Services at any time if
significant changes have occurred or unexpected circumstances take place with
the applicant/accredited CAB. This includes but is not limited to: relocation or
modification of premises, ownership change or merger, personnel changes,
equipment changes, changes in main policies or capability to perform the scope
of accreditation. PJLA has the right to request an on-site assessment resulting
from complaints where evidence of conformity is required. Additionally, follow-up
visits may be required in order to confirm CAB’s corrective action implementation
when severe nonconformities are detected during an assessment. It is the
responsibility of the applicant/accredited CAB to inform PJLA of any significant
changes that could impact their accreditation immediately.

4.9 PJLA reserves the right to terminate the relationship with an applicant or
accredited CAB for fraudulent behavior, if the CAB intentionally provides false
information or conceals information.

5.0 ASSESSMENT CONFIRMATION

5.1 Once the agreement for services is finalized PJLA will contact the applicant CAB
to confirm the scope of accreditation and details of the organization as provided
on the application. The scope of assessment will be developed upon confirmation
of the assessment. Any questions or comments derived from the development of
the scope will be submitted to the CAB for clarification. During the same time the
CAB will discuss arrangements for the assessment (assessors, dates and off-site
premises where activities of their scope are being performed as applicable), to
ensure adequate time and an adequate schedule can be developed to perform
the assessment. No Assessor will be assigned or permitted to conduct any

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assessments where they have participated in more than two (2) preliminary
assessments of the accreditation CAB or in any way has given PJLA the
impression that a conflict of interest could occur between the assessor and the
CAB. CABs will be clearly communicated to in regard to the names of the
assessor(s) assigned and provided the opportunity to object any assessor or
group of assessors. In cases, where an assessor arrives at the CAB location and
detects or is informed of a conflict of interest or a potential conflict of interest
between them and the CAB, then they should contact PJLA headquarters
immediately to discuss the issue. If PJLA finds that the assessor is in a position
that imposes a conflict of interest with the CAB, then a new assessor will be
assigned or the assessment will be terminated. At no such time, will PJLA allow
the integrity and impartiality of an assessment to be jeopardized due to conflict of
interests. PJLA appoints a qualified assessment team that includes members
competent to assess the scope of the CAB, including in-house calibration
activities, as applicable. If an assessment team cannot qualify for the scope of
the CAB, then a technical expert will be added to the team to provide the
necessary technical expertise. Assessors and technical expertise will be
evaluated against PJLA’s Personnel Procedure (SOP-2) which includes
guidelines for education, training and work experience requirements.

5.2 CABs will be provided with a readiness review checklist LF-116, which outlines
documentation to be submitted 30 days prior to the on-site assessment.
Documents should be completed to PJLA headquarters and the assessor 30
days prior to the start of the assessment. Failure to submit the required
documents may result in the cancellation of the assessment.

5.3 CABs will be required to sign all assessment confirmation forms prior to each
assessment. Postponement or cancellation of assessments obligates the CAB to
pay cancellation fees as specified in (LF-3), Agreement for Services.

6.0 DOCUMENTATION REVIEW

6.1 Upon receipt of the requested documentation as outlined in the LF-116 readiness
review checklist, the assessor will review the content of the material to ensure
the readiness of the CAB. The lead assessor or team will complete their review
and notify the CAB if any questions arise. Nonconformities may be detected
during this review process and communicated to the CAB prior to or during the
assessment. If the nonconformities are severe, the assessor(s) will recommend
that the assessment be postponed. Any postponement of the assessment, due to
the documentation review, will be communicated to the CAB in writing.

6.2 Once the documentation review is completed and a recommendation is made to

proceed with the on-site assessment, the lead assessor will develop an
assessment plan. This will include specifics to the assessment including but not
limited to: the scope of the CAB, appropriate standard(s) and references,
location(s), dates, start/end times, names of the assigned management
representatives, assessor names with specific identified tasks, confidentiality

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statements and a listing to whom their final report will be distributed to. CABs will
have the opportunity to review the assessment plan at least 14-days prior to the
assessment and may communicate with the lead assessor of any proposed
changes. PJLA headquarters will also retrieve a copy of the plan to review and
approve within a similar timeframe.

7.0 ON-SITE ASSESSMENT CRITERIA

7.1 Assessments are carried out in accordance to ISO 17011:2017 and consist of the
following:

7.1.1 Opening Meeting is conducted with the CAB’s management to

confirm the scope and purpose of the assessment, review the
assessment plan, reporting procedures and criteria for accreditation,
introduce the assessment team and to confirm all relevant details for
the assessment. The assessment team will also request that the CAB
provides them any details in regard to proprietary information within
their organization. They will explain the levels of possible
nonconformities and observations that may or may not be detected
during the visit. All members available at the opening meeting will also
be required to sign an attendance sheet as evidence of their
participation.

7.1.2 A Detailed Examination of the CAB: personnel, document review,

facilities and equipment. The assessment is conducted at all locations
where key activities are performed. Activities performed at field sites
are coordinated between PJLA and the CAB and witnessed as
available. The CAB shall ensure that contracts exist with their
customers to allow for PJLA to witness activities as requested. An
appropriate number of staff is interviewed to ensure the competency
of the CAB to perform activities covered by its desired scope,
including staff performing in-house calibrations that affect the
traceability of calibrations and/or test results. A technical assessment
of the CAB includes the review of: training records, environmental
conditions, equipment, traceability, reports/certification, calibration
records, measurement uncertainty data, records and method
validation criteria and proficiency testing results. The review of the
CAB’s quality management system will also be part of each
assessment. The CAB is obligated to assist the assessment team by
ensuring that all facilities related to the scope of accreditation are
accessible and that an appropriate number of staff members are
made available to interview. Members of the CAB should participate
with the assessment team by clearly communicating with them on
their processes and have the ability to promptly provide supporting
documentation or records for areas being assessed. Any delays by
the CAB and its staff may cause a delay in accreditation. A witness
schedule of the CAB’s scope of activities will be agreed upon between

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the lead assessor and the CAB to ensure all assessment activities are
witnessed over a 6 year period. This will be documented on the LF-
21supplement form and included in each assessment package

7.1.2.1 During the time of the on-site examination assessors will

clearly communicate any nonconformities or observations
detected to the CAB representative. This includes the
following:

7.1.2.1.1 Major: A total absence of a required system

element, or a series of minor nonconformities
which, taken together, indicate a total
breakdown of a required system element.

7.1.2.1.2 Minor: A single lapse in discipline or control.

7.1.2.1.3 Observation: In addition to major and minor

nonconformities, an “observation” is another
class of assessment finding. While not strictly a
“nonconformance”, a finding classified as an
observation indicates that, in the opinion of the
assessor, clarification or investigation is
warranted to ensure the overall effectiveness of
the system being assessed (Corrective action is
not mandatory for observations).

7.1.2.2 If for any reason the assessment team is having difficulty

identifying whether a certain circumstance is or is not
meeting the intent of the standard or PJLA policy then they
may contact PJLA headquarters for clarification.

7.1.3 Closing Meeting is conducted upon completion of the assessment.

This includes a discussion of the CAB’s performance against the
standard being assessed and any nonconformities or observations
detected. The CAB will be provided a copy of all nonconformities and
observations as well as a detailed assessment report (at the closing
meeting or within 24 hours of the closing meeting). A final
recommendation to accredit or/not accredit will be announced during
this time. The assessment team will inform the CAB of the timelines
required for corrective action responses as applicable. The CAB will
be informed of PJLA’s Appeal and Dispute Procedure (SOP-10) in the
case nonconformities cannot be agreed upon. A final review of the
scope will be reviewed and approved between the assessor(s) and
the CAB and an overview of the final accreditation decision and
certificate submission process will be provided. All members involved
with the closing meeting will be asked to sign an attendance sheet as

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evidence of their participation. Nonconformities sited during the visit
will as be required to be signed by the CAB’s management
representative as indication of their acceptance of the finding(s).

8.0 POST ASSESSMENT ACTIVITIES/CORRECTIVE ACTION SUBMISSION

8.1 CABs are required to submit appropriate corrective action responses for all
nonconformities with sufficient objective evidence of closure. Corrective action
responses should provide the assessment team confidence that the
nonconformity has been corrected and contained. Objective evidence for
statements or activities completed due to corrective action taken should coincide
with the nonconformity and should be clearly identifiable to the assessment team.
Failure to do so will cause the assessor to reject the corrective action, resulting in
a delay of accreditation. CABs should submit corrective action on their corrective
action form in accordance with their corrective action procedure.

8.2 CABs have 60-days from the last day of the assessment to submit corrective
action. Depending on the severity of the nonconformity, this timeline may be
adjusted, or a follow-up visit may be required to verify the effectiveness of the
corrective action. *Note some programs may require different timelines. In this
case, these will be provided to the CAB during the closing meeting* Failure to
submit corrective action on-time or sufficiently may cause the accreditation to be
voided requiring the CAB to re-apply or conduct a follow-up visit or suspension of
a current accreditation. Multiple corrective action submission reviews are strongly
discouraged and may lead to additional assessment time and cost to the CAB as
necessary.

9.0 FINAL ACCREDITATION DECISION

9.1 Once accreditation is recommended by the lead assessor, the assessment

material will be reviewed by PJLA’s headquarter staff and submitted to the
Executive Committee for a final decision to either grant or deny accreditation
without undue delay. Members of the PJLA Executive Committee are
independent parties from the assessment team that have no conflict of interest
with the CAB. Members are selected based on their fields of expertise aligning
with the scope accreditation of the CAB. More than one Executive Committee
Member or Technical Reviewer may be selected to complete the final review.
The final review consists of a complete assessment package review that should
provide executive committee members confidence that the CAB is fully
complying with the standard assessed, PJLA policies and that they have
adequately responded to all nonconformities alleviating any doubt that the
fulfillment of the requirements has been met. The Executive Committee may
reject the assessment and request additional information at its discretion. In this
case, the President, Operations Manager and/or Technical Program Manager(s)
will instruct the lead assessor to retrieve more information from the CAB or the
CAB may be communicated directly from PJLA headquarters. CABs have the

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opportunity to respond to any rejections or comments made by the Executive
Committee. If the accreditation cannot be recommended by the lead assessor or
the Executive Committee, then PJLA will communicate this to the CAB. The CAB
will either be required to completely reapply for accreditation or perform an
extensive follow-up visit. The Executive Committee may also approve the
assessment material on a contingency which may require a follow up of certain
activities at the next assessment or additional documentation to be provided from
the assessor(s). Contingencies made for any breach of the standard assessed,
PJLA policy or any other breach of PJLA’s agreement for services with the CAB
will not be accepted by PJLA headquarters and will result in a rejection.

10.0 CERTIFICATE OF ACCREDITATION

10.1 Should the Executive Committee grant accreditation, PJLA issues a Certificate of
Accreditation. Certificates are developed based on the final scope received from
the assessment team and agreed upon with the CAB. Certificates are developed
based on the policies of PJLA and reviewed by PJLA technical program
management prior to release to the CAB. Certificates contain an initial
accreditation date, an issue date (based on the date of the executive committee
decision) and an expiration date and unique accreditation number and certificate
number. The accreditation number remains the same for the life of the CAB as
the certificate number is adjusted on an on-going basis. Revision dates are also
issued as necessary. In some cases, the issue date may be later than the
executive committee date, as long as the date is after the final approval date.
The contents of the scope of accreditation include a scope statement from the
CAB or a general scope field, based on the preference of the CAB. A supplement
is connected to each certificate that contains the items or activities the CAB is
accredited for including an indication of activities being performed on-site at
customer locations. The appropriate standard is indicated along with disclaimers
to assist with representing the entirety of the accreditation (i.e. CMC statements,
remote/corporate scheme location references (some corporate certificates may
include multiple certificate numbers (i.e. L12-006-1, L12-006-2), off-site activities
references, etc.). The PJLA symbol is provided on each certificate and the ILAC
MRA mark for which PJLA has obtained recognition for.

10.2 A draft of the approved certificate will be provided to the CAB from PJLA
headquarters prior to release. An official copy of the certificate will be provided to
the CAB via email in a non-editable format, hardcopy via mail and also posted on
the PJLA website. Additionally, each CAB will be provided with a copy of the Use
of Accreditation Claims and Symbols Procedure (SOP-3) with the necessary
artwork to promote their accreditation. Additionally, they will be informed about
the use of the ILAC MRA mark that can be used along with the PJLA symbol. All
CABs must adhere to the instructions outlined in (SOP-3) as outlined in their
agreement for services. This includes requirements for the use of the
accreditation symbols and language and the use of the ILAC Mark.

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11.0 MULTIPLE SITE ACCREDITATION:

11.1 Where a CAB is operating through a number of remote locations or facilities, they
may choose to pursue accreditation of all locations under a single accreditation if
all of the following conditions exist:

11.1.1 the CAB has a similar quality management system that is

implemented across all facilities;
11.1.2 the CAB defines a tiered management structure defining ultimate
authority of the entire accreditation;
11.1.3 the CAB can attest that routine internal audits and management
reviews encompass each facility and that they are reviewed by the
designated management holding the ultimate authority over the entire
accreditation. Note-records shall be made available to PJLA for all site
internal audit or management review activities as requested, and;
11.1.4 the authoritative site of the accreditation should be able to
demonstrate their oversight of the following:
11.1.4.1 policy formulation;
11.1.4.2 process and/or procedure development;
11.1.4.3 contract review;
11.1.4.4 approval and decision making on the results of conformity
assessments;
11.1.4.5 management review;
11.1.4.6 internal audit planning and evaluation of the results, and;
11.1.4.7 evaluation of corrective actions.

11.2 On-site visits are conducted at all premises during the initial accreditation where
the above key activities are performed. Upon accreditation all sites will be
assessed on a routine basis throughout the accreditation cycle. In all cases, the
designated authoritative location will be assessed annually, and support
sites/remote facilities will be sampled throughout the accreditation cycle.
Typically, a full system assessment of all facilities identified on the scope of
accreditation is performed over a two-year period. However, depending on the
scope of activities being conducted at each location the schedule of assessments
may be extended out to a 4-year period. A sampling schedule will be developed
during the initial contract stage and modified as necessary throughout the
accreditation cycle.

12.0 MAINTENANCE OF ACCREDITATION

12.1 Surveillance Assessments

12.1.1 The continued fulfillment of accreditation requirements is maintained

by conducting regular surveillance assessments. Surveillance

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assessments occur on-site within 12-months from the initial
accreditation assessment.

12.1.2 Surveillance assessments are conducted to ensure compliance with

accreditation requirements and are typically less comprehensive then
accreditation assessments. At a minimum, the following aspects will
be assessed:

12.1.2.1 inquiries from PJLA to the CAB on aspects concerning the

accreditation;
12.1.2.2 declaration by the CAB with respect to their operation;
12.1.2.3 documents and records, including updates from the quality
manual;
12.1.2.4 CAB’s performance (including through proficiency testing),
and;
12.1.2.5 clauses of both the quality system and the scope of
accreditation activities:
12.1.2.5.1 internal audit and management review;
12.1.2.5.2 previous visit’s findings;
12.1.2.5.3 outstanding corrective action;
12.1.2.5.4 performance in proficiency testing;
12.1.2.5.5 personnel changes and other changes;
12.1.2.5.6 changes in technical personnel or equipment;
12.1.2.5.7 all PJLA policy requirements;
12.1.2.5.8 Accreditation Symbol utilization, and;
12.1.2.5.9 representative sampling of the accredited
activities, covering all areas of competence.

12.1.3 Since surveillance assessments are less comprehensive then initial

accreditation assessments or reassessments, a lead assessor or a
team of assessors may be selected for the assignment as long as
they possess the skills to assess the quality management system
and a portion of or all of the scope of accreditation. Assessors will
be informed of any areas of the scope they are prohibited from
assessing. Previous assessment reports or feedback will be
communicated to the assessor(s) to ensure any follow up activities
are assessed and CAB activities are witnessed that may not have
been witnessed previously.

12.1.4 Surveillance assessments although less comprehensive then full

system assessments (i.e. AC, RA) still allow for nonconformities to be
detected. CABs should follow the requirement as indicated in section
8.0 of this procedure.

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12.1.5 Surveillance assessments are reviewed by PJLA technical staff for
adequacy. If major nonconformities, fundamental system changes or
scope changes occur during the surveillance, then the material will be
sent to the Executive Committee for a final decision.

12.1.6 After the initial accreditation cycle, PJLA reserves the right to amend
the frequency of on-site visits. The interval between on-site
assessments depends on the demonstrated competency of the CAB
during the past accreditation cycle. This is developed from the
recommendation of the lead assessor on previous visits, history of the
CAB in regard to complaints, nonconformity trends and system and/or
technology changes. PJLA along with the lead assessor will make the
final decision to excuse on-site surveillance visits. When on-site
surveillance visits are reduced from the CAB’s accreditation cycle,
PJLA will require the CAB to demonstrate its maintenance of their
accreditation through an off-site documentation review. This review
consists of the following:

12.1.6.1 proficiency testing (PT) data review;

12.1.6.2 internal audit results;
12.1.6.3 management review;
12.1.6.4 corrective actions taken;
12.1.6.5 review of changes occurred in the laboratory, and;
12.1.6.6 off-site technical review of at least one item on the scope
of accreditation.

12.1.7 Designated assessment time will be provided to an assigned assessor

to complete this review. Nonconformities may be detected during these
reviews requiring CABs to following the corrective action requirements
as indicated in section 8.0 of this procedure. CABs will be provided with
an assessment schedule from PJLA that includes the date and
assessor conducting the review and the items required to be submitted.
CABs will receive a final report from the assessor based on the review
of the above items. PJLA staff will review the report to ensure the
accreditation is sustained. In cases where the documentation review
provides any doubt that the CAB is maintaining their accreditation, an
on-site surveillance will be scheduled.

12.2 Proficiency Testing Maintenance

12.2.1 In effort to ensure all CABs meet PJLA’s Proficiency Testing (PT)
Policy (PL-1). CABs are required to develop a 4-year Proficiency
Testing Plan in accordance with (PL-1). The implementation of the
plan is evaluated during on-site assessments. Any deviations from the

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specified requirements for (PT) will be evaluated by PJLA
headquarters and communicated to the assessment team (i.e. use of
other means of (PT) such as intra laboratory comparisons or
repeatability). Any changes to the 4-year (PT) plan should be
communicated to the PJLA assessment team.

12.3 Special Circumstance Assessments

12.3.1 PJLA reserves the right to conduct assessments during the course of
the accreditation period when it is determined that the CAB’s system
may be or could potentially be at harm, resulting in noncompliance
with the standard. Situations such as the following may impose a
special visit:

12.3.1.1 complaint from customers that are directed to the CAB’s

competency and results, and;
12.3.1.2 significant changes to the organization (i.e. ownership,
management, address, technology/equipment change
etc.).

12.3.2 If the changes do not directly affect the CAB’s scope of accreditation
results, then it may be determined that a special assessment is not
required, and the changes will be reviewed at the next assessment.

13.0 REASSESSMENT

13.1 At the end of the CAB’s accreditation cycle, PJLA conducts a complete
reassessment, like the initial accreditation assessment and its processes. Such
assessments consider the maturity of the CAB’s system and previous history
between the CAB and PJLA (i.e., suspensions, complaints and adherence to
PJLA’s policies and accreditation criteria).

13.2 CABs are required to complete a reassessment 2- years from the last full system
assessment. CABs should conduct their reassessment prior to expiration. PJLA
may grant an extension to the certificate for unforeseen circumstances.
Extensions will not be granted for any CAB that has not met their accreditation
obligations (i.e. financial arrangements, scheduling, and corrective action).

13.3 Once a renewal takes place, an Accreditation Cycle review will be completed
which includes an analysis of the CABs nonconformities and the nature of them
(major, minor, repeat, technical concerns that may give any doubt that the CAB
can perform reliable results), assessment reports, complaints, and suspensions.
This review establishes criteria for future assessments including modifications to
the current assessor due to overfamiliarity issues as well as the surveillance type
due 12 months from the renewal (i.e. on-site or documentation review). If there is

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any evidence that the assessor or executive committee member is overfamiliar
with the CAB, then a reassignment of the assessor or executive committee
member should be considered for future assessments.

14.0 SCOPE EXPANSION

14.1 A CAB may request to expand their scope of accreditation at any time through
PJLA’s application process. Scope expansions may be conducted during any
type of routine assessment or alone. For less complex scope expansions (i.e.
request to add analytes, SOP/method using a current accredited technique) can
typically be conducted off-site via documentation review.

14.2 PJLA will assign qualified technical assessors to assess scope expansion
assessments. Assessors should conduct a full technical review of the requested
tests and any quality management system activities impacted by the expansion.
Nonconformities can be detected on scope expansion assessments and are
handled as outlined in section 8.0 of this procedure. All scope expansions are
evaluated by PJLA’s executive committee to grant or deny the extension.

15.0 VIRTUAL REMOTE ASSESSMENTS

15.1 Virtual remote assessments may be utilized for low risk assessment types such
as: preassessments, scope expansions, surveillance, quality management
system reviews, special request assessments related to complaints, follow up
visits or location modifications and as a temporary alternative to full system
assessments (i.e., initial accreditation assessments or reassessments) due to
unforeseen circumstances i.e. natural disasters, pandemics, etc. CABs that have
large scopes of accreditation, high sophisticated techniques, a history of
complaints or serious nonconformities may not be eligible for a virtual remote
assessment.

15.2 PJLA will utilize the LF-138 Virtual Assessment Questionnaire to evaluate each
CAB’s internal system (i.e., electronic documentation, Wi-Fi connection, use of
portable devices) to ensure they are capable to have a remote assessment
performed. CABs that cannot support a virtual remote assessment will be
required to have their assessment on-site. Assessors will follow PJLA’s Virtual
Remote Assessment Work Instruction WI- 27 to ensure assessments are
conducted successfully.

16.0 SUSPENSION, WITHDRAWAL, REDUCTION OF ACCREDITATION

16.1 In accordance with (SOP-11) Suspension, Withdrawal or Reduction of Scope

Procedure, PJLA reserves the right to suspend, withdraw or reduce accreditation
with a CAB at any time.

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16.2 Generally, such actions are considered in the following instances:

16.2.1 CAB fails to complete corrective actions during the agreed timeframe;
16.2.2 CAB persistently fails to conform to Standard and/or PJLA policies;
16.2.3 CAB, in PJLA's judgment, misuses PJLA's Accreditation Symbol,
Certificate of Accreditation, or Accreditation Language as outlined in
SOP-3;
16.2.4 CAB becomes delinquent in its financial obligations to PJLA;
16.2.5 CAB becomes subject to bankruptcy laws or makes any
arrangements or composition with its creditors; enters into liquidation,
whether compulsory or voluntary; and/or appoints, or has appointed
on its behalf, a receiver;
16.2.6 CAB is convicted of an offense tending to discredit the facility's
reputation and goodwill, and;
16.2.7 CAB commits acts that, in PJLA's sole judgment; impugn PJLA's
goodwill, valuable name and reputation.
16.2.8 CAB commits fraudulent behavior
16.2.9 CAB intentionally provides false information
16.2.10 CAB conceals information

16.3 PJLA reserves the right to publicize any actions it may take with respect to
withdrawal, cancellation, reduction or suspension of a CAB’s accreditation.

16.4 PJLA will also cancel accreditation upon the formal written request of applicant
CAB.

16.5 PJLA may take legal action for wrongful actions specified in 16.2.

17.0 DISPUTES AND APPEALS

17.1 The CAB or any interested party may dispute or appeal the decisions of PJLA
with respect to:

17.1.1 refusal to accept an applicant CAB for accreditation;

17.1.2 suspension, withdrawal, reduction, or cancellation of accreditation;
17.1.3 refusal to grant, extend Accreditation;
17.1.4 an appeal by a third party against PJLA's decision to grant
accreditation;
17.1.5 assignment of assessment team;
17.1.6 nonconformities written by the assessment team, and;
17.1.7 any other issue relevant to the accreditation process.

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17.2 CABs have access to the Dispute and Appeal Procedure (SOP-10) via PJLA
website.

18.0 CONFIDENTIALITY

18.1 Except where required by law or statute, PJLA treats any information that comes
into its possession in the course of the accreditation of the CAB confidential.
PJLA staff, including subcontracted staff, assessors, executive committee
members and technical committee members, are required to sign confidentiality
agreements with PJLA to not disclose any information gained from a CAB or
about a CAB through PJLA except when required by law or statute. Requests
received to retrieve information from any interested party of the CAB will only be
distributed upon permission of the CAB.

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