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Accreditation Services

SCC Requirements and Guidance for


the Accreditation of Testing
Laboratories
2018-04-01
Standards Council of Canada
55 Metcalfe Street, Suite 600
Ottawa, ON K1P 6L5

Telephone: + 1 613 238 3222


Fax: + 1 613 569 7808
accreditation@scc.ca
www.scc.ca

Permission to Reproduce

Except as otherwise specifically noted, the information in this publication may be reproduced, in
part or in whole and by any means, without charge or further permission from the Standards
Council of Canada, provided that due diligence is exercised in ensuring the accuracy of the
information reproduced; that the Standards Council of Canada is identified as the source
institution; and that the reproduction is not represented as an official version of the information
reproduced, nor as having been made in affiliation with, or with the endorsement of, the
Standards Council of Canada.

For permission to reproduce the information in this publication for commercial purposes, please
contact info@scc.ca.

© 2018, Standards Council of Canada

Aussi offert en français sous le titre Exigences et lignes directrices du CCN – Accréditation des
laboratoires d’essais.

2 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


Table of Contents
Preface ...................................................................................................................................... 4
1. Scope ................................................................................................................................. 4
2. Normative References ........................................................................................................ 5
3. Terms and Definitions ......................................................................................................... 6
4. General Requirements ........................................................................................................ 7
4.1 Impartiality ................................................................................................................... 7
4.2 Confidentiality .............................................................................................................. 7
5. Structural Requirements ..................................................................................................... 8
6. Resource Requirements ..................................................................................................... 9
6.2 Personnel ......................................................................................................................... 9
6.4 Equipment .......................................................................................................................10
6.5 Metrological Traceability ..................................................................................................11
6.6 Externally Provided Products and Services .....................................................................11
7. Process Requirements .......................................................................................................12
7.1 Review of Requests, Tenders, and Contracts ..................................................................12
7.2 Selection, Verification, and Validation of Methods ...........................................................14
7.7 Ensuring the Validity of Results .......................................................................................17
7.8 Reporting of Results ........................................................................................................17
8. Management System Requirements ..................................................................................19
8.3 Control of Management System Documents (Option A)...................................................19
8.4 Control of Records (Option A)..........................................................................................20
8.6 Improvement (Option A) ..................................................................................................21
8.7 Corrective Actions (Option A) ..........................................................................................21
8.8 Internal Audit (Option A) ..................................................................................................21
8.9 Management Reviews (Option A) ....................................................................................22

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 3


Preface

Accreditation of a testing laboratory by Standards Council of Canada (SCC) is the formal


recognition of the competence of a laboratory to perform specific tests or types of tests
recognized and listed by SCC.

To become accredited, laboratories must meet the general requirements in the international
standard, ISO/IEC 17025:2017 General requirements for the competence of testing and
calibration laboratories. This will be verified by the Standards Council’s accreditation process. In
addition, laboratories must demonstrate competence to perform the specific tests or types of
test for which they wish to become accredited. In addition, there is a number of Program
Specialty Areas (PSA) addressing specific requirements for specialty areas such as
Environmental, Agriculture and Food Products, Forensic, Mineral Analysis, etc. A complete list
of PSAs can be found in the Accreditation Services Program Overview Appendix F.

A listing of each accredited laboratory, with a summary of its accredited testing capabilities by
classes of products and services along with a list of detailed scope of testing is published on the
SCC website, www.scc.ca.

The accreditation procedures of SCC conform to the requirements of the International


Laboratory Accreditation Cooperation (ILAC) and others detailed in the Accreditation Services
Program Overview Appendix F.

Supplementary information regarding the program is available on the SCC website.

1. Scope
This document contains normative and informative guidance for ISO/IEC 17025:2017 accredited
testing laboratories. Laboratories and assessment teams alike must use this document to
assure compliance.

This document covers all accredited testing laboratories, including those labs under the
following PSAs:
 Environmental  Fasteners
 Agriculture Inputs, Food, Animal Health  Information Technology Security
and Plant Protection (AFAP) Evaluation & Testing (ITSET)
 Forensic  Test Method Development and Non-
 Mineral Analysis Routine Testing (TMDNRT)

For the following PSAs, an additional Requirements and Guidance document also applies:

4 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


 Forensics – SCC Requirements and Guidance for the Accreditation for Forensic Testing
Laboratories
 Mineral Analysis – SCC Requirements and Guidance for the Accreditation of Mineral
Analysis Testing Laboratories
 ITSET – SCC Requirements and Guidance for the Accreditation of Information Technology
Security - Evaluation and Testing Facilities (Including Cryptographic Module and Algorithm
Testing facilities)
 TMDNRT – SCC Requirements and Guidance for Accreditation of Laboratories Engaged in
Test Method Development and Non-Routine Testing

Note that this document does not apply to calibration laboratories. For supplemental
requirements and guidance on calibration labs, please contact the National Research Council –
Calibration Laboratory Assessment Service (NRC-CLAS) at www.nrc-cnrc.gc.ca.

2. Normative References
 ISO/IEC 17025:2005 General requirements for the competence of testing and calibration
laboratories
 ISO/IEC 17025:2017 General requirements for the competence of testing and calibration
laboratories

 ISO/IEC 17000:2004 Conformity assessment -- Vocabulary and general principles


 SCC Requirements and Guidance for Calibration and Measurement Traceability in Testing
Laboratories
 SCC Requirements and Guidance for Method Validation in Testing Laboratories
 SCC Requirements and Guidance for the Accreditation Of Testing and Calibration
Laboratories Performing On-Site Testing and Calibrations
 SCC Guidelines For The Presentation Of Laboratory Scopes Of Accreditation
 SCC Requirements & Guidance – Proficiency Testing for Testing and Medical Laboratories
 SCC Requirements and Guidance on the Use of Information Technology in Accredited
Laboratories
 SCC Accreditation Program Overview
 International Vocabulary of Metrology – Basic and General Concepts and Associated Terms
(VIM 3rd edition) JCGM 200:2012
 Guide to the Expression of Uncertainty in Measurement (GUM)
 APLAC TC 005 Interpretation and Guidance on the Estimation of Uncertainty of
Measurement in Testing
 ILAC G17:2002 Introducing the Concept of Uncertainty of Measurement in Testing in
Association with the Application of the Standard ISO/IEC 17025

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 5


3. Terms and Definitions
The following definitions apply to the interpretation of ISO/IEC 17025: 2017 and are based on
ISO 9000. The definitions of VIM also apply.

Policy: a policy is an operational pillar of an organization from which actions and procedures
follow. As such, it must state the overall direction of the organization with regard to the subject
activity and it must be clearly identified as a policy.

Procedure: a procedure must specify a way to perform an activity and must usually contain the
purpose and scope of the activity, what shall be done and by whom, when, where and how it
shall be done. The procedure must also address what materials, equipment and documents
shall be used and how it shall be controlled and recorded.

Conformity: fulfillment of a specified requirement.

Non-conformity: non-fulfillment of a specified requirement.

Verification: confirmation by examination and provision of objective evidence that specified


requirements have been fulfilled.

Validation: confirmation by examination and provision of objective evidence that particular


requirements for a specific intended use are fulfilled. Refer to the SCC Requirements and
Guidance for Method Validation in Testing Laboratories.

Objective evidence: information which can be proved true based on facts obtained through
observation, measurement, test or other means.

Quality Assurance: all the planned and systematic activities that are used to fulfill the
requirements for quality.

Management review: formal evaluation by top management of the status and adequacy of the
management system in relation to the quality policy and objectives.

Record: document which furnishes objective evidence of activities performed or results


achieved.

Preventive action: action taken to eliminate the causes of a POTENTIAL non-conformity,


defect or undesirable situation in order to prevent OCCURRENCE.

Corrective Action: action taken to eliminate the causes of an EXISTING non-conformity, defect
or undesirable situation in order to prevent RECURRENCE.

6 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


4. General Requirements
4.1 Impartiality

ISO/IEC
17025: Additional Requirement Guidance
2017

4.1.1 The statement should refer to both real


and apparent conflicts of interest. It is to
be noted that this clause applies only to
laboratories that are part of a larger
organization.

A third party laboratory is a laboratory


that is independent and not part of the
organization for which the testing is
being conducted; a second party
laboratory is a laboratory that has a user
interest in the object being tested or in
the results of the testing (e.g. a second
party laboratory may be performing
testing for suppliers) and a first party
laboratory performs testing on its own
products (e.g. laboratory and its
customers belong to the same
organization). These designations are
not specifically used by SCC for formal
classification of laboratory types;
however, they are important to some
international bodies.

4.2 Confidentiality

ISO/IEC
17025: Additional Requirement Guidance
2017

4.2.1 These may include confidentiality


agreements and employment contracts
including anyone who can have access
to such information, such as contractors
and visitors. Refer to SCC Requirements
and Guidance on the Use of Information
Technology in Accredited Laboratories.

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 7


5. Structural Requirements

ISO/IEC
17025: Additional Requirement Guidance
2017

5.2 If the roles of Technical Manager and This requirement for technical
Quality Manager are occupied by the management (not necessarily one
same individual, the laboratory shall Technical Manager) addresses the
document how the person separates provision of necessary resources to the
both functions, and how the laboratory laboratory, how technical management is
mitigates potential conflicts of interest. achieved (appointing a Technical
Manager, however named), and Quality
Manager (there must be a person in the
laboratory with the role of Quality
Manager). It is preferable that the roles
of Technical Management and Quality
Manager be appointed to separate
persons.

5.4 Refer to the Accreditation Program


Overview for the use of accreditation
symbols and for claims of accreditation
status

Accredited laboratories shall also comply


with the requirements for the use of the
SCC accreditation symbol detailed in the
Accreditation Agreement, which is also
provided to applicant laboratories as part
of the application package.

5.5 An organisation chart or charts with the


reporting relationship within the
organization and to any parent
organisation or ownership should
normally be a sufficient presentation of
the organisation and management
structure of the laboratory.

5.6 “Single person operations” can be


covered by ISO/IEC 17025:2017 if the
Management System (MS) indicates that
“No services shall be provided during
his/her absence” or words to that effect.

5.7 This requirement is designed to foster

8 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


Top Management commitment and
involvement in the Management System
(MS).

This may include providing evidence of


Top Management attending the annual
management review meetings, being
aware of the quality policies and quality
objectives.

6. Resource Requirements
6.2 Personnel

ISO/IEC
17025: Additional Requirement Guidance
2017

6.2.1 Laboratories are encouraged to maintain


a management system that applies to all
their activities and not only the
accredited activities. Where laboratories
apply different techniques or procedures
in the conduct of activities that are not
accredited, the laboratory personnel
should be able to distinguish between
accredited and non-accredited activities.

6.2.2 Except for the Forensics Program


Specialty Area, laboratories shall not
normally be accredited for the provision
of interpretations and opinions.

6.2.3 All training shall be documented and For effectiveness of training, this may be
recorded. The training records include considered a post-training follow-up
in-house training provided by the evaluation.
laboratory as well as external training.

6.2.4 Job descriptions shall be dated and


there shall be evidence to demonstrate
that each incumbent has read and
understood the content. Job descriptions
shall be updated as necessary to reflect
current job responsibilities and tasks
performed.

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 9


6.4 Equipment

ISO/IEC
17025: Additional Requirement Guidance
2017

6.4.1 The SCC Requirements and Guidance


on the Use of Information Technology in
Accredited Laboratories apply when
electronic media are used in this
Section. This includes equipment
software and data acquisition equipment.

6.4.2 It is essential that laboratories have


access to equipment to perform the
accredited tests and SCC does not
normally consider granting accreditation
when the laboratory is not equipped to
perform the test. However, where some
specialized tests use equipment that is
either rare or prohibitively expensive or
when a specialized facility and operators
are required, SCC may consider
providing accreditation under specific
conditions.

The laboratory shall normally be


furnished with the equipment (or
possess the facility) to be considered for
accreditation. When a laboratory is using
equipment/facilities that are not part of
the laboratory furnishings, the laboratory
is required to maintain records in
sufficient detail to reflect relevant
information (for instance relevant
requirements prescribed in the method
for set-ups and fixtures and
environmental conditions) and allow
SCC assessors to be capable of
evaluating compliance of the equipment.

Equipment and/or facilities that are


outside the laboratory’s permanent
control that are critical to the test must
have records supporting that the
conditions of Sections 6.3 and 6.4 have
been met.

Accreditation can be granted for tests

10 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


conducted on-site. The SCC
Requirements and Guidance for the
Accreditation Of Testing and Calibration
Laboratories Performing On-Site Testing
and Calibrations shall apply in these
cases.

6.5 Metrological Traceability

ISO/IEC
17025: Additional Requirement Guidance
2017

6.5.1 Refer to SCC Requirements and Guidance on calibration intervals can be


Guidance for Calibration and found in ILAC G24:2007 Guidelines for
Measurement Traceability in Testing the determination of calibration intervals
Laboratories for determining the of measuring instruments as well as in
acceptability of calibration sources. NCSLI RP01 document.

For additional requirements refer to ILAC


P10 – ILAC Policy on Traceability of
Measurement Results available at
http://www.ilac.org/

6.5.2 Testing laboratories need to retain


records of verifications of calibration
providers. When testing laboratories use
calibration laboratories that are not
accredited or accredited by an
Accreditation Body that is not an ILAC
MRA Signatory, refer to SCC
Requirements and Guidance for
Calibration and Measurement
Traceability in Testing Laboratories for
additional requirements. These
supplemental requirements enforcing a
rigorous application of the ILAC P10
definition of traceability is a requirement
that SCC must meet as a signatory to
the ILAC MRA.

6.6 Externally Provided Products and Services

ISO/IEC
17025: Additional Requirement Guidance
2005

6.6.1 When a laboratory never performs a test

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 11


and cannot demonstrate competency
and readiness, it shall not be granted
accreditation for that test.

When a laboratory subcontracts a test


for which they are accredited, it shall
preferably be subcontracted to a
laboratory that is accredited to ISO/IEC
17025:2017 by a signatory to the ILAC
MRA for that specific test.” If this is not
possible, the laboratory may choose a
non-accredited laboratory provided they
can demonstrate that the sub-contracted
laboratory meets the requirements of the
appropriate clauses of ISO/IEC
17025:2017.

6.6.2 SCC accredited testing laboratories shall


specify their requirements on purchasing
orders to ensure specifications are
understood so that all purchased
supplies and services will guarantee the
quality of the test result(s).

Example: When purchasing calibration


services, the laboratory shall ensure that
the calibration is for the appropriate
range, that it will include the uncertainty
of measurement, etc.

7. Process Requirements
7.1 Review of Requests, Tenders, and Contracts

ISO/IEC
17025: Additional Requirement Guidance
2017

7.1.1 Under the requirements of this section, This section deals with remedial action
the laboratory shall inform their and Section 8.7 deals with corrective
customers of their intent to sub-contract action.

12 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


prior to having the work sub-contracted.
The laboratory shall obtain consent from If we consider the example of a balance
the customer to sub-contract the testing, found to have a past due calibration
and shall retain evidence of customer status, the following items would fall
consent. under control of non-conforming work,
7.1:
When a laboratory is subcontracting an  stop using the balance (4.9.1a)
accredited test to another laboratory that  check other balances to determine
is part of the same legal entity and is calibration status; isolate any other
accredited by SCC or an SCC- past due balances;
recognized body for the specific test  calibrate any balances past due
being subcontracted, SCC does not (remedial action = correction);
consider the movement of this test item calibration as received and after
between such facilities as adjustment (if adjustments are
subcontracting. The test report produced needed) are needed;
shall however identify the facility that  review results of calibration;
conducted the test. The requirements of  determine that work with this balance
ISO/IEC 17025:2017 Section 7.4 can be resumed based on the
Handling of Test or Calibration Items calibration results as left;
shall apply.  determine impact on previous work
based on the calibration results as
found/received:
 if balances were within calibration as
found/received, there is no need to
recall work;
 if balances were out of calibration as
received, the significance of this non-
conformance shall be evaluated; for
example, the possible impact on
other testing work and if necessary
customers shall be notified.
 evaluate the significance of the non-
conformance (the fact that the
balance was past due for calibration)
to determine if it is infrequent (one
off) or related to a systemic problem
within a specific process or
procedure;
 when the evaluation has confirmed
that this is intermittent or related to a
system problem then initiate
corrective action (a system change
beyond the remedial action of
calibrating them). When there is no
reason to suspect that the
occurrence will be either repetitive or
related to a system problem then
close the non-conformance and
there is no need for a corrective

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 13


action.

The following would then fall under


corrective action (8.7):
 investigate all the direct and indirect
processes related to the
maintenance of the balance
calibration status: causes and
potential causes of the problem
(what were all the possible
contributions that lead to these
balances being past due
calibration?);
 determine the most likely cause or
causes;
 decide if any actions are needed to
eliminate the causes;
 undertake any action necessary to
eliminate these causes and to
prevent such a mistake from
reoccurring;
 do the necessary follow-up;
 monitor for effectiveness;
 close out the corrective action.

The underlying principle is that the


“correction” or “remedial action”
(correcting the non-conformity) is related
directly to the activity as opposed to the
“corrective action” which involves
investigating related processes or
systems to determine the root cause.
Once the true cause is eliminated, the
problem will not reoccur.

7.2 Selection, Verification, and Validation of Methods

ISO/IEC
17025: Additional Requirement Guidance
2017

7.2.1 When a laboratory is accredited for Refer to SCC Requirements and


several fields of testing (e.g. Guidance for Method Validation in
Chemical/Physical and Biological), the Testing Laboratories.
laboratory shall document how they
validate the methods within each field of Refer to the SCC Guidelines for the
testing. Presentation of Laboratory Scopes of
Accreditation for acceptable tests for
When international or national methods accreditation. This document also

14 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


are not followed exactly as written and describes guidelines for in-house
when they are even “slightly modified” methods.
(e.g. addition of new or different QC
material, completely different
instruments, etc.) or used outside of the
method’s intended scope of application,
they are subjected to the same
requirements as a laboratory-developed
method.

If the laboratory is accredited for a


modified standard method, the test
report shall be clear to this effect.

7.2.2 The testing organization to be


accredited, or those already accredited,
which are using laboratory-developed
test methods, shall be able to clearly
demonstrate, by documented evidence,
that any and each test procedure
modification produces reliable results.

Refer to SCC Requirements and


Guidance for Method Validation in
Testing Laboratories.

7.2.3 “Procedure used for the validation” refers


to the specific steps taken to validate the
method.

7.2.4 Testing laboratories shall ensure that Refer to APLAC TC-005 available at
they also receive appropriate https://aplac.org/publications/
uncertainties of measurement from
outside sources of calibration. For additional guidance refer to ILAC
G17 – Introducing the Concept of
Measurement Uncertainty (MU) in
Testing available at http://www.ilac.org/

Measurement uncertainty, as defined by


the Guide to the Expression of
Uncertainty in Measurement (GUM), is
the only pertinent product of calibration
activities. It is important to address both
calibrations that are done in-house by
the laboratory itself and those that are
conducted by outside suppliers.

7.2.5 The SCC Requirements and Guidance


on the Use of Information Technology in
Accredited Laboratories shall apply

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 15


when electronic media are used in this
clause.

7.2.6 For in-house developed and/or modified In addition, it could be part of the
software, requirements in ISO/IEC equipment that needs to be safeguarded
17025:2017 are complex. The software against adjustment.
is considered as a document that needs
to be controlled and validated.

A records control procedure shall be


established when software generates
critical records.
Protection/back up procedure shall also
be established.

The requirements of 7.5 apply when


critical records (such as original
observations, derivations, and
calculations) are maintained
electronically.

This requirement applies to commercial


software that is modified and/or
developed by the user, including user
developed equations in spreadsheets
that conduct data manipulations and
calculations.

Any modifications to software


(developed or off-the-shelf) shall be
validated to show that they are fit for the
intended use.

7.2.7 The validation of software shall include a


test plan identifying a pre-defined series
of inputs that are selected in such a
manner to represent the range of inputs
and to provide sufficient confidence on
the outputs or performance of the
software for the intended use.

The pre-defined inputs are entered using


the software being validated and the
outputs are compared to the expected
results obtained by alternative, proven
methods.

The records from the validation testing


shall provide objective evidence that the
software works as expected over its

16 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


specified range.

The test plan and validation shall be


revised and repeated when there are
changes to the algorithms (8.3
Document Control procedures for the
software).

7.7 Ensuring the Validity of Results

ISO/IEC
17025: Additional Requirement Guidance
2017

7.7.1 Refer to the SCC Requirements &


Guidance – Proficiency Testing for
Testing and Medical Laboratories. Note
that SCC PSA requirements have
specific requirements for Proficiency
Testing. These are defined in the
individual PSA documentation and must
be adhered to.

7.7.2 The analysis of the data resulting from


the monitoring activities of section 7.7
and determining if a correction or
corrective action is required shall meet
the requirements of section 7.1.

7.8 Reporting of Results

ISO/IEC
17025: Additional Requirement Guidance
2017

7.8.1 Refer to the Accreditation Services Accredited laboratories may also use
Program Overview and the SCC’s ILAC MRA logo on their test reports by
customers’ Master Accreditation-Licence signing a Licence Agreement available
Agreement for guidance and from SCC.
requirements on publicizing accreditation
status on test reports. ILAC guidance to clause 5.10 (G.5.10.1)
G.5.10.1 Laboratories that are
The SCC Requirements and Guidance accredited by an Accreditation Body
on the Use of Information Technology in which is a signatory of the ILAC or
Accredited Laboratories apply when regional Multilateral Agreement in the
electronic media are used in this section. field of testing, may state on certificates
and reports, in the appropriate language:

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 17


“SCC is a signatory to the ILAC, IAAC,
and APLAC Multilateral
Agreement/Arrangement for the mutual
recognition of test reports.”

7.8.2 When reporting an accredited test, the


method listed in the report shall be
identical to the method listed on the
laboratory’s SCC scope of accreditation.

7.8.3 It is acceptable for certain laboratories


not to issue a final report. This applies to
cases where the vast numbers of
samples make it impractical for each
report to be signed, or the data for the
final report to be transmitted
electronically to the proper authority.
However, in these cases, the results
must remain traceable to the person
authorizing the result.

A person signing reports does not need


formal technical expertise in the area of
testing being reported. If the person
signing the reports does not have the
technical expertise, the laboratory shall
be able to demonstrate that the results
have been reviewed and accepted by a
person technically qualified.

7.8.4 There are very few cases where it is not


relevant to include such a statement, to
ensure against interpretation as part of a
certification program.
Examples include, but are not limited to:
 for internal Quality Control
laboratories; if the laboratory is
conducting the sampling, testing, and
the analysis of the results;
unique tests, where only one sample
exists and the product is destroyed in the
testing, e.g. some forensic testing.

7.8.5 Refer to “ILAC G8 Guidelines on the


Reporting of Compliance with
Specification”.

7.8.6 Refer to “ILAC G24 Guidelines for the


determination of calibration intervals of
measuring instruments”.

18 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


7.8.7 For opinions and interpretations in
Forensic testing laboratories, Refer to
the SCC Requirements and Guidance
for the Accreditation for Forensic Testing
Laboratories.

8. Management System Requirements


8.3 Control of Management System Documents (Option A)

ISO/IEC
17025: Additional Requirement Guidance
2017

8.3.1 The 'issuing authority' shall be specified


as being a position/title in the
organization. Using only the name of the
organization or department does not
meet requirements of issuing authority
as it does not clearly specify the signing
authority in the organization.

When a laboratory decides to maintain a


system where the controlled documents
available to personnel need not to be
signed by the approver, there shall be
evidence that the documents have been
approved prior to release.

It is not necessary for documents to be


signed by the approvers to indicate that
they are approved. Some electronic
systems control the approval of
documents without signatures. In those
cases, the authority to approve
documents shall also be defined in the
document control procedure. There shall
be a specified level access to electronic
documents corresponding to that
authority.

8.3.2 When extensive changes are made to a The requirement states “practicable” not
document, evidence of additional training “practical”.
for personnel shall be provided and
documented.

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 19


8.4 Control of Records (Option A)

ISO/IEC
17025: Additional Requirement Guidance
2017

8.4.1 This section applies to both paper and


electronic records. SCC Requirements
and Guidance on the Use of Information
Technology in Accredited Laboratories
shall also apply when electronic media
are used as the primary medium for
record retention in this section

8.4.2 The retention period shall be sufficient toThe following descriptions apply to both
establish an audit trail, thus electronic and paper copies of records
demonstrating compliance during SCC and are only intended to clarify the
assessments. requirements:
 Identification: how are the records
Raw data shall be recorded using an identified to distinguish each record
indelible medium with sufficient longevity of the category? By whom and how
to support the established retention time. are sequential numbers assigned?
For example, the first two corrective
action records for the year 2011
could be identified as 2011-01, 2011-
02, etc.
 Collection: How, where and by whom
the records are gathered for their
filing?
 Indexing: How are the records
sorted? For example,
chronologically, alphabetically, area
of discipline, etc.
 Access: Is the access to the records
limited? Who has access and who
authorizes access?
 Filing: How and where are they filed
and who files the records?
 Storage: What is the short and long
term storage? What is the retention
time? Who is responsible for
storage?
 Maintenance: How are the records
maintained and by whom to ensure
their integrity for the pre-defined
retention times?
 Disposal: How are the records
destroyed and by whom? Evidence
needs to be available that the

20 SCC Requirements and Guidance for the Accreditation of Testing Laboratories


disposal has occurred.

8.6 Improvement (Option A)

ISO/IEC
17025: Additional Requirement Guidance
2017

8.6.1 Analysis of opportunities for


improvement may include statistics and
trend analysis.

8.7 Corrective Actions (Option A)

ISO/IEC
17025: Additional Requirement Guidance
2017

8.7.1 This section deals with correcting a


problem that has been determined to be
systemic or potentially repetitive (7.1).
The investigation involves a root cause
analysis which ideally will result in the
identification of all the potential
contributors to the problem. The
correction (remedial action) is the
correction of the immediate problem,
where the corrective action and the
ensuing root cause analysis extends
beyond the immediate problem corrected
and considers related systems and
processes. Corrective action taken to
avoid the problem to reoccur are not
preventive action but part of the
corrective action process. Refer to the
definitions in Section 3 of this document.

8.8 Internal Audit (Option A)

ISO/IEC
17025: Additional Requirement Guidance
2017

8.8.1 SCC requires that such audits be Refer to APLAC TC-002 – APLAC
conducted on an annual basis. Internal Audits for Laboratories and
Inspection Bodies.

8.8.2 When the internal audit is performed by It is not necessary to audit each person

SCC Requirements and Guidance for the Accreditation of Testing Laboratories 21


personnel not independent of the activity or each testing/measurement procedure,
being audited, the laboratory shall or to audit every aspect at one time.
demonstrate the effectiveness and the
impartiality of the internal audit.

Every part of the management system


shall be audited annually. The annual
audit shall include tests and techniques
that are representative of at least the
methods on the scope of accreditation.
The laboratory’s internal audit plan and
programme shall be developed to ensure
that all the accredited tests are audited
over a reasonable specified time frame.

The laboratory shall keep records to


demonstrate the competency of the
internal auditors.

For the audits that include technical


areas, the laboratory shall demonstrate
that at least one of the internal audit
members has the appropriate
capabilities, experience, and/or
knowledge.

8.9 Management Reviews (Option A)

ISO/IEC
17025: Additional Requirement Guidance
2017

8.9.1 SCC requires that such reviews be Where the laboratory stages their
conducted annually. management review as a series of
meetings, there should be one meeting
review that summarizes the year’s
activities and looks forward to the
coming year.

The management review should include


the review of the Quality Policy and
measurable quality objectives. Refer to
the definition of management review in
Section 3 of this document.

- End of Document -

22 SCC Requirements and Guidance for the Accreditation of Testing Laboratories

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