Professional Documents
Culture Documents
SCC Requirements and Guidance For The Accreditation of Testing Laboratories
SCC Requirements and Guidance For The Accreditation of Testing Laboratories
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.
Aussi offert en français sous le titre Exigences et lignes directrices du CCN – Accréditation des
laboratoires d’essais.
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.
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:
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
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.
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.
Corrective Action: action taken to eliminate the causes of an EXISTING non-conformity, defect
or undesirable situation in order to prevent RECURRENCE.
ISO/IEC
17025: Additional Requirement Guidance
2017
4.2 Confidentiality
ISO/IEC
17025: Additional Requirement Guidance
2017
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.
6. Resource Requirements
6.2 Personnel
ISO/IEC
17025: Additional Requirement Guidance
2017
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.
ISO/IEC
17025: Additional Requirement Guidance
2017
ISO/IEC
17025: Additional Requirement Guidance
2017
ISO/IEC
17025: Additional Requirement Guidance
2005
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.
ISO/IEC
17025: Additional Requirement Guidance
2017
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/
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.
ISO/IEC
17025: Additional Requirement Guidance
2017
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:
ISO/IEC
17025: Additional Requirement Guidance
2017
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.
ISO/IEC
17025: Additional Requirement Guidance
2017
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
ISO/IEC
17025: Additional Requirement Guidance
2017
ISO/IEC
17025: Additional Requirement Guidance
2017
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
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.
- End of Document -