SCC Requirements and Guidance for the Presentation of Laboratory Scope of Accreditation, v3

Bulletin date:
Bulletin number:
2022-08

Action required

All SCC-accredited Laboratories and Proficiency Testing Providers shall conform to the latest edition of the SCC Requirements and Guidance for the Presentation of Laboratory Scope of Accreditation, v3. 

 

This document covers the presentation of scopes of accreditation for the following accreditation programs:

  • Testing and Calibration Laboratories (ISO/IEC 17025)
  • Medical Laboratories (ISO 15189)

  • Proficiency Testing Providers (ISO/IEC 17043)

     

Affected customers

All SCC-accredited Laboratories (testing, calibration and medical), Proficiency Testing Providers, applicants, assessors and other relevant stakeholders.

 

Background

The Standards Council of Canada conducted an overall review of the SCC Guidelines for the Presentation of Laboratory Scope of Accreditation stemming from feedback received from interested parties, including SCC-accredited laboratories. 

 

Consultations were undertaken as part of the revision process to bridge gaps and eliminate inconsistencies in the document. This included capturing requirements from the Accreditation Program Overview (POV), bulletins issued by SCC, as well as resolutions and other documents issued by the International Laboratory Accreditation Cooperation (ILAC). The revised edition underwent final review and approval prior to publishing.


Phasing out the Accredited Laboratory No. 
This review coincided with the introduction of new technology at SCC – a Customer Relationship Management database – which is now used to manage laboratory assessments. The Accredited Laboratory No.  that was listed on all accredited laboratory certificates will be phased out. It will also no longer appear when scopes are updated and republished for existing laboratories. For new laboratories, it will no longer be assigned. 


Moving forward SCC will be using customer file numbers as the unique identifier. Customer file numbers already appear on the scopes of accreditation across all accreditation programs. Customers may need to consider this change within their own systems.

 

New requirements

The main changes to SCC Requirements and Guidance for the Presentation of Laboratory Scope of Accreditation, version 3 include the following:

  • Laboratories are now required to present their proposed scopes of accreditation in a defined format.
  • Editorial corrections were made, and references were verified throughout the document.
  • The following documents were added to the new References section:
  1. ILAC G18 Guideline for the Formulation of Scopes of Accreditation for Laboratories, 
  2. EA-4/18: Guidance on the level and frequency for Participation in Proficiency Testing Activities, and
  3. SCC Accreditation Services: Accreditation Program Overview 
  • Sections 5 and 6 were added to provide a framework around fixed and flexible scopes, and what is acceptable or not.  
  • Section 9. Fields of Testing and Description - Testing Laboratories, was expanded to include the Proficiency Testing Providers (PTP) program and the Medical Laboratory Accreditation Program (MLAP).
  • Section 10. SCC Program Specialty Areas (PSAs) and other Accreditation Programs is now organized in alphabetical order.
  • Examples for the testing laboratories – fixed and flexible scopes, PTP and MLAP scope were updated in section 12. Appendix 

 

Deadline

The new version of the document is in effect starting 2022-04-27. Customers shall review their scope and provide an updated scope based on the document’s requirements as part of the documentation they submit for their office assessments scheduled after the transition period 2022-10-27.

 

Questions?

Please contact Vivekananthan Kulasingham, Manager Compliance and Assessment Services at vivekananthan.kulasingham@scc-ccn.ca  or +1-613-238-3222 ext. 350 for more information.