Action required

All SCC laboratories engaged in Test Method Development and Non-Routine Testing shall conform to the revised edition of the SCC Requirements and Guidance for Accreditation of Laboratories Engaged in Test Method Development and Non-Routine Testing (RG-TMDNRT)

This document:

Was approved on 2021-01-15

Was published on 2021-03-02

Is effective as of 2021-01-15

Affected customers

SCC-accredited and applicant laboratories, as well as assessors involved in the TMDNRT program speciality area.

Background

These changes were made in order to align SCC Requirements and Guidance for Accreditation of Laboratories Engaged in Test Method Development and Non-Routine Testing (RG-TMDNRT) to the latest version of ISO/IEC 17025.

New requirements

The requirements have been revised to be in alignment with applicable clauses of ISO/IEC 17025:2017 related to TMDNRT. Below is a list of the main changes in this revised document:

• The scope was expanded to include specific guidelines for laboratories seeking accreditation under PSA-TMDNRT;
• Updates were made to the “Normative References” to include more relevant references and to remove outdating references;
• Updates were made to section 5.5 under “Structural requirements” to include new requirements for NRT activities;
• Updates were made to the competence requirements and providing more guidance on how they can be achieved;
• Updates were made to include guidance to section 6.2 “Personnel”;
• Updates were made to section 7.2. “Selection, Verification, and Validation of Methods” (7.2.1.6) to include maintenance of TMDNRT activities within the flexible scope and connection to appropriate references such as SCC Guidance for The Presentation of Laboratory Scopes of Accreditation and SCC Requirements and Guidance for Method Validation in Testing Laboratories;
• Updates were made to clarify the validation requirement for TMDNRT laboratories for standard methods used outside of its intended scope under section 7.2.2.1;
• Updates were made to divide into separate portions under section 8.4.1 “Control of Records” the requirements for project life cycle records for TMD and NRT activities

The removal of a guidance section related to method verification/validation and associated Annex A associated to performance characteristics (parameters) is to be considered by the laboratory when conducting method development and validation. This section was incorporated into SCC Requirements and Guidance for Method Verification and Validation in Testing Laboratories

Deadline

The new version of the document is effective immediately. Conformity assessment bodies involved in TMDNRT activities are requested to update their on-going processes and practices as soon as possible. Nonconformities will not be raised against the additional requirements until 2021-07-15.

Questions?

Please contact Abdel Kassou, Manager, Compliance and Assessment Services, at abdel.kassou@scc.ca or +1 613 238 3222 ext. 443 for more information.