Program Delivery Update: Testing Laboratory Assessment Mitigation Strategy
Action required
All SCC eligible accredited testing laboratories shall submit their documentation in a timely manner when requested to qualify for the mitigation process.
Affected customers
SCC accredited testing and calibration laboratories that are already transitioned to the 2017 version of the ISO/IEC 17025 standard and who are due for reassessment in 2020-2021.
Background
The prevailing situation surrounding COVID-19 pandemic and travel restrictions has had a significant impact on SCC’s ability to complete assessment activities. This situation has resulted in a considerable backlog of deferred laboratory assessments. SCC, as an internationally recognized signatory, has an obligation to ensure that all accredited organizations continue to meet and demonstrate competence with all requirements (standards/criteria) that appear on their approved scope of accreditation. Demand for resources in the coming months both in terms of managing and conducting the assessments is already high as a number of laboratories are still needing to complete their transition to the ISO/IEC 17025:2017 standard before the due date of June 1st, 2021.
In order to manage this situation, SCC has decided to initiate a mitigation strategy for its 2020-2021 plan of laboratory reassessments by adopting a risk-based approach. While doing this, SCC will ensure that the requirements of ISO/IEC 17011:2017, section 7.9.3 are met; which states “the assessment programme shall ensure that the requirements of the international standards and other normative documents containing requirements for conformity assessment bodies and the scope of accreditation shall be assessed taking risk into consideration”.
This mitigation strategy involves a three-step process.
- In the first step, SCC will perform a desk review on the information collected from the reassessment strategy tool along with supporting documentation submitted. Based on the outcome of this desk review, SCC will decide whether or not a remote assessment is required for the laboratory’s current accreditation cycle.
- SCC will arrange a partial or full remote assessment for those laboratories that are determined to be medium or high risk:
- A partial remote assessment will focus only on the areas of concern and missing gaps identified during the desk review;
- A full remote assessment will consist of a thorough review of the entire quality management system and involves the participation of a technical assessor(s).
Following this, SCC will follow its normal processes to confirm the reaccreditation status of the laboratory.
- For laboratories that are deemed low risk, SCC will proceed to confirm through its established decision process, the reaccreditation status based on the results of the desk review.
This interim measure will be in effect until June 30, 2021.
New requirements
SCC will be sending the Mitigation List of Documents to all eligible laboratories following the issuance of this Bulletin. This activity may replace the reassessment visit due in this accreditation cycle (April 2020 – March 2021) if the desk review determines there is minimal risk, and all documentation provided as evidence of ongoing compliance is acceptable. Prompt completion of this form and submission of all requested documentation is necessary or SCC will proceed automatically with planning a full remote assessment in order to fulfill its responsibilities as outlined in accreditation agreements. Additional documents/records may be requested during the course of the desk review. Upon conclusion of the desk review (assessment), SCC will communicate its decision as to whether a remote assessment (partial or full remote) needs to be conducted or if the requirements have been met for successful reaccreditation.
Deadline
The mitigation strategy described will come into effect immediately.
Questions?
Please contact Abdel Kassou, Manager, Compliance and Assessment Services, at abdel.kassou@scc-ccn.ca or +1 613 238 3222 for more information.