Applicant and accredited laboratories who are being assessed to ISO/IEC 17025:2017 must ensure that their quality systems refer to the new version of the SCC Requirements and Guidance for the Accreditation of Testing Laboratories.
All testing and calibration laboratory customers and assessors
In addition to ISO/IEC 17025, SCC also assesses laboratories against its own requirements documented in the SCC Requirements and Guidance for the Accreditation of Testing Laboratories (RG-LAB). As this document is aligned to numbering structure of ISO/IEC 17025, it had to be revised to align properly with the 2017 version of the standard and its new numbering format and structure.
This work has been completed, and the document is available here for use by laboratories and assessors when using the 2017 version of ISO/IEC 17025:2017:
As well, an associated Criteria Matrix has also been prepared and is available by contacting your Account Manager.
This is the fifth in a series of bulletins that SCC will issue with regards to the transition to the new version of ISO/IEC 17025. The first four are available here:
In principle, no new requirements have been added to the RG-LAB, nor have any requirements been removed; however, in performing the alignment with the ISO/IEC 17025:2017 standard, many sections are rearranged and enhanced with additional clarification. Some of the key changes are outlined below.
TERMS AND DEFINITIONS
Additional terms are included and the definition for the term “Management Review” is modified.
The entire structure of the document is aligned with the layout of ISO/IEC 17025:2017 standard. However only the sections that required additional interpretation or clarification are retained in the RG-LAB document.
The terms Impartiality and Confidentiality are extensively covered in the ISO/IEC 17025:2017 standard. The SCC’s interpretation and expectations regarding these requirements are delineated. Some examples are provided to help the users of the RG-LAB document exploring different options in meeting the requirements of the standard.
REMOVAL OF SOME TERMS
The terms Quality Policy, Preventive Action and Management Representative are removed, however as a concept these terms still remain relevant
AUTHORIZATION TO PREFORM ACTIVITIES THAT HAVE IMPACT ON QUALITY
SCC’s expectation on the activities that require formal authorization is clarified. Additional examples are provided on activities that have impact on quality.
USING EQUIPMENT OUTSIDE THE LABORATORY CONTROLS
SCC’s position on when laboratories intend to use equipment that are outside of their control is explained in detail.
REVIEW OF REQUESTS, TENDERS, AND CONTRACTS
Additional clarification is given on the expectation of SCC about this requirement of the standard. Some examples are provided to help the users of the RG-LAB document exploring different options in meeting the requirements of the standard.
Additional clarification is given on the expectation of SCC about this requirement of the standard.
Although a formal risk assessment is not mandated by the standard, the concept of risk-based management is succinctly intertwined through out the standard. This RG document has attempted to highlight the areas where the concept of risk-based thinking could be applied when implementing the systems.
ADOPTING OPTION B
SCC’s position is clarified when a laboratory chooses Option B that requires the establishment and maintenance of the management system, in accordance with the requirements of ISO 9001 standard.
The new SCC Requirements and Guidance for the Accreditation of Testing Laboratories is effective immediately, no NCR will be raised against the additional requirements before July 1st 2020.
Please contact Abdel Kassou, Manager, Compliance and Assessment Services, at firstname.lastname@example.org or +1 613 238 3222 ext. 443 for more information