Publication new versions of SAP-C002 (IT Service management systems – ISO/IEC 20000-1), SAP-C004 (quality systems – ISO9001) and SAP-C021 (medical devices – ISO 13485)The Dutch Accreditation Council (RvA) has published new versions of the following Specific Accreditation Protocols:
The Dutch Accreditation Council (RvA) has published new versions of the following Specific Accreditation Protocols:
- SAP-C002: Specific Accreditation Protocol for Certification of IT Service management systems according to ISO/IEC 20000.
In comparison with version 4 dated February 28, 2020 the following significant changes have been made:
– Additional document IAF MD 18: 2015 is replaced by ISO/IEC 20000-6;
– Chapter 4: combined audit 27001/20000-1 added.
Click here for latest version of SAP-C002.
- SAP-C004: Specific Accreditation Protocol for certification of Quality Management Systems in accordance with ISO 9001
In comparison with version 3 dated October 2019 the following significant changes have been made:
– Additional documents (was 1.3) deleted. This was a reference to RvA-T041. This document is no longer applicable.
Click here for latest version of SAP-C004.
- SAP-C021: Specific Accreditation Protocol for Certification according to ISO 13485 (medical devices)
Compared to version 4, dated 3 January 2020, the following significant changes have been made::
– 2. Scope of Accreditation; Policy of RvA concerning quality management system requirements of Sterilization Standards on accredited scope of ISO 13485;
– 3.1 Documents to be submitted Due to the new IAF MD 8:2020 the CAB must submit extra information prior to the assessment;
– 3.2 The nature and content of the assessments. Due to the new IAF MD 8:2020 document assessment is also part of surveillance and reaccreditation assessments;
– Annex 1 due to a more detailed registration of the scope of accreditation in MTA 1.5 Sterilization Methods in IAF MD8:2020 the example is extended;
– Annex 2 template for list of certified clients;
– Annex 3 template for list of medical devices other than specified above;
Click here for latest version of SAP-C021.
Keep up to date!
Subscribe to our (Dutch) newsletter and stay updated on the latest developments and job offers. Or follow us via LinkedIn.