What are the national and international standards and guides currently used by TPD and Registrars?

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What are the national and international standards and guides currently used by TPD and Registrars in the Canadian Medical Devices Conformity Assessment System for Quality System accreditation?

Standard or Guide	Canadian Equivalent in National Standard System
ISO/IEC Guide 61: General requirements for assessment and accreditation of certification/registration bodies	No Canadian equivalent. International document used in CMDCAS
IAF Guidance on the Application of ISO/IEC Guide 61: Issue 1, 22 January 1998	No Canadian equivalent. International document used in CMDCAS
ISO/IEC Guide 62 : General requirements for bodies operating assessment and certification/registration of quality systems	CAN-P-10B : Criteria for Accreditation of Organizations Registering Quality Systems
No International equivalent	CAN-P-1517 : Conditions and Procedures for Accreditation of Organizations Registering Quality Systems
IAF Guidance on the Application of ISO/IEC Guide 62 - Issue 1, 2 June 1997	No Canadian equivalent. International document used in CMDCAS
ISO 13485:1996 Quality systems - Medical Devices - Particular requirements for the application of ISO 9001	CAN/CSA-ISO 13485:1998 Quality systems - Medical Devices - Particular requirements for the application of ISO 9001
ISO 13488:1996 Quality systems - Medical Devices - Particular requirements for the application of ISO 9002	CAN/CSA-ISO 13488:1998 Quality systems - Medical Devices - Particular requirements for the application of ISO 9002
ISO 10011-1:1990 Guidelines for auditing quality systems - Part 1: Auditing	CAN/CSA-ISO 10011-1 :1994 Guidelines for auditing quality systems - Part 1: Auditing
ISO 10011-2:1991 Guidelines for auditing quality systems - Part 2: Qualification criteria for quality systems auditors	CAN/CSA-ISO 10011-2 :1994 Guidelines for auditing quality systems - Part 2: Qualification criteria for quality systems auditors
ISO 10011-3:1991 Guidelines for Auditing quality systems - Part 3: Management of audit programmes	CAN/CSA-ISO 10011-3 :1994 Guidelines for auditing quality systems - Part 3: Management of audit programmes
The complete series of final GHTF Guidelines dealing with quality requirements and auditing process is available at www.ghtf.org	No Canadian equivalent. GHTF documents used in CMDCAS
No International equivalent	Q90 : Canadian Medical Devices Conformity Assessment System (CMDCAS)