New IAF Mandatory Documents (MD Series)

[Sidney Vianna]

Departing from the traditional approach of issuing Guidance and Policy documents, the International Accreditation Forum decided to "put more teeth" in it's portfolio and created a set of mandatory documents:

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5. IAF Mandatory Documents (MD Series)
IAF publishes Mandatory Documents which are required to be used by accreditation bodies when accrediting certification/registration bodies to assure that they operate their programs in a consistent and equivalent manner. IAF Mandatory documents are not intended to establish, interpret, subtract from or add to the requirements of any ISO/IEC Guide or Standard, but simply to assure consistent application of those Guides or Standards.

Copies of all published IAF Mandatory Documents are available below.

IAF MD 1:2007 Certification of Multiple Sites Based on Sampling

(Issue 1, issued on 20 November 2007; Application from 15 September 2008)

This document is mandatory for the consistent application of Clause 9.1.5. of ISO/IEC 17021:2006 and is based upon guidance previously provided in IAF GD2: 2005 Annex 3 and IAF GD6:2006, clause G.5.3.5 - G.5.3.13. All clauses of ISO/IEC 17021:2006 continue to apply and this document does not supersede any of the requirements in that standard. This mandatory document is not intended exclusively for Quality Management Systems (QMS) and Environmental Management Systems (EMS) and may be used for other management systems. However, relevant standards may provide specific requirements for multiple sites or preclude the use of sampling (eg. ISO/IEC 27006, ISO/TS 22003).

IAF MD 2:2007 Transfer of Accredited Certification of Management Systems

(Issue 1, issued on 14 December 2007; Application from 15 September 2008)

This document is mandatory for the consistent application of Clause 9.1.1. of ISO/IEC 17021:2006 and is based upon guidance previously provided in IAF GD2: 2005 Annex 4 and IAF GD6:2006 Annex 2. All clauses of ISO/IEC 17021:2006 continue to apply and this document does not supersede any of the requirements in that standard. This mandatory document is not intended exclusively for Quality Management Systems (QMS) and Environmental Management Systems (EMS) and may be used for other management systems.

IAF MD 3:2008 Advanced Surveillance and Recertification Procedures (ASRP)

(Issue 1, issued on 1 February 2008; Application from 15 September 2008)

This document provides normative criteria for advanced surveillance and recertification procedures (ASRP) for consistent application of clause 9.1.1 of ISO/IEC 17021:2006 for determining subsequent adjustments to the audit program. This document addresses only Quality Management Systems (QMS) and Environmental Managements Systems (EMS), in which IAF members have had experience of implementing ASRP or its predecessor methodologies. The use of ASRP is not mandatory, but if an accreditation body wishes to permit their accredited certification body and its client(s) to opt for the use of ASRP, it is a requirement of IAF that the certification body and its client(s) conform to this document and be able to demonstrate conformity to the accreditation body.

[Sidney Vianna]

A fourth mandatory document has been added to the list

IAF MD 4:2008 Use of Computer Assisted Auditing Techniques ("CAAT") for Accredited Certification of Management Systems
(Issue 1, issued on 15 May 2008; Application from 15 September 2008)
This document is mandatory for the consistent application of ISO/IEC 17021:2006 when computer assisted auditing techniques are used as part of the audit methodology. The use of CAAT is not mandatory, but if a certification body and its client opt to use CAAT, it is mandatory that they conform to this document and are able to demonstrate conformity to the accreditation body.

[Sidney Vianna]

ANAB has a new Heads Up document: 130. IAF Documents for the Consistent Application of ISO/IEC 17021

[Sidney Vianna]

The IAF has just released the latest and very important Mandatory Document:
IAF MD 5:2008 Duration of QMS and EMS Audits
(Issue 1, issued on 1 February 2009; Application from 1 May 2009)
This mandatory document was derived from the guidance previously available in two documents, IAF GD2:2005 Annex 2 and IAF GD6:2006 Annex 1. It provides mandatory provisions and guidance for CABs to determine the audit duration for stage 1 and stage 2 initial audits, surveillance audits and recertification audits.
A simple methodology is used to determine the audit duration (stage 1 plus stage 2) from tables based on the effective number of client personnel. For EMS audits, the duration varies according to the complexity of the audit. Factors which could add to, or subtract from the time are applied and checks made to ensure specified caveats are applied and any reductions in time do not exceed requirements specified in this document. The justification for the calculated time is recorded for future audit by an accreditation body.

[howste]

I was wondering when this would come out. Using the IAF Guidance to Guide 62 seemed odd considering that ISO Guide 62 has been obsolete for a while...

[Sidney Vianna]

The latest IAF Mandatory Document:

IAF MD 7:2010 Harmonization of Sanctions
(Issue 1, issued on 15 September 2010; Application from 15 September 2010)
Mandatory document which clarifies situations where sanctions are to be applied to applicant or accredited Conformity Assessment Bodies.

[Sidney Vianna]

Two additional mandatory documents have been added to the series:

IAF MD 8:2011 Application of ISO/IEC 17011 in Medical Device Quality Management Systems (ISO 13485)
(Issue 1, issued on 15 July 2011; Application from 15 July 2012)
The objective of this Mandatory Document is to enable accreditation bodies to harmonize their application of ISO/IEC 17011 for the accreditation of bodies providing audit and certification to ISO 13485.

IAF MD 9 :2011 Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485)
(Issue 1 Version 2, issued on 15 July 2011; Application from 15 July 2012)
Sets out the general requirements for bodies operating audit and certification of organizations' Quality Management Systems in accordance with ISO 13485.

[Sidney Vianna]

And another 2 Mandatory Documents have been added to the list:

IAF MD 10:2013 Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021: 2011
(Issue 1, issued on 11 February 2013; Application from 11 February 2014)
Provides a harmonised approach to how Accreditation Bodies assess a Certification Body’s management of competence in accordance with ISO/IEC 17021:2011.

IAF MD 11:2013 Application of ISO/IEC 17021 for Audits of Integrated Management Systems (IMS)
(Issue 1, issued on 25 March 2013; Application from 25 March 2013)
Provides requirements for the application of ISO/IEC 17021 for the planning and delivery of audits of IMS and, if appropriate, the certification of an organization’s management system(s) against two or more sets of audit criteria/standards