IAF MD9:2017, applicable to ISO 13485 - Medical devices - management systems

Action required

In order to accomplish this, the following approach will be used.   

• First the certification body shall apply for a scope extension to add any new technical areas as per the changes from the 2015 version to the 2017 version of IAF MD9.
• Secondly, a desk review will be conducted by a qualified SCC assessor.  All updated management system documents must be submitted along with evidence that qualified auditors and other responsible personnel are trained to the requirements of IAF MD9:2017. 

Included in the desk review will be these documents submitted to SCC by the CB:

• Transition Plan (if applicable)
• Auditor Records (a minimum of 5) 
• Training records for responsible personnel (a sample) 
• Updated Management System policies and procedures
• Any other applicable documents 

An updated Scope of Accreditation will be prepared by the SCC assessor upon completion of the above activities. This review/transition assessment is billable to the certification body.

Implementation and effectiveness of the mandatory document will be verified during the next scheduled on-site assessment.

Affected customers

All accredited management systems certification bodies who are currently certifying organizations to ISO 13485: 2016 - Medical devices - Quality management systems - Requirements for regulatory purposes must transition to the new version of IAF MD9:2017.

Auditors, and assessors working in the area of medical device management systems (ISO 13485).

Background

IAF MD 9 was published on June 9, 2017, and was effective as of June 18th, 2018.

New requirements

The technical areas listed on Table A1.7 - Parts and Services were added to this version of the document.

Deadline

All transition desk reviews must be complete by October 31, 2019. 

Questions?

Please contact Elias Rafoul, Vice President, Accreditation Services, at elias.rafoul@scc-ccn.ca or +1 613 238 3222 for more information.