Transition to IAF MD9:2022.
Accredited management systems certification bodies that are currently certifying organizations to ISO 13485: 2016 - Medical devices - Quality management systems - Requirements must transition to the new version of IAF MD 9:2022 (PDF) for regulatory purposes.
The following activities will take place as part of the transition:
- The certification body applies for a scope extension to add any new technical areas as per the changes to the 2022 version of IAF MD 9, where applicable.
- A document review is conducted by a qualified SCC assessor, in preparation for the head office assessment. 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 MD9:2022, at least 30 days prior to the assessment start date.
- The implementation of the applicable changes will be verified at the next scheduled head office assessment.
Included in the document review will be these documents submitted by the certification body to SCC:
- 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.
All applicants and accredited management systems certification bodies that 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 MD 9:2022 (PDF).
Auditors and assessors working in the area of medical device management systems (ISO 13485).
IAF MD 9:2022 (PDF), Issue 4 was published on February 1st, 2022, and will be in effect starting February 1st, 2023.
2. Normative references - IAF MD 11 IAF Mandatory Document for Application of ISO/IEC 17021 for Audits of Integrated Management Systems was added to the normative references section on page 5.
5.1 Legal and contractual matters - MD 5.1.2 – was added to the requirements on page 8. It indicates that the CAB shall establish appropriate agreements with their clients to release audit report information to regulators that recognize ISO 13485.
Several changes were made to Annex A (Normative)
- Changes were made to the Main Technical Areas in Table A.1.1 – 1.6 on page 18, which applies to finished medical devices. It now indicates that where the CAB applies for a scope of accreditation for a technical area that has “other than specified above” in the description of the technical area, the CAB shall provide a list of medical devices and include their risk classification to the AB.
- On page 18, it is now indicated that the information provided shall also include a concise statement of the intended purpose of the medical device, and the technical area “Other than specified” may only be used when no other category is applicable. A risk classification should be determined using an appropriate national, regional, or international risk classifications.
- A note was added on page 25 related to “Components, Subassemblies, Maintenance services, Other services (Consulting services related to medical devices)” listed in Main Technical Areas Table 1.7
Several changes were made to the Consideration for suppliers of “Parts and Services” section in Annex B (Normative)
- Table B.1. on page 26 was added
- Table for Knowledge and Skills on page 27 is now referenced as Table B.2, and requirements were added for Parts and Services Auditor (REF Table A.1.7)
- In Annex C – Auditor qualification, training, and experience on page 28, the following was added in section C.2 – Work Experience: Auditors performing audits of organizations solely under Table A.1.7 shall only meet the requirements of ISO/IEC 17021-1 and ISO/IEC 17021-3 and not those in C.2.
- In Annex D (Normative) on page 30 under the section Factors used to determine the audit time, the following were added: i) related to audit time and ii) related to complexity of medical devices.
- Annex D – Conducting ISO 9001 and ISO 13485 Together was added on page 31, and indicates that when determining the required time for conducting an ISO 9001 and ISO 13485 audit together, a minimum of 25% will be added to the minimum number of audit days calculated per Annex D. Conditions where additional time may be required include differences in scope, effective number of personnel, etc. This applies whether the CAB is conducting an integrated audit or a combined audit.
The office assessments must be completed no later than November 30th, 2022, to ensure the transition approval is received prior to the February 1st, 2023 deadline.
Please contact Abdel Kassou, Manager, Compliance and Assessment Services, Accreditation Services, at firstname.lastname@example.org or +1 613 238 3222 ext. 443 for more information.