ISO 9001:2015 to ISO 13485:2016 QMS Transition Instructions

These instructions allow you to upgrade your ISO 9001:2015 Quality Management System (QMS) to include the ISO 13485:2016 requirements for the medical devices industry while retaining the High Level Structure (HLS) of Annex L. The standards are compatible with each other and have common requirements, but their structures are different:

ISO 9001:2015:

• Clause 4          Context of the organization
• Clause 5          Leadership
• Clause 6          Planning
• Clause 7          Support
• Clause 8          Operation
• Clause 9          Performance evaluation
• Clause 10        Improvement

ISO 13485:2016:

• Clause 4          Quality management system
• Clause 5          Management responsibility
• Clause 6          Resource management
• Clause 7          Product realization
• Clause 8          Measurement, analysis, and improvement

You have the ISO 9001 version in place and now have the objective of upgrading the system to include the ISO 13485 requirements. The good news is that since you are familiar with formal management systems, this initiative will be relatively straightforward.

The detailed instructions focus on the areas of the documentation required for the QMS.

• The intent of the main ISO 9001 clauses is shown in blue font,
• The text in italics in the 2^nd right hand column indicates where requirements are included in ISO 13485:2016.
• Use copies of the two standards along with this instruction to pinpoint for your organization the areas that need attention.
• Make notes and add comments in the space available to the right and the left of the column for reference documentation.
• Use the upgrade checklist section on the right side of the table to assign the responsibility for the upgrade and to follow up on its completion.
• Throughout the checklist, reference is made to documented information and the typical procedures and P-xxx numbers that can be found in our combined documentation package for ISO 9001:2015 / ISO 13485:2016.

Included with the transition checklist is the work instruction WI-870-001 dealing with Advisory Notices and Product Recall and referencing various links to FDA and other information and reporting forms. The requirement for notices and recalls is specific to ISO 13485:2016 and is included in the documentation package, but with an effective QMS in place, most medical device companies will not need to deploy the work instruction – it is there, just in case!