13485:2003 to 2016 QMS Upgrade Instructions Transition

ISO 13485:2003 to 13485:2016 Quality Manual Upgrade Instructions
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This instruction / checklist is intended for use in upgrading your Quality Management System for the transition from the ISO 13485:2003 version to the ISO 13485:2016 version for Quality management systems used by organizations involved in the medical devices industry. The above Quality Management Systems are compatible with each other and have common requirements.

You have the 2003 version in place and now have the objective of upgrading the system to the 2016 version. The good news is that since you are familiar with formal management systems, this initiative will be relatively straightforward where documented information for the QMS sets the stage for an understanding of the requirements and of the international standard as a whole.

Essentially, the documentation package for the management system will contain:
  • One Manual with updates to the documented information required for ISO 13485:2016.
  • A group of procedure/system documents in your QMS with updates to reflect a document numbering system related to the new clause numbers and to incorporate the upgrades for ISO 13485:2016 requirements,
  • A group of forms and attachments needed for the procedures and systems.

The documentation will need to be reviewed, upgraded and implemented. The first step is to assign a person responsible for the QMS, such as with a Management Representative to become familiar with the changes for 2016 version of the ISO 13485:2016 standard. Visit http://13485store.com/ for training materials, resources and information on quality management systems requirements.

The following table with detailed instructions focuses on the areas of the documentation required for the ISO 13485:2016 quality management system. As you undertake the task of upgrading your quality management system from the 2003 version to the 2016 version, note that in the left hand column of the instructions, the ISO 13485:2016 clauses shown in bold numbers have changes from 2003 to 2016. The intent of the main clauses is shown in blue font and the text in italics indicates where requirements were included in previous ISO 13485:2003.

Use a copy of the ISO 13485:2016 standard along with this instruction to pinpoint for your organization the areas that need attention. You may want to 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.