- 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
- 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 2nd 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!
- Essentially, the documentation package for the management system will contain:
- One condensed Manual to introduce the documented information required for both standards.
- An existing group of ISO 9001:2015 QMS documents with updates to reflect a document numbering system related to the clause numbers and to incorporate the upgrades for the requirements of ISO 13485:2016
- Existing forms and attachments needed for the documented information and systems.
Which version is right for me?
- Choose 13485:2016 to create a new 13485 Quality Management System
- Choose 13485:2003 to 13485:2016 QMS instructions to modify your existing 13485 QMS to meet the 13485:2016 requirements
- Choose 13485:2016 FDA QMS Upgrade to develop an integrated management system that is 13485 and FDA.QSR (21 CFR 820) compliant as of April 2016 (this is the reference date of the CFR)
- Choose ISO 9001:2015 / 13485:2016 QMS to align ISO 13485:2016 (8 section format) with ISO 9001:2015 (10-Section Annex SL Format).
- This QMS is for organizations (like Contract Manufacturers) who want ONE QMS for both ISO 9001:2015 and ISO 13485:2016.
- Quality Management System Templates covering both the ISO 9001:2015 (Annex SL 10-section format) and ISO 13485:2016 (8-Section format) in ONE combined, Annex SL manual.
If you plan to reconfigure your existing quality manual completely by yourself, you can use either of the Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide any procedure or form templates for the new requirements.
|Price Each||9001:2015 to 13485:2016 QMS Instructions||13485:2016 QMS||13485:2016 FDA with QMS||13485:2016 / 9001:2015 Combined QMS|
|ISO 13485:2016 Quality Manual (not sold separately)||$97.00|
|ISO 13485:2003 to 2016 Upgrade Instructions||$199.00|
|ISO 9001:2015 to 13485:2016 Upgrade Instructions||$199.00|
|ISO 13485:2016 to FDA Upgrade Instructions||$199.00|
|ISO 13485:2016 / 9001:2015 Combined Quality Manual (not sold separately)||N/A|
|ISO 13485:2016 Procedures||$300.00||26||27||26|
|ISO 13485:2016 Forms||$100.00||48||50||65|
|ISO 13485:2016 Flow Charts||$75.00||23||23|