ISO 9001:2015 uses the new Annex SL 10-section format, while ISO 13485:2016 is still based on ISO 9001:2008 8-Section format, which can make a combined 9001-13485 QMS messy.
This combined QMS is fully integrated into one 10-Section Annex SL based format. This allows you to have one manual for both standards and will save your organization from having to change your QMS when ISO 13485 eventually updates their format to meet Annex SL.
Manual, Procedures, and related forms are included, and the Master Document List is completed and ready for your management system.
The QMS documentation covering both the ISO 9001:2015 QMS requirements and the ISO 13485:2016 QMS for medical devices are fully integrated, related forms are included, and the Master Document List is completed and ready for your management system. Our documents, edited by professional technical writers, have been written in Microsoft Word so you can easily edit and customize them to make them your own. When you have questions, our experts are only an email away.
- In the documentation for the manual, the procedures, and forms, guidance (in blue font) is provided to assist you in customizing them to your unique business. Treat the text in blue as “revisions” or information that is specific to your company.
- Note that the specific additions for ISO 13485:2016, Medical Devices – QMS for regulatory purposes are highlighted in yellow.
- In addition, the correlation between the requirements of ISO 13485:2016 and those of ISO 9001:2015 are provided. In each procedure and instruction, the paragraph 3.1.2 is highlighted in yellow and reflects the corresponding ISO 13485 clause numbers.
- Docs are all numbered for an effective control of documented information and are integrated to work together in a seamless system.
- Together, the docs include the content required by the ISO standards.
- Our documents, edited by professional technical writers, have been written in Microsoft Word so you can easily edit and customize them to make them your own. When you have questions, our experts are only an email away.
- QMD-003 Manual meets the requirements of both ISO 9001 and ISO 13485.
- All documents are written in MS Word or Excel format for ease of editing.
- 24 Procedures describing QMS processes,
- 2 Work instructions to outline specific details,
- 55 Forms referenced by the procedures
- Included in the Quality Manual folder are:
- Matrix that reflects the Documentation Flow-Down- Matrix,
- A “QMS-Docs-List”.
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||13485:2003 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 9001:2015 to 13485:2016 Upgrade Instructions||$199.00|
|ISO 13485:2003 to 2016 Upgrade Instructions||$199.00|
|ISO 13485:2016 to FDA Upgrade Instructions||$199.00|
|ISO 13485:2016 / 9001:2015 Combined QMS||$497.00|
|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|