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.
NOTE: It is assumed that you have in place a COMPLETE ISO 13485 QMS! If not, you may need to purchase additional procedures.
This instruction / checklist is intended for use in upgrading your Quality Management System and integrating the FDA.QSR (21 CFR 820) regulations quality management systems used by organizations involved in the medical devices industry.
The Quality Management Systems are compatible with each other and have common requirements.
In ISO 13485:2016, the requirements are described in (4) main clauses:
- Clause 4 Quality management system
- Clause 5 Management responsibility
- Clause 6 Resource management
- Clause 7 Product Realization
- Clause 8 Measurement, analysis and improvement
In QSR (21 CFR 820), the requirements are described in (15) main parts; Subpart A through Subpart O, covering General provisions to Statistical techniques.
Essentially, the documentation package for the management system will contain:
- One Manual with updates to the documented information required to cover both the ISO 13485:2016 requirements and Part 820 of the QSR (21 CFR 820) regulations.
- 13485 FDA QMS versus Requirements
- A group of procedure/system documents in your QMS with updates to reflect both the ISO 13485 requirements and the regulations of Part 820 of the QSR (21 CFR 820).
- A group of forms and attachments needed for the procedures and systems.
A 16-page table with detailed instructions focuses on the areas of the documentation required for the integrated quality management system. As you undertake the task of upgrading your quality management system, note that in the left hand column of the instructions, all the ISO 13485:2016 clauses are shown and in the 4th column of the table, corresponding, or related requirements or no correspondence in QSR (21 CFR 820) are indicated in Italics.
Included are several relevant Procedures & Forms for key requirements:
- P-722, Risk management and related forms F-722-001 and F-722-002
- P-751, Production and process controls and typical routing sheets forms F-750-001 and F-750-002
- P-756, Validation of processes for product realization and example form F-756-001
- P-820, Post production feedback and related customer survey form F-821-001
- P-833, Advisory notices and product recall (standard medical devices reporting forms).
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 L 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 L 10-section format) and ISO 13485:2016 (8-Section format) in ONE combined, Annex L 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 FDA with 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||$299.00|
|ISO 13485:2016 to FDA Upgrade Instructions||$299.00|
|ISO 13485:2016 / FDA Combined Quality Manual (not sold separately)||N/A|
|ISO 13485:2016 / 9001:2015 Combined Quality Manual (not sold separately)||N/A|
|ISO 13485:2016 Procedures||$300.00||5||26||27||26|
|ISO 13485:2016 Forms||$100.00||6||48||50||65|
|ISO 13485:2016 Flow Charts||$75.00||23||23|