- Quality Manual in MS Word format for ease of editing
- Quality Manual includes updates to the documented information required to cover both the ISO 13485:2016 requirements and Part 820 of the QSR (21 CFR 820) regulations.
- Includes 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) written in MS Word or Excel for easy customization.
- Text to address each requirement of the ISO 13485:2016 Standard
- Very clear instructions in obvious Blue Text to show you where to customize your Manual and Procedures
- Required references to the recommended procedures and forms for your quality management system
- Intuitive architecture for easy Document Control
- We’ve numbered the sections of the Quality Manual to correspond with the sections of the ISO 13485:2016 Standard. Registrars LOVE this feature!
- Procedure and Form numbers relate to the section in the Quality Manual.
- This is a downloadable product.
- You will also have the option of purchasing the files on a Jump-Drive during checkout but it is not necessary.
What is included in the Documentation? The Integrated ISO 13485:2106 and FDA-QSR 21 CFR 820 Documentation Package is prepared and ready for customization to your specific company needs and contains:
- The Quality Manual – QMD-002,
- 13485 FDA QMS versus Requirements
- The QMS-Procedures-Forms flow down matrix,
- The QMS-Template Instructions,
- The QMS Procedures – (27)
- The QMS Forms – (44), Attachments – (3) and Templates – (3).
Documenting and Implementing ISO 13485 and FDA-QSR-21CFR-820 To help you meet ISO 13485 and FDA QSR requirements we have developed an integrated management with the documentation that is the perfect solution to create an ISO 13485 / FDA QSR compliant QMS from scratch or upgrade your existing ISO 13485 QMS to become FDA QSR compliant. What is 21 CFR 820? Title 21 of the Code of Federal Regulations (CFR) covers the broad area of food and drugs
- Part 820 outlines
- Quality Systems for medical device manufacturers.
- Current Good Manufacturing Practice (CGMP) requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.
- These requirements are meant to ensure that medical devices are safe, effective, and in compliance with the Federal Food, Drug, and Cosmetic Act.
Where do they each apply?
- ISO 13485 is a global standard that is voluntary in the US but required in some countries. Third party registrars (CB’s) conduct audits to ensure conformance.
- The Food and Drug Administration enforces 21 CFR 820.
- 21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including imported products.
Relationship between FDA-QSR 21 CFR 820 and ISO 13485:2016? They have several differences between them. ISO 13485:2016 is a standard based on ISO 9001:2008 that is specific to medical devices. While the FDA-QSR has more stringent or prescriptive requirements for production and process controls, for device labelling, for device master record, for device history record, for complaint handling & reporting, the requirements of the ISO standard are aligned with the FDA regulations and both can be integrated in one management system to save you time and money.
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 QMS||13485:2016 QMS with FDA||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 13485:2016 to FDA Upgrade Instructions||$199.00|
|ISO 13485:2016 / 9001:2015 Combined QMS||$497|
|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|