The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. ISO 13485 ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
ISO 13485 requires more attention to regulatory requirements and the exception of 9001’s requirement of continuous improvement. ISO 13485 only asks for the QMS to be implemented and maintained.
For more information on ISO 13485 please see our tutorial: Basics of ISO 13485 which covers:
- What is ISO 13485?
- Why become ISO 13485 Registered?
- What are the requirements of the Standard?
- What are the steps to certification?
- And more…
Comparing ISO 9001 to 13485 compares ISO 13485 to ISO 9001, and outlines their:
- Similarities
- Differences
- Comparison of the two written standards
- And more…
To learn more about the Medical Device terminology, please view: ISO 13485 Definitions which covers:
- Medical Device definitions
- Medical Device classifications
- Regulations
- 21 CFR 820 and more…
Medical devices - Quality management systems - Requirements for regulatory purposes
Available for SubscriptionsAvailable in Packages- ISO 13485 / 14971 / 14969 - Medical Devices Package
- ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package
- ISO 13485 and ISO 14971 - Medical Devices Package
- ISO 13485 / ISO 9001 - Medical Devices Quality Management Set
- ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package
- ISO 13485:2016 and ISO 13485:2003 - Medical Devices Transition Set
- ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set
Content Provider
International Organization for Standardization [ISO]
Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
Please first verify your email before subscribing to alerts.Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
Already Subscribed to this document.Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
Iso 13485 Audit Checklist Download