ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes, "Medical devices -- Quality management systems -- Requirements for regulatory purposes".

ISO13485 is an international standard that specifies the requirements for a quality management system for organizations that design and develop, manufacture, install, and service medical devices, as well as design, develop, and provide related services, including manufacturers of materials or components used in medical devices. The standard is drawn from the same basic principles as ISO 9001, but with more emphasis on aspects such as documentation, work environment, risk management, design controls and medical device reporting to comply with regulatory requirements.

The ISO 13485:2016 standard came into effect on March 1!

1. There are a lot of changes and improvements in the new standard, among which the key areas are:

(1) the need for a risk-based quality management system (QMS) process approach that considers the role of the organization;

(2) Greater emphasis on the responsibilities and commitments of top management and applicable regulatory requirements;

(3) Strengthened controls over suppliers and outsourced activities; and risk management is now emphasized throughout the product life cycle.

2. How long will the company transition to the new standard?

A transition period of three years from the ISO 13485:2016 publication date.

3. What should manufacturers, especially those with dual ISO 9001 and ISO 13485 certification, pay attention to?

One of the key factors moving forward for manufacturers holding ISO 9001 and ISO 13485 certifications is the different formats of the two standards. ISO 9001:2015 follows Annex SL - Generic text and high-level structure, while the revised ISO 13485 standard will maintain the ISO Guide 83 format.

4. Why doesn't the revised ISO 13485 follow the Annex SL framework?

Although the revision of ISO 13485 follows the revision of ISO 9001, work on the revision of ISO 13485 actually started in 2010, before the revision of ISO 9001 and other management standards. Therefore, it was decided that the current revision of ISO 13485 maintains the ISO Guide 83 format.

5. Will the ISO 13485 standard be consistent with Annex SL in the future?

Although the current revisions do not have any plans to align ISO 13485 with Annex SL, it is expected that all future revisions to this standard after ISO 13485:2016 have adopted this format, given that all newly revised ISO management systems standards have adopted this format. Appendix SL will be followed.

6. How is ISO 9001:2015 related to ISO 13485:2016?

Annex B of the revised ISO 13485 standard provides a content comparison with ISO 9001:2015.

7. Is it possible for manufacturers to adapt their own management systems to meet both ISO 9001:2015 and ISO 13485:2016 requirements?

possible. However, a management system should take a process approach in order to comply with each or both of the standards. Therefore, a company process that meets both criteria should be established and evaluated.

Although ISO 13485:2016 does not contain requirements for other management systems, the standard enables an organization to align or combine its own quality management system with related management system requirements. Therefore, organizations can adapt their existing management systems to establish a quality management system that complies with the requirements of ISO 13485:2016.