There is a significant overlap between the two standards, namely ISO 9001 and ISO 13485, with the latter covering most of the requirements of the former. However, ISO 13485 still does not encompass all the requirements of ISO 9001 and hence any medical devices manufacturer wishing to implement the requirements of both should address them by establishing an integrated quality management system.
The integrated quality management system shall ensure that the quality manual be prepared covering the requirements of both standards with reference to specific clauses without having to prepare two separate quality manuals. Even though most of the quality procedures align perfectly with each other, it is important however that we specifically mention all the details that would cover the requirements of the both the standards. For instance preparing a document to list out the internal and external issues faced by the organization is an exclusive requirement of ISO 9001 and should be prepared as a part of the integrated quality management system.
Further Correspondence between ISO 13485:2016 and ISO 9001:2015 that are the latest versions of the respective standards can be found as Annex B in the ISO 13485:2016.
For many companies the ISO 9001 provides a very strong basis of quality management system and support their organization strategic planning; however, with the implementation of ISO 13485, a broader risk management can be implemented and compliance can be demonstrated to multiple regulatory and legal requirements. ISO 13485 includes both ISO 9001 requirements and new medical devices and related services requirements and it will only be advisable to implement both the systems at once to save money, time and efforts.
Maven ProfservSeptember 26th, 2023
In the field of medical device manufacturing, risk...Read More
Maven ProfservAugust 3rd, 2023
In the medical device industry, a Clinical Evaluation...Read More