ISO 9001 & ISO 13485 - IQMS

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    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.

    ISO 9001-13485

    Benefits of having an Integrated Quality Management System:

    • Having both certifications in place will ensure that we cater to the needs of the customers that need both, a broader quality standard (ISO 9001), and ISO 13485 certification to prove their compliance to medical device market requirements. This can also help a manufacturer have a competitive edge over their competitors.
    • Having an integrated management system from the start reduces the efforts to pursue either one of the certification in the future and having to update the entire quality management system. You can avoid having to review and update all the policies and procedures in the future.
    • It further reduces the cost and other related expenses that come with getting two certifications at different times i.e. the certification body charges for twice the review and audit of the functions.
    • It greatly reduces the burden of preparing for and facing two, different surveillance audits every year.
    • It also reduces the effort of training the employees multiple times during implementation of different certifications and would give them a clear indication of how records have to be filled keeping in mind the requirements of both standards.

    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.

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