Mark Hammar
January 21, 2015
Implementation, maintenance, training, and knowledge products for Information Security Management Systems (ISMS) according to the ISO 27001 standard.
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Implementation and training products for medical device Quality Management Systems (QMS) according to the ISO 13485 standard.
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Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
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Note: This article was updated according to the ISO 13485:2016 revision.
ISO 13485 is the international standard requirement for a medical device quality management system. Like many other quality management system requirements for special purposes (such as IATF 16949 for automotive production and service parts and AS9100 for use by aviation, space and defense organizations), the ISO 13485 standard is based on the requirements of ISO 9001.
Just like these other standards, ISO 13485 includes the entire ISO 9001 standard with additional requirements included in blue italics text. One major distinction of ISO 13485 is that it is intended to also be required for regulatory purposes as well as a non-statutory requirement for a quality management system.
Until the introduction of the high-level structure in 2015, ISO 9001 and ISO 13485 were very similar standards and it was very easy to build a quality management system that met the requirements of both of them. However, today the situation is slightly different because ISO 13485:2016 still supports the structure of old ISO 9001 revision (from 2008).
The question everyone is asking is why 13485:2016 is so different from 9001:2015, when 13485:2016 came out just 6 months after 9001:2015 was released. Unfortunately, corrections on the ISO 13485:2003 took a long time. The new version of ISO 13485 was ready to be released in 2016 although it relied on ISO 9001:2008. So, when ISO 9001:2015 was finally released with the new structure, 13485:2016 was also already ready for release with the ISO 9001:2008 structure. The ISO organization decided to release 13485 with the old structure.
For information on the differences between ISO 9001:2015 and ISO 9001:2008, see Infographic: ISO 9001:2015 vs. 2008 revision – What has changed?
Besides these differences in the structure, there are also similarities between ISO 9001:2015 and ISO 13485:2016:
In ISO 13485:2016, the manufacturer must show compliance with regulatory requirements in 58 places. For comparison, in ISO 9001:2015 the term ‘’regulatory requirements’’ is only mentioned 11 times.
After some information added in the introductory section that mainly tailors the text to the medical device industry, the first inclusions are in the terms and definitions. There are 14 new terms used by the medical device industry. The differences between manufacturers, importers, distributors, and terms such as clinical evaluation and post-market surveillance are specifically explained.
Listed below are additional requirements for ISO 13485:2016 when compared to ISO 9001:2015:
Clause 4 – Quality Management System
Clause 5 – Management Responsibility
Clause 6 – Resource Management
Clause 7 – Product Realization
Clause 8 – Measurement, Analysis and Improvement
If your organization is at all involved in the medical device industry, ISO 13485 is the QMS standard you should look at for additional requirements above and beyond ISO 9001.
To implement ISO 13485 easily and efficiently, use our ISO 13485 Documentation Toolkit that provides step-by-step guidance and all documents for full ISO 13485 compliance.
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