ISO 13485 is a harmonized standard that formulates requirements for Quality Management (QM) or QM systems (QMS) of medical device manufacturers.
These manufacturers can use ISO 13485 to prove that they meet the MDR and IVDR legal requirements for a QM system. Even the FDA references ISO 13485 in its Quality System Management Regulations (21 CFR part 820).
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On this page, you will find links to articles that will help you set up, operate, and audit Quality Management Systems:
The FAQ on quality management systems and ISO 13485 is a valuable introduction and answers the following questions, among others:
There are many standards and versions defining requirements for quality management:
You can find ISO 13485 as a PDF for download from the Estonian standardization organization, not free of charge but at a reasonable price.
In contrast to ISO 9001, ISO 13485 requires organizations to have a QM manual. This manual must describe the quality objectives and quality policy.
The Quality Management Representative (QMR) usually maintains this manual.
ISO 13485 requires you to describe your processes and procedures. This is usually done with the help of standard operating procedures and work instructions, which, in turn, reference other specification documents such as templates, forms and checklists.
This article provides you with an overview of the necessary standard operating procedures. When writing these standard operating procedures, it is advisable to choose a risk-based approach.
Another article describes the differences between process orientation and process management.
You will find further articles on specific standard operating procedures:
ISO 13485 insists on the validation of processes and tools. Please refer to the following articles:
The effectiveness of the QM system is checked as part of external audits by notified bodies and internal audits. The internal auditors are responsible for the latter.
Part of these audits must also include supplier audits. Furthermore, notified bodies are obliged to carry out unannounced manufacturer audits.
At least for the external audits, there are specifications regarding the audit duration. The Medical Device Single Audit Program (MDSAP) also determines requirements for the duration and subject matter of the audits. This enables manufacturers to prove that they meet the regulatory requirements for the QM system in many countries (EU, FDA, Australia, Japan, Brazil).
The following articles are also relevant for organizations that develop medical devices:
Do you still have questions, for example about setting up your QM system? Then, take advantage of our free micro-consulting service.
The Johner Institute supports medical device manufacturers, their service providers, and laboratories in developing and continuously improving QM systems.
The seminars provide you with the necessary competence:
The Medical Device University supports you in setting up your QM system. The program includes:
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DetailsProcess validation is the verification that a process meets the requirements imposed on its process results. Learn when you must validate which processes (in the context of software) and how to ace validation. Furthermore, find out what process validation has to do with PQ, IQ, and OQ. Process validation: What is it exactly? a) Definition…
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DetailsUnannounced audits are random sampling checks of the quality management systems by notified bodies with the aim of Initial experience with unannounced audits is now available. Update: Changes due to the MDR History of unannounced audits The emphasis on unannounced audits is a result of the breast implant scandal, after which the demand emerged to…
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