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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In 21 CFR part 11, the FDA establishes its requirements for electronic records and signatures, which also apply to medical device manufacturers. A lot of companies print everything out on paper and then sign it by hand to circumvent the requirements of part 11. Is this really necessary?
DetailsWhat MDR and IVDR confuse and why you should not talk about CAPA. The FDA (in 21 CFR part 820 – QSR) and ISO 13485 differentiate between Unfortunately, the MDR and IVDR do not clearly differentiate between these concepts. Some manufacturers also believe they can combine corrective and preventive actions into one single CAPA process. But…
DetailsIn 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among others. Thus, 21 CFR part 820 (Quality System Regulation QSR) is or was the counterpart to ISO 13485.
For many manufacturers of medical devices, an FDA inspection is associated with great stress. Many companies are aware of the possible consequences, such as a public warning letter and even criminal prosecution. But they often don’t know how to avoid these consequences without shutting down the entire company for days. This article shows how This…
DetailsThis FAQ provides answers to the most common questions that companies such as medical device manufacturers have about quality management systems (QM systems) and ISO 13485.
The digitalization of the production is an essential part of the digital transformation of manufacturing companies. However, not all companies benefit to the same extent from digitalization. This article describes,
DetailsThe QM manual is the top document in the document pyramid of the QM system. It is an entry point for employees and auditors to get a quick overview of the QM system. In this article, you will learn when you need a QM manual, its objectives, and what it should contain.
DetailsThe Quality Management Representative (QMR) is also called the quality representative or “management representative” by ISO 13485. In this article, you will learn which tasks the person with this role is responsible for within an organization and which regulatory requirements must be observed.
DetailsA Quality Assurance Agreement (QAA) is a contract between companies such as medical device manufacturers and their suppliers (subcontractors). In these contracts, both parties regulate which obligations the suppliers must fulfill regarding the quality of the devices and services supplied. Find out in this article what content a Quality Assurance Agreement should contain and when…
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.
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