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 a Standard Operating Procedure (SOP), companies define their processes, for example how they develop medical devices or provide services. Standards such as ISO 9001 and ISO 13485 require Standard Operating Procedures. Companies can define these specifications in their quality management manual directly or in independent documents. 1. Standard Operating Procedures: introduction, definitions a) Definition ISO…
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. 1. Regulatory requirements a) Requirements of ISO 13485 The requirements of ISO…
DetailsThe MDR and IVDR, as well as ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, supplier selection, and supplier monitoring. This article not only gives you an overview of the regulatory requirements. It also gives you tips on how to implement them and tells you when a supplier audit is necessary. 1. Basics of supplier management a) Examples…
DetailsInternal audits are inspections of the quality management system (QM system) and its processes by the organization itself. This is why they are also called 1st party audits. ISO 13485 requires internal audits like its “sister standard,” ISO 9001, and other standards and regulations. Therefore, internal audits are also a subject of external audits and…
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. Process validation: What is it exactly? a) Definition…
DetailsMedical device manufacturers are obliged to observe and comply with legal retention periods for documents and records. This article provides an overview of the regulatory requirements for the retention periods for the various document classes. 1. Retention periods for different classes of documents The legal requirements regarding retention periods usually distinguish between the following types…
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…
DetailsThe FDA requires a Design History File DHF in 21 CFR Part 820 (these are the “Quality System Regulations”). DHF should not be confused with the Device History Record DHR or the Device Master Record DMR. This article explains what the Design History File must contain and how it differs from the other two “files.” Design History File The FDA requires…
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