Many regulatory requirements demand that manufacturers define processes and procedures. Such requirements include, for example, EU regulations (MDR and IVDR), standards such as ISO 13485, IEC 62304, and ISO 14971, and the FDA.
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On this page, you will find references to articles on processes and procedures:
The description of processes and procedures differs in their level of granularity. Processes describe WHAT is done. Standard operating procedures describe HOW something is done.
However, regulatory requirements do not always distinguish precisely between the two.
All instructions must ultimately determine
The processes and procedures are part of quality management. This overview page provides a helpful introduction to the topic of quality management.
The article on creating process and standard operating procedures is helpful. This should only be the task of the QM representative for selected processes.
Once the processes have been defined, they must be subjected to process validation.
Manufacturers should note the difference between process orientation and process management.
All manufacturers must define a development process. They should understand the boundaries and interactions between the development plan and process to do this.
Many manufacturers use agile development models for software development. On the other hand, documentation should follow a model more akin to the V-model.
Part of development involves risk management or the risk management process. Here, manufacturers must also analyze the risks posed by inadequate processes, for example, with a process FMEA (pFMEA).
The processes must cover the entire life-cycle of the devices:
The Johner Institute helps manufacturers of medical devices to establish lean and standard-compliant processes and procedures.
This enables you to develop and launch your devices quickly and safely in the planned time and at the scheduled cost.
Contact us so that we can draw up a plan together on how you can establish these processes and procedures in a short time and at minimal cost.
The ISO 15189 standard “Medical laboratories – Requirements for quality and competence” specifies the requirements for a quality management system for medical laboratories. Laboratories are legally obliged to establish a QM system. According to ISO 15189, laboratories that operate in-house IVD medical devices require a QM system, which must be extended by additional chapters. This…
DetailsManufacturers who wish to place medical devices on the market in the EU must comply with the European Medical Device Regulation MDR. This Regulation (EU) 2017/745 on Medical Devices, as it is officially titled, also imposes requirements on notified bodies, distributors, importers, and health institutions such as hospitals.
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…
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.
DetailsThe EU AI Act has been published. Many manufacturers of medical devices and IVD, as well as other healthcare players, are faced with the major task of understanding the 140+ pages of legal text and complying with the requirements. Note: Infringements/violations of the AI Act are punishable by a fine of up to 7% of…
DetailsThe Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities from different countries with one audit. Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g., with ISO 13485 or 21 CFR part 820). In…
DetailsAQL stands for Acceptable Quality Level and is sometimes translated as “permitted reject rate.” The AQL determines when a batch of parts or products is rejected or accepted based on a random sample inspection. However, auditors regularly no longer accept the AQL. What to do? This article provides answers.
DetailsISO 14971 defines the terms “hazard” and “hazardous situation.” Nevertheless, medical device manufacturers often find it difficult to assign concrete cases to either of the two categories. This article provides help.
What 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…
DetailsDeviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies,
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