In most cases, an audit of the quality management system by a notified body is a prerequisite for manufacturers of medical devices to be allowed to market their devices in Europe.
The FDA also audits quality management systems but refers to inspections rather than audits.
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ISO 9000:2015 defines the term audit as follows:
systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.
Depending on the focus of an audit, there are:
A distinction is also made between
System audits/audits of the QM system are the most important ones for medical device manufacturers. If successful, they will receive a certificate authorizing them to place their devices on the market in Europe.
Please also note the overview article on QM systems and the FAQ on QM systems and certifications.
An audit by a notified body is the prerequisite for the notified body to issue a certificate (in accordance with ISO 13485 or Annex IX). This certificate in turn is the prerequisite for placing devices on the market, at least for products of higher risk classes.
Manufacturers may only place their devices on the market on the basis of certificates from a notified body. There are other certification bodies whose ISO 13485 certificates are worthless. There are also providers who are not even accredited for ISO 13485.
The FDA now also requires conformity with ISO 13485 but does not require certificates. It reviews conformity as part of FDA-inspections. However, unlike audits, inspections do not end with a certificate if they are successful.
The International Medical Device Regulators Forum (IMDRF) has launched the Medical Device Single Audit Program MDSAP: An MDSAP audit can be used to fulfill the regulatory requirements for audits and inspections of QM systems.
ISO 19011 describes the requirements for audits (i.e., their planning, implementation and documentation) and for auditors.
Further determinations specify the duration of audits.
If an auditor certifies a “non-conformity”, this can lead to the notified bodies refusing or withdrawing the certificate. In principle, what the auditor checks is known (see Fig. 1):
Fig. 1: Auditors check during the audit the conformity of the QM system with normative and legal requirements as well as the conformity with the company’s own QM system.
In a notice, the EU has regulated in more detail when and how notified bodies may carry out remote audits:
Calls for the possibility to take temporary extraordinary measures, including remote audits, related to notified body on-site audits under the medical devices Regulations have been made by industry as well as notified bodies.
The MDCG has published a Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.
In it, it allows facilitations, e.g:
Do you still have questions, for example about setting up your QM system? Then take advantage of our free micro-consulting service.
The consultants at the Johner Institute not only support you in setting up QM systems, but also audit these systems and prepare you for audits (e.g., with mock audits and mock inspections).
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This seminar will give you the competence you need to act as an internal auditor.
In 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.
This 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.
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