The auditing

An audit (or auditing) examines whether the processes meet all relevant legal requirements and guidelines as well as applicable standards. Audits are carried out by specially trained people (auditors).

As part of quality management, the audit has the character of an audit and provides proof of compliance with the requirements.

DIN ISO 9000: 2015: Audit is...
...systematic, independent and documented process for obtaining objective evidence and its objective evaluation to determine to what extent audit criteria are met...

Depending on the focus of the audit, one speaks of:

  • System audit (conformity of a QM system with the requirements of a standard)
  • Process audit
  • Product audit

Depending on the destination and location of the audit, one speaks of:

  • Supplier audit
  • Unannounced audits
  • Internal audits

ISO 13485 audit

A so-called ISO 13485 audit represents an essential step on the way to marketing a medical device. It is the most important audit for the manufacturer, since the successful completion of this audit is a prerequisite for obtaining a certificate according to ISO 13485. Such an audit will be carried out by a "Notified Body". These positions are accredited, mostly private companies that perform sovereign tasks, among others. in the "approval" of medical devices.

FDA Inspection

The FDA (US Food and Drug Administration) is the responsible authority in the United States for the monitoring of food and pharmaceuticals, medical devices, cosmetics and tobacco products, their production and manufacture. This authority has very extensive powers.

If significant defects are found during an inspection in the company and these (also subsequently) are classified as significant by the inspector or the measures and statements of the entrepreneur are assessed as inadequate, the FDA sends a warning letter, which is also published. If, from the FDA's point of view, there is also no substantial answer, the FDA can issue an import ban for the USA for the inspected production site.

FDA inspections can also be carried out unannounced.

ISO 9001 or combined ISO audits / internal audits

In addition to the certification or surveillance audits, all companies that use a quality management system (QMS) according to ISO 9001 or high-level ISO management systems must carry out internal audits. It is checked whether all current conditions of a quality management system meet the target requirements. Furthermore, potential for improvement is sought. Such audits are carried out internally by trained auditors.

Some companies have certified their quality management system according to more than one ISO standard, a so-called combined management system, or have a QMS according to standards that cannot be certified. Internal audits are an integral part of such QMS.

You can have us carry out internal audits as external auditors, since we are independent consultants and not members of a "Notified Body" or the FDA (no inspectors)


Our services

We can support and advise you as follows

QiP GmbH is not a "Notified Body" or an FDA inspector. We therefore do not carry out these audits / inspections, but we can prepare and accompany you so that they can be successfully completed to your satisfaction without any problems.

  • External audits, e.g. System audit, supplier audit, auditing of contract manufacturers
  • Internal audits
  • Mock audits (e.g. to prepare an FDA inspection or certification audit according to ISO 13485)
  • Co-monitoring
  • Document audits, e.g. QM manual (QMH), technical documentation (TD), CTD dossier, approval documentation, etc.
  • Clinical trial audit, e.g. Trial Master File (TMF, study folder), study documents, on site (test centers)

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