Consulting
Audits

Audits in medical device industry

An audit is generally defined as an analysis procedure aimed at evaluating processes against predefined guidelines and specifications to meet standards. These analyses are carried out by specially trained auditors. As independent consultants, we offer you mock audits, for example, to identify major and minor deviations BEFORE the actual audit takes place.

Internal audit
Internal audit
An internal audit is recommended to check the level of performance. We will gladly take over this task for you.
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Supplier audit
Supplier audit
Suppliers are selected and controlled with care. We can support you in this process.
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Mock Audit
Mock Audit
Like a dress rehearsal, as external auditors we check whether your company is ready for the actual audit.
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GAP Audit
GAP Audit
Determine the difference between actual and target and develop a project plan. We can take over this task for you.
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Internal audit

To guarantee quality in your company in the long run regular reviews and the implementation of appropriate measures are of great importance. An auditor plays an indispensable role in the long-term positive development of your management system.

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Internal audit

Supplier audit

These audits serve either to qualify suppliers before the first delivery or to further develop suppliers in accordance with the internal audit programme or supplier assessment of a company. The supplier auditor is a specially trained person carrying out audits of suppliers independently of the company or division or department for which the auditor is working.

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Supplier audit

Mock audit

Prior to any external audit, e.g. from customer, any authorities or business partners it is advisable to conduct a mock audit comprising approximately the scope of the audit agenda of the auditing body. This serves to be up to date on the current status quo of its own management systems and procedures as well as to safeguard against major or minor deviations found by others in its own system. This approach can avoid costly changes or repeated audits possibly calling your company's business into question.

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Mock audit

GAP Audit

Management systems are regulated by standards or norms and must be regularly adapted to changes in the sector and industry. A special type of audit, the gap analysis or also called delta audit, is used to examine weaknesses and differences of the current management system in comparison to the new standard to be introduced. This analysis makes it possible to identify the gaps and initiate appropriate measures to adapt the system.

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GAP Audit

Do you want to train auditors in-house? Visit the NEMIUS Academy for seminars and in-house trainings.

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