Quality Management System Certification

The purpose of the audit step 1 is to:

• ensure that the company fully understands the standard requirements;
• identify and confirm information about the quality management system scope, the sites concerned, and the regulatory and legal aspects with which the company must comply;
• check that the internal audits and the management review have been planned and carried out;
• determine whether the company is prepared to move on to step 2 of the audit;
• confirm the provisions for carrying out step 2 of the audit.

The results of step 1 will be written up in a report and sent to the company.

This report identifies any discrepancies found that could be considered non-conformities in step 2 of the audit. Depending on the step 1 audit results, step 2 may be postponed or canceled.

The audit consists of a conformity assessment and an assessment of the effective implementation of the quality management system by the company to meet the defined standards.

The audit is carried out by a single qualified auditor or a team of qualified auditors according to the terms set out in ISO 17021-1 and the criteria defined by GMED Group.

During the audit closing meeting, the audit team provides the company with its conclusion and the list of nonconformities that were identified.

For each identified nonconformity, the company submits its root cause analysis and action plan, including corrections and corrective actions.

The audit team finalizes its report, considering the company’s responses.

A GMED Group designated representative, independent of the audit team, analyzes the audit report. The report is then submitted for an opinion and recommendation to the specific GMED Group entity’s internal Comité de lecture (GMED) / decision panel (LNE-GMED UK) which in turn proposes a certification decision.

Based on the audit report, the lead auditor’s conclusions, and the Comitéde lecture (GMED) / decision panel (LNE-GMED UK) opinion, the decision is announced. The company is notified of the decision and, if applicable, one or more certificates are drawn up.

Companies maintain their certification based, firstly, on the commitments they make at the time of application and, secondly, on observations made during follow-up audits, which are conducted at least once a year. If significant changes are made, there may be additional audits to verify that the company is maintaining its quality management system.