Quality Management System Certification
Certification for your quality management system gives you an indispensable tool to access international markets, to consider calls for proposals, and to improve your customer relations.
GMED certifies quality management systems based on the reference standards used by medical device companies: ISO 9001, NF EN ISO 13485, ISO 13485.
- Gathering of information from the applicant manufacturer
- Analysis of information in relation to GMED’s recognition
- Initial audit preparation and planning
- Issuance of interim report to the company
- Submission of action plan by the company, if needed
- Delivery of action plan analysis
- Finalization of audit report and transmission to the company
- Surveillance audit: 1st year
- Surveillance audit: 2nd year
QMS Certification: 6 Key Steps for Manufacturers
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.
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 designated representative, independent of the audit team, analyzes the audit report. The report is then submitted for an opinion and recommendation to GMED’s internal Comité de lecture which in turn proposes a certification decision.
Based on the audit report, the lead auditor’s conclusions, and the Comité de lecture 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.
GMED issues certificates in accordance with international certification rules as set out in ISO 17021-1.
GMED Certification Rules for Quality Management Systems (QMS)
GMED QMS certification processes, in accordance with the rules applicable to quality management system for design, production, distribution or service provision in the health care and medical devices industry.
Focus on Medical Devices
GMED certifies Quality Management Systems for companies in the health care and medical devices industry.