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.
Sections
ISO Certification for Medical Devices
GMED Group certifies quality management systems according to the standards used by medical device companies, including ISO 9001, NF EN ISO 13485, and ISO 13485.
In particular, ISO 13485:2016 is the international standard for medical device quality management systems. It demonstrates your commitment to regulatory compliance, product safety, and operational efficiency. As a result, ISO 13485:2016 certification can help you access global markets and strengthen stakeholder trust. Moreover, with GMED’s expert guidance, you can move through the certification process with greater confidence.
Certification Process
- Gathering of information from the applicant manufacturer
- Analysis of information in relation to GMED recognition
- Initial audit preparation and planning
- Audit
- 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
Purpose of the Step 1 Audit
- Ensure that the company fully understands the standard requirements;
- Identify and confirm information about the quality management system scope, the sites involved, and the regulatory and legal requirements the company must meet;
- Check that the company has planned and carried out the internal audits and management review;
- Determine whether the company is ready to move on to Step 2 of the audit;
- Confirm the arrangements 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, which could become non-conformities during 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.
First, a single qualified auditor or a team of qualified auditors carries out the audit in accordance with 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.
Then, during the closing meeting, the audit team presents its conclusions and shares the list of any nonconformities identified during the audit.
For each nonconformity, the company prepares a root cause analysis and submits an action plan that includes both corrections and corrective actions.
Finally, the audit team reviews the company’s responses and completes the audit report.
A GMED designated representative, independent of the audit team, analyzes the audit report. The report is then submitted for an opinion and recommendation to the 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 first by meeting the commitments they made during the application process. They also do so by addressing any observations raised during follow-up audits, which take place at least once a year. In addition, if the company makes significant changes, there may be additional audits to verify that the quality management system remains effective.
GMED's Accreditation
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
QMS Certification
GMED certifies Quality Management Systems for companies in the health care and medical devices industry.
MDSAP certification
ISO 13485 certification demonstrates your commitment to quality. In addition, for manufacturers targeting international markets, ISO 13485 forms the foundation for MDSAP certification.
As a result, you can use a single audit program recognized by the FDA, Health Canada, ANVISA, TGA, and MHLW.