Quality Management Systems

Diagnostic Audit

Although not a requirement, Medical Device Companies often see the benefit of performing a diagnostic audit before their initial assessment. To ensure a level of preparation in line with the QMS standards, companies chose GMED.

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The Fundamentals

1.Sampling your QMS

The Diagnostic Audit prepares a company for what is expected during the Certification Cycle. Sampling through the Quality Management System, it determines the level of readiness of a company. It introduces Quality Management System Certification but from a Registrar’s standpoint.

2.Observations are Gaps

Observations are “gaps” between the requirements of the standard & the existing quality system elements. By identifying areas that are not fully compliant, companies can focus on correcting these main areas of concern. The Diagnostic Audit helps organizations to fully comprehend the scope of an audit before embarking on their initial QMS assessment.

3.Continuous Improvememnt

A Diagnostic Audit looks into the company’s approach to continuous improvement. Internal audits & Management reviews reveal how well processes & procedures are implemented & how often these are maintained.

4.Advantages & Benefits


  1. Determines your readiness for certification;
  2. Reveals your strong points & weaknesses ;
  3. Familiarizes your organization with the Registrar’s assessment methods;
  4. Optimizes your resources so they can focus on the gaps to be bridged;
  5. Applies to across Quality Management System standards ( ISO 13485,  ISO 9001,etc.)

Embark on your certification journey

  • Convenient I We schedule it anytime
  • Economical I You define the scope of your audit
  • Confidential I The audit results are yours
  • Rapid I We accommodate your needs

ISO 13485:2016 & ISO 9001:2015

A 2-day course to help you tackle any QMS challenges

Jun 10 - 10 Palo Alto, CA

ISO 13485:2016 & ISO 9001:2015 | Quality Management Systems

2-day Training for RA/QA Professionals of the Medical Device Industry: ISO 13485:2016 & ISO 9001:2015 | Quality Management Systems

Jun 10 - 10 Palo Alto, CA

The Transition to ISO 9001:2015 I Quality Management Systems

Training for RA/QA Professionals of the Medical Device Industry: The transition to ISO 9001:2015 – Quality management systems.

Initial QMS Certification

GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016.