Thinking of Outsourcing Your ISO 13485 Audits?
We can help…
Our ISO Consultants can do everything, from:
- Managing your ISO 13485 Internal Audit program
- Conducting ISO 13485 Internal Audits at your direction
- Reviewing your ISO 13485 Internal Audits and ensuring your are in conformance with the ISO requirements
- Training your ISO 13485 Internal Auditors and leading them through an ISO 9001 Internal Audit
Whichever option you choose we are careful to follow your format, forms and ISO 9001 Internal Audit and Corrective Action processes to ensure a seamless transition and full conformance at the time of your next surveillance audit.
THE BEST PART….. we take our ISO Auditor ‘hat’ off as we go and offer suggestions and improvements to your ISO System.
Processes You Can Rely On
MOCG has been conducting ISO internal audits for 25 years.
We have always followed a process approach, having adopted it right from the start. When we say ‘the start’ we mean BS5750 the standard before ISO 9001 was first established in 1987. We teach hundreds of auditors each year how to audit correctly using our proven in-depth approach as their method.
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Better
Our goal is to ensure that your employees and your ISO 13485 System is ‘over’ prepared for any external or customer audit. Take the worry out of ISO 13485 conformance.
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Precise
We are precise about the interpretation of the standard. We are very clear with what the standard is requiring, and when we think something is a better, more efficient idea for you.
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Analytics and Reporting
Gain valuable insights into your data and make informed decisions.
Never make a change based on auditor bias. We will never report a non-conformance that we don’t tie back to an ISO clause.
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Interpretation
We continuously challenge each other and undergo formal training about interpretation and application of the requirements. Nobody else better understands, can apply or communicate the meaning of the standard.
Using MOCG for our ISO 13485 Internal audits…
Made our ISO 13485 surveillance audits and re-certification a formality. The deep dive and tough questions were asked during the ISO 13485 internal audit and we were in great shape for our registration agency. We want out ISO 13485 internal audits to find our problems not the 3rd party auditors or customer auditors.
– Industrial Machinery Manufacturer
MOCG ISO and Performance Improvement Consulting 