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Report writing for certification
I would like to get an explanation of the report writing for this certification. Whether it is in international practice or has its own set of requirements requires two auditors, one viewing the scope of the quality management system and other one for the technical scope (by the technical expert). Is it provided by two auditors or is it just an auditor?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Jun 25, 2019
I hope your explanation and cooperation of this matter. Thank you.
Answer:
The number of auditors depends on the size of the company (how many employees), process/product complexity (whether there is sterilization, whether the product is being run in a clean room) and how many products should be audited. Besides, not every auditor covers all areas. So, some auditors may be only for QMS, while other auditors are specific only for some processes (eg sterilization). The certification body itself determines how many auditors they will send and how much report there will be.
This wh ite paper helps you to prepare for the ISO certification audit and explains what the auditor can and cannot do.
https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit
Answer:
The number of auditors depends on the size of the company (how many employees), process/product complexity (whether there is sterilization, whether the product is being run in a clean room) and how many products should be audited. Besides, not every auditor covers all areas. So, some auditors may be only for QMS, while other auditors are specific only for some processes (eg sterilization). The certification body itself determines how many auditors they will send and how much report there will be.
This wh ite paper helps you to prepare for the ISO certification audit and explains what the auditor can and cannot do.
https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit
Expert
Kristina Zvonar Brkić
Jul 09, 2019
We've received additional questions:
> 1. Hi, i need more further information about ISO 13485 report writing. How many report should be given to the client for one certificate ISO 13485?
Answer:
I assume that by „how many report should be given to the client for one certificate ISO 13485“ you mean how many reports certification body provide to the clinet after the certification audit is finished. If that was your question, than this is the answer to it.
-The number of reports depends on the Certification body rules. Some certification companies have one report, while others have two: Management Summary and List of findings.
If I missunderstand the question, can you please provide some clarification. Thank you in advance.
>2. Lead auditor must be responsible to prepare the report but, how about technical expert part?
Answer:
Lead auditor is responsible for preparing and finalizing the report. Technical expert fulfills only the part that is related to the area that he audited.
>3. Does it make sense if the audit and report (summary certification report) shall be covered by only one auditor?
Answer:
Yes, the audit report can be covered only by Lead auditor. He is responsible for it. But, if there is a Technical expert in the audit team, it should be mentioned somewhere in the report.
For more details on how the certification process looks like, what are the phases of the certification audit, what auditor can and cannot do, and how to solve non-conformities from certification audit, please take a look at the following material:
What to expect at the ISO certification audit: What the auditor can and cannot do
https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit
> 1. Hi, i need more further information about ISO 13485 report writing. How many report should be given to the client for one certificate ISO 13485?
Answer:
I assume that by „how many report should be given to the client for one certificate ISO 13485“ you mean how many reports certification body provide to the clinet after the certification audit is finished. If that was your question, than this is the answer to it.
-The number of reports depends on the Certification body rules. Some certification companies have one report, while others have two: Management Summary and List of findings.
If I missunderstand the question, can you please provide some clarification. Thank you in advance.
>2. Lead auditor must be responsible to prepare the report but, how about technical expert part?
Answer:
Lead auditor is responsible for preparing and finalizing the report. Technical expert fulfills only the part that is related to the area that he audited.
>3. Does it make sense if the audit and report (summary certification report) shall be covered by only one auditor?
Answer:
Yes, the audit report can be covered only by Lead auditor. He is responsible for it. But, if there is a Technical expert in the audit team, it should be mentioned somewhere in the report.
For more details on how the certification process looks like, what are the phases of the certification audit, what auditor can and cannot do, and how to solve non-conformities from certification audit, please take a look at the following material:
What to expect at the ISO certification audit: What the auditor can and cannot do
https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit
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Jun 25, 2019
Jul 09, 2019
Jul 09, 2019