QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives.

[ebrahim]

Dear,
Hope I find someone who can help with the following.

We are looking for a Written quality policy with clear Scope of the QMS as per ISO 13485, Clause 4.2, Requirements for regulatory purposes for Medical Devices Authorized Representatives..
The policy should contain the following policies:
1- Company Policy
2- Distribution ( Defined procedures and processes Forms)
3- Importation ( Defined procedures and processes Forms)
4- Complaint Handling ( Defined procedures and processes Forms)
5- Adverse Events ( Defined procedures and processes Forms)
6- Recalls ( Defined procedures and processes Forms)
7- Alerts and modifications ( Defined procedures and processes Forms

 

[indubioush]

The quality policy is not the same thing as documented procedures. Requirements for the quality policy are defined in section 5.3 in ISO 13485.

 

[ebrahim]

The quality policy is not the same thing as documented procedures. Requirements for the quality policy are defined in section 5.3 in ISO 13485.

Thanks for your clarification, so if you could tell me how I can got those documents written .

 

[indubioush]

These procedures are usually written by someone who works for the organization that will use them. It seems like you are new to all of this. Is that correct. Do you already have a medical device company that you are working with? If so, you can ask their quality assurance or regulatory people to help you out. You could also hire a consultant to assist you in setting up your quality system.