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Processes and records for CE purposes

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Guest user Created:   Dec 11, 2019 Last commented:   Dec 16, 2019

Processes and records for CE purposes

We are currently using the templates to design our ISO 13485 processes, primarily to apply for CE under the MDR of our new medical device. In the light of this, you could help me out with the following.
  • We designed this medical device together with an engineer of a foreign medical device production facility, which is already ISO13485 compliant.
  • The product will only be produced for us, with our name on it. Some sort of Own Brand Labelling (OBL), but not completely the same.
  • Based on the relevant risk classification rules, we classified the medical device in risk class IIa.
  • We will have full access to all information and data needed to construct the technical file.
My question:
  1. Are there any ISO13485 processes and records in the template kit that would not be necessary for CE purposes, or would all be necessary, taking into account risk class IIa?
  2. How would an auditor exactly assess the implementation and operating effectiveness of these processes? I would guess according to the corresponding records, but how do they assess whether all records are in place for all cases that a record had to be registered?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 11, 2019
1. Are there any ISO13485 processes and records in the template kit that would not be necessary for CE purposes, or would all be necessary, taking into account risk class IIa?

From your description I do not understand what kind of medical device is your product. But, following procedures you can delete if following processes are not applicable for you: 17_Procedure_for_Equipment_Maintenance_and_Measuring_Equipment; 12_Procedure_for_Sterile_Medical_Devices; 05_Procedure_for_Infrastructure_and_Work_Environment.

In case of OBL you need to explain in Quality manual relationship with the company that makes your product for you, how you will be informed of any changes in production, who is responsible for the final quality control, when and in what situations you will audit them. These elements should be also part of the Quality agreement.

 

2. How would an auditor exactly assess the implementation and operating effectiveness of these processes? I would guess according to the corresponding records, but how do they assess whether all records are in place for all cases that a record had to be registered?

In the case of the OBL, it is mandatory for auditor to audit company where production is placed. When you receive an audit plan from an auditor for your quality system, it will also specify the time for auditing the manufacturing company.

For more information What to expect at the ISO certification audit: What the auditor can and cannot do, you can read in following white paper: https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit

 

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Guest user Dec 12, 2019

Thank you very much for your prompt answering.

So if I understand correctly the auditor will also need to audit the relevant processes at our external foreign production facility, as part of our ISO 13485 certification process. How would this relate to the fact that these exact processes are already ISO13485 certified processes? Would this help in any way? Could the auditor (partly) rely on this?

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Kristina Zvonar Brkić Dec 16, 2019
1. So if I understand correctly the auditor will also need to audit the relevant processes at our external foreign production facility, as part of our ISO 13485 certification process

Yes, you understood it correctly - the auditor will also need to audit the relevant processes at your external foreign production facility, as part of your ISO 13485 certification process. When it comes to the manufacture of medical devices, production must be audited during the audit, regardless of whether the production takes place within the company or is outsourced.

2. How would this relate to the fact that these exact processes are already ISO13485 certified processes? Would this help in any way? Could the auditor (partly) rely on this?

According to the definition from ISO 13485:2016 who manufacturer is (3.10) - natural or legal person with responsibility for design and/or manufacture of a medical device....; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s). No metter that your manufacturing process is outsourced, it is your responsibility over it and need to be audited as your process. The fact that this company is ISO 13485 certified only helps them as much as they know what to expect during the audit.

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