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Question on large/small business certification

Well, in this case certification will remain with organisation which is certified and not with your contract or with you. Incase there is any process movement to the small business, it should be included as a part of certified scope or managed as a controlled external provider.

Confidentiality Statement

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Temperature mapping of storage areas ISO13485

Yes, you are right when you say that temperature mapping is not mandatory or required in ISO 13485. However, what is required in point 7.5.11 is that the manufacturer must protect the product from alteration, contamination, or damage when exposed to expected conditions during processing, storage, handling, and distribution. If your warehouse is racked and tall or divided (to have more rooms), then temperature mapping is needed to make sure that the temperature distribution is equal, that is, that the products, regardless of where they are located within the warehouse, are stored at the same temperature.

If this is not the case, and your storage is in one room, of normal height, and you can prove that the temperature distribution is equal, then you can justify that temperature mapping is not necessary.

QMS Scope for Food Product Distribution - Can I Limit It?

Yes, you can limit the products covered by your QMS. It is a common practice to define the scope of a QMS to include only certain products or services. This decision is a management decision and can be based on various factors, such as the value of certification to your customers or strategic business goals. For example, you can choose to include only coffee and milk powder in the QMS scope and exclude orange juice. This allows you to focus your quality management efforts on specific areas of your business.

Please check in this Free webinar - ISO 9001:2015 Clause 4 - Context of the Organization, Interested Parties, and Scope (slide 8) an example of the flexibility with scope within ISO 9001.

Classification of medical device according to MDR

According to the provided information, since it goes on the implant and therefore into the body, in my opinion classification Rule 21 is applicable - Devices composed of substances that are introduced via a body orifice or applied to the skin, but for all other cases - class IIb (similar like vaginal gels). For more details please see MDCG 2021-24 Guidance on classification of medical devices.

Complex Therapeutic System - MD with ancillary medicinal substance + systemic drug

Yes, you can combine trials. But please pay attention to the following:
- clinical research for medical products must comply with ISO 14155:2020.
- Such clinical research must be registered with the European Medicine Agency.
- contact your notifying body and see with them that before starting the clinical research, you give them the plan of the clinical research for inspection so that they can be sure that the research plan is well set.
- study in detail the points of the MDR - from Article 61 to Article 82

IATF 16949 CERTIFICATION BODIES

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Access Control Policy - Managing Records

Hi All,

I'm drafting the Access Control Policy in Conformio.

At chapter "4. Managing records kept on the basis of this document" it asks for the management of 2 types of Records.

one is quite clear, it demands the management of an Access Control Review register.

The second one instead is not totally clear to me, what I don't fully understand is if we need to keep a register for only tracking the privileges (access rights granted to roles or users that usually wouldn't have them) or if we need to track every single access given to all the employees on all the used applications.

Can someone suggest what should be tracked?

Thanks in advance

Best Regards

Igor

Access Control Policy - Map Job titles to User Profiles

I am drafting the Access Control Policy in conformio.

In the section 3.2, I initially have drafted the User profiles, Applications and access rights for each SW that we are using.

Then I need to map the User Profiles to the job Titles.

The question is: When mapping the Support Administrator profile, can I simply map to the Job title "mid management" or do I need to specify Support Mid Management?

What I mean is that it is obvious that the Support software administration will never be assigned to the HR Mid management, but do we need to be specific when drafting the mapping between a User Profile and a Job Title?

Will an auditor accept a high level definition?

Thanks

Best Regards

Igor