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Distributor traceability
When it comes to traceability, the AS9100 standard does not give detailed requirements on how to do this, but only says that you need to control the unique identity if that is a requirement, and retain documents necessary to ensure this traceability.
So, as per the standard, your question goes back to what your customer's requirements are. If your customer allows waivers on traceability, then that is acceptable, but if not, then it is not acceptable. As the standard is used by any organization within aerospace, the requirements only describe what needs to be done but need to be supplemented with the customer and legal requirements.
For a bit more on the traceability requirements in AS9100, see the article: How to meet traceability requirements in an AS9100D-based QMS, https://advisera.com/9100academy/blog/2019/06/05/as9100-traceability-requirements-how-to-meet-them/
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Reviewing incidents in Conformio Management Review
We have the same problem here
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UPDATE ADDRESS
If you plan to move the department of the system to another address then have to update what records? Note: Only use the network of the new address, the rest is managed according to the old system. Thanks! -
Secure Development policy
There is a paragraph in the Secure development policy which states: In addition to the risk assessment performed according to the Risk Assessment and Risk Treatment Methodology, Head of RD must perform the annual assessment of the following: the risks related to unauthorized access to the development environment the risks related to unauthorized changes to the development environment technical vulnerabilities of the IT systems used in the organization the risks a new technology might bring if used in the organization the risk a new development methodology and/or programming language might bring if used in the organization the risks related to licensing requirements The question is, is this assessment to be done in the Risk Register or is it an additional document that needs to be drafted by the Head of R&D? Thanks -
Question on large/small business certification
The answer depends on how the ISO 9001 certification is structured within the big business.
If the big business is ISO 9001 certified at an organizational level, it keeps certification.
If the certification was contract-specific, the certification may no longer apply to that contract. The small business would need to become ISO 9001 certified if required for the contract. -
Confidentiality Statement
We are drafting the Confidentiality Statement through Conformio. To do this we have downloaded a template which should be edited based on the specific clauses are required in the company. This document should involve both employees and external parties. The issue is that we do not have a single document for all. For example for the employees the confidentiality statements are added in the employement letter which also references the employee handbook which has additional clauses, while for third parties there is a specific NDA. So the question is, how am I supposed to say all this since I have a single template? Best Regards -
Edit Risk register
Hi there We want to edit the Impact and Likelihood fields for certain risks on the Risk Register. How do we do this? thank you. -
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.
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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.