ISO 9001 - Expert Advice Community

Process element

How do I create a process register, to contain all the company's processes and objectives to also include risk and opportunities?

ISO 9001 Design and Development exemption

My company is currently exempt from Section 8.3 for Design and Development because we don't do design here. Our design is done at our facility who is under their own ISO Certification and we are just an in between. 

We are considering the addition of an engineer that would do design but would be completely controlled by our facility's processes, practices, and systems. They would just be seated at our facility as convenience to our customers and not under our systems and processes. Does our facility need to comply to Section 8.3 even though we still don't technically have design under our control?

Design and development

I am currently working on design and development, for which I studied Standard clause 8.3, my question is what type of documents do I need to fulfill the requirements of clause 8.3 and can I have any such formats for Planning, input, controls, outputs, and changes?

Quality control statement

I'd like to ask you if it is compulsory to add in a quality control statement in all SOPs?

ISO 9001 and non-conformities

I have a non-conformity for 7.5 -Documented Information. The company forms, processes etc have various logoss, document control formats etc. As it is something that will take a long time and is essentially a project can I set an objective and then close out the non-conformity? Or will it remain open until ALL company documents have been rebranded in the same format/font/logo etc.??

ISO 9001 clause 4.4 requrements

I am having troubles of picturing the idea of how to fulfill the requirement of clause 4.4. What is to be required for each sub-clause and how to match it to what my organisation does?

Carrying out activities and specific training

Do the requirements in ISO 9001:2015 focus on how activities are carried out?
Does the training clause also include training about the specific process to enhance the competence of employees?

Risk & Opportunity Management

The new clause 6.1.2 Risk & Opportunity. Do we need to list all the opportunities that arose from the risks listed even though the risk severity is low?

ISO 9001 record management

For record management, is it mandatory to stamp the record (with he dare received)? Or just follow the issuing date stated by the external party (sender)?

ISO 9001 external document control

For external document, we implement and use Received with date which is similar to Mastercopy.

[Option 1] My question is, if the original one we received is stamped with received with date and then we have to control the distribution by stamp again Controlled Copy. This means we have two different at external doc front page.

or

[Option 2] We keep the original as received then photocopy and stamp Received with date. Photocpy again the original then stampe Controlled copy.

Which one is the correct one to do? Option 1 or 2?