ISO 9001 - Expert Advice Community

Monitoring risk management

How can you properly monitor the risk management if there is one person assigned for analyzing risk?

Imparting ISO 9001 implementation benefits

How do you make people understand that proper implementation of the ISO 9001 QMS benefits the organizations and NOT THE AUDITORS?

ISO 9001 for Law firms

Control of records ISO 9001

What do we mean by control of record and what are the major active in ISO 9001:2015?

Defining calibration criteria

I would like to ask one concern for How we defining or identify acceptance criteria for calibration? Could you please suggest us?

Does acceptance by exception by the customer must always be formalised by the supplier?

I need to understand if the acceptance in derogation by the customer must always be formalized by the supplier? I recently did an audit, I saw that the NCs are kept, etc ... while the request in derogation is not ... (otherwise by email, etc.) subsequent actions taken.
Usually, our suppliers open their own internal NC, with their own form and send it to us with the request in derogation. For the less serious ones, they send us a simple email (they already know that they are simple reports). 

ISO 9001 Organization and stakeholders context analysis

How would you conduct an organization and stakeholders context analysis?

ISO 9001 Secondary review

The company I work for is a biotechnology company and we hold ISO 9001 certification. We keep records as required by ISO, however, I was wondering if the quality department needs to perform a secondary review on all or some of the records. 

ISO 9001 QMS

I'm totally new to ISO 9001 standards but I'm assigned to prepare a quality manual and quality management system. Kindly guide me about the basic procedure and standards to read and understand.

ISO Waste collection service

Can a waste collection service exclude clause 8.3 for its scope?