ISO 9001 - Expert Advice Community

Certification upgrade

Hi, I'm a certified ISO 9001:2008 lead auditor, for some reason I haven't transit my certificate to ISO 9001:2015. Can you guide how to convert?

Controlled documentation difference

What is the difference between controlled internal documentation, controlled external documentation, and controlled data?

Major vs Minor nonconformity

Could you please let me know what is the difference between major and minor nonconformity?

Could you please provide any practice tests/incidences to rule out any nonconformity present in the scenario?

Clause 8.3. applicability

Would ISO 9001 clause 8.3 'Design and development of products and services' be applicable to a scientific research lab, which has an R&D department to design Standard Operating Procedures for use in-house to produce scientific data?

ISO 9001 for international quality mark

I have a start-up business. One of my products is exclusive to my company as we have designed it. So if I need to take an international quality mark or a legal stamp for that, what should it be? Is ISO standard for the product or for the organization?

ISO 9001 and calibration

If my company has passed ISO 9001:2015 check, can I do calibration and make report for customer?

Does my company need calibration Lab or not?

Procedure for determining context of the organization

Clause 4.1 says there shall be a determination of external and internal issues (the context of the organization). Is the procedure for determining the context of the organization is non-mandatory?

Needs and expectations of interested parties

I am looking for the needs and expectations of interested parties as per the ISO 9001:2015 standard.

Outsourced Process

I would like some guidance on how to draft an Outsourced process according to ISO 9001:2015.

Risk and opportunity assessment

What is the best time interval to assess/re-assess the risk and opportunity?
Do I need to have operational and strategic risk and opportunity assessments separately?