ISO 9001 - Expert Advice Community

Collated Nonconformances

Hi! I'm quite new to ISO 9001:2015. I am currently designated as the Lead Internal Quality Auditor in our company. I would like to know who will be responsible or tagged for collated Nonconformances for each clause in 9001:2015? Thank you in advance for your replies.

Documentation Hierarchy

Hi I need support to organise and map organisation documentation. How it should be organised as mandatory corporate documents

Level 1 documents

 1 Manuals
1.2 Policy
1.3 Strategy
1.4 Main Process Titles
1.5 Sub-Process

or shall we have policy first and them manuals. What is the diffrence between policy and manual?

Thanks

Internal Audits

What is the importance of internal audit findings while preparing iso IMS certification?

Sustainability and Environmental Management

What would I say to the directorate and or business owner to convince them that sustainability and environmental management need to be at the forefront of the business? particularly when considering 2030 and 2050 targets.

Specific pharma industry question

Detailed risk management Examples in the solid dosage forms manufacturing processes. e.g cross contamination & cleaning validation.

Will ISO 9001:2015 be updated until 2030?

I have a question about the status of ISO 9001:2015 and whether it will continue to be in effect without any modifications or if there is a new version that supersedes it. Specifically, I would like to know if the latest version, ISO 9001:2015, will remain valid until the year 2030.

Your clarification on this matter would be greatly appreciated, as it will help us ensure our compliance and quality management systems align with the current ISO standards.

Implementing Clause 8.4

How can ISO 9001 - Clause 8.4 be easily implemented?

Quality Control Processes

Without quality management system in place, what is the first step in developing a quality Control process as a quality Control officer in a government agency (with six different departments) responsible for monitoring and regulating activities of licensed manufacturing and service companies in a Free Trade Zones.

Procurement and ISO 9001

How do procurment and ISO 9001 work?

Is it mandatory to use a consultant for QMS and should we request a certificate from the auditor?

Is there any specific clause that makes it mandatory to use a consultant for QMS?  And also acquiring an Auditors certificate from a consultant? Even when we're not new in QMS certification?