ISO 9001 - Expert Advice Community

ISO 9001 - Control Chart in Monitoring Variation

How is the control chart in monitoring variation in laboratory analysis work?

ISO 9001 and Gap Analysis and Internal Audit

A) As far as getting help, I need to understand better the stage 1 audit (what is being done exactly (checklist with each clause and the mention whether it is present or not in the auditee organization? How to re-use the checklist for stage 2 - a bit septic of generic/standard checklist) and eventually discussed with auditee (Past management reviews and audits some people say) to assess readiness for stage 2.

B) I also was very interested with your discussion on the gap analysis vs internal audit and the different perspectives of each. Is the checklist the same? With additional column in the case of internal audit to write what is actually being found and observed. Is this right?

C) I was also interested in the different ways to organize an internal audit: department by department, process by process or clause by clause. I am wondering when it is best to choose which anda whether there is such a thing a department x clause and process x clause matrices.

Internal Audit

Greetings!

Let me know how we can plan and counduct internal audit. What's steps are mandatory for internal audit. 

Audit Reporting

If an internal auditor found a nonconformance during pre-audit planning but failed to discuss/mention it during the audit, can/should the auditor include it in the audit report?

Context of the organisation and its impact on the organisation and mitigation actions

I am trying to identify the context of the organisation. I would like you to assist me in how these contexts impact an organization and mitigation actions.

ISO 9001 - Rules for hiring and onboarding new staff

If an employer has this ISO certification, what rules are in place for them when hiring and onboarding new staff please in a permanent capacity?

Change Management and QMS

Hi, I wanted to know where change management procedures are captured in a QMS.

How to meet the MTBF objective?

What are the tools required to meet the MTBF objective?

How to know if the clause 8.3 is applicable to an organisation?

Non-conforming products

I am interested in: for the nonconformig products: 1.  who make the "UAI" ? 2 is always necessary to contact the Customer to approve the out of spec "dimensions"?