Further to you email below, the quality manual in ISO 9001:2015 is not required anymore. So where should we define the scope of the quality management system, and the key processes and procedures ??
Exclusion of clause 7.5.2 from ISO 9001:2008
I m working in a sales and servicing of fire extinguishers products industry,is 7.5.2 applicable as an exclusion?
Training effectiveness and job descriptions
I have few questions, please:
Understanding context of the organization
Context of organization - Understanding the organization and its context, and understanding the needs and expectations of interested parties
Documents and records serial number
Why are documents and even records need to have a serial number?
Appendix Clarification
In document control procedure are Appendix 1,2,3,and 4 equal to level 1,2,3,and 4 documents? I have a quality records index in my current QMS that includes retention time, would that index be the same as Appendix 4?
The purpose of non-conformance record
What then is the advantage for the report as far as management is concern(regarding to non conformance report)?
Auditing without documented audit procedure
How is internal audit is listed in the mandatory documents as well as non mandatory documents under the section- List of mandatory documents required by ISO 9001:2015" Internal audit program (clause 9.2) and Results of internal audits (clause 9.2) are mandatory but Procedure for internal audit (clause 9.2) are not mandatory) without a procedure can you run internal audit program?
Document control
What are necessary documents that Document Controller must have from other department? Is it necessary all documents or forms? what are those necessary forms that Document controller must collect or must keep?
ISO 9001 risk assessment and FMEA
Please, kindly advise me that how to do risk based assessment & context of the organization. If we use FMEA tools for this, can you send us sample sheet.