Guest
Guest
Create New Topic As guest or Sign in
Assign topic to the user
-
Outsourced processes in scope
"Is it necessary to document the outsourced processes in the scope?” -
interested parties
Hallo, § 4.2 b) of ISO 9001:2015 specifies that the interested parties relevant to the QMS need to be identified. Some assessors are recommending using the SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats), well known in project management, but what would be in the philosophy of the Norm the internal and external interested parties? In advance, thank you for any answer. - Michel -
Context and multiple sites
"We have multiple sites and the same management system and same scope. Do we need to have different context of the organization and interested parties?” -
New Quality Processes
The Quality Manual for my organisation is quite a generic document as it contains the high-level manner in which the organisation meets the requirement of the standard. There is some high-level process described but there is no detailed procedure, which I understand to be the correct way, i.e. the manual documents the 'what' we do; not 'how' we do it. Various key procedures (how we do it) which fall in-scope have recently changed, but the nature of these procedures does not necessitate a change to the Quality Manual. What is a good way of capturing these procedure changes; would it be a specific document? A list of key procedures perhaps? Thanks for your help. Brian. -
Design alterations
"If a company alters the original design of a job without redesigning drawings, does this mean you need to include clause 8.3 even if you are not the designer.” -
Before certification audit
"For first time certification audit preparation, the organization must conduct management review and internal audit? Please explain.” -
Recruitment and competencies
"I Recruit for Cruise line and I need to be MLC compliant. They mention using the ISO standard, so I am wondering where to look for the section that would help me.” -
Gap Analysis
"I recently started working at CNC machine shop. They hired a consultant to do all paperwork that ISO 9001 required (QMS manual, QAM, etc.) it’s never been revised. I trying to work on it for the first time as a challenge to improve my qualifications and demonstrate that I can do more than I do right now. How would I know that what they have now it's good to be audit or revised?” -
Selling consulting services
"CONSULTING FOR A PHARMACEUTICAL COMPANY ON ISO 9001 CERTIFICATION. I WANT TO KNOW HOW TO GO ABOUT WITH WRITING THE PROPOSAL, AND ALSO HOW TO BILL THE COMPANY FOR MY SERVICES. WHAT PROCESS DO I NEED TO GO THROUGH TO ACHIEVE THIS?” -
ISO9001: Integrating QMS and Business Processes
How can I integrate business process with quality management system process? (Regarding article: https://advisera.com/9001academy/blog/2017/03/07/aligning-quality-objectives-of-the-qms-with-the-strategic-direction-of-the-company/)