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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/) -
QMS implementation priority
"I am student currently working on my master thesis with the topic of the implementation of QMS in SMEs. The topic deals with the question, which parts/components of a QMS a SME should implement first in order to have the fastest results and the best cost/impact ratio. It might be important to know that because SME often don’t have the resources to implement the complete QMS at one time, but rather would implement the components that have the most positive impact in a short period of time. After successful implementation they can also implement step by step the other components. Like an evolutionary QMS. DO you have any literature or advice that could help me deal with that topic?” -
Training or awareness
"i have created a new attendance register for our contractors i am not sure under which clause it must be filed, 7.2 or 7.3?”