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Context and risks (1)
"The statement of context is new to me along with the risk-based approach. Although I have been in quality for quite some time - understanding what goes where and the application of these "two areas" are a little mind boggling.” -
Approved documented information
"I am currently going through an approval process on behalf of Airbus at a supplier. They have recently changed a lot of their documentation in line with the new ISO9000 requirement however I notice that the new documents only have a Compiled by Section and there is no subsequent Approved by section also the compiled by was done by a sub contracted person and not a direct employee. Would this not lead them to an audit finding in the future?” -
Objectives and planning for QMS
"I would like to prepare an process for Quality Objectives and planning for QMS in which it should be Eligible to apply for ISO standards. So, is there any kind of procedure or flowchart which can define the process." -
Swot/Interested Parties
"Hi I am a production manager at a soap manufacturing company.Can you send me examples of templates for SWOT and also INTEREST PARTY for my for my department. Can you send the samples that covers my duties as a production manager?" -
Procedure for clause 8.4
"Do you have a detailed procedure for section 8.4, Control of externally provided processes, products and services?" -
Internal audit requirements (1)
"Can our internal auditor just take the free course without the exam and still be compliant with ISO 9001:2015? how would one tell if we need to have it? We are a small company 8 employees. We have our Audit approaching and realized the auditor that the company had for 2008 standards had a certificate.... the auditor that we used this year for 2015 does not have a certificate and I didn’t know if that was mandatory or not” -
Operations' risks in the chemical industry
"What would you say, a few pointers are for operations risk in research and development in a chemical company would be?" -
Auditing outsourced processes (1)
“We are going to audit our outsourced process so which clause of ISO 9001:2015 is most applicable’” -
Issues are not necessarily negative (1)
"Presently we are working for the ISO certification of the Water District where i work for. One report that they are asking to us is the REGISTRY OF OPPORTUNITIES & RISKS BASED ON EXTERNAL & INTERNAL ISSUES, & INTERESTED PARTIES, and in tabular form we need to fill these in. 1.Factors 2.Description 3.Issues 4.Opportunities (+) / Risks (-) 5.Risk level (severity & likelihood) 6.Action(s) 7.Resource(s) needed 8.Responsible / Date 9.Method to monitor results My question here is that, is the "issue" necessarily mean negative factor that gives the Water District opportunities and risks?” -
Initial steps in ISO 9001
"We have achieved Management approval and backing to move forward with ISO 9001 certification. As early as next week we will begin in earnest. I will keep you posted on our needs as we move forward. What would you suggest as our initial step?"