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Approved supplier list
"Is a approved supplier list required by ISO 9001/ 2015 Standard?” -
Risks an opportunities at department level
"Please help on “Opportunities & Risk for Material Controlling dept.”, how I can take preparation for” -
Addressing risks
"I am in the phase of transition and have my certification audit on March 26. we are a medical laboratory, medium sized about 30 employees. we already have ISO 9001:2008 implemented. my question is about addressing risks: should it be the risks for final results? or risks that we have found in the SWOT analysis” -
Use of structured templates
"What does QMS have to say about documents that do not follow a structured template?” -
ISO 9001 Use of Quality Tools
I’m reading a current article about quality control tools and I am trying to find information specifically on what Quality tools ISO 9001:2015 uses. I am currently under the assumption that there are not any specific tools that ISO uses -
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.”