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Quality policy, a framework for setting quality objectives
"Would you please inform me of How to state the following sentence in the Quality Policy "Provides a framework for setting quality objectives"? And what does "framework" mean?” -
Documenting Risks and Opportunities
"Is 4.1 and 4.2 the only places where documenting Risk and Opportunities is required?” -
Required documented information
"Can you tell me when the standard says in 8.1.a determining the requirements for the products and service, does this mean that I need to have a record that we determined or is there no requirement to document this?” -
Documented information
"We currently have our QMS stored on our intranet. We maintain a parts and product list on our intranet within quickbase and also on our website. Is it acceptable to just maintain these particular lists on our website, with control, and eliminate those databases from quickbase QMS intranet? It would be so much easier for us this way." -
Maintenance plan
"What is a maintenance plan? Where of it's composed?" -
Monitoring internal and external issues
" If I identify the Internal and External issues my next step is to monitor. How to monitor that issue?” -
Non-scheduled audits
"I would like to know what ISO 9001 standard says about improvisation internal auditing?" -
Risk-based approach example
"As we write up the processes for our company, I reached the risk section and I am not sure what to address. -
No Quality Manual?
"If the Quality manual is gone then where we need to identify the clause 4.2?” -
Risk based thinking and audits
"Can you advise as to the best way to conduct internal audits under the new standard do you audit each department based on all the clauses on the new standard or just risk based thinking. The risk and mitigations etc. Your guidance will be appreciated."