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Determining causes in internal audits
"We are a multi-site organisation with ISO 9001 systems and a team of internal quality auditors. The internal auditors obviously check implementation against the system and raise NCRs where there are shortfalls. This is done using a Corrective Action Request (CAR) and the form specifies what requirement hasn’t been complied with. The auditee is then asked to identify the root cause and corrective actions. We have had a comment that the internal auditor should identify the root cause / corrective action. I struggle with this because the detail of why it wasn't complied with is only truly understood by the auditee. Q. Is it correct to place the responsibility onto the manager to find root cause etc OR should it be done by the internal auditor do this OR both?” -
Form identification
"Can we use a dynamic form for testing record that may have slightly different information for each product family but is basically the same. Do we need to change the rev or have different forms? Seems to many forms would be bad as would one form that does not have all the information. Having the basic "frame" be controlled but the specific information fluid makes more sense.” -
Documenting risks and opportunities
“How can we documented risks to fulfill requirements of ISO 9001:2015?” -
Certification costs
“I would like to know if doing the audits to obtain ISO certificates is free for companies, such as hospitals.” -
Internal audit is different from gap analysis
“Do we have to do an internal audit this year, if we carried out a full gap analysis against each clause, in preparation for our transition? If you do, would you have a sample template?” -
Documenting Quality Policy & Quality Objectives
"The mandatory documents Quality Policy & Quality Objectives have to be 2 stand-alone documents, or can they be contained within a Quality Manual?” -
Lack of information in non-conformance description
"What action to be taken when non-conformance given during surveillance audit due to internal audit not cover few clauses?” -
Herramientas para la transición
Cuáles son las herramientas necesarias que necesito para implantar la ISO 9001 2015 en los procedimientos del sistema de calidad dentro de la organización ya que ellos solo manejan la norma ISO 9001 2008 -
ISO 9002 and ISO 9003
"Were ISO 9002 and ISO 9003 auditable standards? -
Lessons Learnt Program
"My company is ISO 9001:2015 certified, I would like a detailed procedure for implement new quality Lessons Learnt Program”