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  • Determining root cause of nonconformity

    We are running a ISO system and would seek your advice on how to do a root cause analysis on a CAR that states, quote: “There is no audit report compiled for the internal audit undertaken in October 2016”.

  • Determining scope of QMS

    Hi, I work at a telecommunications company. I have a problem understanding the domain of application of ISO 9001: 2015. As a matter of fact, I work in the quality division and we want an ISO 9001 certification. We have several services and I will like to know if we can certify a single service or if we are obliged to certify all our services?

  • Creating procedure for competence

    Hi! I'm from personnel department, I am having a hard time how to create guidelines/procedures for competence. I am a certified public accountant by profession and now transferred to personnel department, so everything is new to me. Kindly help me please. Do you have a simple format of job description also?

  • Quality policy in healthcare organization

    Can the Quality Policy for a healthcare organization be a statement or it needs to be descriptive?

  • Documenting training and awareness

    I am starting to prepare the documents for the training module of each position in the particular department. I would like to clarify that competence training and awareness is necessary to have documentation or give some sample of documents that need to prepare.

  • Interpretation of risks and opportunities

    We are currently 9001-2008 registered and just had our surveillance audit for upgrading to 9001-2015. In reading/digesting the new Standard, it’s my opinion that each element is a matter of interpretation. It’s not black or white, it’s gray. Example: Risks and Opportunities. I was looking for additional input to help solidify my opinion of “interpretation”.

  • Demonstrating competence for ISO 9001:2015

    I am working as Quality Assurance manager. We are a ISO 9001: 2008 certified organization. We are hoping to upgrade to ISO 9001: 2015 version by the end of this year. Related to this I have some queries:

  • Nonconformity in production process

    We are a manufacturing company and sometimes when we manufacturing the parts. The parts get made incorrectly and have to be redone.

  • Where to start with ISO 9001 transition

    How to initiate in our company 2015 start with which document Quality Manual is mandatory or not?

  • Nonconformity and related clauses

    In the ISO 9001:2015 standard, if our Fabrication shop drills holes in the wrong place on a part and it has to be redone (the problem was caught before the part left our facility), should I cite Clause 8.7.1? We would do an NCR but on my NCR’s, I also cite clauses from the standard and I want to be sure I am using the best one.
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