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Quality Management System and its Processes.

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by senior, Feb 27, 2019.

  1. senior

    senior Member

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    Guys,
    I have a question.
    In ISO9001:2015 standard clause 4.4.1 e it says
    :assign the responsibilities and authorities for these processes
    Does this means quality procedures is approve by QMR or authorize personal only.

    What if quality procedures review by HOD but approved by not QMR and personal not authorize by top management for such approval.
    Will this be consider as a finding during ISO audit.
     
  2. Qualmx

    Qualmx Well-Known Member

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    If the document says like that and is not that way, is a NC
     
  3. tony s

    tony s Well-Known Member

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    Definitely NO. ISO 9001 does not prescribed that approach. Even a QMR is no longer a requirement. Review and approval should be assigned to the relevant owners of the process (e.g. managers, top management).
    Unless you defined in your company's own procedure/policy that approval MUST be done by the QMR only.
     
  4. senior

    senior Member

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    Thank you Tony S,
    The standard says: assign responsibility and authorities for these processes.
    If we dont assign then it will become another finding.
    Dont you think so.
     
  5. tony s

    tony s Well-Known Member

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    Yes. But assigning responsibilities would not be a problem. This can be done in many ways such as:
    • by specifying in the job descriptions;
    • include responsibilities in the documented manual, procedures or instructions;
    • by identifying the people with assigned responsibilities on organization charts;
    • by issuance of appointment letters.
     
  6. senior

    senior Member

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    Thank you so much Tony,
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This isn't the same as assigning responsibilities. It's authorizing documents - that's different. Making responsibility assignments, along with authority, is like creating "Process Owners". Process Owners are usually held accountable by top management for the performance of their process, aren't they? Sales VP is responsible for sales performance, Manufacturing Vp for Right First Time etc performance.
     
  8. BufferMess

    BufferMess Member

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    Procedures are different than processes in many ways. Usually in a QMS where a QMR is active, he or she is the one preparing the procedures and TM approves them.

    You can implement process responsibilities in this way:
    1. Assign a responsible person for process management.
    2. Assign responsible persons for monitoring and verification activities. Detail the responsibilities further to lower positions of process structure.
    3. Prepare job descriptions for each formal position. Keep balance between responsibility and authority when preparing the documents.

    Having process managers signing the job descriptions and TM approving them will meet the requirements. QMR should provide necessary knowledge and support to process owners in shaping the process documents.
     
    Last edited: Feb 27, 2019
  9. tony s

    tony s Well-Known Member

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    QMRs should not be the one preparing the procedures. To make people own and be responsible to their processes, the "process owners" (see samples by Andy) should write their procedures. An active QMR can have other responsibilities than just writing procedures, such as:
    • convening meetings to review the QMS;
    • liaise with external parties (e.g. CBs or consultants) on matters related to QMS;
    • keep track the implementation of corrective actions;
    • oversee administrative and logistical support during the conduct of relevant workshops/training;
    • monitor performance of departments in achieving their set objectives;
    • even conduct audits.
     
  10. senior

    senior Member

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    I agree with Tony,
    QMR should not be preparing procedures.
    Process owners should prepare their own procedures and review by respective HODs.
    It will be better if review and approve by respective HODs.
    This makes them answerable for their procedures and processes to TM
     
  11. StephJ

    StephJ Member

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    Sorry to wade in on this thread but I would appreciate your expertise and feedback. We transitioned from ISO 9001:2008 to ISO 9001:2015 standards and as such introduced 19 procedures that followed ISO guidelines. However, alongside these we also have work instructions which are used by our staff in their day to day work (creating designs and all other admin/support staff follow work instructions for their various departments). Are the ISO procedures relevant to us or are they superceded by the work instructions? Any help gratefully received as I find this area rather confusing.

    Thank you in advance.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi and welcome in (wading is a good choice of words!)

    It's not uncommon to ask about the need for procedures vs instructions. ISO 9001 doesn't care these days, leaving it, instead to the organization to determine. I'm interested to know, since 2015 doesn't mention procedures specifically, how did you decide to adopt 19? Could you list them? It might be that it's overkill for many requirements, to proceduralize them.
     
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  13. StephJ

    StephJ Member

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    Hi Andy,
    Thanks for your reply. The procedures were suggested to us by the consultancy we used to help us build our new QMS system and the procedures are as follows:

    Control of Documented Information
    Control of Communications
    Control of Risks and Opportunities
    Control of Environmental Aspects
    Control of Occupational Hazards
    Control of Compliance Obligations
    Control of Targets & Objectives
    Control of Competence & Awareness
    Control of Infrastructure and Natural Resources
    Control of Design and Development
    Control of Purchasing and Procurement
    Control of Non-conformity and Corrective Actions
    Control of Envirironmental Emergency Situations
    Control of Accidents & Incidents
    Control of Client Satisfaction
    Control of Data Analysis
    Control of Internal Audits
    Control of Management Reviews
    Control of Improvement

    Most of these are covered by our internal work instructions and we also have measures in place which cover the other procedures.

    Advice welcomed, thank you in advance.
     
  14. KyleG

    KyleG Active Member

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    I am not sure of what your company does, but you dont need a written procedure or process for everything you do, just records of each. "Control of Client Satisfaction" we use CARs and scorecards along with a weekly mancom meeting to discuss customers. "control of Management reviews" i have a MRM agenda with a schedule and i store the minutes in a folder. I would question why the consultant wants you to have all these, it seems like thats what the consultant wants you to have not what the standard says
    Hope this helps.
     
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  15. Golfman25

    Golfman25 Well-Known Member

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    While not needed, it is helpful to have something which walks you thru the process. We use flowcharts. Keep it simple.
     
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  16. KyleG

    KyleG Active Member

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    Thats fair to say, I have a relatively small company few moving parts. Would be harder to do things wrong than right. I also agree if your company needs it have it. But dont create just to create because the auditor/consultant/person says so unless they can point it to the standard.
    Hope this helps
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Steph J, these appear to be ISO 14001 type requirements, not ISO 9001. Can you confirm that you have an EMS (environmental) and not a QMS (quality)? If so, we'll move the thread.
     
  18. tony s

    tony s Well-Known Member

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    The consultant did more than what you need to justify the price you have to pay him/her.
     
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  19. StephJ

    StephJ Member

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    Thank
    you for your advice! That's really helpful. The company is a Civic Engineering consultancy and most of the work is providing designs for building projects so most work is office based. The engineers and support staff all follow in-house work instructions and we also have guidance for suppliers, client satisfaction, training, etc. When we made the transition from 2008 to 2015 standards I was totally new to QM and didn't question the Procedures that were being put in place. However, we are now developing our online portal for staff to access and I think the Procedures will actually be confusing.
     
  20. StephJ

    StephJ Member

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    This sounds like a good idea to keep it simple by using flowcharts.
     
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