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ISO 9001:2015 General

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by KyleG, Jan 3, 2019.

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  1. KyleG

    KyleG Active Member

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    Hey guys, i was curious if anyone knows of online courses i can take to help understand and or implement ISO. I currently am working on work instructions and SOP's. i understand most of the standard (at least i think i do), but i am struggling identifying how to answer the standard. 5.1.1 for example of course our top level management takes accountability for the QMS we communicate it engage associates etc. but how do i "prove" that to the standard. Any advice on where to start would be greatly appreciated. I am starting from scratch developing and implementing it for a start up. Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    On line not recommended, however, several good books out there. Where are you located?
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    STOP! It's the biggest mistake you'll ever make.
     
  4. KyleG

    KyleG Active Member

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    Northern Nevada.
    Why Should i not be making work instructions?
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    May I suggest you reach out to these people? https://www.nevadaie.com/quality-management-systems.html

    There may be grant funding available to ease the burden.

    There are many reasons why YOU shouldn't be developing documentation, not least of which is ISO 9001 doesn't actually require them! There are many adverse situations you are creating by doing this. STOP and, until a lot of questions have been answered, like "When, Why, What, How, Who" etc nothing should be done. (except getting educated - not "trained" - on ISO)
     
  6. tony s

    tony s Well-Known Member

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    If the absence of documented instructions will put the operation of your processes at risks of producing discrepant outputs, noncompliance with regulatory requirements or NC against customer specific requirement, then by all means document them. Clause 4.4.2 mentioned "To the extent necessary...a) maintain documented information to support the operation of its processes". Don't write instructions or SOPs for the sake of just documenting them. Maybe this is what Andy means.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Partly, Tony. The bigger issue is, Kyle is creating a monster. He will have to feed that monster since, a bit like kids and puppies, the care after the first few days always falls to the parents despite the kids saying "Oh yes! We'll take care of it!"

    Seriously, people will not want anything to do with a document written by someone else. They won't own it. It is unlikely to be written about things they need or in a manner that is effective. As a result, you'll have a system of documentation, not a documented system. Then comes the internal audits: Auditors will discover that people aren't "following instructions" and then management start to "discipline" the workers for noncompliance. And so it goes...
     
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  8. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @KyleG
    I would agree in part with both @tony s and @Andy Nichols .

    Yes, often documentation is created for the sake of creating and this should be avoided.
    Yes, it is best (correct) to incorporate the teams and determine what "documentation" (if any) is needed and then include them in the (task them with?) documentation process.

    Some considerations:
    1- You want any "rules" broad enough to allow permissible flexibility and avoid the proverbial "shoot yourself in the foot", "paint yourself in a corner", etc..etc...BUT ensure they capture what your organization's intent is.
    2- If the "documentation" (however that looks) is gone or wrong, what will the consequence be? This will help the organization identify potential documentation needs.
    3- Without any documentation, how will the organization ensure sustainability? (when you and the other authors are no longer with the company)
    4- Be sure that any documentation that IS created, is created not only for those who currently exist in the organization, but also those who do NOT yet exist in the organization.

    In regards to …
    "5.1.1 for example of course our top level management takes accountability for the QMS we communicate it engage associates etc. but how do i "prove" that to the standard."

    While your question is specific to 5.1.1. (a generic "macro" level comment), you are obviously aware of some more specific Top Management requirements...(i.e. customer focus, quality policy, responsibility and authority, management review, etc... It is likely there will be evidence of Top Management involvement in these functions (for example, Management Review mandates that "Top Management shall review..." and then goes on to require "The organization shall retain documented information as evidence of the results of management reviews." These activities will (should) provide evidence. Also, results (i.e. performance evaluation metrics) can provide evidence.
    Whatever you do, I would certainly council against required checklists, approvals, meeting attendance, etc... by members of top management simply for the sake of providing "proof".



    Hope this helps.

    Be well.
     
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  9. Laura N.

    Laura N. Member

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    Might I inquire why online is not recommended?
    Also could you expand on what good books are out there. I am in Northern California and am helping implement AS9100 for a manufacturing company, and am always looking for good sources to learn from. Thank you!
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome Laura!

    The creation of a Quality Management System is NOT a one person job. Hence, unless everyone (the management team, that is) is going to take the same on-line course at the same time, you won't all understand the same things. Secondly, most on-line learning isn't learning. There's little/no interaction and little actual practical involvement. It's more talking heads and about "ISO" than the practices of implementation - which can't realistically be delivered this way, since it's not tailored to your unique and specific needs. It'll be "vanilla" ice cream and that's only fine it your not looking for mint chocolate chip.

    Craig Cochran's ISO 9001 book is a good basic ISO 9001 book. The AS9100 additions are pretty easy to read.
     
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  11. Laura N.

    Laura N. Member

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    Nice! Good to know I am going in the right direction.... I have that book and am just reading it. Thank you!
     
  12. tony s

    tony s Well-Known Member

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    Better still, if you have questions that a book can't answer, just post it here.
     
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  13. pkfraser

    pkfraser Active Member

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    Andy

    They may be very capable, but when they say on their website: "Quality Management Systems are sets of standards that have been developed by the International Organization for Standardization (ISO)" I am a bit concerned. The QMS is what an organisation does, and how it does it (structure, policies and processes), to ensure customer satisfaction. Any standard is "just" a way to get a QMS recognised.
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Isn't it more important that the practical assistance the client gets is effective?
     
  15. pkfraser

    pkfraser Active Member

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    Of course it is, but I would be concerned about their view of the differences between a "management system", "a description of a management system" and an "external standard", in case the client is given confusing advice. It suggests a lack of clarity if nothing else, and nowadays a website is a brochure for what the supplier has to offer. It should be very easy to get it right (although ISO themselves seem to have difficulty with some of the terms they use - as demonstrated by their current discussions on the definition and use of the term "management system" for one(!)
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not at all. I'd wager the marketing folks wrote something and the quality folks haven't seen it. Occam's razor. Nothing more. Nothing less. We shouldn't indulge conspiracy theories.
     
  17. pkfraser

    pkfraser Active Member

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    Andy
    You have lost me on the conspiracy front...

    I was merely pointing out for the benefit of KyleG, and anyone else looking for guidance, that since (according to ISO 9000) a customer is a “person or organization that could or does receive a ... service that is intended for or required by this person or organization", potential customers such as KyleG are deemed to be customers (in the context of ISO 9001) and, since ISO9001:2015 (clause 8.1) states that "communication with customers shall include ... providing information relating to ... services", and clause 7.5.2 requires "documented information to be reviewed for suitability", I was surprised at the statement on the website in case it misled someone starting out on an ISO9001 journey.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's been happening since "Say What You Do..."
     

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