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Developing schema for Quality Manual

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Elisa_Rebeca, Feb 1, 2016.

  1. Elisa_Rebeca

    Elisa_Rebeca Member

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    Hello, I need somo help please... I'm doing the manual of my company, to get the ISO ... and I am a little confussed about the scheme, somebody can help me please? Our scheme is this... it's rigth?
    1. Objective
    2. Scope
    3. Responsibilities
    4. Abbreviations and Definitions
    5. References
    6. Policies
    7. Procedures
    8. Records
    9. Change control
    10. Annexes
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome Elisa! I would list References #3, Policies #4, Procedures #5, and Responsibilities #6.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I've found this type of thing to be more window dressing than actually necessary. People "like" this stuff, but when I create documents it's quite possible to work these topics into the pre-amble and leave the rest out. I've never found it necessary to include "policies" or "definitions" etc. In fact, to be most user friendly, the "how" gets presented 6th in order? I'd ask why that's done that way. After 25 years of doing management systems, I can't find a compelling reason to use such a complex (and for the most part unnecessary) structure.
     
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  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    This being intended for a manual, I am unclear if the expectation is to just list them or cite them chapter and verse. Given the company is apparently new at this, it makes sense to make a QA Manual in which to list the system's objectives, scope etc. and a brief of the other subjects. Although a QA manual is no longer required, many of my clients will continue to have one because some reference point is useful and things like scope and policy need to be documented somewhere.
     
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  5. RoxaneB

    RoxaneB Moderator Staff Member

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    I suppose what I find myself wondering is WHY have all of this in the manual? WHO is this for? WHO gains value from this document or the sections of it?

    Having an Objective and Scope in the manual seems unusual to me - I don't think I've seen these sections at the manual level.

    Responsibilities...with regard to what? The manual? The QMS? All the reference policies and procedures within the QMS? If it means the responsibilities associated with the manual, I can sort of understand having them in here - especially if includes the approvals. But for the other options, why repeat the information that can be found within the manual, policies and procedures?

    Abbreviations and Definitions - I like having this outside of the manual and making it become a "Glossary of Terms" for new employees.

    Not sure what you mean by References. Sections 6-8 also seem a bit...off. If you're writing a Quality Manual, I think many organizations that are new to the approach typically follow the structure of the standard (each section can essentially be a policy...a high level document that simply says what your organization promises to do) and reference applicable procedures (lower level documentation that gets into who, what, where, when, why, how aspects of a process (such as corrective action or document control)) within the appropriate section. Forms to be used within the QMS are typically referenced within procedures.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm wondering if it came as part of one of those "kits" where the client has to fill in the details...:rolleyes:
     
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  7. Elisa_Rebeca

    Elisa_Rebeca Member

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    I'm confussed!!!! I took a course about "Manual of procedures" ISO ... and our instructor told us that scheme... it`s wrong???
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's not "wrong", it's often that some instructors form their materials around old fashioned methods and practices - and sometimes their reasoning for doing it this way is that it didn't attract any adverse comments (or non-conformities) from a Certification Body auditor. "You can get certified if you do it this way..."

    Back in the 1987 version of ISO 9001, there were references to procedures and work instructions (for process controls). As a result, people imagined a "pyramid" of documentation levels as a way to document their Quality system. It wasn't "required" but became a model - yet in many cases the use of such a model was a force fit to the organization. This pyramid was also supported in many ways by the mantra about ISO implementation being "say What You Do, Do What You Say" - which is of course, inaccurate for many reasons.

    Today, ISO 9001 has removed an prescriptive requirements for documented procedures etc. It is now up to the organization, based on the understanding of their interested parties and their context, to determine WHAT documentation is necessary to accomplish their goals.

    Sadly, some training providers haven't adjusted their approach to meeting the needs of their clients, because they hang on to a model for documentation which is now close to 25 years out of date...
     
  9. Elisa_Rebeca

    Elisa_Rebeca Member

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    Andy,
    I'm confussed!!!! I took a course about "Manual of procedures" ISO ... and our instructor told us that scheme... it`s wrong???
    Thank u, so much!
     
  10. MCW8888

    MCW8888 Well-Known Member

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    Welcome Elisa!!! I attempted to write a manual because my Line Manager wants to know what the new manual would look. So I had the following: (1) Context of the Organization; at the end is a reference to the Business Risk Analysis that I got from the RESOURCE section of this forum (2)Scope and Exclusion (3) SIPOC and at the end is a reference to masterlist of documents; (4) Responsibility Matrix mainly to make sure there are back-up responsibles. So now I only have 4 sections which I am still fine-tuning. I have seen manuals that follow the clauses of ISO9001:2015. But a manual is not even a requirement so you can make up any scheme you want as long as it make sense to your organization. I also included a section on Quality Policy and business objectives which I cut and paste from our corporate website. There's no sense developing new policy and objectives when we are suppose to align with the stakeholders policy and objectives. Anyway this is just a draft. I may still change the format before 2017.So do not be confused. Just be creative.
     
  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    As in business plan templates? Most I have seen contain much of this stuff: issues, internal and external stakeholders, market, risks to business, responsibilities, contingency plans, etc. There is no shame in following a framework if an organization is comfortable with the result.

    Elisa, I wonder if your instructor was basing his course on ISO 9001:2008. The new standard's requirements read quite a bit differently; including no requirement for a quality manual at all or the 6 documented procedures Document control, record control, etc.) Do you have a copy of the 2015 version?
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I was thinking one of those "ISO 9001 QMS in a Can" deals. Everything pre-written, just change the names...
     
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  13. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I know you were. Now that we have 2015, the business plan template does basically the same thing. Is that bad?
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Insofar that some I've seen require little to no input from the people who buy them, and that they can become a bureaucratic burden because of their content and format, yes! I think there's a difference too in there being a template - as in a set of headings - which the client has to complete their information and a set of predetermined content (often written around such a set of headings). I've seen this approach to documenting a QMS where clients don't have the wherewithal to modify the contents to suit their operations and ended up with some very bizarre documents. One I recall, a "records control procedure" indicated that some kind of DoD approved electronic "scrubber" was to be used to wipe electronic files at the end of the records' life! The client was a 10 person, automotive machine shop! I kid you not...
     
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  15. MCW8888

    MCW8888 Well-Known Member

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    In the old system, the Quality Manual and the 6 procedures are called ISO procedure and has nothing to do with HSSE or Product Quality!! That's what put the ISO into a silo and managed by a quality coordinator. I have a quality manual template that I can just change the name. I can really use that and take the path of less resistance.
     
  16. MCW8888

    MCW8888 Well-Known Member

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    OK with me but it still reflects the old ISO scheme. The new ISO is called New and Improve ISO.

    If you want you can try to create a simple Manual covering section 4 and post it here for comments. We are all on a journey and are as confused as everyone else (except the Moderators). Just try to create your CONTEXT OF THE ORGANIZATION. Shomashekar posted one before, but I cannot copy it because my business is totally different from his. I have to create my own context. I gathered all my friends and treated them to a SWOT lunch. You can also have CONTEXT OF THE ORGANIZATION lunch and learn and invite your Top Manager. Just be bold. Share your learnings with us.
     
  17. RoxaneB

    RoxaneB Moderator Staff Member

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    I was wondering that, too, but if it's part of a kit, I don't think Elisa_Rebeca would be asking about the format or structure.

    But...

    A 'manual of procedures' is difference than a quality manual, in my opinion. The second one is usually a repetition of the standard with the company's name thrown in (although, companies that go above and beyond the mere requirements of the standard, know to turn this document into something that adds value to the organization's stakeholders). The first sounds like a book (electronic or hardcopy) that contains the procedures required by the standard.
     
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  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The business plan templates I have seen require all the details: who is your market, who are your internal stakeholders, who are your external stakeholders, do you have regulations to which you must comply, who is your competition, what are your contingency plans, etc. They come loaded with so many of the right questions that the end product becomes valuable to the extent that the user supplies and acts on the information. I am thinking of small businesses, run by people who do not know all the things that must be addressed. They have to get their questions answered somewhere - not all of them know to come here. ;)
     
  19. charanjit singh

    charanjit singh Member

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    For small businesses, in the manufacturing sector, I propose the following simple Context, though the exact wording can vary depending on the nature the business:

    "To manage our manufacturing business profitably by supplying the products/services that satisfy our customer's requirements at all times. Primarily, the interested parties in the context of our business are -

    1. Our customers, whose requirements we must meet,
    2. Our suppliers of input material and services, who must meet our mutually agreed requirements.
    3. Our staff/workers, who must be adequately skilled/trained and motivated in order to carry out the designated processes to achieve the end
    objectives."
     
  20. RoxaneB

    RoxaneB Moderator Staff Member

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    The original post in this thread was not about context. Elisa_Rebeca was asking about document structure/format, I believe.
     
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