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Setting up the ISO9001 for a sole proprietor company

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by YK TANG, Jan 24, 2016.

  1. hogheavenfarm

    hogheavenfarm Well-Known Member

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    I think I agree with Jennifer, in cases where the practitioner is not fully knowledgeable of the standard this could be a serious issue. Other than that however, I find that I am harder on myself and my own work than that of others, precisely because I stay ahead of the curve on these things and it is my job to do so. Others get a bit of benefit of the doubt as they are not 9001 experts, nor do I really expect them to be. Here I fall back to spirit of the intent, not the letter of the law.
     
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Independent of what, precisely? People often quote words, without understanding the meaning of those words. Some state the auditor MUST come from another department, for example. Is that "independence"? Nope! Independence is freedom from bias etc and being able to demonstrate objectivity. If the auditor deals in facts, then this objectivity is demonstrated. To suggest that a) a CB auditor will have to issue an NC for self audit is incorrect, and just an opinion, not a fact and b) any CB auditor who doesn't take each case on its merits and evaluates the facts, isn't doing their job (and this has been true long before 2015 came along)
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    For some, perhaps. I have audited my own work. I have found that the passage of time allows me to look back at what I'd done and view it objectively. To suggest that it's natural for all to accept what we have created or implemented isn't fair, in my experience.
     
  4. Leonid

    Leonid Well-Known Member

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    I ask to evaluate an implication of the assertion that internal self-audit is all right. If so, the internal auditors per se are not needed. Each employee in any organization will audit its own job in the frame of internal audit.
     
  5. hogheavenfarm

    hogheavenfarm Well-Known Member

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    If each employee is auditing his own work, he is still an internal auditor, they will always be needed, whether formally as an auditor -or not. But that is not the point I was making. Some people with higher understanding of the standard may be able to self audit, but I would not expect every factory employee to be at that level. Implied is that the QM or MR or lone internal auditor has the background and knowledge to be able to do this objectively, not that it is a condition I would expect to see plant wide.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not so! Not everyone is objective and unbiased. We simply cannot go from one extreme to the other. Saying on one hand that the auditor MUST be independent to then saying anyone can audit their own work is a little extreme isn't it? As quality professionals, aren't we supposed to be the voice of reason?
     
  7. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I can appreciate if you are able to perform to the outside of the bell curve. My statement was based on years of working in public education and in industry of various kinds. I still think most of us benefit from at least an occasional second opinion, particularly if we don't have many years of your level of experience.
     
  8. tony s

    tony s Well-Known Member

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    If I am a "one-person company", as the OP premised, and wants certification to ISO 9001, I'll take a course on ISO 9001 and learn how to audit against the requirements of the standard. Once I have the knowledge and techniques, I'll audit the processes needed to deliver my products to my customer. The auditing skills may come later, but practice makes perfect. Once I'm comfortable that I have an adequate and certifiable QMS, I'll proceed with my certification goal.

    The requirement in clause 9.2.2c says "select auditors and conduct audits to ensure objectivity and impartiality of the audit process" and nothing about "auditors shall not audit their own work". If I have to select a CB, my first question will be: "Will you raise an NC if I am the one auditing my QMS processes?" If the CB answers "Yes", then I have to look for another CB with more agreeable approach.
     
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  9. Leonid

    Leonid Well-Known Member

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    CB will always issue NC on self-audit as the audit has not been independed process as per its definition in ISO 9000:2015.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Could you help qualify this statement? There are many, many CBs in the World. Have you seen this as a general practice in all parts of the World?
     
  11. hogheavenfarm

    hogheavenfarm Well-Known Member

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    The issue here is that 9001 has dropped the 'not audit his own work' clause, while 9000:2015 continues to define it precisely that way, albeit in the Notes.
    Notes 1 and 3 of 3.13.1 say "carried out by personnel not being responsible for the object audited." and "Independence can be demonstrated by the freedom from responsibility for the activity being audited." which is largely what 2008 said. So by dropping this reference, 9001 muddied the waters once again. It would be interesting to get to the bottom of this at some point, because now you have "the standard says" vs. "the normative reference says.."
     
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The term independent is used in 9000:2015 in 3.13.1 to describe the process: "...systematic, independent and documented process (3.4.1) for obtaining objective evidence..." but the note points us to 3.4.5: "...carried out by personnel not being responsible for the object audited.

    The Note in 3.6.1 describes object as "...can be material (e.g. an engine, a sheet of paper, a diamond), non-material (e.g. conversion ratio, a project plan) or imagined (e.g. the future state of the organization)."

    Therefore: when we consider the entire standard and not a single subclause, we can arrive at the understanding that an internal auditor is not specifically required to be independent of the process. The standard has simply reworded the previous version's requirement to not audit one's own work.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I believe that, sometimes, we use what a CB would "allow" to taint our viewpoint of what ISO 9001 implementation is about. Regardless of Certification, because it's still only optional, we have to look at this and say, if the sole proprietor would be implementing the requirements, what would they do? How would they know what complied or not. If it doesn't say, in the actual Internal Audit requirement, that "I can't audit my own work", then what will the sole proprietor do? Will they read the definitions? See what it says about internal audits?

    A previous tenet of the standards was that it could be implemented by ANY size of organization. Can this be true still, based on what's posted? Should an organization of 1 be forced to obtain a (costly) external resource to perform the audit?
     
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  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    If a CB will issue a NC for this I suggest it is time for the Dispute process so the auditors can get the straight story. There may be no better way to cure the tendency to over-think this.
     
  15. tony s

    tony s Well-Known Member

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    I hope somebody here in QFO has the access to ISO/TC 176 to request for an interpretation regarding "one-person company" auditing its QMS processes. You may check on the attached files.
     

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  16. tony s

    tony s Well-Known Member

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    Yes. ISO's website mentions "All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides." See http://www.iso.org/iso/catalogue_detail?csnumber=62085
     
  17. hogheavenfarm

    hogheavenfarm Well-Known Member

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    The Note in 3.6.1 describes object as "...can be material (e.g. an engine, a sheet of paper, a diamond), non-material (e.g. conversion ratio, a project plan) or imagined (e.g. the future state of the organization)."

    Jennifer, are you saying this note exempts the process? I am a bit confused here. I took it as the intent of the note was to cover everything that could be audited.
    I fully agree that applicability is intended to be scaled to the size of the operation, this is why this subject always is one on my hit list. It just seems that the notes can be read different ways.
     
  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    "Object" includes the suggested example of project plan. So let's look at an annual schedule as a project plan. Someone who did not make the schedule should audit the schedule. A object can also be an individual audit.

    I expect the terminology would have been "process" versus "object" if the entire audit process was expected to be audited by someone else. In this way a 2-person organization could avoid auditing their own work.

    A one-person organization would be more challenged. I do believe the standard wants to maintain objectivity by not auditing our own work (the objects described as examples in 3.6.1). For this I, and many others have often suggested people reach out to their local ASQ chapter, Small Business Development Center (SBDC) or even a college department for capable persons to help out. Ideally a swap of audit services might be made with another organization so as to avoid big costs.
     
    Last edited: Mar 16, 2016
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