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Hours to complete

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Stephen Sheehan, May 4, 2018.

  1. Stephen Sheehan

    Stephen Sheehan Member

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    Hi everyone,

    My name is Stephen and I have only just recently completed a Dip of QA with SAI global and now my boss has tasked me with the job of getting our company ISO9001:2015 registered within a 12 month period. My boss is very interested to know what is the average "man hours" to complete the implementation of a QMS and then also how many man hours does it take to maintain a QMS. Our company is only 100-150 staff working in the health sector of delivering allied health services to the elderly.

    Is there anyone who could let me know how long it took for them to create a QMS from scratch and how many (estimated) man hours it took?

    Look forward to hearing from someone :)
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome and what a great question for a first post!

    A difficult one, and really it will be very dependent upon what your organization has in place due to the way it's grown, involvement of customers, regulatory requirements etc.

    Firstly, for an organization of the headcount, 12 months is a reasonable timeframe, including the registrar process of auditing. As far as your role, it'll be a full time role initially, mainly as a project manager and cat herder. Having implemented a significant number of QMS in a large variety of industries, I'm confident that you'll also need the leadership team for a couple of hours a week too. There may be a few others involved, but this will vary from a few hours to maybe 20 hours a month.

    Once certified, someone will need to act as process owner for internal audits and a couple of other processes which you don't currently do, so maybe 20 hours a month.

    My good friend Roxane is in the health care biz and she might be able to shed some greater detail.
     
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  3. RoxaneB

    RoxaneB Moderator Staff Member

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    Hi, Stephen and welcome!

    Further to Andy's reply, other items that can impact the registration process include, but are not limited to:
    • Existing management system components (e.g., documentation, training processes, management review, etc.)
    • Leadership commitment (i.e., they cannot simply say do it and then check up on you in 12 months)
    • Your own familiarity with the standard
    • Your own familiarity with the organization
    • Provision of additional resources as you progress further along the timeline (e.g., training, auditors, document authors, etc.)

    So, while there is undoubtedly an average "man hours" number out there, the unknown variables at this stage render it almost meaningless. Twelve months does sound like a sufficient amount of time, yet again, think of all those little variables as little wrenches just waiting to cause some potential havoc. #DeviousSpanners

    Until you know more about the situation and the work that needs to be done, I'm not certain that you can confidently provide a number or range of time. A gap analysis would highlight the areas that require work or some tweaking or perhaps no attention whatsoever. It would provide you some context upon which to plan out the implementation (and hours). Maintenance of a QMS can, theoretically, decrease in required man hours over time...presuming it's developing into a mature system (i.e., one that goes beyond simply getting a piece of paper to hang up on the wall in the main lobby). Or perhaps it just seems like it decreases over time as the activities become built into our everyday routines.

    As Andy alluded to, I am in community health care (most of my career has been in manufacturing, however, with a hop over into the financial realm for a bit) - we're a not-for-profit organization that offers in-home care and services for clients of all ages and at varying stages of life.
     
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  4. Stephen Sheehan

    Stephen Sheehan Member

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    Thanks so much Andy and Roxanne :) Starting this journey has been daunting, but I believe I am starting to get my head around it a bit more lately.

    Very exciting that you work in community health care Roxanne! I'm probably going to pick your brain a fair bit! Just starting the gap analysis now and I'm likely to have plenty of questions.

    I'm currently stuck on 8.3 in regards to design and development. Our company provides Allied Health services, where we receive a referral to see a client --> assess client --> create a plan with the client to help them achieve their goals --> report is written by practitioner --> report is peer reviewed by senior practitioner --> report is then sent to case manager --> if approved by case manager, then services begin --> ongoing success of plan is reviewed at each subsequent visit --> full reassessment completed in 3 months with report with update of clients needs and goals and change in plan as needed. All reports are retained as documented information and communicated to case managers and relevant staff.

    Since each of our practitioners "design and develop" an individual program for each client, is that considered design and development under this standard? And if so is there a step we are missing to satisfy 8.3?

    Thanks in advance!
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Stephen: Typically, the Design and Development requirements relate to the service, not the individual client/customer/patient. It's like the difference between a car design and the specific packages of trim, colors, wheels and other features which the design is offered in. What you describe isn't "design" in the conventional sense of the standard, IMHO.
     
  6. tony s

    tony s Well-Known Member

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    Since 8.3 is about Design and Development of "Products and Services", organizations need to be clear about their products and services. Some questions might be considered to determine applicability of 8.3:
    1. what is the organization's product/service that is intended for, and required by, a customer? (see Note 1 of Scope of ISO 9001:2015);
    2. who sets the requirements for the product/service to be designed/developed?
    3. who transforms the requirements for the product/service into more detailed requirements/charateristics? (see 3.4.8 of ISO 9000:2015)
    4. who conceptualizes the output of the design and development process (i.e. prototype, beta version, model, blue print, draft, pathway)?
    5. who has the overall responsibility when product/service characteristics are changed?
    If the answers to questions 3 to 5 resulted to being "your organization", then, IMHO, 8.3 is applicable to your organization.
     

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