1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Simplest Way to implement

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Sein Wan, Jan 17, 2022.

  1. Sein Wan

    Sein Wan New Member

    Joined:
    Jan 17, 2022
    Messages:
    1
    Likes Received:
    0
    Trophy Points:
    1
    I am reaching out from Papua New Guinea. I am very interested in the standard. I am familiar with it so I thought. But recently I have come across a hurdle.

    I would appreciate your thoughts on my issue. I have been asked to implement a QMS for my current company. And although there are preexisting documents they do not really cut it as far as our compliance to the standards go.

    The boss is a bit troubled about the whole documentation yet he still wants QMS.

    Are there any simple steps or things I can do to implement? I also do understand QMS requires top management support. So in that sense am I doomed to fail?



    Thank you

    Sein
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    709
    Likes Received:
    510
    Trophy Points:
    92
    Location:
    Upper Midwest- USA
    Good day and welcome to the site @Sein Wan .
    Don’t discount what your organization already does. Don’t discount the documentation your organization already has in place. Instead of looking at your existing processes/methods through the eyes of the standard , instead, look at the standard through the eyes of your existing processes/methods. ISO 9001 is not overly prescriptive…, so don’t make it more difficult than it is.

    Hope this helps
    Be well.
     
    tony s likes this.
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    What makes you think this?

    Are there any simple steps or things I can do to implement? There are steps, yes, but how simple they are is going to depend on many things. Let's not overlook the fact that you are going to be creating a formal, process centered way to run the business. Many people don't see the need.

    Failure comes in degrees. So, yes, unless you and your leadership have realistic expectations, borne from understanding the standard and what it means (for example NOT running off and having a formal risk management process, doing FMEAs etc, when a simple SWOT analysis will do) you will have a degree of failure. You must take management along as you step through the various implementation phases.
     
  4. yodon

    yodon Well-Known Member

    Joined:
    Aug 3, 2015
    Messages:
    198
    Likes Received:
    115
    Trophy Points:
    42
    An interesting observation. Why is the boss troubled about documentation? Is he/she opposed to consistency in operations or just thinking "if it's documented, it's overly bureaucratic"? 9001 has really downplayed "documentation" and frequently, things like process flows and diagrams can be more effective at communicating to the team.

    What's the motivation for the boss to want a QMS - just to get certified or to continually improve?
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Good point! Another thought is that - as is frequently the case - people like to make a bureaucracy of the documentation! If I were a senior manager and thought that ISO required the kinds of documents people create for their QMS, I'd be highly troubled. When I see procedures etc which have multiple headings, including:-

    Purpose
    Scope
    Applicability
    Responsibilities
    Definitions
    Related Documents
    References
    Procedure
    Forms
    Records
    Change History

    I'd be running in the other direction...
     
  6. pkfraser

    pkfraser Active Member

    Joined:
    Aug 1, 2015
    Messages:
    93
    Likes Received:
    61
    Trophy Points:
    17
    Location:
    Aberdeen Scotland
    Sein

    The reason for documenting your system can include: standardisation of processes / making life easier for new staff / compliance with a standard / identifying and resolving current problems / getting ready for expansion...
    Why was it done the first time, and which is it this time round (for you or rather for your boss)?
     
  7. BradM

    BradM Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    394
    Likes Received:
    314
    Trophy Points:
    62
    Location:
    Arlington, TX
    Welcome to the forum!!

    I guess I might be interested in how much your organization has mapped your processes, and to some extent, identify value-added and non-value added process steps.

    As far as your existing documentation, I would be more concerned with how your existing procedures align with current processes, more than how they currently fit in some preconceived outline of ISO 9001:2015.
     
  8. QueenOfQuality

    QueenOfQuality Member

    Joined:
    Jan 29, 2022
    Messages:
    12
    Likes Received:
    4
    Trophy Points:
    2
    The easiest way to do this is with Gap analysis. Firstly a gap analysis against the current document content to see if it meets the required/recommended content for an SOP, then against the required documents listed in the standard.
    • Monitoring and measuring resources (7.1.5.1)
    • Monitoring and measuring equipment calibration records* (clause 7.1.5.2)
    • Records of competency in staff (clause 7.2)
    • Product/service requirements review records (clause 8.2.3.2)
    • Design and development inputs record (clause 8.3.3)
    • Records of design and development controls (clause 8.3.4)
    • Records of design and development outputs(clause 8.3.5)
    • Record of design and development changes (clause 8.3.6)
    • Criteria for evaluation and selection of suppliers (clause 8.4.1)
    • Characteristics of product or service to be provided (clause 8.5.1)
    • Identification and Traceability records (8.5.2)
    • Records about customer property including any changes (clause 8.5.3)
    • Production/service provision change control records (clause 8.5.6)
    • Release of products and services (clause 8.6)
    • Control of nonconforming outputs (clause 8.7.2)
    • Monitoring and measurement results (clause 9.1.1)
    • Internal Audit results (9.2.2)
    • Results of the management review (clause 9.3.3)
    • Results of corrective actions including opportunities for improvement (clause 10.2.2)
     
    Bhelnar Villanueva likes this.
  9. QueenOfQuality

    QueenOfQuality Member

    Joined:
    Jan 29, 2022
    Messages:
    12
    Likes Received:
    4
    Trophy Points:
    2
    Please rememeber that ISO covers over 30,000 differing standards, all with different requirements. Some standards require this, and others ie 15189, require more. Sometimes documents are covering multiple standards. If a company has an eQMS this is easy to manage electronically, but it is suprising how many companies have all their documents stored on a network drive with no proper docmument control system...

    I have a document heirarchy - the policy contains the basic info everyone needs to have an awareness of, the SOP contains the beurocratic part that is required including the procedural steps, then the working instruction is a step by step, detailed guide to the procedure, without all the waffle. Induction of new starters uses the policies, training uses the full SOP and then day to day practice uses the WI.
     
    Steve l likes this.
  10. Steve l

    Steve l Member

    Joined:
    Feb 24, 2022
    Messages:
    8
    Likes Received:
    3
    Trophy Points:
    2
    Hi sein,
    There are many good replies here. I am sensing that you have been given the task to implement a QMS and that you are looking around for an appropriate one to have certified.

    Having implemented iso 9000 many years ago and been the qm for many years I know that you may benefit from my experience. Unless you intend to learn to be an effective qm you will be forever banging your head against a brick wall trying to deal with organisation members resistant to the changes needed.

    First principle is that of the dominant mind. know that you have the power of knowledge that other organisation members don't. It doesn't mean you walk up to senior management and hit them across the head to beat them into submission. It means you guide conversations in the direction you want and show them how doing things a certain way will get them what they want sooner, better, and more profitably.that "way" is a combination of their current procedures modified by principles of the standard you wish to apply.

    You don't need to talk about getting certification unless the company needs it to deal with customers.

    Next principle is to learn communication skills with all types of people. everyone has characteristics of a small number of personality types. Once you can characterise an organisational member you will be more effective at getting the best out of each. All top executives of public companies have impeccable people skills these days. There is no reason you couldn't write your own ticket once you've got a proven record having implemented and run an effective QMS that adds profit to the bottom line.

    It's also an opportunity to involve suppliers as well as customers to buy into your QMS and lock them into long term deals that would cause major inconvenience to change thereby creating a captive customer base. The possibilities are as long as your imagination takes you. This is what I call the principle of the third alternative, a mastermind group.

    I have seen too many "one size fits all" QMS systems implemented by consultants eager to impress clients about how much they knew with bloated documentation poorly written. they merely create a red tape jungle that is resented by everyone involved and provides multiple opportunities for non-comformances by auditors. Auditors can sense when a business is trying to hide things. Instead, if you have a robust , lean system that you know intimately the auditor becomes your friend. Know how to write up an effective QMS yourself and some powerful but simple improvement tools. Once your bosses and key organisation members see the value of your QMS your job becomes a breeze.

    If you don't get big pay raises you can leave and become a consultant known for implementing value adding profit QMS especially in non English speaking companies.
     
    Last edited by a moderator: Feb 25, 2022
    tony s likes this.
  11. Steve l

    Steve l Member

    Joined:
    Feb 24, 2022
    Messages:
    8
    Likes Received:
    3
    Trophy Points:
    2
    @Sein Wan PS I'm also a certified breakthrough coach. I help people breakthrough their self-imposed barriers to confidence, career advancement, self-worth and wealth. This is an additional optional second part of the course. Learning to apply it with other key executives will certainly get you noticed and sought after and make you invaluable to whichever organisation you choose to work with.

    Best of luck
     
  12. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    926
    Likes Received:
    1,081
    Trophy Points:
    92
    Location:
    Ontario, Canada
    With all due respect, Steve, this approach is rife with arrogance. It is presumptuous of any change agent to walk in with the belief that their way is the best way. Change agents need to continually learn and recognize that the way that worked years ago or worked for the last company may not work here. Change agents need to adapt and, in order to this, change agents must...well...change. This means listening to stakeholders and understanding the blockers to change. The benefits of such an approach can take a change agent well beyond the role of merely implementing a QMS.

    The approach of doing it this new way because it's "better and more profitable" is akin to telling a child to not touch a hot stove because they'll be burned. You've failed to effectively explain why change should happen, at least in such a way that would give an organization pause to returning to their old ways. Maybe you cover this in your training - if so, you've failed to articulate here in a manner that resonates.

    Please, cite your source for this. I have a feeling that there are many here who would disagree with you, including those with years of real world experience.

    If an organization is all about the bottom line, your promises of "write your own ticket" and "big pay raises" contradict such a culture.
     
  13. Steve l

    Steve l Member

    Joined:
    Feb 24, 2022
    Messages:
    8
    Likes Received:
    3
    Trophy Points:
    2
    Well Roxanne, "with all due respect" is metaspeak for no respect so please call a spade a spade. I've read several books by top ceo's and worked under some ceo's and gone to seminars by top level trainers, I've forgotten many of them. However, innovation has been a major reason for their success and fat pay packets. Just look at GE and Apple. Both Jack Welch and Steve Jobs weren't that clever. They promoted very clever people and had people skills to get the best out of them. Which one do you consider yourself to be Roxanne? Clever or good people skills? Read rich Dad, poor Dad by kiyosaki, it may just open your eyes. Another great book is the slight edge. You don't have to be much better than your competitors to be much more valuable to your team. That includes business executives as well as sports stars. Take Michael Jordan. He wasn't the most talented, he just outworked his competitors but even he wasn't better than 2 "ordinary" NBA players yet he earned much more than their combined earnings. I'm sorry you feel the way you feel, I've just been around different circles to you.
    Best of luck Roxanne
     
  14. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    926
    Likes Received:
    1,081
    Trophy Points:
    92
    Location:
    Ontario, Canada
    Steve, for someone who implies great learning from these top executives with "impeccable people skills," I would offer that one of those learnings would be on the proper spelling of an individual's name.

    It's truly wonderful that you've read books, gone to seminars, and even had the opportunity to work with some amazing people. So have I in my many years of experience. This post, however,...this thread...isn't about me. For the record, I do not consider myself to be Jack Welch or Steve Jobs. I am humble enough to recognize that my sandbox is different than theirs. My response was to challenge your tone and seemingly close-minded technique.

    I also recognize that the Jack Welches and Steve Jobs' are the wonderful outliers in business and innovation. And for every Michael Jordan there were a multitude of "normal" NBA players. So, please, showcase your outliers, your beautiful exceptions to the norm, but recognize that most people fall somewhere in the middle and are perfectly content to be there.

    We welcome those with experience and those without here in QFO. You are not, however, the only one with experience in implementing and sustaining a management system (and, dare I say, culture) within an organization. Confidence in one's ability is truly wonderful, but when it's replaced by arrogance, it's off-putting as a consultant, a trainer, and poster.
     
    John C. Abnet likes this.
  15. Steve l

    Steve l Member

    Joined:
    Feb 24, 2022
    Messages:
    8
    Likes Received:
    3
    Trophy Points:
    2
    My apologies roxane, the autospeller defaulted after i had moved on.

    I fail to see where i have been arrogant. I have not contradicted anyone else posting here. My point about the people i mentioned was that they are not much smarter than average people and michael Jordan apparently did not make it as a member of his high school team(maybe it was his college team?) i admit to being unsure. However, all of them worked on themselves harder in the right areas till they shone through.

    True, there is also a need for many indians to complement the chiefs. I just occer to train chiefs rather than indians
     
  16. Steve l

    Steve l Member

    Joined:
    Feb 24, 2022
    Messages:
    8
    Likes Received:
    3
    Trophy Points:
    2
    Apologies, the last post cut me out for time. I have reproduced it here.

    My apologies roxane, the autospeller defaulted after i had moved on.

    I fail to see where i have been arrogant. I have not contradicted anyone else posting here. My point about the people i mentioned was that they are not much smarter than average people and michael Jordan apparently did not make it as a member of his high school team(maybe it was his college team?) i admit to being unsure. However, all of them worked on themselves harder in the right areas till they shone through and hired the best and brightest coaches/mentors they could afford. (I'm including getting jobs within mentors' organisations).

    True, there is also a need for many indians to complement the chiefs. I just prefer to train chiefs rather than indians. If anyone is happy where they are then more power to them. I'm not here to step on toes and there are many to skin a cat. Unlike what you accuse me of, i am not a "my way or the highway" type. Your consultancy is just as relevant for the right businesses as mine. I merely provide a point of difference.

    Fyi, you should learn the top 10 metaspeak phrases including elimination of the word "but" from your vocabulary. Saying any to your senior bosses will get you on the slide to oblivion faster than you can ask where am i going. But then again you need not take any advice from me, take it from linguists instead.
     
    Last edited: Feb 25, 2022
  17. Jeff Myers

    Jeff Myers Member

    Joined:
    Apr 27, 2023
    Messages:
    5
    Likes Received:
    3
    Trophy Points:
    2
    Old thread I know, new member here attempting to get answers on traceability and I stumbled onto Steve and Roxane having a pissing contest. Yay you guys, excellent team players :)