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ISO9001 Help

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Martin, Jan 5, 2016.

  1. Martin

    Martin New Member

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    Hello,


    I'd like to introduce myself and hopefully get some guidance. I'm a recent engineering grad and was hired a month ago as a catch-all "project engineer" at a small manufacturer (17 employees). One of my tasks is to ultimately implement ISO9001:2015 but I’m faced with the challenge of not fully understanding the company’s procedures/policies, as well as, knowing very little of ISO9001. At times this feels like a herculean task.

    Our company manufactures custom sensors for refineries so our clients (Shell, Saudi Aramco, etc) usually require a qms and many layers of documentation. They often ask for our ISO9001 certification and we explain that we have an “ISO9001 equivalency program”.

    In 2005 the company hired a consultant to help implement ISO9001. He produced a quality manual for us but to me it seems like the standard regurgitated with our company name stuck in there. The company never took up any of the policies required by ISO9001:2000 and it fell by the wayside. The employees felt the documentation requirements to be burdensome and not in line with what the company needed. The quality manual though is still sent to customers asking for our qms documentation (along with some other cobbled together docs).

    The good news is that upper management is completely on board with implementation even if it requires substantial changes or costs. So far, I have purchased the FDIS and read/skimmed it. I have also done quite a bit of online reading about ISO9001, trying to wrap my head around the requirements and what my path forward should be.

    Some preliminary questions for you:

    Should I be looking at taking a class?
    Should we hire someone to teach a class on location for multiple employees?
    Can you point me in a general direction forward from here?

    Pardon my ignorance and general questions. Thanks in advance for your patience and help.
     
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  2. MCW8888

    MCW8888 Well-Known Member

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    It is recommended that you take the class because there are significant changes to the ISO standard that you need to understand and implement

    If your Top Mangement is on board, you should hie someone to teach the class on-site for multiple employees including above all Top Management. They are accountable for the implementation of this new standard.

    If one of the moderators of this site is willing to conduct the on-site training, I would highly recommend that you contact them.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Martin! Been there, done that. Please feel free to call me (248) 681 9665 for some ideas on how you can get started. No fees, no sales pitch...
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    With a company your size, I would recommend finding co-operative class. Basically a local trade organization, school, etc. will get 3-6 companies who then share a consultant who provides training and guidance. When we did it, we met once per month (each company brought 2-3 employees) and each month had a "homework" assignment. Each class would tackle a part of the standard. The benefits were that you had peers in the classroom setting that you could bounce ideas off and you all shared the costs of the consultant. At the end, each company had the basic documentation to move forward.

    And while it feels like a herculean task, I would bet you have about 80% of it already covered. That's the 80% that is just common sense good business practices. Good luck.
     
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  5. Sidney Vianna

    Sidney Vianna Well-Known Member

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    Martin, based on how you wrote your post, I am sure you can "decipher" ISO 9001 (whatever edition) without much external help. You can peruse ISO's own support material @ http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm, but, in usual fashion, not much help there, in my estimation.

    My advice is for you to:
    1. understand all of your organization's operational processes; from there,
    2. identify all the steps, activities and processes that can affect the conformity of your products to customer, regulatory and self-imposed requirements
    3. manage all of this with the goal of preventing problems, enhancing customer satisfaction and continually improve the product and operation.

    This basically would make you compliant with the intent of ISO 9001.

    Good luck.
    PS. you might note I did not use the word quality.
     
  6. James

    James Active Member

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    I was fortunate to have a very good lean consultant when we undertook ISO as a smaller company, even now we only have around 25 employees. He's very affordable and very good, if you want his contact information let me know. Otherwise there is a lot of help you can get here once you get going. Take Andy up on his offer to call, then go from there. We can help steer you a bit better when you get your feet down.
     
  7. MCW8888

    MCW8888 Well-Known Member

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    I recommend that you call Andy Nichols.
     
  8. Martin

    Martin New Member

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    Thanks all for the quick replies.

    Andy, I'll give you a call at some point. May be in a few days. I really appreciate that offer.

    I'll be posting here again as more specific questions arise moving forward. I'll also continue to "lurk" and read others' posts.

    Thanks again.
     
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  9. Qualmx

    Qualmx Well-Known Member

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    Martin
    I started my ISO in a similar situation.I will tell you what worked for me.
    I got training in the ISO standard also for the auditing process.
    Additionaly I hired a consultant for about 6 months spending two days per week.obviously he carried out a schedule of activties which included training for the ceo,for the heads,support in the development of document, other training for the rest of the employees, audit training ,also he performed 2 internal audits.
    Finally we got the certification on time.
    At the end of the project I evaluated if really was worth the $$ spent of the consultant and I concluded the next.
    Dont try to save $$ to your boss avoiding the consultant support and doing it by yourself alone, thinking that with just some training will be enough,you may face terrible surprises, it might be very risky for you, your business and your clients.
    On the other hand, it is not to design Nasa rockets, you can do it alone, but after you have had a decent training, also have seen how other iso systems have been working in daily activities, in audit sessions, talking with other ISO users, how they got the certification, looking in the web for advices, and so on.
    Consultants know tips ans tricks,and they have walked the roads,the know how to lead you toward the certification.
    Dont hesitate in contact me if you need additional info.
    Regards.
     
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Excellent advice! A course may be useful, however, you should check on how successful the implementation advice was. Lots of course providers "talk" about implementation - some use mythology or what they themselves learned in another course! The course provider should have a number of solid implementation experiences to draw from - and "we got them registered" ISN'T a qualification...
     
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  11. Qualmx

    Qualmx Well-Known Member

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    Im in agree with you Andy.
    Regards
     
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  12. David Sanabria

    David Sanabria Active Member

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    Everyone of the comments are spot on - I would like to recommend that you spend a few hours perusing the YOU TUBE for ideas on how to proceed.

    https://www.youtube.com/results?search_query=iso+9001+version+2015

    In addition, have periodic meetings with upper management and a business plan on how to run a business from a quality perspective - and documented it (flowcharts work great but it is only one tool out of many).

    Get back to us with a progress report - so we could share what work or did not work
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd suggest exercising extreme caution with anything found on Youtube - anyone can post their stuff, doesn't mean they have expertise/experience (or even half a clue if what they are telling you is accurate). Someone sent me a link to a presentation for shop floor people on ISO 9001:2015! Now, why, you'd have to ask yourself, would ANYONE from a manufacturing shop floor, be the slightest bit interested in knowing what changed from 2008 to 2015?
     
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  14. David Sanabria

    David Sanabria Active Member

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    Andy,
    Totally agree that with any resources out in the internal a WARNING label should be attached. I only point to YOUTUBE as another source to stimulate the search for what works for your company and yes - there is a lot of trash out there - thanks for the clarification.
     
  15. Andrej

    Andrej Member

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    It is true that there is a lot of questionable material on Youtube, but there are also some very good videos. There are 14 sessions on Quality Planning and 16 sessions on Quality Improvement which I recommend to every person starting to work in quality profession.

    Juran on Quality Planning: Session 1 - Introduction



    Juran on Quality Improvement: Session 1 - Proof of the Need

     
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  16. Martin

    Martin New Member

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    I spoke with Andy on the phone, he was very helpful.

    We are planning on hiring a consultant to guide us in implementation in a couple months.

    One thing I forgot to ask Andy but will ask the group, do you have any recommended supplemental reading? I'm open to buying books etc.

    Thanks again,
     
    Last edited: Jan 12, 2016
  17. charanjit singh

    charanjit singh Member

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    Martin, there is a lot of good advice that you already have on this forum. I have noted that you are a recent engineering graduate hired about a month ago. Considering this the best advice is the 3 steps that Sydney has already given you. This would be the starting point. With my 58 years of experience in Quality discipline, I can assure you that a clear understanding all operational processes is an essential starting point. You can then try and translate each requirement of the standard in terms of your own processes. Please avoid cut and paste type of advice that some people may give you.

    Good luck
     
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  18. AkShef

    AkShef New Member

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    Martin, I realise you're already underway with help from Andy, but thought I would post how I tackled achieving ISO to help future readers.
    I was in a similar position - I hadn't even heard of ISO 9001 and was required to drive its implementation in a small 14 person company.
    But... to encourage you, it's achievable even though it feels like a mountain to start with!

    What I did:
    1. I didn't go to any courses but did a lot of reading and used the elsmar forum (and hopefully you can use this one) to get familiar with the standards and ISO. All that said, if you have the option to go on a course, I'd take it. I think you could get to certification with or without the course it may just be quicker to get the knowledge.
    2. As suggested by Sidney earlier, I identified company processes relevant to meeting customer requirements and delivering products/service
    3. I drew flowcharts of each process so I knew what happened in each of them, regardless of whether the process steps complied with relevant standards. This really helped me to know where we were starting from and to also know what changes employees would need to make. NOTE: Instead of having written procedures I drew all processes with flowcharts which was faster, easier to read, much preferred by staff and passed the audit!
    4. Throughout this I was meeting weekly with top management, and daily consulting with employees. This involved them in the process and helped with getting their buy-in (very important!). I also had an external consultant come in for about 2 hours (total) a few months into the journey to glance at our documentation and check we were on the right track. If we hadn't been on the right track the plan was to hire the consultant to help us.
    5. I identified areas requiring major changes to get them underway (eg, we needed specific procedures called for by the standard), before targetting smaller changes (eg, ensuring documented approval of particular tasks). I used the forum for any areas I was a little unsure.
    6. I had an external consultant perform an internal audit to help us find holes in our system before we had the true audit. I also asked for their help on achieving a few aspects of the standard.
    7. I made appropriate changes and after seeing how the consultant audited, I then did my own audit with the staff to identify any further problems.

    A few other things which made our lives easier and helped to make ISO work for the business:
    We didn't try to make a QMS separate from the business as quality is integrated throughout all business activities. So instead of QMS policy and objectives, we have our business management system policy and objectives.
    We used a wiki which significantly reduced documentation difficulties. We had several auditors compliment us on its ease of use, organisation structure, and speed of finding documents/evidence.

    Hopefully that's helpful! All the best :)
     
    Last edited: Feb 19, 2016
  19. tony s

    tony s Well-Known Member

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    That's why I love this forum. Sharing your ideas and experiences really demonstrate that the "People Helping People" concept hasn't died. Thanks AkShef!
     
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  20. AdenaBurnette

    AdenaBurnette Member

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    Hello All - What a great find I have discovered in this forum!!! Thanks in advance for all of the help I have already received, I look forward to hearing your feedback about the seemingly tons of questions that come from each question I have!

    A little background. I am the project manager of a small manufacturing company in northern Idaho. We have about 35 employees currently and we manufacture aftermarket agricultural equipment. Our bread and butter has been leveling systems for combines, but we are diversifying our product lines and have began doing many other projects as well as beginning to try and balance our workload with securing some government contracting work (we are a HUBZone Certified Small Business). I happen to be the CEOs daughter, meaning that I have grown up in this business since I was a small child, so I know a very good amount of the daily operations and processes that go on here. (Short of a 5 year span after college, I have worked here since high school). When I returned to work here back in 2010, my task was to get our "tribal knowledge" documented. After spending a year or two working on writing down every single thing that our company does, that task kind of fell to the wayside and other projects took precedent (government contracting, implementing online warranty program, etc.). Let me clarify that we simply were on the wrong path; we didn't understand then what should/shouldn't be written in a document form vs. a tasklist vs. work instruction, etc. We were under the premise that if we did it, it should be written out - in case the person responsible for that task was hit by a bus and someone else had to come in and complete their job with no knowledge of how it was done. (Sorry....off on a tangent here!)

    Back in 2005ish, we first set out to become ISO compliant. We bought the $500 implementation package from the9000store.com and a few employees attempted to tackle the project, but somehow it again, fell to the wayside. Now that we are serious about getting into government contracting (as well as economically strained, due to market flux) we are seeing the serious importance and value in not only getting compliant, but ISO certified and following through 100% with the recommendations and requirements of a business improvement program.

    Late last year, we hired a consultant (who came from the recommendation of someone at a PTAC office) and she had us seriously spinning our wheels with "True North" and creating our "Process Sequence and Interactions Chart" and "Turtle Diagrams", etc. I kept thinking that this was just too much. It was too deep, too crazy, too wasteful. I got my hands on Mike Micklewright's "Lean ISO 9001 Adding Spark to your ISO 9001 QMS and Sustainability to your Lean Efforts" and his words only validated my gut feelings. I couldn't get anyone to explain to me how the things named above were adding any value or checking off any requirements of the standard. (When I tried to get the consultant to answer those questions, she wanted to do a teleconference at $XX/hour.) So after a few weeks of pleading my case, we dropped the consultant and I have been flying partially blind in getting this off the ground. (I am still daily crossing my fingers that I am leading us in the right direction!)

    At this point, I took the standard and broke down the sections into requirements on a spreadsheet and then I began a gap analysis to see where we were falling short and what we needed to do to become compliant. At first glance, it looked like we had a LOT to do, but then I realized that, being a successful business for 23+ years has probably got us 85%+ covered on the ISO stuff and we were most likely missing some documentation and retention.

    Our management and leadership is 100% supportive of this endeavor. We are hesitant to begin to involve each employee (shop floor level) in the implementation, because like a lot of things, they get told "we are going to start this new thing..." and a few weeks later it is done and over with and they get tired of the most recent new idea. But, we have had each department director, as well as CEO and myself meeting a few times a week to discuss where we are with our implementation of the items that showed up with the gap analysis. I do my best to keep from getting too deep in the much with this, but I'm sure you all know it's easy to do.

    This week at our most recent meeting, the CEO asked me "How positive are you that we are going to hit our mark?" This was his way of saying, "We have a goal to be ready for an internal audit by 6/1/16. We are working our tails off to get there. When 6/1 gets here, are we going to be 90% compliant with a few NCs or are we going to be WAY off?" I looked at him with a blank face, because of course I am hoping that I've got all of my bases covered and we are going to be pretty good come 6/1, but what if we aren't. Is there a way for me to survey now what we've been doing to meet the standard so that I can shift directions if need be? Is there a place that I can talk with pros about ISO and/or an auditor to ask some questions about our direction? Then I find this place! JACKPOT - Hopefully!

    I read through this thread closely and I plan to take in the advice that has already been put out here for Martin. Thanks for that! It's so nice to get some direction!!!

    A few questions that I know off the top of my head:

    1. After reviewing (the book I wrote) above, is there anything glaring that any of you see that I should be shifting/doing differently???

    2. Is there a requirement in 2015 to have a process that notifies customers if we have their property in our possession that becomes damaged or no longer returnable? (We rarely have customer property, so it would be very rare that this would be necessary. If it's not required per the standard, at this time, we probably wouldn't be interested in implementing such a process).

    3. What is the best form of document control? Do small companies such as ours purchase some sort of software that does this? Is it handled just within file folders in Windows Explorer where permissions can be set to "read only" and such to provide control? (This would require then one person to do all of the changes or updates to files. I'd prefer the owner/person who executes a process or task list to be the one that updates it.) Is there some other option that I'm missing?

    4. Job Descriptions/Knowledge Matrix/Training or Skills Matrix: Being a small company, many of our positions overlap and/or change depending on how many people we have in a given department. We have a hard time thinking that job descriptions are the best way to describe a given position, due to the fact that each position changes frequently based on needs. We have determined that it may be better to have a Knowledge Matrix for each department (explains what skills/training would be necessary to be able to complete tasks in a certain area) in addition to each department also keeping a Training or Skills Matrix up to date (which explains who has completed training in what area). That way the two matrices can be used together to determine who could fill a position needed at any given time. Does this suffice the standard? Is this a common way of handling this requirement or is there something I'm missing that is much more recommended?

    5. One of the main areas we have lacked in in the past is documentation of design and development efforts. We see now, looking back at some things, why it would be useful to document better. We have created a Product Launch Milestone template that starts with tasks such as an Early Product Definition (very generic idea), Business Case (market research, rough virtual design, financial review, etc)., Customer Requirements, etc. What is best practice when trying to document the infancy stages of a potential new product? What does the file structure look like? How detailed does the standard require our documentation to be?

    6. Lastly (for now!) I saw earlier in this thread that one very nice man (Andy Nicols) gave his phone number for a free, no sales pitch phone call - would I be able to utlize that?!?! I wasn't the one that it was shared with, but I thought maybe I could get in on the benefit of it!

    I guess that's a good enough start for now. I have a feeling I'll have many more questions for each of you. Again, thanks in advance for your help!
     
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