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.

How to state QMS scope as you phase-in ISO registration at numerous locations?

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Patts, Jun 13, 2016.

  1. Patts

    Patts Member

    Joined:
    Aug 4, 2015
    Messages:
    17
    Likes Received:
    6
    Trophy Points:
    2
    My company has numerous locations, some performing different operations, some performing essentially the same work. We developed a common quality manual, quality policy, and “high-level” procedures and have plans to get ISO 9001:2008 registration at 2 of our sites, one in a few months, the other by ~Feb.2017 (we will transition to ISO 9001:2015 in a year). Besides the common docs., these facilities have site-specific work instructions. The next locations in line will register directly to ISO 9001:2015.

    My question is: How to list the scope in the quality manual as we phase in our QMS implementation? I tried to be creative - being careful not to say the QMS is fully implemented where it isn’t, but hoping to avoid revising the manual every time we add a location (unless that’s the only way). I stated our QM and quality policy are common and shared with all U.S. sites… and that the scope of business activities, products and services included at each business unit is specified on the applicable ISO certificates as they are achieved… - it doesn’t read well and I’m not sure it’s acceptable or advisable. A consultant told me I had to have a separate QM for each location, at least ones not under a common corp. cert. But I still want to consider options to keep just one QM.

    Could I link the manual to a matrix that lists every business unit, its scope, physical location, and “status of ISO 9001 QMS implementation? The status of the first site might be: “Registration scheduled for Sept.2016”, the second “Registration planned for 1st Qtr. 2017”, the rest “ISO 9001 QMS in development”. Is this too far-fetched? Has anyone seen something like that? Could I update the matrix without revising the QM? Do you think it would it be acceptable in an ISO audit?

    We’ll revise the QM (required or not, we still want a basic one) once we are achieving ISO 9001:2015. But even then we’ll be faced with this since not all locations will be ready for ISO audits at the same time. This could span all next year or longer.

    In reading posts in this forum, I often appreciate reading “outside the box” suggestions. Thank you in advance for any input!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,719
    Likes Received:
    1,887
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    The scope comes from understanding the "context of the organization". What's your statement here:
    Why not post it, so we can advise?

    They are wrong.
    I'm not understanding how this relates to the question. A scope is that. Think telescope, microscope or periscope. It's the boundaries of your QMS - not the locations. It simply describes the "shape" of the QMS and, typically describes products/services.
     
  3. Patts

    Patts Member

    Joined:
    Aug 4, 2015
    Messages:
    17
    Likes Received:
    6
    Trophy Points:
    2
    Seems I may be using the word “scope” incorrectly. I thought I needed to include in the QM the scope of the registration, same as would be listed on the ISO certificate, which would include location, correct? In fact the consultant said to list the street address, not just the town and state. Mainly, I was referring to 4.2.2 a) –
    4.2.2 Quality manual
    The organization shall establish and maintain a quality manual that includes
    a) the scope of the quality management system, including details of and justification for any exclusions

    Here is what I call the “scope” for one location: “The design, manufacture, and delivery of custom converted foam and corrugated packaging, serving the automotive, pharmaceutical, medical equipment, electronics, and computer industries, at MyCompany in AnyTown, AnyState, U.S.A.

    Another one will be different: “Procurement, receipt, storage and fulfillment of products including packaging materials and supplies for a diverse customer base including industrial, automotive, pharmaceutical, and food industries, at MyCompany Distirbution Warehouses in the U.S. (numerous locations).”

    I attached a file with my earlier attempt to state what I thought was "scope" without promising all sites comply at this time. I do appreciate the help!
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,719
    Likes Received:
    1,887
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Is this what the whole company does? If so, that's your scope. As far as the manual goes, you could put the different activities in the manual, but often those can be fluid and you don't necessarily want to be changing manual often...
     
  5. Patts

    Patts Member

    Joined:
    Aug 4, 2015
    Messages:
    17
    Likes Received:
    6
    Trophy Points:
    2
    The part you extracted is the scope at one, and only one, location. A paragraph in my earlier attachment described the overall company, and says "...business units including manufacturing (and I specified the types), distribution, equipment sales and technical services." But not one location does ALL of that. Some distribution operations have no manufacturing, for example. And we have ~4 different manufacturing-type operations with little overlap on operations performed and products produced.

    I agree that I don't want to change the manual often, but I'm still unclear on how to meet 4.2.2 a) without it sounding like all are meeting the QMS requirements when they aren't yet. Did you have any comments on the file I attached? I apologize if I'm missing the basic point, but I must be missing the basic point! Thank you!
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,719
    Likes Received:
    1,887
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    This is your scope. You're confusing - probably because the consultant is confusing - with the scope of certification rules. If your QMS is common over all locations, that's sufficient to define the scope at a 30,000ft level.
     
  7. Patts

    Patts Member

    Joined:
    Aug 4, 2015
    Messages:
    17
    Likes Received:
    6
    Trophy Points:
    2
    Got it - thank you very much for your time and patience with me!
     
    Andy Nichols likes this.
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,719
    Likes Received:
    1,887
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Happy to help - if you are satisfied with the result!
     
  9. Patts

    Patts Member

    Joined:
    Aug 4, 2015
    Messages:
    17
    Likes Received:
    6
    Trophy Points:
    2
    Andy, I got very good direction from you and it fits what I thought/hoped to be true, but to be honest am still a bit confused. So if I could just clarify that I understood you correctly before our QM goes to the Stage 1 audit... 1) the scope of our QMS is what must (4.2.2.a) be stated in the quality manual, and can describe the output of my entire company's various businesses since our intent is common QM and policy and high-level SOPs (Control of Doc./Records, CAPA, NCM...), even if some sites have not yet fully implemented the QMS (i.e., can't show full CAPA records, don't yet do internal audits...), and it does not need to mention locations/addresses or specific differences site-to-site, while 2) the scope of the ISO certification is specific to each business unit or location, does not need to be stated in the QM but will be on the ISO certificates. And stating the scope of our entire QMS in our QM does not imply that all of it complies with the ISO standard at this point in time. My confusion comes from not just the one consultant, but why there is so much discrepant info. "out there" - most on-line searches for scope and QM examples do state a need to name the precise operations and locations. Your opinion and experience is very valuable; I just hope to be clear on the facts to defend my position. Thank you, again!
     
    Andy Nichols likes this.
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    3,719
    Likes Received:
    1,887
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Hi Patts. Happy that you came back to be fully clear on this...

    So, let's think of it this way: You and your organization have no interest in Certification, CBs and certificates(!). Your management DO want to implement ISO 9001 as a tool to get better control over the business processes and the way they interact - between locations, departments etc.

    They see that ISO 9001 requires a scope statement and in a leadership meeting someone guides them to the conclusion that, like looking through a microscope it's what's being done to satisfy customers seen ("from above") within that viewing area. What you do in terms of product, key processes and services to satisfy the customer. You might end up with a statement which says: "The Manufacture of blah, blah, blah." (Just like your earlier description). Where this locations and addresses etc comes into pay is purely from the pov of certification - and most people (and hence what you read on the interweb) confuse "doing ISO" with "being Certified to ISO" and the rules which apply to that specific circumstance.
     
  11. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,172
    Likes Received:
    867
    Trophy Points:
    112
    Location:
    Laguna Philippines
    Just to add more info. I've read your draft scope and I agree with Andy that your QMS main scope statement should be "Manufacturing, Distribution, Equipment Sales, and Technical Services". But you may need to describe the products that you manufacture, distribute, sell and the services your organization offer. To do this, immediately after the main scope statement, you can insert a matrix like the one below:
    upload_2016-6-15_12-14-40.png

    I am recommending this since ISO 9001 certificates indicate the site address and your CB may need to issue a certificate for each site indicating the relevant scope. ISO 9001:2015 clause 4.3 also mentions "The scope shall state the types of products and services covered..."
     
    Andy Nichols and Jennifer Kirley like this.
  12. Patts

    Patts Member

    Joined:
    Aug 4, 2015
    Messages:
    17
    Likes Received:
    6
    Trophy Points:
    2
    Update on this: I had already drafted a matrix similar to tony s's suggestion, but had not included it in the manual itself because the CB's "Sr. Certification Manager" agreed with me (by phone, so I don't have it in writing) that the scope listed in our QM could be broad and not list such specifics. However, we had a Pre-Assessment audit last week and the auditor insisted it needed to list the specific scopes and addresses of the sites. Since that was different than the Cert.Mgr. said, after we bantered back and forth a bit, he agreed (a little grudgingly, I think) to go back to her with my "appeal". The audit report now states that she agrees with him. He wrote: "Since you intend to have more than one scope you need a method of associating a scope with the site, such as the address or site name." I feel he did not directly address my question of difference between scope of QMS and scope of ISO certification, but I think the solution is to comply by referencing in the QM a separate document that lists this info. and can be updated more frequently than the QM. Curious if anyone has an opinion on this situation and my proposed remedy?
     
    Atul Khandekar likes this.
  13. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,172
    Likes Received:
    867
    Trophy Points:
    112
    Location:
    Laguna Philippines
    You are right that your CB treats differently the scope of the QMS against the scope of the certification. This is mainly because when a CB has to issue certificates for an organization with multiple sites, normally they have to indicate the site address on each individual site's certificate. An Annex can be referenced on the statement of your organization's scope to guide the reader of your QM on sites that have already earned ISO certification. I believe this has more to do in your CB's procedures than in ISO requirement for describing your QMS scope.
     
    Patts likes this.
  14. Patts

    Patts Member

    Joined:
    Aug 4, 2015
    Messages:
    17
    Likes Received:
    6
    Trophy Points:
    2
    Thank you, tony s. I am fine with the solution and in fact had stated it in my original post: "Could I link the manual to a matrix that lists every business unit, its scope, physical location, and “status of ISO 9001 QMS implementation? ... Could I update the matrix without revising the QM?" The replies and discussion since that post have been very helpful, and I feel I've come full-circle on this topic! Thanks!
     
  15. oghall

    oghall New Member

    Joined:
    Aug 5, 2016
    Messages:
    3
    Likes Received:
    1
    Trophy Points:
    2
    We have maintained a multi-site certification for a while. How we had identified individual location scopes was by activities identified (General descriptions like Manufacturing, Design, Management) on the scope listed for the individual locations on our certification. (Appendix page and individual location certs our CB provides.) We also maintain an appendix to our Quality Manual listing locations and whether they are Manufacturing or support. But no detail to the activities performed at them Recently had an audit NC because our Quality Manual does not define the exclusions to a specific location that was audited. (The location was on the appendix list.) My thought is to correct by adding a statement on the appendix that the scope of the individual locations is identified on the scope documented on the certificate. For example Manufacturing and Design versus Manufacturing only. (We also include the product and assembly type in the scopes.) Any Thoughts?
     

Share This Page