1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
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.

An organization must follow its own procedures

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Phil Scott, Nov 6, 2018.

  1. Phil Scott

    Phil Scott Member

    Joined:
    Jul 26, 2018
    Messages:
    17
    Likes Received:
    2
    Trophy Points:
    2
    I'm sure there is a requirement that an organization must meet the requirements of ISO 9001:2015 and, as part of that, must also meet the requirements of its own QMS procedures. I just can't seem to find it in the standard. Please, take pity and rub my nose in the clause/subclause. THANKS!
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    160
    Likes Received:
    83
    Trophy Points:
    27
    Good day @Phil Scott ;
    Yes, you are correct. The "requirement" is laced throughout the standard. (e.g. 4.3 "The organization" 'shall determine the boundaries....scope;, 4.4 "The organization shall establish...management system, ...processes needed.."; 5.1.1 "ensuring ...the resources"; ensuring ...meets intended results...etc..etc..etc…

    However, I assume what you are referring to is

    9.2 Internal audit


    9.2.1 The organization shall conduct internal audits at planned intervals to provide information on


    whether the quality management system:


    a) conforms to:


    1) the organization’s own requirements for its quality management system;


    Hope this helps.

    Be well.
     
  3. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    681
    Likes Received:
    443
    Trophy Points:
    62
    Location:
    Laguna Philippines
    There is no categorical statement, but, in my own views, here are some related requirements:
    • 4.4.1c - "determine and apply the criteria and methods..." - if the procedure contains the criteria and method;
    • 8.1d - "implementing control of the processes in accordance with the criteria" - if the procedure contains the criteria;
    • 8.5.1a.1 - "the availability of documented information that defines... the activities to be performed" - perform the activities as defined in the procedure;
    • 8.6 - "release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed" - if the procedure contains the planned arrangements, it must be satisfactorily completed;
    • 9.2.1a.1 - "conforms to... the organization’s own requirements for its quality management system" - if the procedure contains the requirements, then the auditee need to demonstrate conformance during internal audit.
     
  4. Phil Scott

    Phil Scott Member

    Joined:
    Jul 26, 2018
    Messages:
    17
    Likes Received:
    2
    Trophy Points:
    2
    Thanks John!
    Phil
     
    John C. Abnet likes this.
  5. Phil Scott

    Phil Scott Member

    Joined:
    Jul 26, 2018
    Messages:
    17
    Likes Received:
    2
    Trophy Points:
    2
    Thanks for the guidance Tony. I think the 9.2.1a1 citation has the language I remember.
    Phil
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,137
    Likes Received:
    1,100
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    It's not in the standard! There's simply no mention of procedures, so it can't make it a requirement to follow them...(I don't agree with my friends above!);)

    However, it DOES state, in 4.4.1 "the organization shall establish, IMPLEMENT, maintain and continually improve a quality management system, including the processes needed..."

    It's up to the organization to decide whether procedures are necessary to accomplish this.
     
    John C. Abnet likes this.
  7. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    160
    Likes Received:
    83
    Trophy Points:
    27
    As @Andy Nichols nichols accurately pointed out @Phil Scott , there is indeed no longer a requirement for actual "procedures". I was somewhat presumptuous in my initial response to you. Yes, the organization must ensure...

    a) conforms to:

    1) the organization’s own requirements for its quality management system;


    , however, it is true that there is no requirement for these "organization’s own requirements" to be in a "procedure".

    Be well.
     
    Andy Nichols likes this.
  8. Phil Scott

    Phil Scott Member

    Joined:
    Jul 26, 2018
    Messages:
    17
    Likes Received:
    2
    Trophy Points:
    2
    Right. I understand there are limited procedural requirements, but if an organization has seen fit to issue a procedure to control some aspect of its QMS it must follow said procedure.
    Peace.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,137
    Likes Received:
    1,100
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Can I ask why it is you're questioning this salient point? Why are you looking for something in the standard to tell people to "follow procedure"?
     
  10. Phil Scott

    Phil Scott Member

    Joined:
    Jul 26, 2018
    Messages:
    17
    Likes Received:
    2
    Trophy Points:
    2
    Andy - If by "questioning" you mean challenging, the answer is I'm not.

    I internally questioned where in the standard was language that, as I seemed to recall it, used words like "...including the organization's own procedures." I was not able to find those or similar words and thought others would point it out.

    I think 9.2.1a1, pointed out by Tony S and John Abnet, was as close to what I recall as I needed.

    Thanks for your help!
    Phil
     
  11. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    594
    Likes Received:
    679
    Trophy Points:
    92
    Location:
    Ontario, Canada
    There are times we ask for the 'why' behind the question to give us better context before answering.

    You're correct in that some people - who think they're being really smart or trying to be jokers - may ask "With all of these requirements, where is the requirement that we need to actually do what we say we do?" It's tempting to respond with a really big eye roll and a huge "Duuuh!", thus implying that you're calling them out on their "questioning this salient point" (to use Andy's term).

    We have laws in society. Does it specifically say anywhere that we must follow them? What happens if we don't? There are consequences.

    We stop for a stop sign. Why? The law says that we shall stop for a stop sign. But where is it written that we must obey the law?

    It's the same thing with documented procedures. They were not created for kicks and giggles. They were created to enable and support the ability of the organization to consistently meet client/regulatory/contractual/other requirements. To deviate from them would serve what purpose? Unless one enjoys consequences... ;)
     
    Andy Nichols and tony s like this.
  12. bkirch

    bkirch Member

    Joined:
    Jun 24, 2016
    Messages:
    31
    Likes Received:
    2
    Trophy Points:
    7
    Another clause in the standard that might apply to this discussion is 7.5.1(b) "The organization's quality system shall include b) documented information determined by the organization as being necessary for the effectiveness of the quality system".

    Maybe my interpretation of that clause is incorrect but I interpret documented information as procedures, records, etc. It is the documentation that the organization feel is needed for the quality system to be effective. No, it does not say in that this documented information is required to be followed, but if an organization creates documented information they feel necessary for the effectiveness of the quality system, isn't the requirement to follow that information assumed?
     
  13. Phil Scott

    Phil Scott Member

    Joined:
    Jul 26, 2018
    Messages:
    17
    Likes Received:
    2
    Trophy Points:
    2
    I appreciate your feedback and, of course, completely concur it would be senseless for an organization to have documented information (procedures) that didn't have to be followed..

    Again, my only question was where the standard used language similar to the words "...including the organization's own procedures." Seriously, it just that simple. No hidden agenda to support an organization not following their own procedures.

    As helpfully pointed out by others, there are many clauses that reasonably support that an organization must follow its own QMS procedures. 9.2.1a1 gets at the language I recalled.
     
  14. Mohamed Hakam

    Mohamed Hakam New Member

    Joined:
    Nov 21, 2018
    Messages:
    4
    Likes Received:
    0
    Trophy Points:
    1
    Let me simplify this topic, the organization may not interpret the standard requirements ISO 9001:2015, so the quality team should map the standard in the procedure while define it with the stakeholder as the standard states "what to do" and the organization states "How to do". The defined procedure explains how to achieve the standard requirements through the procedure activities.
     
  15. Phil Scott

    Phil Scott Member

    Joined:
    Jul 26, 2018
    Messages:
    17
    Likes Received:
    2
    Trophy Points:
    2
    Thanks Mohamed, but my only question was where the standard used language similar to the words "...including the organization's own procedures."
    As they often say in courtroom T.V. dramas, the question has been asked and answered. :)
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,137
    Likes Received:
    1,100
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Can you help me understand this statement?
     
  17. Mohamed Hakam

    Mohamed Hakam New Member

    Joined:
    Nov 21, 2018
    Messages:
    4
    Likes Received:
    0
    Trophy Points:
    1
    I mean the quality representative is the one who is capable of mapping the standard requirements into procedure to be implemented across the organization. for example, when the standard is talking about "Control of externally provided processes, products and services" in clause 8.4, the quality may write in the store procedure that upon receiving materials the technical team will perform the technical inspection for all material or take samples and issue reports and non-conformity if found.
     
  18. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,137
    Likes Received:
    1,100
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    What is this? There's no such role in ISO 9001:2015. Process owners should know the relevant requirements of the standard.
     
  19. Mohamed Hakam

    Mohamed Hakam New Member

    Joined:
    Nov 21, 2018
    Messages:
    4
    Likes Received:
    0
    Trophy Points:
    1
    I know that this role is disappeared in 2015, but what i meant is the person who eligible to understand the standard and start mapping it in the organization process and procedure
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,137
    Likes Received:
    1,100
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    This isn't for one person. The process owners should do this. One of the biggest mistakes people make is to start doing things themselves instead of providing leadership and working with the various people of the organization. Someone has to be coach and mentor, yes, but that gets done as a player/coach on a team.
     

Share This Page