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.

Statutory and regulatory requirements, only for products and services?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Feb 24, 2018.

  1. Qualmx

    Qualmx Well-Known Member

    Joined:
    Oct 7, 2015
    Messages:
    443
    Likes Received:
    58
    Trophy Points:
    27
    Location:
    Mexico
    Hi all
    When identifying statutory and regulatory requirements applicable to our business , come to mind, what are those that we strictly have to comply with.

    Reading the standard, it focuses most to meet customer compliments which means
    laws and rules related to products and services. (see below)

    However I ´ve seen , that others ISO users or auditors, recommend to include other laws and regulations, that have to be in compliment, e.g. local accounting laws, state tax,etc. even if they are not related directly to products and services.

    I know that in order to have a business, it is needed to comply with such government requirements, but those laws are not related directly to products and services and should not be included into the QMS.

    Suppose if a company produces plastic tires, well, will have all the processes needed to comply with that product as well, statutory and regulatory rules, but I dont have to worry about to comply
    with accounting local rules included into QMS.

    Such accounting activities when managed in the wrong way, could affect product indirectly but not directly.

    Where in the standard is explained clearly this point?

    Note that in IAF (below) also is focused in products and services.

    Please share your opinions in this matter.

    Thanks


    From ISO 9001 2015
    <<<<<
    1 Scope
    This International Standard specifies requirements for a quality management system when an
    organization:
    a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
    b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
    <<<<<
    FROM IAF (auditing practices)
    ISO 9001 Auditing Practices Group
    Guidance on:
    Statutory and regulatory requirements
    ISO 9001 requires an organization to identify and control the statutory and regulatory
    requirements applicable to its products and services. It is up to the organization to
    determine what is required within its QMS.

    The organization should demonstrate that the statutory and regulatory requirements
    applicable to its products and services have been properly identified, are available and easily
    retrievable.
     
  2. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    732
    Likes Received:
    361
    Trophy Points:
    62
    Only apply to you're products and services. It you go beyond that you are way out of scope and will cause you all kinds of trouble.
     
    Qualmx likes this.
  3. Qualmx

    Qualmx Well-Known Member

    Joined:
    Oct 7, 2015
    Messages:
    443
    Likes Received:
    58
    Trophy Points:
    27
    Location:
    Mexico
    I agree with you Golfman25

    Other users´s opinions are welcome.
     
  4. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,249
    Likes Received:
    942
    Trophy Points:
    112
    Location:
    Laguna Philippines
    Most of the statements in ISO 9001 that mentions "statutory and regulatory requirements" are those that are applicable to "products and services". These include:
    • 0.1a Introduction General
    • 1a Scope
    • 4.2 Understanding the needs and expectations of interested parties
    • 8.2.2a.1 Determining the requirements related to products and services
    • 8.2.3.1d Review of requirements related to products and services
    • 8.3.3 Design and development inputs

    However, in the scope there is also a statement that says:
    • 1b - This International Standard specifies requirements for a quality management system when an organization...aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
    This could mean that there are "statutory and regulatory requirements" related to the "processes" and should be fulfilled also. Clauses relevant to this can include:
    • 5.1.2a Customer focus
    • 5.2.1c Developing the quality policy
    • 6.2.1c Quality objectives and planning to achieve them
    If I am going to deliver products that satisfy all the applicable statutory and regulatory requirements, shouldn't I need to take into account also the legal requirements on transportation (e.g. anti-smoke belching law, traffic regulations, speed limits, etc.). If your business continuity is going to be affected because of violations on state tax laws, isn't it worthwhile to take this into account?
     
    Qualmx likes this.
  5. Pondo

    Pondo Member

    Joined:
    Jun 6, 2016
    Messages:
    11
    Likes Received:
    2
    Trophy Points:
    2
    Sounds like you are opening yourself up to endless effort with little return.
     
  6. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,249
    Likes Received:
    942
    Trophy Points:
    112
    Location:
    Laguna Philippines
    Why would ensuring your organization complies with regulatory requirements to ensure business continuity an "endless effort with little return"?
     
  7. Serious Man

    Serious Man Active Member

    Joined:
    Oct 24, 2017
    Messages:
    79
    Likes Received:
    27
    Trophy Points:
    17
    Because not all rules have to be followed. You don't know which one, so risk ignoring all of them.
    Death, bankruptcy, claim recovery would tell you which one are really important.
    Who has two lives, enough time and money to survive a bankruptcy and enough money to pay claims?
    It seems a lot of people have.

    Who are these people who had created this and other management standards?
    Where are we in matter of knowledge, experience, time spent on thinking over words they put in standar comparing to them?
    Are they faultless gods?
    No, but I believe they are minimum one lifetime ahead of me.
     
    jaltangerel likes this.

Share This Page