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Shall the results of monitoring the context issues be documented?

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

  1. Leonid

    Leonid Active Member

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    Shall the monitored information about external and internal issues (4.1) and interested parties and their relevant requirements (4.2) be retained as a documented information as per 9.1.1? What do colleagues think?
     
  2. drgnrider

    drgnrider Member

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    IMO - How can you monitor progress without recalling a little more accurately where you have been or what the original goal/intent was? I remember events, but not ALL the details, or relevant details and some might remember them differently. Going to have to maintain some form of documentation, even if, initially, it is only meeting minutes.
     
  3. Leonid

    Leonid Active Member

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    I asked does monitoring per 4.1 and 4.2 fall formally under the 9.1.1 requirement or not.
     
  4. Somashekar

    Somashekar Moderator Staff Member

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    I believe this connects with Organization knowledge and it shall be maintained and made available to the extent necessary.
    Its up to the maturity of the organization and people and the way in which it decides knowledge retention.
    One of the best perhaps is to understand and make the management review meaningful ... [The organization shall retain documented information as evidence of the results of management reviews.]
     
  5. tony s

    tony s Well-Known Member

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    Although 4.1, 4.2 and 9.1.1 mentioned the word "monitor", IMHO each has its distinct INTENT but all are necessary to achieve the organization's intended results.
    • Clause 4.1 requires the organization to "monitor" information about external and internal issues that can have an effect on an organization's approach to develop objectives. Similarly, clause 4.2 requires organization to "monitor" information about the needs and expectations of interested parties due to their effect or potential effect on the organization's ability to consistently provide conforming products/services. Thus, the intent of both 4.1 and 4.2 focus in monitoring the "inputs".
    • Clause 9.1.1 requires organizations to "monitor" information needed to ensure valid results and further requires organizations to retain documented information as evidence of the results. Thus, the intent focuses in monitoring the "outputs".
    At any rate, only clause 9.1.1 requires documented information, but these information are those that pertain to "outputs".
     
  6. Leonid

    Leonid Active Member

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    The "outputs" as well as QMS performance belong to organization's context. Information about relevant context issues is subject to monitoring per 4.1 and 4.2. According to 9.1.1, “the organization shall determine the methods for monitoring needed to ensure valid results…and shall retain appropriate documented information as evidence of the results”. IMHO these requirements are applicable to outputs of 4.1 and 4.2..
     
  7. tony s

    tony s Well-Known Member

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    Retaining documented information concerning 4.1 and 4.2 is any organizations' prerogative - but there is no statement in ISO 9001:2015 that categorically requires an organization to retain them. However, retaining appropriate documented information "as evidence of the results" is clearly stated in 9.1.1. These information are necessary to measure the "performance and effectiveness" of the quality management system. Unlike with the intent of 4.1 and 4.2, which aim to understand the organization's context and needs/expectations of the interested parties.

    The "outputs" here, I believe, pertain to the result of 9.1.1 - not of 4.1 and 4.2. ISO 9001 clause 9.1.1 is about "performance evaluation" and if we take a look at ISO 9000:2015, "performance" is defined as "measurable result".
     
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Is this the reason for holding and recording management reviews? It isn't rocket science...
     
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  9. tony s

    tony s Well-Known Member

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    Good point Andy. A quick review of Management Review clause clarifies (to me) the following:
    • connection of 9.3.2b with 4.1;
    • connection of 9.3.2c and its sub-statements with 9.1.1 statement that says "The organization shall evaluate the performance and the effectiveness of the quality management system"
    Further, the answer to the statement of 9.1.1a that says "what needs to be monitored and measured" with regard to "performance and effectiveness" has been well itemized by 9.3.2c sub-statements that include:
    • customer satisfaction and feedback from interested parties;
    • extent of achievement of quality objectives;
    • process performance and product/service conformity;
    • nonconformities and corrective actions;
    • monitoring and measurement results;
    • audit results;
    • performance of external providers.
     
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  10. MCW8888

    MCW8888 Well-Known Member

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    "Retained documented information" means Record-yes.
     
  11. Tony Wardle

    Tony Wardle Member

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    Reading through the standard and relating this back to our organisation ---

    We have company KPIs and departmental KPIs.

    As I understand this -
    9.1 is statement that says you ''shall' have some sort of measurement -
    9.1.2 makes it clear that ''customer satisfaction'' is not negotiable
    9.1.3 says you need some analysis and assumes you have data

    So, yes, I would say that some documented information could well be anticipated and expected.

    Certainly, this is the route I plan to take, as it good business practise in any case.
     
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