ISO 9001 - 4.1 Understanding the organization and its context (Part 3)

In the previous post, I began a formal review of the requirements established in Subclause 4.1 of the ISO 9001: 2015 Standard.

 

I identified the first four requirements of this subclause, and as you may have noticed, this identification was achieved by comprehensively breaking down the first sentence of this subclause. Now, in this post, before identifying the other requirements included in this part of the standard, I would like to present, as a support to those who wish to properly comply with these requirements, some methodologies that can be of great use in organizations to identify these issues, both external and internal, and that way they could meet those first four requirements.

 

First, we should remember, according the ISO 9000: 2015 standard, the definition of the term determination: activity to find out one or more characteristics and their characteristic values.

 

For the organization to be able to reach the determination of the external issues that are relevant both for its purpose and its strategic direction, it is recommended that it use a methodology equivalent to that the so called PESTEL method, through which the organization can analyze the different factors that are outside its control (external issues), which turn out to be, as is mentioned in the Note 2 of this sub-clause, the political, economic, social, technological, environmental and legal factors. By joining the initials of all these factors, as an acronym, we have the name of this method, PESTEL.

 

This method of analysis can help a working group selected by the organization to better understand both the markets and the competitive position of the organization itself, to strategically plan and carry out market studies in new or existing markets. In relation to Subclause 4.1 of ISO 9001: 2015 standard, what is intended to achieve with the application of this method is, for that group, to identify, prioritize and select the external issues that are relevant to the organization and are considered in the establishment of the objectives of its quality management system.

 

Now, in relation to the possible determination of internal issues, which are relevant to both its purpose and its strategic direction, it is important that the organization uses a methodology equivalent to McKinsey's "7S" method. This method is called this way, because it involves the analysis of seven factors that are under the control of the organization (internal issues) and all of them begin with the letter "S", and which are the following: strategy, structure, systems, shared values, skills, staff and style.

 

In relation to Sub-Clause 4.1 of the ISO 9001: 2015 standard, what is intended to be achieved with the application of this “7S” method is for the selected working group to identify, prioritize and select the internal aspects that are relevant to the organization for being controlled and aligned and that are considered in establishing the objectives of its quality management system.

 

If this topic is of interest to you, in my next post I will present a description of how these two methods (PESTEL and  McKinsey 7 S) can be applied by an organization.

 

In this sense, in order to comply with these first identified requirements, it will be important for the organization to identify the methodology that it will be applying to determine these issues, both external and internal, as well as the records, or documentation to be retained for providing evidence of results achieved, as for the actions taken, such as brainstorming sessions, analysis of the information presented, identification, prioritization and selection to determine the external and internal issues relevant to the organization, as well as the information used for its analysis.

For now, then, I will continue with the identification of the four missing requirements in this Sub-clause 4.1 of the referred standard, and which are the following:

  

Requirement No. 5: The organization shall monitor information about these external issues.

 

Requirement No. 6: The organization shall monitor information about these internal issues.

 

Requirement No. 7: The organization shall review information about these external issues.

 

Requirement No. 8: The organization shall review information about these internal issues.

 

I can show you now the eight requirements established in the Sub-clause 4.1 of the ISO 9001standard.

 

Now, with respect to the last four requirements of this sub-clause 4.1, in addition to the difference in terms of external and internal issues, we find two terms, monitoring and review, which we should also separate in terms of their meaning, since they are referring to different activities, and therefore correspond to different requirements.

 

The ISO 9000: 2015 standard defines monitoring as “determining the status of a system, a process, a product, a service or an activity”.

   

If we analyze this definition and the established requirement No. 5, we have to comply with this requirement, the organization should monitor the information on external issues considered relevant, both for the purpose and for the strategic direction, by means of some method that allow it to observe, measure, record and compare, during an appropriate period of time, and check if these issues remain relevant, either for the purpose or for the strategic direction of the organization, or if it is necessary to modify the original assumptions of these issues or some of their factors, discarding or incorporating some, or if necessary to carry out the analysis again, in light of the variations detected in these assumptions. From this, the organization should generate and maintain the appropriate records or documentation to be retained.

 

Similarly, with respect to requirement No. 6 mentioned above, the organization should monitor the information regarding internal issues that were considered pertinent both for the purpose and for the strategic direction, by means of a method that allows it to observe, measure and record and compare, during an appropriate period of time, and check if these questions remain relevant, either for the purpose or for the strategic direction of the organization or, where appropriate, modify the original assumptions of said questions or some of its factors, discarding or incorporating some, or to apply corrective actions regarding the planning, operation and control of any of these issues, to achieve their proper alignment. Remember that these issues are internal and, therefore, are under the control of the organization itself. In the same way, the organization should generate and maintain the appropriate records or documentation to be retained.

 

Now, we should remember the definition used in ISO 9000: 2015 standard for the term review: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.

 

Regarding requirement No. 7 previously identified, to achieve its proper compliance, the organization should review all information analyzed on external issues. This review should be through a formal evaluation of each of the supporting documents or publications for the identification, prioritization and selection of external issues, and compare it with new publications, reports or more updated data, to ensure that these issues continue being valid in terms of the relevance identified by the organization or, where appropriate, make the necessary adjustments. Again, the organization  should generate and maintain the appropriate records or documentation to be retained.

 

Finally, in relation to requirement No. 8, the organization should review all the information analyzed for the working group on internal issues. for identifying the relevant internal issues, and compare it with new reports or updated data, to ensure that these issues remain valid in terms of the relevance identified by the organization or, where appropriate, make the necessary adjustments. As in the previous cases, the organization should generate and maintain the appropriate records or documentation to be retained.

 

 

Author:

 

Ernesto Palomares Hilton