Without a clear understanding of the strengths, weaknesses, opportunities, and threats of an organization, strategies could fail, and objectives may not be achieved. If PESTLE influences SWOT, the opposite cannot be said.
The SWOT analysis, in fact, is similar to an evaluation of an organization's capabilities. The results are often extremely subjective and will vary depending on who conducts the analysis, which is why it is better to have it done by a heterogeneous group of people. Identifying strategic issues is the very heart of the strategic planning process. These issues fall into three well-defined categories:
- issues that have already occurred and likely require immediate action;
- those that may require action in the near future but can be managed as part of the organization's normal planning cycle;
- issues that do not require any action at the moment but must be monitored over time
The ISO 9001:2015 does not require a PESTLE or SWOT analysis, nor any documented information in this regard, but it would be extremely difficult, if not impossible, to monitor and review the identified issues over time without any record of the work done. If these analyses are carried out as part of the strategic planning process, it must be accepted that some factors influencing the organization may not affect its quality system. This should help make the development of the quality system perceived as part of the strategic planning rather than something isolated.
If these analyses are conducted during the strategic planning process, they offer an opportunity to filter the results obtained through the expected results from the quality system to identify relevant issues for the management system. To demonstrate, as required by the standard, that the external and internal issues relevant to quality have been determined, one can:
- provide evidence of a process to determine:
- how problems are identified
- how their criticality is determined
- how decisions are made regarding who should be involved in addressing the issue and according to what responsibilities;
- how the information is used to make changes to the quality system
- present evidence that the purpose and strategic direction of the organization have been communicated to those who conducted the analysis;
- show how the expected results from the quality system that were determined have been aligned with the organization's stated purpose and the direction it has decided to follow;
- present evidence of the analysis conducted to understand the context of the organization and the knowledge derived from it;
- select the different issues identified and show how it was decided which ones were critical and should be addressed through specific actions;
- show how the identified issues have been addressed in the policies and processes of the system
Obviously, once identified, both external and internal issues should be monitored over time and periodically reviewed. Operationally, this means observing the changes that become evident in the information collected during the review of the system's internal and external maps and repeating the PESTLE and SWOT analyses to determine whether changes have had a significant impact on the results of the analyses. Monitoring must be continuous over time, not something to be done once. Why is this necessary? The significance of external and internal factors changes continuously because issues are influenced by changes in the global environment, so the system analysis must be consistently repeated. How often to do this will, of course, depend on the market sector in which the organization operates.
In sectors where technology or economic conditions change rapidly, revisions must be made more frequently, and it will also be necessary to review these factors whenever there are changes in the organization that could affect its strengths and weaknesses.
Having established that continuous monitoring of the organization's context, its issues, risks, and opportunities must be done, the next step is to understand how to choose the best monitoring method based on how quickly the collected data may change. However, if there are a large number of issues, monitoring them all — even at different frequencies — can become a significant burden and result in a cost on a more-than-annual basis.
For this reason, to establish the frequency of monitoring, one must also consider the organization's ability to react to individual changes. Demonstrating that internal and external issues relevant to the organization are monitored and reviewed periodically can be done by:
- presenting evidence of a process to determine:
- how internal and external issues should be monitored
- how the criteria for identifying factors capable of causing major changes are established
- how often the collected data should be reviewed and by whom
- selecting a representative sample of the initial analyses made and showing how critical issues are monitored and how the results obtained are examined as planned
- showing how changes in the collected information have impacted the quality system, changing it