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Which ISO 9001 requirements should be revised by the post-pandemic QMS?

Readaptation was not an option for companies but a necessity given the current economic context. And as in all sectors, from the perspective of the quality management system, it is important to analyze the changes to ISO 9001 requirements. 

In this post we list the main regulatory requirements that must be considered for reassessment by managers in their respective organizations.

Organization Context (Strategic Planning)

In order to meet requirement 4.1- Organization Context (Strategic Planning) of the ISO 9001:2015 standard, managers need to reassess the business model. Including a new sales approach, new products and services and a change in the value proposal to be delivered to customers, are examples of issues that can be taken into account in the new strategic planning.

It is worth remembering that the new strategy will change the associated strategic indicators.


Organizations usually treat the scope of the Quality Management System (requirement 4.3 of ISO 9001) as something “immutable”. Although the changes are not so frequent, the scope is for sure subject to changes.

Managers will need to review the scope of the Quality Management System if, based on the new strategic planning, changes have occurred in the products and / or services offered by the organization.

Leadership and commitment

With the global economy in retraction, requests related to postponement of payment terms, contract cancellations, etc., are already a living reality. Although this has a direct impact on the companies’ cash flow, now more than ever, leaders will need to evaluate each case, promoting actions that minimize the economic effects arising from this practice.

Requirement 5.1.2 c) of the ISO 9001: 2015 standard highlights: “Top management must demonstrate leadership and commitment with respect to customer focus, ensuring that the focus on increasing customer satisfaction is maintained.”

Although this is an important premise, it will be up to managers to evaluate each client request so that, with common sense and balance, the relationship between the parties is not discontinued.

Risks and opportunities

Many managers will immediately review their company’s risk and opportunity management system – as required by requirement 6.1 of the ISO 9001: 2015 standard – including scenarios such as pandemic, etc. Is there a need?

Risk and Opportunity Management Models should be revised, including infrequent events such as the pandemic. However, the effectiveness of this system will be seen only in companies that have already identified opportunities from this unusual event (pandemic), implemented actions aimed at reaching these opportunities.

It is also worth remembering what the requirement 10.2.1, item e) of ISO 9001 establishes when dealing with non-conformities.

“When non-compliance occurs, including those arising from complaints, the organization must update risks and opportunities determined during strategic planning, if necessary.”

Plan changes

The changes brought about by COVID-19 may affect other requirements, which include:

8.1- Operational planning and control;
8.2.4- Change in requirements for products and services;
8.3.6- Changes in design and development;
8.5.6- Control of changes.

In that case, it is critical that the organization plan how these changes will occur. The current version of the ISO 9001 standard has strengthened the importance of planning when considering these requirements. So, remember that before implementing any changes, whether related to QMS (6.3), products / services (8.2.4), design and development (8.3.6) or company processes (8.5.6), the planning must be formalized. Only then, the organization can reduce the risks associated with the implementation of actions without due care.

Critical analysis of management

If one of the premises of quality management is continuous improvement, it is impossible not to pay attention to critical analysis, especially from a global event like the one we are experiencing.

In this sense, it is important that during the meeting of the Senior Management, the following items should be evaluated more carefully:

9.3.2 b) – Changes in external and internal issues that are relevant to the Quality Management system;
          c) – Information regarding the performance and effectiveness of the Quality management system;
         d) – Sufficiency of resources;
         e) – Effectiveness of actions taken to address risks and opportunities;
         f) – Opportunities for improvement.


Management standards such as ISO 9001: 2015 are excellent guides for organizations that seek to direct actions in a logical and planned way. In this sense, re-reading the 10 requirements highlighted in this post and reviewing quality actions based on processes, tend to consolidate the management of these organizations, strengthening their performance in the market.

The way in which organizations “respond” in times of crisis is a determining factor for their business continuity. The best answers do not come, as previously thought, from the greatest but from from the most prepared.

If you are looking to expand your knowledge about quality management, talk to our experts or try our solution for free. They help more than 55,000 professionals worldwide to manage their organizations’ QMS simply and efficiently.

Read more about: covid, iso 9001, QMS, quality management.
Thatiana Sestrem


May 11, 2020

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