ISO 9001:2015 – 5.2.1 -Establishing the quality policy – Part 3

  

Welcome back to this blog. I hope that the information presented here is of interest to you, that it somewhat enriches your knowledge of ISO 9001:2015 standard and its requirements.

 

In the first part on this section of the standard, we carried out the analysis of the first three requirements. If you wish to access this entry, click here:

In the second part we continue with the analysis of the following nine requirements of this group corresponding to Section 5.2.1 Establishing the quality policy, which in turn is part of Sub-clause 5.2 – Policy, of this ISO 9001 standard. If you wish to access this post, click here.

 

In this third part we will be analyzing the rest of the requirements that derive from this section.

 

It is important that when we consider establishing, implementing, verifying, reviewing, auditing and maintaining the quality policy, we should take into account all the elements presented in those previous entries, as well as those presented in this one.

 

So that you can identify all the requirements that are broken down in this Section 5.2.1 of the ISO 9001 standard, I present the complete list again:

 

 

 

As I have mentioned in other entries regarding analysis of requirements of management system standards, we should be careful when reading these requirements, since the way in which the texts are presented in these standards, when separating each requirement individually, seems that these are repeated. However, each of them sets a different specification from the others.

 

As with all requirements derived from Sub-Clause 5.1 – Leadership and commitment, all  requirements of this Section 5.2.1 – Establishing the quality policy, have been established some responsibilities for the top management of the organization. In the case of Section 5.2.2 – Communicating the quality policy, its derived requirements refer to quality policy, although its application falls partially on top management, but also assign responsibilities to other members of the organization.

 

We should be aware that the most costly, but also perhaps the most common (and often unidentified) deficiency in the operation of management systems based on standards is the lack of commitment from top management.

 

There may be a wide variety of failures in management systems, and they may often be identified and corrected. But the identification of failures by top management is very complicated, both because of the ignorance of the personnel and even of auditors, as well as possibly because of the fear of receiving reprisals.

 

Paradoxically, those who should be more aware of and committed to these management systems are the ones who least comply with the responsibilities assigned to them by these standards. This is partly because they don't know the standards well, they can't identify the responsibilities assigned to them, and those responsible for operating these systems either don't know them, or don't dare enforce those responsibilities. Auditors, both internal and external, are also responsible for these deficiencies, who generally ask them very generic questions about the leadership they exercise, but usually do not ask specific questions that can reveal these failures. And the same happens with the evaluators of certification bodies, who, due to ignorance of these issues, I suppose, prefer to focus on evaluating the operational and methodological aspects of the management systems than evaluating compliance with the responsibilities of top management.

 

The ISO 9001:2015 standard establishes the following requirements derived from the Section 5.2.1, and I present them with the corresponding progressive numbering, as I have been presenting all the requirements of this standard that I have been analyzing.

 

 

Requirement No. 104: Top management shall establish a quality policy that includes a commitment to satisfy application requirements.

 

When we analyzed requirement No. 92, we saw what it means “to establish” the quality policy. This requirement refers, in particular, to the fact that when is integrating all the elements to establish the quality policy, top management should include a commitment to meet all applicable requirements. Among those applicable requirements, it should consider all those established by the ISO 9001:2015 standard, as well as all the complementary requirements that the organization itself has established for its quality management system. Additionally, all those statutory and regulatory requirements with which the organization should comply must be included, considering the location of its facilities, as well as its processes, products, services and markets served, and should also include contractual requirements, which have been mutually agreed with customers, and that are related to quality.

 

 

Requirement No. 105: Top management shall implement a quality policy that includes a commitment to satisfy applicable requirements.

 

In the same way, when we analyzed requirement No. 95 we saw what it means “to implement” the quality policy by top management, but this requires that the aforementioned policy includes a commitment, on the part of the organization, to meet all applicable requirements.

 

It may seem like it repeats with the previous requirement, but it doesn't. For this, it is convenient to remember that establishing is not the same as implementing. In order to properly meet this requirement, top management should ensure that when the quality policy is being implemented, the stated commitment to meet all applicable requirements is being met. To do this, it should establish monitoring and measurement programs to confirm that all requirements established by the ISO 9001:2015 standard are being met, so the additional ones that the organization itself has established for its QMS, all the applicable statutory and regulatory requirements that the organization should comply with, considering, as mentioned, the location of its facilities, as well as its processes, products, services and markets served, and it should also include the contractual requirements, which are those that have been mutually agreed with the customers, and that are related to quality.

 

 

Requirement No. 106: Top management shall maintain a quality policy that includes a commitment to satisfy applicable requirements.

 

When we analyzed requirement No. 98 we saw what it means “to maintain” the quality policy by top management. Particularly in this requirement it is established that the aforementioned policy includes this commitment to meet all applicable requirements.

 

In order to meet this requirement appropriately, top management should ensure that, when taking actions to maintain its quality policy, all necessary elements are considered so that the previously established commitment to meet all applicable requirements is also maintained, and for this, it should carry out a review of all the appropriate sources of information, to ensure that all requirements that had originally been identified as applicable, including those of the ISO 9001:2015 standard, the complementary ones established by the organization itself, the statutory and regulatory requirements, and also those contractual that have been mutually agreed with customers, and that are related to quality, continue to be so, or the necessary adjustments are made so that the aforementioned policy continues to be valuable.

 

 

Reqirement No. 107: Top management shall establish a quality policy that includes a commitment to continual improvement of the quality management system.

 

This requirement refers to the fact that when integrating the quality policy to be established by top management, it includes a commitment to continuous improvement of the quality management system.

 

In a previous entry I told you that one of the characteristics of management systems based on standards, being open systems, is that they tend to entropy, to their uselessness and destruction. That is why the only way to keep such a system operating efficiently is for it to continuously improve, and for this reason all these management system standards establish continuous improvement as a requirement, as stated in this standard, that includes the Clause 10 – Improvement, and that is why the quality policy should include this commitment to design and manage processes for the continuous improvement of QMS.

 

 

Reqirement No. 108: Top management shall implement a quality policy that includes a commitment to continual improvement of the quality management system.

 

In order to meet this requirement appropriately, top management should ensure that, when implementing its quality policy, it creates the conditions for processes related to continual improvement to be properly managed and can be confirmed, with sufficient evidence, the expected improvement in performance of QMS, in accordance with the established objectives.

 

 

Reqirement No. 109: Top management shall maintain a quality policy that includes a commitment to continual improvement of the quality management system.

 

In order to apply this requirement appropriately, top management should ensure that, when taking actions to maintain its quality policy, all the necessary elements are considered so that both the commitment to improvement, such as the process management for improvement and requirements for these processes are met.

 

Just to end this section, in accordance with Technical Specification ISO/TS 9002:2016 - Quality management systems — Guidelines for the application of ISO 9001:2015, in order to establish the quality policy, inputs such as the following can be considered:

 

— A clear understanding of the context of the organization, including the current performance of its management system and the needs and expectations of its relevant interested parties;

 

— The organization’s strategic direction, based on its mission, vision, guiding principles and core values.

 

— The level and type of future improvements needed for the organization to be successful;

 

— The expected degree of customer satisfaction;

 

— The resources needed to meet intended results;

 

— The potential contributions of relevant interested parties.

I really hope that these three entries dedicated to analyzing the requirements derived from Section 5.2.1 – Establishing the quality policy, have brought to light some of requirements that very few people observe and practically no organization complies with.

 

In the next entry we will continue with the analysis of requirements derived from Section 5.2.2 – Communicating the quality policy, of this ISO 9001:2015 Standard.

 

I will appreciate if you upload your doubts or comments, about this analysis, in this post.

 

Author:

 

Ernesto Palomares Hilton