ISO Implementation Phase III – Reviewing Clause 5 and 6 "shall" Statements

In this series of articles we are discussing implementing an ISO 9001 Quality Management System (QMS) in four distinct phases. By breaking the implementation into stages, it becomes more manageable and less overwhelming. In phase one, the general requirements described in Clause 4 of ISO 9001 QMS requirements are implemented, and in phase two the elements of continual improvement from Clause 8 are set in place and practiced.

Management Commitment is Vital to ISO 9001 Success

Now we are starting phase three: implementing the requirements of Clause 5 – Management Responsibility and Clause 6 – Resource Management. While there are a number of required documents we created to meet requirements from Clauses 4 and 8, Clauses 5 and 6 are long on stated requirements (“Top Management shall … ,” “The organization shall … “), but they have few required documents and records.

In Clause 5, the responsibilities of meeting the requirements of the ISO 9001 QMS are put squarely on the shoulders of top management. Those who are familiar with how organizations tend to function know that the success or failure of any organizational endeavor depends on the commitment of top management. If top management does not see it as important or a priority, then it becomes starved for resources and eventually dies. Whatever top management focuses on, however, becomes a priority for the whole organization. This is certainly true for implementing, maintaining, and improving the ISO QMS.

There are specific requirements relating to Management Review in Clause 5, including a management review meeting record. Otherwise, there are no specific requirements to create particular records showing management’s commitment and responsibility. The requirement is a general one of providing evidence of commitment.

ISO 9001 Is Generic Application Depends on the Organization

It is this type of general requirement that many organizations struggle with. In contrast with specific requirements that are straightforward (for example, an Internal Audit procedure that includes responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results), these more general “shall statements” require organizations to come up with their own method of compliance.

One way to deal with these less specific requirements is to convert “shall statements” into questions. For example, top management has to answer the question, “How do we ensure appropriate communication processes are established and that communication takes place regarding the effectiveness of the QMS?” The formal language in the standard seems intimidating and adds to the difficulty. Appropriate communication processes? But most organizations have communication processes; it is just a matter of recognizing them and being aware that those activities meet a requirement of the ISO 9001 standard. For example, perhaps you have monthly department head meetings, and departments have weekly staff meetings. Perhaps you have an on-line or printed quality newsletter. These are all communication processes.

Focus on ISO Compliance Not Unnecessary ISO Documentation

So in a sense, phase three is about reviewing and considering requirements in Clause 5 and Clause 6, and then recognizing how your organization meets them. You don’t have to have procedures or even records in order to comply, unless you feel they are important for the needs of your organization. Obviously, as you work through this, when you recognize a weakness or an area of non-compliance it is time to implement new or altered methods. But as in our communication example, frequently organizations are doing things that comply with the requirements. It is just a matter of being cognizant of them, plus knowing what evidence exists that verifies your compliance.

Clause 6, Resource Management, requires a similar approach. Phrase the “shall statements” as questions and then give reflective responses. For Clause 5 and 6 you may want to capture these responses in notes for your own purposes or for training, but there is no requirement to do so. In terms of compliance, just be sure you can answer the question appropriately when the internal or external auditor asks, and that others give answers that are consistent with your compliance methods. Be aware, however, that after you give an auditor the answer, he or she will then seek objective evidence that you do, indeed, do things that way (such as meeting agendas, minutes, or collaboration from the earlier communication example).

Training Records Are Required in ISO 9001

Let’s emphasize, however, the training record requirement for Clause 6 of the ISO 9001 QMS Requirements. Many auditors agree that this is a common area of weakness among ISO 9001 certified organizations. So one focus for phase three of ISO 9001 QMS implementation should be creating a training record system where education, training, skills, and experience are captured. In larger organizations this probably has to be handled at the department level, but there should still be consistency throughout the organization. This will require a systematic approach that is communicated through training, examples, etc., to department leaders.

So there is no simple advice or direct methods for complying with the requirements found in Clause 5 and Clause 6. Phase three is as much about understanding and awareness as it is about creating new processes and documentation. Each and every organization has to decide how they currently fulfill them or how they will fulfill them. It is this flexibility, however, that makes ISO 9001 flexible enough to be applied to any type of organization.

Our next and final piece in the series will cover phase 4, implementing ISO 9001 Clause 7 – Product Realization, also known as design, development and fulfillment. Here the ISO 9001 Requirements are heavy on records that many organizations have difficulty with in terms of compliance. We will discuss ways to simplify and streamline Clause 7 compliance.

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Posted on Monday, March 16th, 2009 under ISO Quality Standards, Strategic Process Improvement

Licensed under a Creative Commons Attribution 3.0 United States License.

Originally published by Bizmanualz, Inc. under the title ISO Implementation Phase III – Reviewing Clause 5 and 6 "shall" Statements.

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