Changes to ISO 9001 for Clauses 5 and 6

In the last newsletter, I reviewed the proposed changes for clause 4 of the draft ISO 9001:2009 standard. This month, we’ll look at the suggested changes for clause 5, Management Responsibility, and clause 6, Resource Management.

5. Management Responsibility
The clause 5 changes are a revision to Management Commitment to include statutory requirements, as well as, clarify that the Management Representative must be a member of the organization’s management.

5.1 Management Commitment

a) communicating to the organization the importance of meeting customer as well asstatutory and regulatory requirements, 

Under clause 1.1 Scope – General, there is a new Note that says “statutory” and “regulatory” requirements may be expressed as “legal” requirements.

5.5 Responsibility, Authority, and Communication

Most organizations already appoint a Management Representative that is a member of their own management team. The change below clarifies that requirement.

5.5.2 Management Representative

Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes: 

However, I’ve encountered a few small companies that have outsourced the Management Representative role to their consultant. I wonder if this clarification is aimed at that practice?

6. Resource Management
6.2 Human Resources
6.2.1 General

The revision for this clause is from work affecting “product quality” to work affecting “conformity to product requirements”. Quality is the degree to which a set of inherent characteristics fulfils requirements; Conformity is the fulfilment of a requirement.

Personnel performing work affecting product quality conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

I doubt this change will result in new interpretations of the requirement. Anyone performing, verifying, or managing work within the scope of the quality management system, including supporting services, can affect conformity to product requirements.

6.2.2 Competence, Training, and Awareness, and Training

The clause title has been changed from “Competence, Awareness, and Training” to “Competence, Training, and Awareness”. Maybe the thought was that awareness comes from some form of training and should be last in the title. And, that is also the sequence of the requirements as listed within clause 6.2.2.

The same change made to clause 6.2.1 regarding conformity to product requirements has been included in this sub-clause:

a) determine the necessary competence for personnel performing work affectingproduct quality conformity to product requirements,

Use below of the phrase “where applicable” seems to recognize that training or other actions may not be necessary, since individuals may already have the necessary competence. And, since “these needs” could be taken out of context, the requirement has been revised to specifically mention competence.

b) where applicable, provide training or take other actions to satisfy these needs achieve the necessary competence,

In the past, people have struggled with how to evaluate the effectiveness of the actions taken, which have been viewed primarily as training. The sub-clause below has been modified to focus more on competency instead of the effectiveness of the training.

c) ensure the effectiveness of the actions taken, ensure that the necessary competence has been achieved,

Evidence for the current requirement has in some cases included students evaluating the effectiveness of their training. However, this approach would not relate as well for the revised requirement as an evaluation of their skills.

6.3 Infrastructure

The only change under Infrastructure was to include “information systems” as an additional example of a supporting service.

c) supporting services (such as transport, or communication or information systems).

6.4 Work Environment

The only change to this clause was to add a Note to explain the term Work Environment by providing examples of work environment conditions for achieving product conformity.

Note: The term work environment relates to conditions necessary to achieve conformity to product requirements such as clean rooms, anti-static precautions, and hygiene controls.