Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter – 4

MANAGEMENT RESPONSIBILITY

Author – K. R. Singhal


There are following clauses under this section:
5.1 – Management commitment
5.2 – Customer focus
5.3 – Quality policy
5.4 – Planning
5.5 – Responsibility, authority and communication
5.6 – Management review


Management commitment
(Please refer to Clause 5.1 of ISO 9001:2008)

Top management must provide evidence of its commitment to the following:
development of the QMS
implementation of the QMS, and
continually improving the effectiveness of the QMS

Top management must provide such evidence of the above by the following:
communicating the importance of meeting customer and legal requirements to the organization (employees and people working on behalf of the organization)
establishing the quality policy (please refer to clause 5.3 of ISO 9001:2008 for requirements of quality policy)
ensuring that quality objectives are established (please refer to clause 5.4.1 of ISO 9001:2008 for requirements of quality objectives)
conducting management reviews (please refer to clause 5.6 of ISO 9001:2008 for requirements of management review), and
ensuring the availability of resources (please refer to clause 6 of ISO 9001:2008 for requirements of resource management

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.1.


Customer focus
(Please refer to Clause 5.2 of ISO 9001:2008)

Top management must ensure the following with the aim of enhancing customer satisfaction:
that customer requirements are determined, and
that customer requirements are met

In this connection, please refer to clause 7.2.1 of ISO 9001:2008 for determination of requirements related to the product and clause 8.2.1 of ISO 9001:2008 for requirements of customer satisfaction.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.2.

Quality policy
(Please refer to Clause 5.3 of ISO 9001:2008)

Top management must ensure the following:
The quality policy is appropriate to the purpose of the organization,
The quality policy includes a commitment to comply with requirements,
The quality policy includes a commitment to continually improve the effectiveness of the QMS,
The quality policy provides a framework for establishing quality objectives.
The quality policy provides a framework for reviewing quality objectives.
The quality policy is communicated within the organization.
The quality policy is understood within the organization.
The quality policy is reviewed for continuing suitability.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.3.

Planning
(Please refer to Clause 5.4 of ISO 9001:2008)

There are following two sub-clauses in this clause:
1.4.1 – Quality objectives
1.4.2 – Quality management system planning

Quality objectives
(Please refer to Clause 5.4.1 of ISO 9001:2008)

Top management must ensure that quality objectives (including those objectives needed to meet requirements for product) are established within the organization at (i) relevant functions, and (ii) relevant levels.

The quality objectives must be:
measurable, and
consistent with quality policy

Quality management system planning
(Please refer to Clause 5.4.2 of ISO 9001:2008)

Top management must ensure the following:
That the planning of the QMS is carried out in order to meet the general requirements mentioned in clause 4.1 of ISO 9001:2008.
That the planning of the QMS is carried out in order to meet the quality objectives.
That the integrity of the QMS is maintained when changes to the QMS are planned.
That the integrity of the QMS is maintained when planned changes to QMS are implemented.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.4.1 and clause 5.4.2.

Responsibility, authority and communication
(Please refer to Clause 5.5 of ISO 9001:2008)

There are following three sub-clauses in this clause:
5.5.1 – Responsibility and authority
5.5.2 – Management representative
5.5.3 – Internal communication

Responsibility and authority
(Please refer to Clause 5.5.1 of ISO 9001:2008)

Top management must ensure to define responsibilities and authorities. Top management must ensure to communicate the defined responsibilities and authorities within the organization.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.5.1.

Management representative
(Please refer to Clause 5.5.2 of ISO 9001:2008)

Top management must appoint a member of the organization’s management as management representative. The management representative, irrespective of other responsibilities, must have responsibility and authority including the following:
to ensure that processes needed for the QMS are established
to ensure that processes needed for the QMS are implemented
to ensure that processes needed for the QMS are maintained
to report to the top management of the organization on the performance of the QMS
to report to the top management of the organization on any need for improvement in the QMS
to ensure promotion of awareness of customer requirements throughout the organization

It has been clarified in the note given at the end of this clause that the responsibility a management representative can include liaison with external parties on matters relating to the QMS.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), clause 5.5.2 is modified with clarity that member of the organization’s own management must be appointed as a management representative. The old version allowed organization to appoint any member of management to manage organization’s quality management system. It did not clearly mention that the management representative must be a member of the organization’s own management; as such there were instances where organizations had appointed outsiders as management representatives. Now this is clear that the management representative must be member of organization’s own management.

Internal communication
(Please refer to Clause 5.5.3 of ISO 9001:2008)

Top management must ensure that appropriate communication processes are established within the organization. Top management must ensure that communication takes place within the organization regarding the effectiveness of the QMS.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.5.3.

Management review
(Please refer to Clause 5.6 of ISO 9001:2008)

There are following three sub-clauses in this clause:
5.6.1 – General
5.6.2 – Review input
5.6.3 – Review output

General
(Please refer to Clause 5.6.1 of ISO 9001:2008)

Top management must review the organization’s QMS at planned intervals (as decided by the organization) to ensure:
continuing suitability of the QMS
continuing adequacy of the QMS, and
continuing effectiveness of the QMS

The management review of the QMS must include the following:
assessing opportunities for improvement to the QMS, and
need for changes to the QMS, including the quality policy and quality objectives

The organization must maintain records from management review.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.1.

Review input
(Please refer to Clause 5.6.2 of ISO 9001:2008)

The input to management review, carried out by the top management, must include information on the following:
results of audits (external as well as internal)
customer feedback
process performance
product conformity
status of preventive actions
status of corrective actions
follow-up actions from previous management reviews
changes that could affect the QMS, and
recommendations for improvement

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.2.

Review output
(Please refer to Clause 5.6.3 of ISO 9001:2008)

The output of the management review, carried out by the top management, must include any decisions and actions related to the following:
Improvement of the effectiveness of the QMS
Improvement of the effectiveness of the processes of the organization
Improvement of product related to customer requirements, and
Resources needs of the organization

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version) there is no change in the requirements of clause 5.6.3.

Questions

What are the key changes in clause 5.1 (Management commitment) in ISO 9001?
What are the key changes in clause 5.2 (Customer focus) in ISO 9001?
What are the key changes in clause 5.3 (Quality policy) in ISO 9001?
What are the key changes in clause 5.4 (Planning) in ISO 9001?
What are the key changes in clause 5.5 (Responsibility, authority and communication) in ISO 9001?
What are the key changes in clause 5.6 (Management review) in ISO 9001?
Whether an outside personnel or QMS expert can be appointed Management Representative as per ISO 9001:2008?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.