To Jim and JaneB
I disagree with you,however although we are somewhat moving away from the original question, we are still with the M/R or D/M/R as in my case.
What you say is not neccessary, is to me very clear when I read the standard requirements.
5.5.1 Responsibility and authority
The lines of responsibility and reporting for all personnel are documented on the company organization chart, which appears in Appendix A of this document. In order to ensure that personnel understand their authorities and responsibilities associated with the quality system, authorities and responsibilities are further documented in specific procedures.
General
All authorities and responsibilities reside with top management and are delegated to functions and/or individual members of staff within their control as appropriate. All personnel who manage, perform and/or verify work are responsible for the quality of products produced by the company. All such personnel are authorized to identify and record problems relating to products, processes, and the quality system as a whole. All staff and personnel have the responsibility to comply with documented procedures and the direction of management. All personnel have the responsibility to assure that processes in which they are working are in a state of control and that the tasks are completed in a responsible manner. All personnel are also responsible for identifying nonconforming product, marking such product as being nonconforming, notifying management, and controlling further processing until the problem has been corrected. To prevent non-conformities, they may also initiate, recommend, or provide solutions through designated channels, such as the Corrective and Preventive Action system.
5.5.2 Management Representative
Irrespective of other duties, the Management Representative (shown on the organizational chart) has the main responsibility and authority for establishing, implementing, and maintaining the quality system and ensuring that it continues to be compliant with the requirements of ISO 9001. The Management Representative is responsible for evaluating the effectiveness of the quality system and reporting on it to executive management and other attendees at scheduled Management Review Meetings, and for making suggestions to improve the system.
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.
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. (How will you obtain records without these meetings)
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
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
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
