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Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site today: http://www.WhittingtonAssociates.com This
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The requirements for clause 5, Management Responsibility, are summarized below. To see a summary of all the ISO 9001:2000 clauses, go to ISO 9001:2000 Requirements at the Resources section of our web site. 5. Management Responsibility 5.1 Management Commitment Top management must provide evidence of its commitment to develop and implement the quality management system, as well as, continually improve its effectiveness by:
5.2 Customer Focus Top management must ensure customer requirements are determined and met in order to improve customer satisfaction. 5.3 Quality Policy Top management must ensure the quality policy is:
5.4 Planning 5.4.1 Quality Objectives Top management must ensure quality objectives, including those needed to meet product requirements, are established at the relevant functions and levels within the organization. Quality objectives must be measurable and consistent with the quality policy. 5.4.2 Quality Management System Planning Top management must ensure that planning for the quality management system:
5.5 Responsibility, Authority, and Communication 5.5.1 Responsibility and Authority Top management must ensure responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management Representative Top management must appoint a member of management who, irrespective of other duties, has the responsibility and authority to:
Note: The responsibility of a management representative may include liaison with external parties on matters pertaining to the quality management system. 5.5.3 Internal Communication Top management must ensure the appropriate communication processes are established and carried out within the organization regarding the effectiveness of the system. 5.6 Management Review 5.6.1 General Top management must review the quality management system at planned intervals to:
Records of the management reviews must be maintained. 5.6.2 Review Input Inputs for management review must include information on:
5.6.3 Review Output Outputs from the management review must include any decisions and actions related to:
If you have any questions
about the new requirements, send a note to: Larry@WhittingtonAssociates.com. The key differences for the first five of the ISO 9001:1994 clauses are shown below (with the corresponding ISO 9001:2000 clause numbers identified). To see the differences for all 20 clauses, go to ISO 9001:2000 Differences at our web site. 4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document and Data Control
If you have any questions
about the differences, send a note to: Larry@WhittingtonAssociates.com. Clause 4.2.1 of ISO 9001:2000 identifies the requirement for a quality policy, quality objectives, quality manual, and procedures. Documented Statement of Quality Policy ISO 9001:2000, clause 5.3, requires top management to ensure the quality policy is:
The policy must include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. Note that the quality policy must be controlled, which means paying particular attention to these 4.2.3 sub-clauses:
Documented Statement of Quality Objectives ISO 9001:2000, clause 5.4.1, requires top management to ensure quality objectives, including those needed to meet product requirements, are established at the relevant functions and levels within the organization. Quality objectives must be measurable and consistent with the quality policy. Some organization may discover that their current quality objectives are really broadly stated goals instead of specific, measurable targets. These defined quality objectives are subject to document control since they represent your current plan and will be revised in the future. Quality Manual ISO 9001:2000, clause 4.2.2, specifies the minimum content for a quality manual. It must be established and maintained with:
Although not specifically required in the quality manual as before, providing an outline of the structure of your documented system would be a good idea. Also, the new standard no longer says the quality manual must cover all the requirements of the standard. However, if all the requirements are not addressed, it would appear that they have been excluded from your system. The format and structure of the quality manual is up to the organization and depends on the size and complexity of their system. Of course, ordering the sections by the clause numbers of the new standard will make it easier to ensure no requirements are overlooked. The quality manual may be the reader’s first impression of your system. You want it to convey your management commitment to quality and represent your organization well. Required Procedures ISO 9001:2000 clause 4.2.1(d) explains that the quality system documentation must include the documented procedures required by the standard. Six documented procedures are identified in the standard (4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3) and have to be controlled in accordance with the requirements of clause 4.2.3. Some organizations may find it convenient to combine the procedures for several activities into a single procedure, for example, corrective action and preventive action. Others may choose to document an activity with more than one procedure, for example, internal audits. Procedure for Control of Documents Documents required by the quality management system must be controlled. A documented procedure must be established to define controls to:
Note that reviewing documents and updating them as necessary implies an ongoing review process to ensure your documents are valid and current. The 1994 version of the standard said the nature of document changes had to be identified, where practical. ISO 9001:2000 dropped the “where practical”. Changes should be identified in the document or an attachment. The new standard has added that documents must be legible and readily identifiable. ISO 9001:2000 also clarified that control of external documents includes the control of their distribution. Procedure for Control of Records Records required for the quality management system must be controlled. These records must be established and maintained as evidence of conformance to requirements and to demonstrate the effective operation of the quality management system. Records must remain legible, readily identifiable, and retrievable. A documented procedure must be established for the control of records:
Although a few words have been
dropped from the description of the activities addressed by the record
control procedure, the basic intent is the same Procedure for Internal Audit The organization must conduct periodic internal audits to determine if the quality management system, conforms to planned arrangements, conforms to requirements of ISO 9001, and is effectively implemented and maintained. A documented procedure must address the responsibilities and requirements for:
Prior audit results must now be considered when planning the audit program, in addition to considering the status and importance of the areas to be audited. The new standard requires the audit criteria, scope, frequency and methods to be defined. We knew to do this based on our audit training, but now it is spelled out as a requirement. ISO 9001:1994 states the auditor must be independent of those with direct responsibility for the audited activity. The new standard says the auditor must be impartial and objective, and that the auditor cannot audit their own work. The revised text may give small organizations more latitude in assigning auditors. Although ISO 9001:1994 requires an internal audit procedure, the new standard specifies the procedure must define responsibilities and requirements for planning and conducting audits, reporting results, and maintaining records. Procedure for Control of Nonconforming Product The organization must ensure any nonconforming product is identified and controlled to prevent its unintended use or delivery. These activities and related responsibilities and authorities must be defined in a documented procedure. The ISO 9001:1994 standard identifies several actions that might be taken to deal with nonconforming product. The product could be reworked, accepted by concession, regraded, or rejected or scrapped. The new standard covers these actions in different words. Clause 8.3 says one way of dealing with nonconforming product is by "taking action to eliminate the detected nonconformity". This is the definition of “correction” from ISO 9000:2000, which states in a note that the correction may be to rework or regrade the product. When the new standard refers to actions to preclude the original intended use or application of the nonconforming product, it covers rejecting or scrapping. Both of the standards refer to concessions as an option. However, there is a new requirement that for any nonconforming product detected after delivery or use, the organization take action appropriate to the effects, or potential effects, of the nonconformity. Be sure to address this possibility in your procedure. Procedure for Corrective Action The organization must take corrective action to eliminate the cause of the nonconformity and prevent recurrence. Corrective action must be appropriate to effects of the problem. The documented procedure for corrective action must define requirements for:
The new standard clarifies that corrective action is to prevent the “recurrence” of a detected nonconformity. Although worded differently throughout the clause, the requirements are basically the same. Some auditors have expressed a concern that 8.5.2 (f) only requires the "reviewing of corrective action taken". They point out that clause 4.14.2 (d) of ISO 9001:1994 required "application of controls to ensure that corrective action is taken and that it is effective". Based on the definition of “review”, corrective actions must still be effective. ISO 9000:2000 defines Review as the "activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives." Procedure for Preventive Action The organization must determine the action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions must be appropriate to the anticipated effects of the potential problem. The documented procedure for preventive action must define requirements for:
The new standard clarifies that preventive action is to prevent the “occurrence” of potential nonconformities. Although worded differently throughout the clause, the requirements are basically the same. Most organizations have a combined
corrective and preventive action procedure. Although the new standard
identifies the need for a corrective action procedure and a preventive
action procedure, they can be placed together if the resulting procedure
addresses the unique differences of their requirements. ISO/TS 16949 for the automotive industry has been revised for ISO 9001:2000. Although the US delegation voted No, the draft document received a 79% approval. An approval vote of 67% is needed to ratify an ISO Technical Specification, so publication is expected by March of this year. Since 8 countries voted No, the release of ISO/TS 16949 may end up being delayed to accommodate their concerns and comments. As a result, automotive suppliers should wait for the official final version instead of using the draft document that was approved. Watch for announcements from the Big Three on their polices about registration to QS-9000 or ISO/TS 16949:2002. If QS-9000 suppliers are asked to make a transition to ISO/TS 16949:2002, the cutoff may match the current ISO 9001:2000 deadline of December 15, 2003. ISO standards are reviewed
for possible revision every 5 years. However, technical specifications
are revised after only 3 years. Once a technical specification has been
revised, its next change is to become a full international standard or
to be eliminated. That being the case, ISO/TS 16949 will likely become
ISO 16949:2005. To enroll in any of these public classes, go to the Class Schedule at our web site, or call us at 800-404-7585. The classes taught by Larry Whittington are shown in gold. ISO 9001:2000 Lead Auditor
(ANSI/RAB-NAP Accredited) - CEEM, Inc.
ISO 9001:2000 Internal Auditor
(ANSI/RAB-NAP Accredited) - CEEM, Inc.
ISO 9001:2000 Auditor Transition
(RAB-Approved)
Implementing ISO 9001:2000
(for New Systems)
ISO 9001:2000 Conversion
(for Existing Systems)
* * Note: A two-day Conversion course is available for on-site classes. Quality System Documentation
(Revised for ISO 9001:2000)
Understanding ISO 9001:2000
Requirements
To arrange an economical on-site
class, please call us at 800-404-7585.
© 2000-2002 Whittington & Associates, LLC. All rights reserved. |
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