|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
1. Understand New and Changed Requirements When you are planning a trip, you must know your starting point and ultimate destination to decide on the most efficient and effective route. Similarly, you need to understand the new and changed ISO 9001:2000 requirements before plotting your transition path. Start by ordering the ISO 9001:2000, ISO 9000:2000, and ISO 9004:2000 family of standards. Copies can be purchased at http://qualitypress.asq.org. Before opening the ISO 9001:2000 Requirements standard, review the quality concepts described in the ISO 9000:2000 Fundamentals and Vocabulary standard. If you are unsure of any of the terms, look up their definitions in section 3 of ISO 9000:2000. When you examine ISO 9001:2000, pay particular attention to the process approach described in its Introduction section. The process model illustrates the clause linkage based on the plan-do-check-act approach. Refer to Annex B in the new ISO 9001 standard to see the clause correspondence between ISO 9001:2000 and ISO 9001:1994. Now you are ready to begin reading through the requirements to understand the differences. The ISO 9004:2000 standard provides guidance on performance
improvements beyond the basic requirements of ISO 9001:2000. For ease
of reference, these requirements are shown in ISO 9004:2000 as boxed text.
Since ISO 9004:2000 uses the same clause structure as ISO 9001:2000, it
can be used to gain a better understanding of the requirements by seeing
possible practices. Remember, however, that your system will be evaluated
against ISO 9001:2000, not ISO 9004:2000. http://www.iso.org/iso/en/iso9000-14000/iso9000/2000rev4.html that highlights the key requirement differences. 2. Determine Scope and Permissible Exclusions ISO 9001:2000 is intended to be generic and applicable to all organizations, regardless of type, size, and product category. However, not all requirements in the new standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may exclude some specific requirements. Clause 1.2, Application, in ISO 9001:2000 states that requirements can be excluded only if they are limited to clause 7, Product Realization. Exclusions are acceptable only if they do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. If you find your organization cannot apply a Product Realization requirement, you must define and justify the exclusion in the quality manual. In addition, any publicly available documents such as registration certificates and marketing materials should be carefully phrased to avoid confusing or misleading customers and end users regarding the scope of your quality management system. Part of defining the scope of your system is deciding on the products and sites to include for registration purposes. A clear description of the scope is of increased importance since certificates cannot be issued for ISO 9002 or ISO 9003 after the transition period ends in December 2003. Another consideration is that any outsourced processes must be identified and controlled. If a product realization process is outsourced to an external organization, that is not adequate justification for excluding the process from your quality management system. Refer to clause 4.1, General Requirements, in ISO 9001:2000 for the specific outsourcing requirement. See the Clause 1.2 guidance at: http://www.iso.org/iso/en/iso9000-14000/iso9000/2000rev6.html 3. Adopt the Process Approach A “process” is a system of activities that uses resources to transform inputs into outputs. The “process approach” promoted by ISO 9001:2000 systematically identifies and manages these processes and their interaction within a quality management system. As mentioned in an earlier tip, the process model illustrates the linkage of ISO 9001:2000 clauses (4-8) based on the plan-do-check-act approach. This PDCA methodology can be applied to all processes. In the Plan step, you establish the objectives and processes necessary to deliver results in accordance with customer requirements and organization policies. These processes are implemented in the Do step. Then you monitor and measure the processes in the Check step and report the results. The Act step takes the actions needed to continually improve process performance. An advantage of the process approach is the ongoing control it provides over the linkages between individual processes within a system of processes, as well as, their combination and interaction. According to clause 4.2.2 in ISO 9001:2000, the quality manual must describe the interaction of the processes within the quality management system. 4. Revise Quality Manual and Procedures The documentation for a compliant quality management system must include the quality policy, quality objectives, quality manual, required procedures, and other documents deemed necessary for its effective planning, operation, and control. These requirements are covered in clause 4.2.1 of ISO 9001:2000. You may already have the necessary documentation in place for the new standard. However, check your current documents to ensure they adequately address the new and changed ISO 9001:2000 requirements. For organizations registered to ISO 9001:1994 along with a specific industry scheme (QS-9000 for automotive, TL 9000 for telecommunications, or AS9100 for aerospace), you may find that many of the new ISO 9001:2000 requirements are already being practiced within your current system. What the standard does not tell you is how all this information should be documented. Avoid creating overly complex or burdensome documentation. Use the transition period as an opportunity to examine your current documents for the right level of detail, usable formats, and business value. You might even decide to define some processes (and not document them) due to their simplicity, and rely instead on the skills, training, and experience of the people doing the work. This approach may cause auditors to adjust their auditing techniques and focus more on interviewing individuals and observing operations. However, you need to do what is best for your business, which may be to reduce the amount of documentation compared to your current system. Although not required, some organizations may choose to revise their quality manual to reflect the new clause structure of ISO 9001:2000. The quality manual must address the scope of your system and provide the details of any excluded requirements. In addition, it must describe the interaction between processes and include or reference the procedures. Only six procedures are specifically required by the new standard: Control of Documents (4.2.3), Control of Records (4.2.4), Internal Audit (8.2.2), Control of Nonconforming Product (8.3), Corrective Action (8.5.2), and Preventive Action (8.5.3). Although these procedures are part of current systems, they will need to be revised to incorporate the new and changed requirements of ISO 9001:2000. The other procedures required by ISO 9001:1994, e.g., contract review, design control, purchasing, and training, are no longer required by ISO 9001:2000. However, defined processes for these areas are still necessary and must comply with the requirements. Many organizations will see the business value in retaining and revising their existing procedures. It is also unlikely that lower-level work instructions will be affected by the new requirements. As you examine your current documentation, consider using electronic media for easier access and better document control. Process mapping will help you identify your product realization processes and will enable your organization to more clearly determine what documentation is critical for the application of its quality management system. The extent of the documentation, and the use of electronic media, will vary due to organization size, activity type, process complexity, and personnel competence. While the documents can be in any form or media, they must be maintained and controlled. For more documentation guidance, see: http://www.iso.org/iso/en/iso9000-14000/iso9000/2000rev7.html 5. Focus on Expanded Top Management Role ISO 9000:2000 defines top management as the person or group of people who directs and controls an organization at the highest level. Top management leadership, commitment, and active involvement are essential for an effective quality management system. Every sub-clause in clause 5, Management Responsibility, begins with the phrase “Top management shall”. Top management must provide evidence of their commitment to the development and implementation of the quality management system, as well as, the continual improvement of its effectiveness. Management must focus on meeting customer requirements and establishing the quality policy and objectives. Responsibilities must be defined and communicated within the organization. The system must be planned and the results reviewed at planned intervals. Review these duties with top management and explain the expected benefits for the organization. You need them as willing and active participants in the transition effort. 6. Establish Measurable Quality Objectives When you drive down the road, you can glance at the indicators on the dashboard to see how your car is performing. In a similar fashion, your organization needs to identify the key quality measures for evaluating the performance of your quality management system. First, use the quality policy statement as the framework for establishing your process and product goals. Then set specific, measurable targets on the path to attaining these goals. The product objectives will be largely determined by your product specifications. Focus your attention on the process objectives and the methods you will use to measure process performance. These objectives must be established at the relevant functions and levels within your organization. See clause 5.4.1 on Quality Objectives for the specific requirements. Provide the necessary resources to collect the product and process data. Analyze the data (as called for by clause 8.4) and use the facts for more effective decision making. If your desired results are not being achieved, identify the actions necessary to make it happen. ISO 9001:2000 requires an effective system, in other words, a system that is carrying out activities according to planned arrangements and achieving planned results. An efficient system is certainly desirable, but not required by the standard. Efficiency relates to the resources used to achieve the desired results. Keep this in mind as you set objectives. 7. Prepare Your Transition Plan We began these tips by talking about planning a trip. To know your starting point, you should assess your current system against the requirements of the new standard (your destination). This gap analysis will identify any missing documentation and practices. Knowing the needed deliverables, you can determine the appropriate activities and assignments to enhance your current system for compliance with ISO 9001:2000. Develop the transition schedule in consultation with your registrar. Depending on your system status and business needs, you may decide to make the transition quickly by having your entire system assessed during your next scheduled surveillance visit. Or, you can stage the transition over several surveillance visits to minimize its impact and possibly reduce the registrar costs. Your registrar will develop an assessment plan with you to meet the desired timing for your registration to the ISO 9001:2000 standard. You must maintain compliance with the ISO 9001:1994 standard during the transition period to keep your current certificate in place. A key consideration is to maintain the currently required procedures during the transition (you can’t drop these procedures, even if ISO 9001:2000 doesn’t require them). Clause 5.4.2 of ISO 9001:2000 requires planning any system changes and maintaining the integrity of the system during the changes. Switching to the ISO 9001:2000 standard is a significant change for your system and its planning may be the subject of an audit. Have your planning evidence ready. Registrars want to see several months of system operation before conducting an audit. Your will need to collect records as evidence your system is complying with planned arrangements, meeting requirements, and effectively achieving the planned results. You can view Transition Planning Guidance at: http://www.iso.org/iso/en/iso9000-14000/iso9000/2000rev4.html for advice on making the move to ISO 9001:2000. 8. Inform Organization of Changes and Plans It is important to keep everyone within the scope of your quality management system informed of your plans and progress. Clause 5.5.3 of ISO 9001:2000 requires internal communication channels be established to share information about the effectiveness of your quality management system. Top management will rely on internal communications to convey the importance of meeting customer requirements. The organization must also make employees aware of the relevance and importance of their activities and how they contribute to achieving the quality objectives. Providing this information will involve everyone in helping to improve performance and meet the established objectives for their areas. Management should actively encourage feedback and communications from people within the organization. 9. Update Your Internal Audit Program Clause 8.2.2, Internal Audit, requires an organization to consider the process status and importance when planning an audit program. Since the quality management system will be revised to comply with ISO 9001:2000, your internal audit schedule should focus on the areas of new and changed practices. In addition, the internal audit procedure must be updated to comply with the requirements of clause 8.2.2. Don’t overlook training your internal auditors on ISO 9001:2000. The auditors need to understand how the new clause structure and requirements will affect their audit plans. Instead of auditing by clause, the organization may decide to audit by functional area. Auditors should consider the new audit trails and expected evidence for compliance with ISO 9001:2000. For example, to audit to the requirements on quality objectives requires consideration of clause 5.4.1, quality objectives, as well as, related clauses that refer to quality objectives (4.2.1.a, 5.1.c, 5.3.c, 5.4.2.a, 5.6.1, 6.2.2.d, 7.1.a, and 8.5.1). Use of an electronic version of the standard will help auditors identify important cross-references. The Registrar Accreditation Board has approved ISO 9001:2000 transition training courses for certified auditors. You should consider this same training for your internal auditors. You can see a full list of RAB-approved training courses at: http://www.rabnet.com/content/ISO9k2k/ApprovedCourses.htm Internal audits should be conducted against your modified system to determine the degree of compliance and to identify actions for your transition plan. Ensure the system is ready and objective evidence is available before the registrar arrives for the assessment. 10. Identify Areas for Continual Improvement According to clause 8.5.1, the organization must continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. Management should continually seek to improve process effectiveness rather than wait for problems to reveal opportunities for improvement. When a problem does occur, the cause must be determined and a corrective action taken to prevent its recurrence. The new standard emphasizes planning for the system, its resources, its processes, and the measurements necessary to evaluate performance. Part of the planning is to anticipate what might go wrong and try to prevent the occurrence of these potential problems. Even when processes are producing compliant products, the processes could be more efficient and effective. The aim of a continual improvement program is to increase the odds of satisfying customers by identifying areas needing improvement. After setting improvement objectives, the organization searches for possible solutions, selects and implements the appropriate one, and evaluates results to confirm objectives are met. The documented quality policy statement must include a commitment to continual improvement. To ensure this focus, the management representative must report to top management on the need for any improvements. In fact, recommendations for improvement must be one of the management review inputs and any actions or decisions regarding improvements must be recorded. Tips and Guidance We hope you find these tips, as well as, the guidance in the referenced documents at the ISO web site, useful in your transition planning. Although your registrar cannot consult on possible practices, they should be involved in setting up the transition audit schedule and interpreting requirements. Effective application of these new and changed requirements in your system, along with continual improvement, will lead to enhanced customer satisfaction and business success. Best wishes for a safe and enjoyable journey.
About the Author Larry Whittington is President of Whittington & Associates, a quality system training, consulting, and auditing company located in Marietta, Georgia. He is an ASQ Certified Software Quality Engineer and Quality Auditor. Both the RAB and IRCA have certified him as an ISO 9000 Lead Auditor. He is also a trained TickIT Lead Auditor for software systems and a certified QS-9000 Lead Auditor for the automotive industry. Mr. Whittington can be contacted at 770-517-7944, or by e-mail at Larry@WhittingtonAssociates.com. |
||
|
|
|
|
|
|
