June, 2001 Newsletter Articles

Ten Tips for Moving to ISO 9001:2000 – 1. Understand New and Changed Requirements

Jun 30, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 2. Determine Scope and Permissible Exclusions

Jun 29, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 3. Adopt the Process Approach

Jun 28, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 4. Revise Quality Manual and Procedures

Jun 27, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 5. Focus on Expanded Top Management Role

Jun 26, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 6. Establish Measurable Quality Objectives

Jun 25, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 7. Prepare Your Transition Plan

Jun 24, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 8. Inform Organization of Changes and Plans

Jun 23, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 9. Update Your Internal Audit Program

Jun 22, 2001 in Newsletter | 0 comments

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...

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Ten Tips for Moving to ISO 9001:2000 – 10. Identify Areas for Continual Improvement

Jun 20, 2001 in Newsletter | 0 comments

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...

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