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ISO 9001:2000 Clause | ISO 9001:2000 Requirement | Quality Policy Statement |
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7.2.2: Partial Clause—Amendment to Product Requirements | In the case where product requirements are changed, we must ensure that both relevant documents are amended and relevant personnel are informed changes | Excellent's customer service representatives ensure that amendments to contracts are in written form by means of sales orders, reviewed by all affected departments by means of the request for quote (RFQ) report, and then accepted or rejected in written form and returned to the customer. |
7.3.6: Partial Clause—Design and Development Validation | Product validation is to be performed in accordance with specifications to make sure that the product meets customer requirements | After acceptance by the chief engineer of the final design review and verification testing report, the project engineer contacts the customer and schedules an in-plant validation test with the customer present. The elevated temperature electrical and mechanical validation test results are compared to the customer's specifications, and upon acceptance the customer signs off on the final product release form. |
4.2(c): Partial Clause—Control of Documents | Make sure that changes and current revision levels are identified | Document changes are accomplished using the document change form. Changes are reviewed by qualified personnel prior to approval. Revisions made to controlled documents are highlighted to the changes made. Revisions are tracked by the revision number and effective date. Changes to documentation are approved by those identified by management as the appropriate authority. The document control administrator maintains the authorization lists. Management makes the decision whether or not a change impacts the regulatory status of licensed product. |
6.3: Partial Clause—Infrastructure | Determine, provide, and maintain the infrastructure needed to achieve conformance to product requirements | Production equipment and machines are regularly maintained by the maintenance department following the schedules and recommendations provided by their manufacturers or, if unavailable, the recommendations of an appropriate equipment engineer. Performance and accuracy of the equipment is continuously monitored by the production foremen. |
8.2: Partial Clause—Monitoring and Measurement of Product | Records need to indicate the person(s) authorizing product release | 100% inspection is performed on all boards built on either the prototype or production lines. The inspections are performed by quality control personnel. Pass/fail data is recorded on the traveler by means of QC stamps, and the records are maintained in the quality assurance laboratory files. |
6.2.2(b): Partial Clause—Competence, Awareness, and Training | Provide training or take other actions to fulfill training needs | The personnel department or representative at each of Excellent's plants is responsible for coordinating all training programs and for maintaining all records pertaining to training. This process is documented in SOP TR6.2-01. New employees at each plant receive, as a minimum, instruction on plant safety, the ISO 9000 quality system overview, skills instructions, and basic statistical concepts. The personnel department or representative at each plant surveys each department at least annually to identify on-the-job training and cross-training needs. The information is reported to the general manager who prepares the training plans and issues the training schedules to each department manager. Each department manager creates the required on-the-job training exercise to fulfill those needs and assigns an appropriately skilled trainer or trainers. |
8.1: Partial Clause—General | Determine the appropriate analytical methods, including statistical techniques and the extent of their use | At the Excellent Corporation, the need for statistical or data analysis is decided on jointly by the quality assurance, engineering, and production departments in accordance with document QAP-8.1-01. The application of any statistical technique is directed for use only when it is clearly determined that such techniques will result in an improved process. Statistical and data analysis is required in the areas of process capability, machine control charts, in-process data collection records, quality reject records, inspection records, and material review board (MRB) records to ensure process reliability. Pareto and histograms are presented to management by the quality assurance department as part of the monthly review. |
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