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| Chapter | /Section | Title |
|---|---|---|
| 38 | 15 | TITLE OF CHAPTER 15 |
| 15.10 | Quality System Objectives and Implementation | |
| 15 Quality System Objectives and Implementation To assure that a company or division will meet the ISO 9000 requirements and receive certification, the following process should take place: Management Decision and Commitment Adequate Training and Evaluation Compliance with Appropriate Standards Audit and Registration Some of the obstacles that can interfere with successful implementation and that must be avoided can include, unrealistic time frames, resistance to change, lack of management commitment, insufficient training, subjective interpretation of the standards. The areas most frequently resulting in Non-Certification by companies to date have been in document control, design control, purchasing, inspection and testing, quality system, process control and inspection, measuring and test equipment. Although all areas of the company's quality assurance required to be in compliance with the standard, management should perform extra reviews to ascertain compliance in these above areas. The appropriate personnel under the direction of management should review the standards and develop, implement and maintain a minimum set of quality systems and procedures to satisfy the desired ISO 9000 standard. Further, these personnel will provide confidence to management that the intended quality is being achieved and is: a. Documented b. Demonstrable c. Effective d. Maintained The following 20 elements are included in the ISO 9000 auditable standards and will serve as guidelines to personnel for ensuring complete and thorough quality assurance system development and documentation: Management Responsibility Quality System Contract Review Design Control Document and Data Control Purchasing Customer Supplied Product Product Identification and Traceability Process Control Inspection and Testing Inspection, Measuring and Test Equipment Inspection and Test Status Control of Non-conforming Product Corrective and Preventative Action Handling, Storage, Packaging and Delivery Quality Records Internal Quality Audits Training Servicing Statistical Techniques | ||
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