ISO 9001 design and development process

Design Control Most manufacturers in developing countries produce goods to designs obtained from external sources. Suppliers of large companies and governmental organizations obtain their designs from their customers. Manufacturers of general consumer products either operate under license from developed countries or copy the designs of imported products. The bulk of the developing countries export products are produced as per designs, […]

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ISO 9001 quality system under section 4.2

ISO 9001, section 4.2 provides that the “supplier shall create, document and keeps quality system which means of confirming that the product meets to particular needs. It can be seen that this documentation consists of several tiers of documents, each successive tier becoming more detailed. At the apex is the quality manual, this briefly describes all the elements of a […]

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ISO 9000 certification

The ISO 9000 certification is a great performance for any company and it surely calls for celebration. After the excitement is created by ISO 9000 certification is over, there is likely to be a general tendency to relax. If this is not checked, it will defeat the very purpose of establishing a quality system. Implementing ISO 9000 is not a […]

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ISO 9001 management responsibility

Any enterprise operating on the basis of modern management principles needs to define its objectives. The broad methodology for achieving these objectives in the form of a corporate policy. As has been seen in earlier chapters, quality is an important element in the success of an enterprise. A corporate policy document should therefore visibly demonstrate top management’s commitment to the […]

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Document and data control ISO 9001

Clause 4.5 of ISO 9001 requires the supplier to establish and maintain documented procedures to control all documents and data pertinent to the quality system. The aim of this clause of the standard is to ensure that only authentic documents and data are used and that these are readily available to the personnel performing various tasks affecting the quality of […]

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Corrective and preventive action ISO 9001

Clause 4.14, which serves as the basis for quality improvement, is one of the most important clauses of the ISO 9001 standard. The 1994 revision has made the clause more comprehensive in that. It also covers preventive action, and the effective handling of customer complaints and reports of product nonconformities. Corrective action It will be impracticable for manufacturing enterprises experiencing […]

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1994 versions of ISO 9001, ISO 9002 and ISO 9003

The 1994 versions of the quality assurance standards ISO 9001, ISO 9002 and ISO 9003 specify three sets of quality system requirements. It can be used for external quality assurance purposes. The requirements in these external quality assurance standards are viewed as minimum good-business practices for a supplying company in any industry. The requirements are stated mainly in terms of […]

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The structure of the ISO 9000 standards

The ISO 9000 series of standards consists of two broad categories of standards : core standards and supplementary guidance standards. We have to know about the structure of ISO 9000 standards. Core standards The five core standards are : ISO 9000-1: 1994. Quality management and quality assurance standards – Part 1 : regulations for selection and use. This standard clarifies […]

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Significant changes in the ISO 9001:1994 revision

The significant changes in the ISO 9001:1994 revision are given below : Significant changes in ISO 9001:1994 Management responsibility: The relevance of the quality policy to customer expectations and needs as well as to the suppliers internal organizational goals has been enhanced. The clause emphasizes the need to address process and quality system problems, rather than only the nonconformity of […]

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