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Extra resources for The ISO 9000 Essentials, A Practical Handbook for Implementing the ISO 9000 Standards

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2] 2) If there are any exclusions claimed, are these exclusions limited to the requirements within Clause 7 of the standard? 3) Do any of the exclusions claimed affect the organization’s ability, or responsibility, to provide product that fulfills customer requirements and applicable regulatory requirements? April 2001 53 PLUS 9001 © CSA Licensed to/Autorisé à Larry Malinowski, Bradford White, on/le 9/20/2002. Single user license only. /Permis d'utilisateur simple seulement. Le stockage, la distribution ou l'utilisation sur le réseau est interdit.

Le stockage, la distribution ou l'utilisation sur le réseau est interdit. Table 3 illustrates a standard that states requirements (ISO 9001:2000) in relation to a standard that gives guidelines for performance improvements (ISO 9004:2000). Table 3 ISO 9001:2000 and ISO 9004:2000 Requirement Standard ISO 9001:2000 Guideline for Performance Improvement ISO 9004:2000 Enhance customer satisfaction through meeting customer requirements (including having product meet customer requirements) Achieve competitive advantage through exceeding customer requirements (including having product meet enhanced expectations) Effectiveness Efficiency Minimum set of requirements The best practice Compliance to the requirements which are Guidance, not requirements auditable Requirements either have or have not been met Degrees of excellence Ability to achieve customer requirements and improve processes by reducing risks and preventing failure Ability to achieve superior performance and delighted customers Figure 6 also illustrates the relationship between ISO 9001:2000, ISO 9004:2000, and other quality management system standards (here, ISO 13485 for medical devices is used to illustrate such a link).

The scope of the QMS should be based on the nature of the organization’s products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory, and regulatory requirements. An organization is not obliged to include all the products that it provides within the scope of its QMS, or to address the realization processes for products that are not included within the QMS. If an organization chooses to implement a QMS with a limited scope, however, this should be clearly defined in the organization’s quality manual and any other publicly available documents, to avoid confusing or misleading customers and end users (such documents include, for example, certification/registration documents and marketing material).

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