ISO 9000 Quality Systems Handbook, Fifth Edition

Summary

In this chapter we have examined the requirements contained in Section 7 of ISO 9001. This is the largest section of the standard and covers the result-producing process of an organization. We have examined the product realization processes both in general and specific terms through a series of processes that took us from receipt of a customer enquiry to post-delivery activities. However, we have learnt that these processes are not necessarily triggered by customer orders and can also be triggered by a marketing process feeding requirements that have been derived from an understanding of market needs into a design process. This changes contract review into product requirement review and brings in all those functions that might have been excluded from the management system such as marketing, sales and design. We have learnt that we cannot ignore the first two requirements of Clause 7.6 as they apply to all organizations and that the integrity of every device used to determine whether or not a requirement has been met does need to be managed. A recurring theme through this section of the standard is the absence of requirements for documented procedures. Taking one example to illustrate this trend; instead of requiring organizations to establish and maintain documented procedures for customer communication, the standard requires the organization to determine and implement effective arrangements for communicating with customers, thereby focusing on results rather than on the documentation. We have learnt that every one of the requirements is important and examined several solutions to...

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