Apart from being a standard in its own right, ISO 9000 is a family of international standards that define quality management system requirements. There are four core standards in the family: ISO 9000, ISO 9001, ISO 9004 & ISO 19011. ISO 9000:2015 explains the concepts, the principles and defines the terms used in the family of international quality management system standards.
ISO 9001:2015 specifies quality management systems requirements. Its purpose is to provide an equitable basis for assessing the capability of organizations to meet customer and applicable regulatory requirements – it is not a design specification for a quality management system. Also ISO 9001 is applied -
In general the type of organizations that use ISO 9001 of which there are over 1.2m worldwide, tend to be those that have customers that will only trade with suppliers that have ISO 9001 certification. If your customers don't require ISO 9001 certification, you don't need to use ISO 9001 but you might find the standard useful in providing a set of principles and a framework on which to build a robust quality management strategy. Many successful organizations are not ISO 9001 certified and have no wish to go down the certification road.
ISO 9001 applies when invoked in a invitation to tender or a contract and this is normally the case where a customer needs confidence that its suppliers have the capability to meet specific requirements. Where a customer can verify that its requirements have been met on receipt of a product or service, there is no need to impose ISO 9001 on these suppliers. However, many organizations impose ISO 9001 on their suppliers regardless of it being a necessity.
The principal changes are as follows:
More details on specific requirements that have been added, withdrawn or changed are included in Chapter 2 of the ISO 9000 Quality Systems Handbook 7th Edition.
Apart from ISO 9001 itself, and the information on this website, by far the best source of information about the requirements, what they mean, why they are necessary, how to apply them and how to demonstrate conformity is the ISO 9000 Quality System Handbook 7E that covers all 300 of the requirements as well as concepts, principles, flow charts etc.
By far the best way to use these standards is to firstly read them all starting with ISO 9000. Unless you have a clear understanding of the concepts and principles, the other standards won't make much sense. The read ISO 9004 to get an idea of the kind of areas your management system needs to cover. Then put them down and design your management system around your business using the concepts in ISO 9000. When you have designed your business processes, consult ISO 9001 to identify any aspects you have overlooked. DON'T design your system around ISO 9001. It was not intended to be used in this way and its primary use is in assessing management systems just like a test specification is used to test a product. You wouldn't design your product around the test spec would you?
Chapter 5 of the ISO 9000 Quality Systems Handbook 7E provides a practical guide to using these standards.
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