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ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages available from the national standards organization in each country. Only ISO 9001 is directly audited against for third-party assessment purposes. Contents of ISO 9001:2015 are as follows: Section 1: Scope; Section 2: Normative references
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). [1]
Section 5.2 of the ISO 9001:2015 standard requires a written, well-defined quality policy that is communicated and understood within an organization. Section 5.2 also sets out some of the requirements for quality policies. [4]
ISO 9001:2015 considers Validation: To ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Design validation is similar to verification, except this time you should check the designed product under conditions of actual use.
The new standardized document, called 9100, was still based on ISO 9001:1994(E), although it was published separately by each country's aerospace association or standards body (AS 9100 in the U.S). AS 9100 added 55 aerospace industry specific amplifications and requirements to ISO 9001:1994.
ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
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