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It was released as AS 9100 to the international aerospace industry at the same time as the new version of ISO 9001. AS 9100A was actually two standards referenced in one publication: Section 1 defines an updated QMS model aligned with the updated ISO 9001:2000 publication while Section 2 defines a legacy model aligned with ISO 9001:1994.
As with IATF 16949 for the automotive industry and AS9100 for the aerospace industry, TL 9000 specializes the generic ISO 9001 standard to meet the needs of one industrial sector, which for TL 9000 is the information and communications technology (ICT) sector—extending from service providers through ICT equipment manufacturers through the ...
ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
The ISO 9001 standard requires organizations seeking compliance or certification to define the processes which form the QMS and the sequence and interaction of these processes. Butterworth-Heinemann and other publishers have offered several books which provide step-by-step guides to those seeking the quality certifications of their products.
They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery. The standards are reviewed every few years by the International Organization for Standardization.
In quality engineering they often address the quality attributes of availability, security, safety, reliability and performance. With the help of quality models like ISO/IEC 25000 and methods like the Goal Question Metric approach it is possible to attribute metrics to quality objectives. This allows measuring the degree of attainment of ...
First article inspection can fulfill the process validation requirement of a quality management system such as ISO9001, EN9100, and AS9100. Within the Aerospace industry SAE AS9102 Aerospace First Article Inspection Requirement is used.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
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