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4.1 General Requirements

This is the overall requirements for ISO 9001, this clause requested organization to establish the ISO 9001 system, document down the processes in procedure, implement what the procedure request , maintain the system and continual improve its effectiveness according to the ISO 9001 requirements.


The steps we need to follow are:




In ISO 9001:2008 version, it reinforces the control of outsourcing processes (note 2) that affects the product conformity to requirements. Organization shall define the control method applied to these outsourced processes in the ISO 9001 QMS.


Note 1: include processes for Management Responsibility, Resource Management, Product Realization, Measurement, analysis and improvement. (In other words, beside the organization operation processes, ISO 9001 QMS processes also need to identify).


Note 2: is a process that the organization chooses to perform by an external party.


ISO 9001 Clause 4.2 Documentation Requirements

4.2 Documentation Requirements

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