Used 109 times, Last modified on 14 Apr, 2014

A general checklist of the main ISO 9001 quality requirements – this is not an official checklist.

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1.2 Application
— This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to c...
4.1 General requirements
— The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accorda...
4.2.1 General - Documentation requirements
— The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual...
4.2.2 Quality Manual - Documentation
— The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of a...
4.2.3 Control of documents - Documentation
— Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according t...
4.2.4 Control of records - Documentation
— Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be cont...
5.1 Management commitment - Management Responsibility
— Is the top level of management committed to the development and implementation of the QMS? Top management shall provide evidence of its commitment...
5.2 Customer focus - Management Responsibility
— Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8....
5.3 Quality policy - Management Responsibility
— Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with r...
5.4.1 Quality objectives - Planning
— Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relev...
5.4.2 Quality management system planning - Planning
— Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as...
5.5.1 Responsibility and authority - Responsibility, authority and communication
— Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.
5.5.2 Management representative - Responsibility, authority and communication
— Top management shall appoint a member of the organization's management who, irrespective of other responsibilities, shall have responsibility and a...
5.5.3 Internal communication - Responsibility, authority, and communication
— Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place reg...
5.6.1 General - Management Review
— Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and ...
5.6.2 Review inputs - Management review
— The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformi...
5.6.3 Review output - Management reviews
— The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality managem...
6.1 Provision of resources - Resource Management
— The organization shall determine and provide the resources needed a) to implement and maintain the quality management system and continually improv...
6.2.1 General - Human Resources
— Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills a...
6.2.2 Competence, training and awareness - Human Resources
— The organization shall a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where a...
6.3 Infrastructure
— The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure incl...
6.4 Work Environment
— The organization shall determine and manage the work environment needed to achieve conformity to product requirements. NOTE The term “work environ...
7.1 Planning of product realisation - Product Realisation
— The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the ...
7.2.1 Determination of requirements related to the product - Customer-related processes
— The organization shall determine a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b...
7.2.2 Review of requirements related to the product - Customer-related processes
— Has the organisation reviewed the requirements related to the product? The organization shall review the requirements related to the product. This...
7.2.3 Customer communication - Customer-related processes
— The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information, b) en...
7.3.1 Design and development planning
— The organization shall plan and control the design and development of product. During the design and development planning, the organization shall ...
7.3.2 Design and development inputs
— Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include a) functional and perfor...
7.3.3 Design and development outputs
— The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved p...
7.3.4 Design and development review
— At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) a) to evalu...