ISO9001：1994 Standard
Quality systeems—Model for quality assurance in design,development,production,installation and servicing

1 Scope
This International Standard specifies quality system requirements for use where a supplier’s capability to design and supply conforming product needs to be demonstrated.
The requirements specified are aimed primarily at achieving customer satisfaction by prevent nonconformity at all stages from design through to servicing.
This International Standard is applicable in situations when design is required and the product requirements are stated principally in performance terms, or they need to be established, and confidence in product conformance can be attained by adequate demonstration of a supplier’s capabilities in design, development, production, installation and servicing.
NOTE 1 For informative references, see annex A.
Normative reference
The following standard contains provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.
ISO 8402:1994, Quality management and quality assurance—Vocabulary.
Definitions
For the purposes of this International Standard, the definitions given in ISO 8402 and the following definitions apply.
product: Result of activities or processes.
NOTES
A product may include service, hardware, processed materials, software or a combination thereof.
A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts), or a combination thereof.
For the purposes of this International Standard, the term “product” applies to the intended product offering only and not to unintended “by-products” affecting the environment. This differs from the definition given in ISO 8402.
tender: Offer made by a supplier in response to an invitation to satisfy a contract award to provide product.
3.3 contract: Agreed requirements between a supplier and customer transmitted by anymeans.
4 Quality system requirements
4.1 Management responsibility
4.1.1 Quality policy
The supplier’s management with executive responsibility shall define and document its policy for quality including objectives for and commitment to quality. The quality policy shall be relevant to the supplier’s organizational goals and the expectations and needs of its customers.
The supplier shall ensure that the policy is understood, implemented and maintained at all levels of the organization.
4.1.2 Organization
4.1.2.1 Responsibility and authority
The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to:
a) initiate action to prevent the occurrence of any nonconformities relating to the product, process and quality system;
b) identify and record any problems relating to the product, process and quality system;
c) initiate, recommend or provide solutions through designated channels;
d) verify the implementation of solutions;
e) control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
4.1.2.2 Resources
The supplier shall identify resource requirements and provided adequate resources, including the assignment of trained personnel for management, performance of work and verification activities including internal quality audits.
4.1.2.3 Management representative
The supplier’s management with executive responsibility shall appoint a member of the supplier’s own management who irrespective of other responsibilities, shall have defined authority for:
a) ensuring the quality system is established, implemented and maintained in accordance with the appropriate standard, and
b) reporting on the performance of the quality system to the supplier’s management for review and as a basis for improvement of the quality system.
NOTE 5 The responsibility of a management representative may also include liaison with external parties on matters relating to the supplier’s quality system.
4.1.3 Management review
The supplier’s management with executive responsibility reviews the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of the appropriate standard and the supplier’s stated quality policy and objectives.
Records of such reviews shall be maintained.
4.2 Quality system
4.2.1 General
The supplier shall establish, document and maintain a quality system as a means of ensuring that product conforms to specified requirements.
The supplier shall prepare a quality manual covering the requirements of the appropriate standard.
The quality manual includes or makes reference to the quality system procedures and outlines the structure of the documentation used.
4.2.2 Quality system procedures
The supplier shall:
a) prepare documented procedures consistent with the requirements of the appropriate standard and the suppliers stated quality policy, and
b) effectively implemente the quality system and its documented procedures.
4.2.3 Quality planning
The supplier shall define and document how the requirements for quality will be met. Quality planning is consistent with all other requirements of the supplier’s quality system and is documented in a format to suit the suppliers method of operation.
The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:
a) the preparation of quality plans;
b) the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality;
c) ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation;
d) the updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation;
e) the identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;
f) the identification of suitable verification at appropriate stages in the realization of product;
g) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element