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ISO9001：1994 StandardQuality 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.
2 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.
3 Definitions
For the purposes of this International Standard, the definitions given in ISO 8402 and the following definitions apply.
3.1 product:
Result of activities or processes.
NOTES
1. A product may include service, hardware, processed materials, software or a combination thereof.
2. A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts), or a combination thereof.
3. 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.
3.2 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.
