【正文】 er shall identify and plan the production, installation and servicing processes which directly affect quality and has ensured that these processes are carried out under controlled conditions. Controlled conditions include the following:a) documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality。c) established and maintained quality records of acceptable subcontractors. Purchasing dataPurchasing documents contain data clearly describing the product ordered, including where applicable:a) the type, class, grade or other precise identification。c) any obsolete documents retained for legal and/or knowledgepreservation purposes are suitably identified. Document and data changesChanges to documents and data are reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise.The designated functions/organizations have access to pertinent background information upon which to base their review and approval.The nature of changes is identified in the document or on appropriate attachments, whichever is practical. Purchasing GeneralThe supplier shall establish and maintain documented procedures to ensure that purchased product conforms to specified requirements. Evaluation of subcontractorsThe supplier shall:a) evaluated and selected subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements。c) identifies those characteristics of the design that are crucial to the safe and proper functioning of the product.Design output documents are reviewed before release. Design reviewAt appropriate stages of design, formal documented reviews of the design results are planned and conducted.Participants at each design review include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required.Records of such reviews are maintained. Design verificationAt appropriate stages of design, design verification is performed to ensure that the design stage output meets the design stage input requirements.The design verification measures are recorded. Design validationDesign validation is performed to ensure that product conforms to defined used needs and/or requirements. Design changesAll design changes and modifications are identified, documented, reviewed and approved by authorized personnel before their implementation. Document and data control GeneralThe supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of the appropriate standard including, to the extent applicable, documents of external origin such as standards and customer drawings. Document and data approval and issueThe documents and data are reviewed and approved for adequacy by authorized personnel prior to issue.A master list or equivalent document control procedure identifying the current revision status of documents shall be established and is readily available to preclude the use of invalid and/or obsolete documents.The control ensures that:a) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed。c) the supplier has the capability to meet the contract or order requirements. Amendment to a contractThe supplier shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the organization. RecordsRecords of contract reviews are maintained. Design control GeneralThe supplier shall establish and maintain documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met. Design and development planningThe supplier shall prepare plans for each design and development activity.The plans describe or reference design activities, and define responsibility for their implementation.The design and development activities are assigned to qualified personnel equipped with adequate resources.The plans are be updated as the design evolves. Organizational and technical interfacesOrganizational and technical interfaces between different groups which input into the design process are defined and the necessary information documented, transmitted and regularly reviewed. Design inputDesign input requirements relating to the product, including applicable statutory and regulatory requirements, are identified, documented and their selection reviewed by the supplier for adequacy.Inplete, ambiguous or conflicting requirements are resolved with those responsible for imposing the requirements.Design input take into consideration the results of any contract review activities. Design outputDesign output is documented and expressed in terms that can be verified and validated against design input requirements.Design output:a) meets the design input requirements。 where no written statement of requirement is available for an order received by verbal means, the supplier shall ensure that the order requirements are agreed before their acceptance。g) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element。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。c) ensuring the patibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation。e) control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory co