256 ones 3.6.9 repmr ISO 9000 action on a nonconforming product ( 3.4.2 ) t0 make it acceptable for the intended use NOTE 1 Repair includes remedial action taken on a presnously conforming product tO restore it for use, for example as part Of maintenance. NOTE 2 Unlike rework ( 3.6.7 ) , repair can af- fect or change parts 0f the nonconforming prod- uct. 3.6.10 scrap action 0 Ⅱ a nonconforming product ( 3.4.2 ) t0 pre- clude its origlnally intended use EXAMPLE Recycling, de struction. NOTE ln a nonconforming servlce situation, use IS precluded by discontinuing the sersnce.

288 ISO 9000 sequent recalibration, comparlson with the met- rological requirements for the intended use 0f the eqmpment, as well as any required sealing and labelling. NOTE 2 Metrolog1caI confirmation IS not achieved until and unless the fitness of the mea- surmg eqmpment for the intended use has been demonstrated and documented. NOTE 3 The requirements for intended use ⅲ - clude such considerations as range, resolution and maxlmum permissible errors. NOTE 4 Metrological requn•ements are usually distinct from, and are not specified in, product re- qmrements. 3.10.4 measuring measurmg instrument, software, measurement standard, reference material or auxiliary appara- tus or combination thereof necessary tO realize a measurement process ( 3.10.2 )

116 ISO 9001 completed, unless otherwise approved by a rele- vant authority and, where applicable, by the cus- tomer. 8.3 ControI of nonconforming product The organization shall ensure that product which does not conform tO product reqmrements iS iden- tified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming pro duct. Where applicable, the organization shall deal with nonconforming product by one or more 0f the fol- lowing ways: d) by taking action t0 eliminate the detected nonconformity; by author1Zing itS use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; by taking action t0 preclude its orlginal in- tended use or application; by taking action appropriate to the effects, or

270 ISO 9000 performing alternative calculations, comparing a new design specification ( 3.7.3 ) With a similar proven design specification, undertaking tests ( 3.8.3 ) and demonstrations, an d revlewing documents prior tO 1SSue. 3.8.5 validation confirmation, through the provlslon of objective evidence ( 3.8.1 ) , that the requirements ( 3.1.2 ) for a specific intended use or application have been fulfilled NOTE 1 The term "validated" is used to desig- nate the corresponding status. NOTE 2 The use conditions for validation can be real or simulated. 3.8.6 qualification process process ( 3.4.1 ) t0 demonstrate the ability to fulfil specified requirements ( 3.1.2 )

250 3.6.2 nonconformity ISO 9000 non-fulfilment of a requirement ( 3.1.2 ) 3.6.3 defect non-fulfilment of a requirement ( 3.1.2 ) related t0 an intended or specified use NOTE 1 The distinction between the concepts defect and nonconformity ( 3.6.2 ) is important as it has legal connotations, particularly those asso- ciated with product liability issues. Consequently the term "defect ” should be used with extreme caution. NOTE 2 The intended use as intended by the customer ( 3.3.5 ) can be affected by the nature 0f the information, such as operatmg or mamtenance instructions, provided by the supplier ( 3.3.6 ). 3.6.4 preventive action

258 3.6.11 concesslon ISO 9000 permission tO use or release a product ( 3.4.2 ) that does not conform tO specified requirements ( 3.1.2 ) NOTE A concession is generally limited to the delivery 0f a pro duct that has nonconforming characteristics ( 3.5.1 ) within specified limits for an agreed time or quantity Of that product. 3.6.12 deviation permit permission t0 depart from the origmally specified requirements ( 3.1.2 ) 0f a product ( 3.4.2 ) prior tO realization NOTE A deviation permit is generally glven for a limited quantity 0f product or peri0d 0f time, and for specific use.

106 ISO 9001 software t0 satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE Confirmation of the ability of computer software tO satisfy the intended application would typic ally include it s verification and configuration management t0 maintain its suitability for use. 8 Measurement, analysis and improvement 8.1 General The organization shall plan and implement the momtoring, measurement, analysis improve- ment processes needed b) t0 demonstrate conformity to product requlre- ments, t0 ensure conformity 0f the quality manage- ment system, and t0 continually improve the effectiveness of the quality management system. This shall include determination of applicable

d) e) f) 96 ISO 9001 the availability and use of monitoring and measurmg eqmpment, the implementation of monitoring and mea- surement, and the implementation 0f product release, deliv- ery and post-delivery activities. 7.5.2 Validation ofprocesses for production and service pr0VIS10n The organization shall validate any processes for production and seruce pr0VIS10n where the result- ing output cannot be verified by subsequent mo Ⅱ 1- toring or measurement and, as consequence, de- ficiencies become apparent 0 Ⅱ ly after the product IS 1 Ⅱ use or the service has been delivered. VaIidation shall demonstrate the ability of these processes tO achieve planned results. The organization shall establish arrangements for these processes including, as applicable,

100 ISO 9001 7.5.4 Customer property organization shall exerclse care customer property while it is under the organization's con- trol or being used by the organization. The organl- zation shall identify, verify, protect and safeguard customer property provlded for use or lncorpora- tion into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records (see 4.2.4 ). NOTE Customer property can include intellec- tual property and personal data. 7.5.5 Preservation of product The orgamzation shall preserve the product dur- ing internal processing and delivery t0 the intend- ed destination in order to maintain conformity to reqmrements. As applicable, preservation shall include identification, handling, packaging, stor- age and protection. Preservation shall also apply t0 the constituent parts of a product.

54 ISO 9001 A documented procedure shall be established to define the controls needed d) f) g) t0 approve documents for adequacy prior t0 lssue, tO revlew and update as necessary and re-ap- prove documents, t0 ensure that changes and the current revi- SIOn status Of documents are identified, t0 ensure that relevant verslons 0f applicable documents are available at points of use, tO ensure that documents remain leglble and readily identifiable, tO ensure that documents 0f external origln determined by the organization to be neces- sary for the planning and operation 0f the quality management system are identified and their distribution controlled, and tO prevent the unintended use Of obsolete doc- uments, and t0 apply suitable identification t0 them if they are retained for any purpose. 4.2.4 ControI of records Records established to provide evidence of confor-