ASQ-Q9003-1994.pdf

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1、ANSI/ASQC Q9003 ADOPTION NOTICE ANWASQC Q9003, Quality Systems-Model for Quality Assurance in Final Inspection and Test,“ was adopted on 15 September 1994 for use by the Department of Defense (DoD). Proposed changes by DoD activities must be submitted to the DoD Adopting Activity: Office of the Assi

2、stant Secretary of the Air Force for Acquisition, Deputy Assistant Secretary for Management Policy and Program Integration, Manufacturing and Quality Division, ATTN: SAF/AQXM, 1060 Air Force Pentagon, Washington, DC 20330-1060. DoD activities may obtain copies of this standard from the Standardizati

3、on Document Order Desk, 700 Robbins Avenue, Building 4D, Philadelphia, PA 191 11-5094. The private sector and other Government agencies may purchase copies from The American Society for Quality Control, 61 1 East Wisconsin Avenue, Milwaukee, WI 53202. Custodians: Navy - OS Air Force - 05 Army - AR A

4、dopting Activity: Air Force - 05 (Project QCIC-0187) AREA QClC DISTRIBUTION STATEMENT A: Approved for public release; distribution is unlimited. Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/20

5、07 11:47:36 MDTNo reproduction or networking permitted without license from IHS -,-,- AMERICAN NATIONAL STANDARD Quality Systems-Model for Quality Assurance in Final Inspection and Test AMERICAN SOCIETY FOR QUALITY CONTROL 611 EAST WISCONSIN AVENUE MILWAUKEE, WISCONSIN 53202 Copyright American Socie

6、ty for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:47:36 MDTNo reproduction or networking permitted without license from IHS -,-,- ASaC Q9003 94 0759506 0001356 833 ANSVASQC Q9003-1994 AMERICAN NATIONAL STANDARD Qu

7、ality Systems-Model for Quality Assurance in Final Inspection and Test Revision of first edition (A NSI/ASQC Q93- 1987) Prepared by American Society for Quality Control Standards Committee for American National Standards Committee Z- I on Quality Assurance An American National Standard Approved on J

8、uly 18, 1994 Descriptors: quality assurance, quality assurance program, quality systems, tests, inspection, reference models. American Natwml Standurh: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is i

9、ntended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in any respect preclude anyone, whether he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures no

10、t conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition. Cuurion Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require

11、that action be taken to reaffirm, revise, or withdraw thii standard no later than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. Copyright American So

12、ciety for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:47:36 MDTNo reproduction or networking permitted without license from IHS -,-,- ASQC Q9003 94 W 0759506 0003357 77T H Printed on acid-free nxycled paper Publish

13、ed b y : ASQC 611 East Wisconsin Avenue Milwaukee, Wisconsin 53202 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:47:36 MDTNo reproduction or networking permitted without license from IH

14、S -,-,- ASQC Q9003 7Y 0757506 0001358 bob ANSI/ASQC 49003- 1 9 9 4 Contents l s c o p e 1 2 Normathe reference 1 3 D e f i n i r i m 1 4 Quality-system requkments 1 4 . 1 Managementsibility 1 4 . 2 Qualitysystem . 2 4 . 3 contract review 2 4 . 4 Design control . 3 4 . 5 Document anddata conml 3 4 .

15、6 Purchasing 3 4 . 7 control ofcustomer-mppliedproduct. 3 4 . 8 Product i d e n t i f i c a t i o n a n d traceability 3 4 . 9 control . 4 4 . 1 0 Inspectionandtesting 4 4 . 1 1 C o n t m l o f i n s p e c t i o n . m e a s u r i n g . a n d t e s t e q u i p m e n t . 4 4 . 1 3 contrdofnonconformin

16、g product., . 5 4 . 1 5 Handling.storage.pclckaging.preservation.andd accepted order: Agreed requirements between a supplier and customer transmitted by any means. 4 QUALITY-SYSTEM REQUIREMENTS 4.1 Management responsibility 4.1.1 Quality policy The suppkfs management with executiw responsibility sha

17、ll define and document its policy Erw quality, including objectives Erw quality and its commitment to quality. The tional goals and the expectations and needs of its cus- tomers. The supplier shall ensure that this policy is u n - , implemented, and maintained a t all le The suppliers management wit

18、h executive responsibility shall c) the,asnecessaryofminspectionandtest- h g techniques; d)theidentificationdanyminspectionandtestmea- m e n t requirement inmlvhg capability that exceeds the known state of the art in sufkient time for the neededcapabilitytobede; 43.1 General e) the identitication of

19、 suitable verifmion at the hished The supplier shall establish, document, and maintain a product state; qual ments of this American National Standard. T h e quality g) the identibtion and prepItbn of quality m r d s manual shall include or make reference to the quality- (see 4.16). mm and outline th

20、e ” of the NOTE 8 T h e quality plan rekd t o (see 4.2.3a) may be in the form of a reference to the appropriate docu- mentationusedinthequalitysystem. NOTE 6 Guidance on quality manuals is giwn in Is0 mented plDcedures that fwm an integral part of the sup- 10013. pliers quality s y s t e m . 4.23 Qu

21、ality-system procedures 4 3 CONTRACT REVIEW T h e s u p p l k r h a l l a) p p a r e documented procedures consistent with the requirements o f this American National Standard and the suppliers stated quality p o l i c y , and b) effectively implement the quality system and its docu- 43.1 General Th

22、e supplier shall establish and maintain documented proceduresforcuntractreviewandiorthecoordinationof these activities. mented procedures. 43.2 Review For the purposes of this American National Standard, the Before submission of a tender, or the acceptance of a range and detail of the procedures t h

23、 a t form part of the contract or oder (statement of requirement), the tender, 2 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:47:36 MDTNo reproduction or networking permitted without l

24、icense from IHS -,-,- ASQC 09003 94 0759506 000L3b3 T73 ANSI/A!?QC 49003- 1994 contract, or order shall be reviewed by the supplier to ensure that: a) the requirements are adequately defined and docu- mented; where no written statement of requirement is available for an order received by verbal mean

25、s, the supplier shall ensure t h a t the order requirements are b) any difference between the contrxt o r accepted erdet requirements and those m the W e r are m o l * c)thesupplierhasthecapabiitomeetthecontractor accepted order requirements for hished product. agreedbeforetheiracceptance; 433 Amend

26、ment t o a contract Thesuppliershallidentifyhuwanamendmenttoacon- tract is made and un-rectly transferred to the functions concerned within the suppliers organization. 43.4 Records R e c a r d s o f c o n t r a c t r e v i e w s s h a l l b e m a i n t a i n e d ( s e e 4 . 1 6 ) . NOTE 9 Channels f

27、or communication and interhces with the customers organization in these contract maaers should be e s t a b l i s h e d . 4.4. DESIGN CONTROL ThesmpeofthisAmericanNationalStandarddoesnot include quality-system requirements for design control. This subclause is included to align the clause numbering

28、with ANWASQC Q9001-1994. 4.5 DOCUMENT AND DATA CONTROL 4.5.1 General The supplier shall establish and maintain documented p r o c e d u r e s t o m t K d a l l d o c u m e n t s a n d d a r a t h a t t o the requirements of this American National Standard including, t o the extent applicable, docume

29、nts of sternal origin such as standards and customer drawhgs. NOTE10 Documentsanddatamaybeinthefrmof anytypeofmedia,suchashardcqyoaelectmnkmedia. 4.53 Document and data approval and issue the document sand data shall be re vie wed and f a r adequacy by authorized personnel prior to i s s u e . A mas

30、ter list or equivalent document-control procedure identifying the current revision status of documents shall beestaEdishedandbedyavailabletopre!cludetheuse of invalid and/or obsolete documents. Thiscontrolshallensurethat: a) the pertinent issues of appropriate documents are ;rvailaMeatalllocahswhere

31、operationsessentialto the effective functioning of the quality system are per- fwmed; b) invalid and/or obsolete documents are promptly removedfromallpointsofisflleoruse,orothenvise assuradagainstunintendeduse; c) any obsolete documents retained for legal and/or bledge-pxeservation purposes are suit

32、ably identi- fied. 453 Document and data changes Changes t o documents and data shall be reviewed and approved by the Same functions/organizations that per- formed the original m i e w and approval, unless specif- cally designated otherwise. The designated functions/ organizations shall ha% access t

33、o pertinent backgmuml infrmationuponwhichtobasetheirreviewandapproval. where practicable, the n a t m of the change shall be iden- hified in the document o r the appropriate attachments. 4.6 PURCHASING IhescopeofthisAmericanNationalStandarddoesnot Mude quality-system requirements for purchasing. Thi

34、s subclause is included t o align the clause numbering with ANWASQC Q9001-1994. 4.7 CONTROL OF CUSTOMER-SUPPLIED PRODUCT The supplier shall establish and maintain documented procedures for the control of verification, storage, and maintenance o f customer-supplied product pmvided f a r incorporation

35、intotheproductorforrelatedactiv- ities.Anysuchpxuductthatislost,damaged,orisother- wiseunsuitableioruseshallberecordedandreportedto the customer (see 4 . 1 6 ) . oftheresponsibtopruvideacceptaMeproduct. 4.8 PRODUCT IDENTIFICATION AND TRACEABILITY Where and to the extent that traceability is a specif

36、ied requirement,thesupplkrshallestabl b) identify all inspection, measuring, and test equipment that can affect Et quality, and calibrate and adjust them at prescribed intervals, or prior to use, against certified equipment having a known valid dationship to internationally or nationally recognized

37、standards. Wherenosvchstandardsexist,thebasisusedfwcali- bration shall be documented; c) define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identicahn, loca- fion, frequency of checks, check method, acceptance cri

38、teria, and the action to be taken when results are d) identify inspection, measuring, and test equipment with a suitable indicator or approved identification fecord to e) maintain calibrath records fw i n - , measuring, and test equipment (see 4.16); f) assess and document the validity of previous i

39、nspec- t i o n a n d t e s t r e s u l t s w h e n i n s p e c t i o n , m e a s u r i n g , o r t e s t equipment is found to be out of calibration; g) ensure that the environmental conditions are suitable for the calibrations, inspections, measurements, and h)ensurethatthehandling,preservation,and

40、storageof Unsatisfactory; tfstsbeiicarriedout; i n s p e c t i o n , measmring, and test equipment is such that theaccuracyandfitnesforusearemaintain safeguard inspection, measuring, and W E a c i l i t i e s , includ- ingbothtestandtestsoftware,fromjust- ments which would indidate the calibration s

41、 e t t i n g . Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:47:36 MDTNo reproduction or networking permitted without license from IHS -,-,- AS4C 49003 94 W 0759506 000L3b5 84b ANSI/ASQ

42、C Q9003-1994 NOTE 12 The metrological confirmation system for measuring equipment gi=n in IS0 10012 may be used forguidance. 4.12 INSPECTION AND TEST STATUS Theinspectionandteststatusofproductshallbeidenti- fied by suitable means, which indicate the conformance or noncmfommofproductwithregardtoinspe

43、ctionand tests p e r f o r m e d . The ident on the nonconfrmities, submitted Ex management review (see 4.1.3). 4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION, AND DELIVERY 4.15.1 General The supplier shall establish and maintain documented procedures for handling, storage, p a c k a g i n g , pres

44、ervation, b) debmine and implement appopriate correctiw action c) ensue that devant information on the actions taken is and delivery o f completed product after 6nal inspection and test. 4.15.2 Handling The supplier shall provide methods of handling product that prewnt damage o r deterioration. 4.15

45、3 Storage Thesuppliershallusedesignatedstorageareasorstock moms to prevent damage or deterioration of product, pending delivery. Appropriate methods for authorizing receipttoanddispatchsllchsuchshallbestipulated. In order to detect deterioration, the condition of product in shallbeassessedatappropri

46、ateintervals. 4.15.4 Packaging The supplier shall control packing, packaging, and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements. 4.15.5 Preservation The supplier shall apply appropriate methods for F r - vation and segregation o

47、f product when the product is under the suppliers conml. 4.15.6 Delivery Thesupplierarrangeforthepmtectionofthequality o f product after final inspection and test. Where contrac- tually specified, this protection shall be extended to include to destinaton. 4.16 CONTROL OF QUALITY RECORDS Thesuiersha

48、llestablishandtainmbdof priate quality records t o demonstrate conhrmance of the fmished product to specified requirements and the efec- tiwaperationoftheq*system. Quality records shall be legible and identifiable to the productinvolwi.Qualityrecordsthatsubstantiakconfor- manceofthefinishedplroductwiththespecSedrequie- ments and the effective operation of the quality system shallberetainedforanagreedperiodandmadeavailable on request. NOTE13 Recordsmaybeintheformofanytypeof media, such as hard copy o r electronic media. 5 Copyright American Society for Quality Provid

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