API Q1第九版符合性矩阵表FM-186 Q1 9th Conformity Matrix_Rev 2

1、API Spec Q1 9th Edition Conformity MatrixPage 1 of 30FM-186 Rev 2 Effective 7/16/2013Company:Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed inyour Quality Management System Documentation

2、. If you are applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes foreach requirement being excluded. See Section 1 of Q1 for a list of allowable exclusions. Facility Name/ID:Date:Reference: API Spec Q1 9th Ed NOTE: Areas shaded in blue are new API Spec Q1 9th E

3、dition requirements.ParagraphNumberISO9001:2008ReferenceReferenceRequirementTier 1 (Quality Manual)Document Number/ID, Revision Level,Document Description Tier 2 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description Tier 3 (Procedure/Work Instruction)Document Number/ID,

4、 Revision Level,Document Description 4Quality Management System Requirements4.1Quality Management System4.1.14.1; 4.1c; 7.1;8.5.1GeneralThe organization shall establish, document, implement,and maintain at all times a quality management system forall products and servicing provided for use in the pe

5、troleumand natural gas industry. The organization shall measurethe effectiveness and improve upon the qualitymanagement system in accordance with the requirementsof this specification.4.1.25.1b; 5.3a;5.3b; 5.3c; 5.3dQuality PolicyThe organizations policy for its commitment to quality shallbe defined

6、, documented, and approved by topmanagement. The organizations top management shallreview the quality policy to ensure that it is appropriate tothe organization, is the basis for the development ofquality objectives (see 4.1.3), and is communicated,understood, implemented, and maintained at all rele

7、vantfunctions and levels within the organization. The policyshall include a commitment to comply with requirementsand continually improve the effectiveness of the qualitymanagement system.4.1.35.1c; 5.4.1;7.1aQuality ObjectivesManagement, with approval from top management, shallensure that quality o

8、bjectives, including those needed tomeet product and customer requirements, are establishedat relevant functions and levels within the organization.The quality objectives shall be measurable and consistentwith the quality policy.4.1.44.1a; 7.1PlanningManagement shall ensure that:a) criteria and meth

9、ods needed for the operation andcontrol of all quality management system processes aredetermined, managed, and effective; and5.4.2ab) planning of the quality management system is carriedout in order to meet the requirements of this specification.4.1.5CommunicationAPI Spec Q1 9th Edition Conformity M

10、atrixPage 2 of 30FM-186 Rev 2 Effective 7/16/2013Company:Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed inyour Quality Management System Documentation. If you are applying for exclusions

11、 to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes foreach requirement being excluded. See Section 1 of Q1 for a list of allowable exclusions. Facility Name/ID:Date:Reference: API Spec Q1 9th Ed NOTE: Areas shaded in blue are new API Spec Q1 9th Edition requirements.ParagraphNumberI

12、SO9001:2008ReferenceReferenceRequirementTier 1 (Quality Manual)Document Number/ID, Revision Level,Document Description Tier 2 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description Tier 3 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description

13、 4.1.5.15.5.3InternalManagement shall ensure that appropriate communicationprocesses are established within the organization and theeffectiveness of the quality management system iscommunicated.5.1aThe organization shall establish processes to ensure that:a) importance of meeting customer, legal, an

14、d otherapplicable requirements is communicated at relevantfunctions within the organization; andNR in 9001*b) results of analysis of data (see 6.3) are communicated atrelevant levels and functions within the organization.4.1.5.25.2; 7.2.3ExternalThe organization shall determine and implement a proce

15、ssfor communicating with external organizations, includingcustomers, to ensure requirements are understoodthroughout contract execution and product realization. Thecommunication process shall address:7.2.3ba) execution of inquiries, contracts, or order handling andamendments (see 5.1);7.2.3ab) provi

16、sion of product information, including productnonconformities identified after delivery to the customer(see 5.10.4);7.2.3cc) feedback and customer complaints (see 6.2.1); andNR in 9001*d) when required by contract, providing informationrequired by product quality plans and subsequent changesto those

17、 plans (see 5.7.2).4.2Management Responsibility4.2.14.1d; 5.1; 5.1e GeneralTop management shall ensure the availability of resourcesessential to establish, implement, maintain, and improvethe quality management system.Management shall provide evidence of its commitment tothe development and implemen

18、tation of the qualitymanagement system and continually improve itseffectiveness by:5.1c a) ensuring that quality objectives are established includingkey performance indicators for use in data analysis; and5.1db) conducting management reviews (see 6.5).API Spec Q1 9th Edition Conformity MatrixPage 3

19、of 30FM-186 Rev 2 Effective 7/16/2013Company:Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed inyour Quality Management System Documentation. If you are applying for exclusions to your QMS

20、, please indicate “Excluded” in the Tier 1/Tier 2 boxes foreach requirement being excluded. See Section 1 of Q1 for a list of allowable exclusions. Facility Name/ID:Date:Reference: API Spec Q1 9th Ed NOTE: Areas shaded in blue are new API Spec Q1 9th Edition requirements.ParagraphNumberISO9001:2008R

21、eferenceReferenceRequirementTier 1 (Quality Manual)Document Number/ID, Revision Level,Document Description Tier 2 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description Tier 3 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description 4.2.25.5.1R

22、esponsibility andAuthorityResponsibilities, authorities, and accountabilities ofpersonnel within the scope of this document shall bedefined, documented, and communicated throughout theorganization.4.235.5.2ManagementRepresentativeTop management shall appoint and maintain a member ofthe organizations

23、 management who, irrespective of otherresponsibilities, shall have responsibility and authority thatincludes:5.5.2aa) ensuring that processes needed for the qualitymanagement system are established, implemented, andmaintained,5.5.2bb) reporting to top management on the performance of thequality mana

24、gement system and any need forimprovement;NR in 9001*c) ensuring initiation of action(s) to minimize the likelihoodof the occurrence of nonconformities (see 6.4.3); and5.5.2cd) ensuring the promotion of awareness of customerrequirements throughout the organization.4.3Organization Capability4.3.16.1;

25、 7.1bProvision ofResourcesThe organization shall determine and allocate the resourcesneeded to implement, maintain, and improve theeffectiveness of the elements of the quality managementsystem.4.3.2Human Resources4.3.2.16.2.2a; 6.2.2b;6.2.2cGeneralThe organization shall maintain a documented procedu

26、refor defining personnel competency and identifying trainingrequirements or other actions to achieve the necessarycompetency of personnel whose responsibilities fall withinthe scope of the quality management system. Theprocedure shall include provisions for determining anddocumenting the effectivene

27、ss of the training or otheractions taken toward the achievement of requiredcompetency.4.3.2.26.2.1PersonnelCompetencePersonnel shall be competent based on the appropriateeducation, training, skills, and experience needed to meetproduct and customer requirements. API Spec Q1 9th Edition Conformity Ma

28、trixPage 4 of 30FM-186 Rev 2 Effective 7/16/2013Company:Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed inyour Quality Management System Documentation. If you are applying for exclusions

29、to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes foreach requirement being excluded. See Section 1 of Q1 for a list of allowable exclusions. Facility Name/ID:Date:Reference: API Spec Q1 9th Ed NOTE: Areas shaded in blue are new API Spec Q1 9th Edition requirements.ParagraphNumberIS

30、O9001:2008ReferenceReferenceRequirementTier 1 (Quality Manual)Document Number/ID, Revision Level,Document Description Tier 2 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description Tier 3 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description

31、NR in 9001*Evidence of the determination of competence of personnelshall be recorded and maintained (see 4.5).4.3.2.36.2.2Training andAwarenessThe organization shall:NR in 9001*a) provide for quality management system training and jobtraining;NR in 9001*b) ensure that customer-specified training and

32、/or customer-provided training, when required, is included in thetraining program;NR in 9001*c) ensure that the frequency and content of training isidentified;6.2.2dd) ensure that its personnel are aware of the relevance andimportance of their activities and how they contribute tothe achievement of

33、the quality objectives; and6.2.2ee) maintain appropriate records of education, training,skills, and experience (see 4.5).4.3.36.3; 6.4Work EnvironmentThe organization shall determine, provide, manage, andmaintain the work environment needed to achieveconformity applicable to the manufacture of the p

34、roduct.Work environment shall include:6.3aa) buildings, workspace, and associated utilities;6.3bb) process equipment and its maintenance (both hardwareand software) (see 5.7.8);6.3cc) supporting services (e.g. transport, communication,information systems); and6.4d) conditions under which work is per

35、formed such asphysical, environmental or other factors.4.4Document Requirements4.4.14.2.1GeneralThe quality management system documentation shallinclude:4.2.1aa) statements of quality policy and quality objectives;4.2.1bb) a quality manual that addresses each requirement of thisspecification and inc

36、ludes:4.3.2.2PersonnelCompetenceAPI Spec Q1 9th Edition Conformity MatrixPage 5 of 30FM-186 Rev 2 Effective 7/16/2013Company:Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed inyour Quality

37、 Management System Documentation. If you are applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes foreach requirement being excluded. See Section 1 of Q1 for a list of allowable exclusions. Facility Name/ID:Date:Reference: API Spec Q1 9th Ed NOTE: Areas shaded i

38、n blue are new API Spec Q1 9th Edition requirements.ParagraphNumberISO9001:2008ReferenceReferenceRequirementTier 1 (Quality Manual)Document Number/ID, Revision Level,Document Description Tier 2 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description Tier 3 (Procedure/Work

39、 Instruction)Document Number/ID, Revision Level,Document Description 4.2.2a1) the scope of the quality management system, includingjustification for any exclusions to specific qualitymanagement system elements (see Section 1);4.1b; 4.2.2c2) a description of the sequence and interaction betweenthe pr

40、ocesses of the quality management system;NR in 9001*3) identification of processes that require validation (see5.7.1.5); and4.2.2b4) reference to documented procedures that control thequality management system processes;4.2.1cc) documented procedures established for the qualitymanagement system;4.2.

41、1d; 7.1bd) documents and records, to ensure the effectiveplanning, operation and control of its processes, andcompliance with specified requirements; andNR in 9001*e) identification of legal, and other applicablerequirements to which the organization claims compliancewhich are needed to achieve prod

42、uct conformity.4.4.2NR in 9001*ProceduresAll procedures referenced within this specification shall beestablished, documented, implemented, and maintainedfor continued suitability.4.4.34.2.3Control ofDocumentsThe organization shall maintain a documented procedurefor the identification, distribution,

43、and control ofdocuments required by the quality management systemand this specification, including required documents of anorigin external to the organization.4.2.3a; 4.2.3bThe procedure shall specify responsibilities for approvaland re-approval and shall identify the controls needed toensure that t

44、he documents required by the qualitymanagement system, including revisions, translations andupdates:4.2.3a; 4.2.3ba) are reviewed and approved for adequacy prior to issueand use,4.2.3cb) identify changes and revision status,4.2.3ec) remain legible and readily identifiable, and4.2.3dd) are available

45、where the activity is being performed.4.4.1GeneralAPI Spec Q1 9th Edition Conformity MatrixPage 6 of 30FM-186 Rev 2 Effective 7/16/2013Company:Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addres

46、sed inyour Quality Management System Documentation. If you are applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes foreach requirement being excluded. See Section 1 of Q1 for a list of allowable exclusions. Facility Name/ID:Date:Reference: API Spec Q1 9th Ed NO

47、TE: Areas shaded in blue are new API Spec Q1 9th Edition requirements.ParagraphNumberISO9001:2008ReferenceReferenceRequirementTier 1 (Quality Manual)Document Number/ID, Revision Level,Document Description Tier 2 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description Tier

48、 3 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description 4.2.3fDocuments of external origin shall be controlled to ensurethat the relevant versions are used and maintained.4.2.3gObsolete documents shall be removed from all points ofissue or use, or otherwise identified

49、to ensure againstunintended use if they are retained for any purpose.NR in 9001*Procedures, work instructions and forms required by thequality management system shall be controlled.4.4.4NR in 9001*Use of ExternalDocuments inProduct RealizationWhen API product or other external specificationrequireme

50、nts, including addenda, errata, and updates, areused in the design or manufacture of the product, theorganization shall maintain a documented procedure forthe integration of these requirements into the productrealization process and any other affected processes.4.54.2.3; 4.2.4Control of RecordsThe o

51、rganization shall maintain a documented procedure toidentify the controls and responsibilities needed for theidentification, collection, storage, protection, retrieval,retention time, and disposition of records. NR in 9001*Records, including those originating from outsourcedactivities (see 5.6.1.6),

52、 shall be established and controlledto provide evidence of conformity to requirements and theorganizations quality management system.4.2.4Records shall remain legible, identifiable, and retrievable.Records shall be retained for a minimum of five years or asrequired by customer, legal, and other appl

53、icablerequirements, whichever is longer.5Product Realization5.1Contract Review5.1.1NR in 9001*GeneralThe organization shall maintain a documented procedurefor the review of requirements related to the provision ofproducts and required servicing.5.1.27.2.1Determination ofRequirementsThe organization

54、shall determine:7.2.1aa) requirements specified by the customer;7.2.1c; 7.2.1db) legal and other applicable requirements; and4.4.3Control ofDocumentsAPI Spec Q1 9th Edition Conformity MatrixPage 7 of 30FM-186 Rev 2 Effective 7/16/2013Company:Instructions Please provide a Tier 1 (Quality Manual) refe

55、rence and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed inyour Quality Management System Documentation. If you are applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes foreach requirement being excluded. See Section

56、 1 of Q1 for a list of allowable exclusions. Facility Name/ID:Date:Reference: API Spec Q1 9th Ed NOTE: Areas shaded in blue are new API Spec Q1 9th Edition requirements.ParagraphNumberISO9001:2008ReferenceReferenceRequirementTier 1 (Quality Manual)Document Number/ID, Revision Level,Document Descript

57、ion Tier 2 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description Tier 3 (Procedure/Work Instruction)Document Number/ID, Revision Level,Document Description 7.2.1b; 7.2.2c) requirements not stated by the customer but considerednecessary by the organization for the provis

58、ion of theproduct.7.2.2Where the customer provides no documented statement ofthe requirements, the customer requirements shall beconfirmed by the organization and records maintained (see4.5).5.1.37.2.2Review ofRequirementsThe organization shall review the requirements related toprovision of products

59、. This review shall be conducted priorto the organizations commitment to deliver product to thecustomer and shall ensure that:7.2.2aa) requirements are identified and documented;7.2.2bb) requirements differing from those previously identifiedare resolved; and7.2.2cc) the organization has the capabil

60、ity to meet thedocumented requirements.7.2.2Where contract requirements are changed, the organizationshall ensure that relevant documents are amended and thatrelevant personnel are made aware of the changedrequirements.7.2.2Records of the results of the review, including resultingactions, shall be m