1、Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas IndustryAPI SPECIFICATION Q1NINTH EDITION, JUNE 2013EFFECTIVE DATE: JUNE 1, 2014ERRATA, FEBRUARY 2014 ERRATA 2, MARCH 2014ADDENDUM 1, JUNE 2016Special NotesAPI publications nece
2、ssarily address problems of a general nature. With respect to particular circumstances, local,state, and federal laws and regulations should be reviewed.Neither API nor any of APIs employees, subcontractors, consultants, committees, or other assignees make any war-ranty or representation, either exp
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9、or the violation of any authorities having jurisdiction with which this publication mayconflict.API publications are published to facilitate the broad availability of proven, sound engineering and operating prac-tices. These publications are not intended to obviate the need for applying sound engine
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13、uteForewordNothing contained in any API publication is to be construed as granting any right, by implication or otherwise, for themanufacture, sale, or use of any method, apparatus, or product covered by letters patent. Neither should anythingcontained in the publication be construed as insuring any
14、one against liability for infringement of letters patent.Shall: As used in a standard, “shall” denotes a minimum requirement in order to conform to the specification.Should:As used in a standard, “should” denotes a recommendation or that which is advised but not required in orderto conform to the sp
15、ecification.This standard shall become effective on the date printed on the cover but may be used voluntarily from the date ofdistribution.This document was produced under API standardization procedures that ensure appropriate notification andparticipation in the developmental process and is designa
16、ted as an API standard. Questions concerning theinterpretation of the content of this publication or comments and questions concerning the procedures under whichthis publication was developed should be directed in writing to the Director of Standards, American PetroleumInstitute, 1220 L Street, NW,
17、Washington, DC 20005. Requests for permission to reproduce or translate all or any partof the material published herein should also be addressed to the director.Generally, API standards are reviewed and revised, reaffirmed, or withdrawn at least every five years. A one-timeextension of up to two yea
18、rs may be added to this review cycle. Status of the publication can be ascertained from theAPI Standards Department, telephone (202) 682-8000. A catalog of API publications and materials is publishedannually by API, 1220 L Street, NW, Washington, DC 20005.Suggested revisions are invited and should b
19、e submitted to the Standards Department, API, 1220 L Street, NW,Washington, DC 20005, standardsapi.org.iiiContentsPage1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Normati
20、ve References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Terms, Definitions, and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21、. 13.1 Terms and Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.2 Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
22、. . . . . . . . . . . . . . . . . . 44 Quality Management System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44.1 Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23、 . . . . . . . . . . . . . . . . . 44.2 Management Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54.3 Organization Capability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24、. . . . . . . . . . . . . . . . . . . . . . . . . . . . 64.4 Documentation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74.5 Control of Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Product Realization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85.1 Contract Review . . . . . . . . . . . . . . . . . . .
26、 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85.2 Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95.3 Risk Assessm
27、ent and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95.4 Design and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105.5 Con
28、tingency Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125.6 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
29、 . . . . . . . . . . 125.7 Production and Servicing Provision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145.8 Control of Testing, Measuring, and Monitoring Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
30、. . . . 185.9 Product Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195.10 Control of Nonconforming Product. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
31、 . . . . . . . . . . . . . 205.11 Management of Change (MOC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216 Quality Management System Monitoring, Measurement, Analysis, and Improvement . . . . . . . . . . . . . . 216.1 Gene
32、ral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216.2 Monitoring, Measuring, and Improving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
33、. . . . . . . 226.3 Analysis of Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236.4 Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
34、. . . . . . . . . . . . . . . . . . . . . . . . . 236.5 Management Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Annex A (informative) Use of API Monogram by Licensees . . . . . . . . . . . . . . . .
35、 . . . . . . . . . . . . . . . . . . . . . . . . . 26Annex B (informative) Cross-reference from API Q1, 9th Edition to API Q1, 8th Edition . . . . . . . . . . . . . . . . . . 29Annex C (informative) Cross-reference from API Q1, 8th Edition to API Q1, 9th Edition . . . . . . . . . . . . . . . . . . 4
36、0Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47vIntroductionThis specification has been developed to address quality management systems for organizations that manufacturep
37、roducts or provide manufacturing-related services under a product specification for use in the petroleum and naturalgas industry. It defines the fundamental quality management system requirements for those claiming conformity to therequirements of this specification.The requirements of this specific
38、ation are consistent with those of other quality management system documents (e.g.API Q2). The requirements are structured in a way to minimize the likelihood of nonconformity. While this specificationmay include some elements of other management systems (such as those particular to environmental ma
39、nagement,occupational health and safety management, financial management, or risk management), it does not include allrequirements specific to those systems. This specification may be used either in conjunction with or independent ofother industry-specified documents.This specification can be used b
40、y internal and external parties, including certification bodies, to assess theorganizations ability to meet customer, statutory, and regulatory requirements applicable to the product and theorganizations own requirements.This specification promotes the integration of a process approach into the appl
41、ication of specific sections whendeveloping, implementing, and improving the effectiveness of a quality management system. This provides forcontinuous control over the stated requirements, as well as facilitating the overlap of processes. For an organization to function effectively, it has to determ
42、ine and manage numerous linked activities. An activity thattransforms inputs into outputs can be considered a process. Process activities include determination of needsthroughout the organization, provision of resources and product realization, identification of the proper sequence ororder in a seri
43、es of activities, monitoring and measuring the effectiveness of the activities performed, and applyingchanges or corrections to those activities as needed. Goal of the DocumentThe goal of this specification is to provide the minimum requirements for the development of a quality managementsystem that
44、 provides for continual improvement, emphasizes defect prevention, and strives to minimize variation andwaste from manufacturing organizations. It is designed to promote reliability in the manufacturing sector of thepetroleum and natural gas industry. It is not the intent of this specification to im
45、ply uniformity in the structure of qualitymanagement systems or uniformity of documentation.Applicability of API Specification Q1 and API Specification Q2 This specification establishes the API quality system requirements necessary for organizations to consistently andreliably manufacture products i
46、n accordance with API or other specifications for use in the petroleum and natural gasindustry. This specification is also applicable to, and sets requirements for, all organizations desiring to acquire andmaintain a license to use the API Monogram and applies at all times within the organization wh
47、en a location has beenlicensed by the API Monogram Program. API Q1 applies to those activities that otherwise may be considered aservice (such as heat treatment, threading, or testing) if these activities or the results of these activities are identifiedas an API monogrammable product under any appl
48、icable API product specification in the API Monogram Program.API Q2 (Specification for Quality Management System Requirements for Service Supply Organizations for thePetroleum and Natural Gas Industries) establishes the API quality system requirements necessary for service supplyorganizations to con
49、sistently and reliably provide services that meet customer, legal, and other applicablerequirements. This specification applies to service-related activities in oil and gas well construction, intervention,production, and abandonment, as well as equipment repair/maintenance. This specification does not apply to the APIMonogram Program or any product that is identified by license as eligible for marking with the API Monogram.vii1 Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry 1 Scope This specification es
