Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry

API SPECIFICATION Q1 NINTH EDITION, JUNE 2013

ERRATA, FEBRUARY 2014

ERRATA 2, MARCH 2014

ERRATA 3, OCTOBER 2019

ADDENDUM 1, JUNE 2016

ADDENDUM 2, MAY 2018

EFFECTIVE DATE: MAY 1, 2019

Date of Issue: October 2019

Affected Publication: API Specification Q1, Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry, 9th Edition, June 2013

Errata 3

Page 16, Section 5.7.2: The bulleted list shall be updated as follows:

The product quality plan required by contract shall address each of the following as a minimum:

1. description of the product to be manufactured;

2. required processes and documentation, including required inspections, tests, and records, for conformance with requirements;

3. identification and reference to control of outsourced activities;

4. identification of each procedure, specification, or other document referenced or used in each activity; and

5. identification of the required hold, witness, monitor, and document review points.

Special Notes

API publications necessarily 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 API's employees, subcontractors, consultants, committees, or other assignees make any warranty or representation, either express or implied, with respect to the accuracy, completeness, or usefulness of the information contained herein, or assume any liability or responsibility for any use, or the results of such use, of any information or process disclosed in this publication. Neither API nor any of API's employees, subcontractors, consultants, or other assignees represent that use of this publication would not infringe upon privately owned rights.

Classified areas may vary depending on the location, conditions, equipment, and substances involved in any given situation. Users of this specification should consult with the appropriate authorities having jurisdiction.

Users of this specification should not rely exclusively on the information contained in this specification. Sound business, scientific, engineering, and safety judgment should be used in employing the information contained herein. API is not undertaking to meet the duties of employers, service providers, or suppliers to warn and properly train and equip their employees, and others exposed, concerning health and safety risks and precautions, nor undertaking their obligations to comply with authorities having jurisdiction.

Information concerning safety and health risks and proper precautions with respect to particular materials and conditions should be obtained from the employer, the service provider or supplier of that material, or the material safety datasheet.

API publications may be used by anyone desiring to do so. Every effort has been made by the Institute to assure the accuracy and reliability of the data contained in them; however, the Institute makes no representation, warranty, or guarantee in connection with this publication and hereby expressly disclaims any liability or responsibility for loss or damage resulting from its use or for the violation of any authorities having jurisdiction with which this publication may conflict.

API publications are published to facilitate the broad availability of proven, sound engineering and operating practices. These publications are not intended to obviate the need for applying sound engineering judgment regarding when and where these publications should be utilized. The formulation and publication of API publications is not intended in any way to inhibit anyone from using any other practices.

Any manufacturer marking equipment or materials in conformance with the marking requirements of an API standard is solely responsible for complying with all the applicable requirements of that standard. API does not represent, war- rant, or guarantee that such products do in fact conform to the applicable API standard.

All rights reserved. No part of this work may be reproduced, translated, stored in a retrieval system, or transmitted by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Contact the Publisher, API Publishing Services, 1220 L Street, NW, Washington, DC 20005.

Copyright © 2013 American Petroleum Institute

Foreword

Nothing contained in any API publication is to be construed as granting any right, by implication or otherwise, for the manufacture, sale, or use of any method, apparatus, or product covered by letters patent. Neither should anything contained in the publication be construed as insuring anyone 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 order to conform to the specification.

This standard shall become effective on the date printed on the cover but may be used voluntarily from the date of distribution.

This document was produced under API standardization procedures that ensure appropriate notification and participation in the developmental process and is designated as an API standard. Questions concerning the interpretation of the content of this publication or comments and questions concerning the procedures under which this publication was developed should be directed in writing to the Director of Standards, American Petroleum Institute, 1220 L Street, NW, Washington, DC 20005. Requests for permission to reproduce or translate all or any part of 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-time extension of up to two years may be added to this review cycle. Status of the publication can be ascertained from the API Standards Department, telephone (202) 682-8000. A catalog of API publications and materials is published annually by API, 1220 L Street, NW, Washington, DC 20005.

Suggested revisions are invited and should be submitted to the Standards Department, API, 1220 L Street, NW, Washington, DC 20005, standards@api.org.

iii

Contents

Page

1. Scope 1

2. Normative References 1

3. Terms, Definitions, and Abbreviations 1

   1. Terms and Definitions 1

   2. Abbreviations 3

4. Quality Management System Requirements 4

   1. Quality Management System 4

   2. Management Responsibility 5

   3. Organization Capability 6

   4. Documentation Requirements 7

   5. Control of Records 8

5. Product Realization 8

   1. Contract Review 8

   2. Planning 9

   3. Risk Assessment and Management 9

   4. Design and Development 10

   5. Contingency Planning 12

   6. Purchasing 12

   7. Production and Servicing Provision 14

   8. Control of Testing, Measuring, and Monitoring Equipment 18

   9. Product Release 19

   10. Control of Nonconforming Product 19

   11. Management of Change (MOC) 20

6. Quality Management System Monitoring, Measurement, Analysis, and Improvement 21

   1. General 21

   2. Monitoring, Measuring, and Improving 21

   3. Analysis of Data 22

   4. Improvement 22

   5. Management Review 23

Annex A (informative) Use of API Monogram by Licensees 25

Annex B (informative) Cross-reference from API Q1, 9th Edition to API Q1, 8th Edition 29

Annex C (informative) Cross-reference from API Q1, 8th Edition to API Q1, 9th Edition 40

Bibliography 47

v

Introduction

This specification has been developed to address quality management systems for organizations that manufacture products or provide manufacturing-related services under a product specification for use in the petroleum and natural gas industry. It defines the fundamental quality management system requirements for those claiming conformity to the requirements of this specification.

The requirements of this specification 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 specification may include some elements of other management systems (such as those particular to environmental management, occupational health and safety management, financial management, or risk management), it does not include all requirements specific to those systems. This specification may be used either in conjunction with or independent of other industry-specified documents.

This specification can be used by internal and external parties, including certification bodies, to assess the organization‘s ability to meet customer, statutory, and regulatory requirements applicable to the product and the organization‘s own requirements.

This specification promotes the integration of a process approach into the application of specific sections when developing, implementing, and improving the effectiveness of a quality management system. This provides for continuous control over the stated requirements, as well as facilitating the overlap of processes.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity that transforms inputs into outputs can be considered a process. Process activities include determination of needs throughout the organization, provision of resources and product realization, identification of the proper sequence or order in a series of activities, monitoring and measuring the effectiveness of the activities performed, and applying changes or corrections to those activities as needed.

Goal of the Document

The goal of this specification is to provide the minimum requirements for the development of a quality management system that provides for continual improvement, emphasizes defect prevention, and strives to minimize variation and waste from manufacturing organizations. It is designed to promote reliability in the manufacturing sector of the petroleum and natural gas industry. It is not the intent of this specification to imply uniformity in the structure of quality management 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 and reliably manufacture products in accordance with API or other specifications for use in the petroleum and natural gas industry. This specification is also applicable to, and sets requirements for, all organizations desiring to acquire and maintain a license to use the API Monogram and applies at all times within the organization when a location has been licensed by the API Monogram Program. API Q1 applies to those activities that otherwise may be considered a service (such as heat treatment, threading, or testing) if these activities or the results of these activities are identified as an API monogrammable product under any applicable API product specification in the API Monogram Program.

API Q2 (Specification for Quality Management System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industries) establishes the API quality system requirements necessary for service supply organizations to consistently and reliably provide services that meet customer, legal, and other applicable requirements. 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 API Monogram Program or any product that is identified by license as eligible for marking with the API Monogram.

Specification for Quality Management System Requirements for Manufacturing Organizations for the

Petroleum and Natural Gas Industry

1. Scope

   
   

   This specification establishes the minimum quality management system requirements for organizations that manufacture products or provide manufacturing-related processes under a product specification for use in the petroleum and natural gas industry.

   
   

   This specification specifies the requirements of a quality management system for an organization to demonstrate its ability to consistently provide reliable products and manufacturing-related processes that meet customer and legal requirements.

   
   

   If an organization performs activities addressed by this specification, no claims to exclusion of those activities are permitted. Where any requirement of this specification cannot be applied due to the nature of an organization, the requirement can be considered for exclusion. Where exclusions are made, the basis for claiming exclusions is to be identified. Furthermore, such exclusions cannot affect the organization's ability, or responsibility, to provide products and related servicing that meet customer and applicable regulatory requirements. Exclusions are limited to the following sections:

   
   

   • 5.4, Design and Development;

     
     

   • 5.7.1.2, Servicing;

     
     

   • 5.7.1.5, Validation of Processes for Production and Servicing;

     
     

   • 5.7.5, Customer-supplied Property;

     
     

   • 5.8, Control of Testing, Measuring, and Monitoring Equipment.

   
   

   The quality management system requirements specified in this specification are in alignment with the section requirements and format of document used for the provision of services and use of service- related product (API Q2). Information marked “NOTE” are not requirements but are provided for guidance in understanding or clarifying the associated requirement.

   
   

2. Normative References

   
   

   The following referenced document is indispensable for the application of this document. For this dated reference, only the edition cited applies.

   
   

   ISO 9000:2005, Quality management systems—Fundamentals and vocabulary

   
   

3. Terms, Definitions, and Abbreviations

3.1 Terms and Definitions

For the purposes of this specification, the terms and definitions given in ISO 9000 and the following shall apply. When identical terms are defined in ISO 9000 and this specification, the following definitions shall apply.

3.1.1

acceptance criteria

Specified limits of acceptability applied to process or product characteristics.