Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry
API Specification Q1, Ninth Edition, June 2013
Effective Date: June 1, 2014
API Spec Q1, 9th Edition 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 API Spec Q1.
The requirements of API Spec Q1 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 API Spec Q1 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. API Spec Q1 may be used either in conjunction with or independent of other industry-specified documents.
API Spec Q1 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.
API Spec Q1 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 API Spec Q1
The goal of API Spec Q1, 9th Edition is to provide the minimum requirements for the development of a quality managementsystem that 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 API Spec Q1 to imply uniformity in the structure of qualitymanagement systems or uniformity of documentation.
Applicability of API Specification Q1 and API Specification Q2
API Spec Q1 establishes the API quality system requirements necessary for organizations to consistently andreliably manufacture products in accordance with API or other specifications for use in the petroleum and natural gasindustry. API Spec Q1 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 when a location has been licensed 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 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. API Spec Q2 applies to service-related activities in oil and gas well construction, intervention,production, and abandonment, as well as equipment repair/maintenance.
API Spec Q2 does not apply to the APIMonogram Program or any product that is identified by license as eligible for marking with the API Monogram.
Scope of API Spec Q1, 9th Edition
API Spec Q1 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.
API Spec Q1, 9th edition 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 API Spec Q1, no claims to exclusion of those activities are permitted. Where any requirement of API Spec Q1 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;
- 18.104.22.168, Servicing;
- 22.214.171.124, 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 API Spec Q1 are in alignment with the section requirements and format of document used for the provision of services and use of service related product (API Spec Q2). Information marked “NOTE” are not requirements but are provided for guidance in understanding or clarifying the associated requirement.