API SPECIFICATION Q1 TENTH EDITION Quality Management System Requirements

API Q1 Specification for Quality Management System Requirements for Organizations Providing Products for the Petroleum and Natural Gas Industry

The American Petroleum Institute (API) developed API Spec Q1 10th Edition specifically for Organizations Providing Products for the Petroleum and Natural Gas Industry. It’s one of the most prestigious company-based certifications that your organization can obtain to demonstrate its commitment to a sound quality management system. Furthermore, it allows your organization to meet the global demands of an increasingly competitive environment. For starters, ISO 9001:2015 is the basis for most (if not all) of the industry-specific quality management standards. It’s a flexible international standard that outlines the framework and guiding principles for quality management. Achieving ISO certification allows manufacturers to improve the quality of products or services while simultaneously lowering the cost of quality. On the other hand, API Spec Q1 10th Edition structurally deviates from the standard ISO 9001 series, but the results of a compliant quality management system are still the same. API Spec Q1 builds upon the classic structure of the ISO 9001 series by addressing risk and other QMS elements, but takes a different approach to quality management by bringing risk assessment and risk management into the fold. Additionally, there are some other key differences between ISO 9001 and API Q1, including:

• Formalizing employee competency and training
• Reinforcing risk assessment and risk management throughout the standard
• Contingency planning
• Controlling the supply chain
• Preventative maintenance
• Validation of designs
• Change management

API Monogram Licensing Program Requirements Part 1 – General Requirements

1. The information contained herein details the applicable requirements for Organizations seeking approval to use the API Monogram Mark.
2. To obtain and retain an API Monogram license, an Organization must have a documented and functioning quality management system in place that meets both the requirements of API Spec Q1® (Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry), and at least one of the applicable API Product Specifications.
3. Issuance of the license(s) is dependent upon a successful evaluation of the Organization’s quality manual, API Spec Q1 Conformity Matrix and satisfactorily passing an on-site audit of the Organization’s facility and processes by API through its designated auditors. Site audits are required to verify demonstrated capability of the Organization to meet program requirements. Associated audit expenses will be paid by the facility.
4. Review the requirements stated in API Spec Q1 and the applicable API Product Specification(s) for which your Organization is seeking a license. If your Organization feels that its manufacturing processes meet all the stated quality requirements to obtain an API Monogram License for one or more product specifications, please complete and submit the following:
   • API Certification Programs Application If your Organization is seeking one or more API Monogram licenses and/or registrations, this form must be completed and signed.
   • API Monogram License Agreement For each API Product Specification for which you are requesting licensing, a separate License Agreement must be completed and signed. NOTE: The applicant is not allowed to use the API Monogram until all steps in the process have been completed (including satisfactorily passing an on-site audit), the applicant has paid the applicable fees, the applicant has agreed to comply with all terms and conditions of the agreement, and signed the License Agreement.
   • Licensing Information Form: For each API Product Specification for which you are requesting licensing, a separate Licensing Information Form must be completed. Please submit the appropriate forms as applicable to the Product Specification(s).

If you do not have a Licensing Information Form for any of the API Product Specifications listed, you may obtain one online at website at www.api.org/certifications/monogram/documents/licensing-forms.cfm.

To request a form, please contact API Certification Programs:

API Certification Programs 1220 L Street, NW Washington, DC 20005-4070, USA

Phone: (+1) 202-962-4791 Fax: (+1) 202-682-8070

Email: certification@api.org Web: www.api.org/monogram

Do not submit a Licensing Information Form(s) without a completed API Monogram License Agreement(s) (see Part 4 – API Monogram License Agreement), your API Certification Programs Application, your Quality Manual, API Spec Q1 Conformity Matrix and License Fee. For instructions on where to send your submission, see Part 6 – Fee Schedule.

Introductions

API Q1 has been created to deal with quality management systems for organizations in the petroleum and natural gas sector. It lays out the essential requirements for organizations claiming compliance with API Q1. It can be used by organizations providing products for use in this industry. API Q1 defines “product” as the output intended for customers. Earlier versions only applied to organizations making physical products, providing services for physical products, or involved in manufacturing processes. The aim of API Q1’s requirements is to reduce the chance of errors. While API Q1 might include some aspects of other management systems, it doesn’t cover all their specific requirements. It can be used alongside other industry guidelines. Both internal and external parties, including certification bodies, can use API Q1 to check if an organization meets customer, legal, and its own requirements. API Q1 encourages integrating a process approach when developing, implementing, and improving the effectiveness of a quality management system. This ensures continuous control over requirements and facilitates the overlap of processes. To function effectively, an organization must manage various connected activities. Any activity that turns inputs into outputs can be seen as a process. These process activities involve identifying needs, providing resources, realizing products, sequencing activities, monitoring effectiveness, and making necessary changes or corrections. API Spec Q1 10th Edition addresses the following types of organizations in the petroleum and natural gas industry.

• manufacturing
• engineering/design
• physical product realization activity providers such as those performing:
• welding
• heat treating
• coating/plating
• machining
• inspection
• testing
• servicing
• physical product-related activity providers such as those performing:
• distribution
• logistics
• software development

The verbal forms used to express the provisions in this document are as follows.

Shall: As used in a standard, “shall” denotes a minimum requirement to conform to the standard.
Should: As used in a standard, “should” denotes a recommendation or that which is advised but not required to conform to the standard.
May: As used in a standard, “may” denotes a course of action permissible within the limits of a standard.
Can: As used in a standard, “can” denotes a statement of possibility or capability

Goal of API QI

The aim is to establish the essential criteria for creating a quality management system that encourages dependability and allows for ongoing enhancements. The focus is on preventing errors, reducing differences, and avoiding inefficiencies. This specification does not aim to suggest that all quality management systems should have the same structure or documentation.

Structure of API Q1: 10^th Edition

1.Scope

This section review section 1, scope, of the API Q1 10^th edition specification. This specification established the minimum quality management system requirements for organizations that provide products for use in the petroleum and natural gas industry..

2.0 Normative references

The text makes reference to API Q1, and some or all of its content serves as requirements for API Q1. For dated references, only the tenth edition mentioned is applicable. For undated references, the most recent edition (including any addenda) is applicable.

ISO1 9000:2015, Quality management systems—Fundamentals and vocabulary

3.0 Terms, Definition and Abbreviations

3.1 Terms and Definition

For the purpose of API Q1: 10^th Edition, the terms and definitions given in ISO 9000 and the following shall apply:

3.1.1 acceptance criteria: Specified limits of acceptability applied to process or product characteristics.

3.1.2 acceptance inspection: Demonstration through monitoring or measurement that the product conforms to specified requirements.

3.1.3 calibration: Process of comparison to a standard of known accuracy, comparison of results against TMMDE (testing, measuring, monitoring, and detection equipment) acceptance criteria, and, if applicable, making needed adjustment.

NOTE Calibration of non-adjustable equipment can be referred to as verification.

3.1.4 compliance: Act of satisfying (verb) or the status of having satisfied (noun) legal requirements.

3.1.5 critical: Deemed by the organization, product specification, or customer to be of significant importance and requiring specific action.

3.1.6 delivery: Point in time at which the agreed transfer of ownership takes place.

3.1.7 design acceptance criteria (DAC): Requirements applied to characteristics or combinations of those characteristics, of materials, products, or components to achieve conformity to the specified design requirements and/or required design performance.
NOTE 1 DAC can be equal to MAC.
NOTE 2 Required design performance is often stated in technical specifications.

3.1.8 design validation: Process of proving a design by testing to demonstrate that the product conforms to design requirements and performs as intended.
NOTE Design validation can include one or more of the following (this is not an all-inclusive list):
a) prototype tests,
b) functional and/or operational tests,
c) tests specified by industry standards and/or regulatory requirements,
d) field performance tests and reviews.

3.1.9 design verification: Process of examining design outputs to determine conformity with specified requirements.
NOTE Design verification activities can include one or more of the following (this is not an all-inclusive list):
a) confirming the accuracy of design results through the performance of alternative calculations,
b) review of design output documents resulting from design activities,
c) comparing new designs to similar proven designs.

3.1.10 key performance indicator (KPI): Quantifiable measure that an organization uses to gauge or compare performance.

3.1.11 legal requirement: Statutory or regulatory requirements.

3.1.12 management [noun]:
A person or group of persons with authority and responsibility for the conduct and control of all or part of an organization.
NOTE For some organizations, top management (see ISO 9000) and management are the same.

3.1.13 manufacturing acceptance criteria (MAC): Requirements applied to characteristics or combinations of those characteristics, of materials, products, or components to achieve conformity to DAC and other product manufacturing requirements.
NOTE 1 MAC can be equal to DAC.
NOTE 2 For services, product realization can be substituted for product manufacturing.

3.1.14 outsource [outsourced activity]: Function or process that is performed by an external supplier on behalf of the organization.

3.1.15 preventive maintenance: Systematic servicing of equipment, machines and/or facilities for the purpose of maintaining a satisfactory operating condition.

3.1.16 procedure: Organization’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements.
NOTE 1 This definition was previously identified as a “control feature” in earlier editions of this specification.
NOTE 2 A procedure can be in many forms, e.g. work instructions, flow diagrams and manuals.

3.1.17 product: Output of an organization intended to be provided to a customer.
NOTE As used in this document, the term ‘product’ can include, but is not limited to, hardware, software, production activities, or product related activities such as: servicing, storage, distribution, and logistics.

3.1.18 product realization: Set of interrelated or interacting activities (processes) necessary to provide product.

3.1.19 remote assessment: Assessment conducted by person(s) not physically present at the location being assessed.

3.1.20 risk: A situation or circumstance that has both a probability of occurring and a potentially negative consequence.

3.1.21 servicing: Maintenance, adjustment, and/or repair performed on a product after delivery and/or on-site installation.

3.1.22 supply chain: Suppliers and associated sub-supplier(s) required for product realization.

3.2 Abbreviations

For the purposes of this specification, the following abbreviations shall apply.

DAC: design acceptance criteria
ITP: inspection test plan
KPI: key performance indicator
MAC: manufacturing acceptance criteria
MOC: management of change
MPS: manufacturing process specification
PCP: process control plan
QAP: quality activity plan
QMS: quality management system
QP: quality plan
TMMDE: testing, measuring, monitoring, and detection equipment

4 Quality Management System Requirements

4.1 Quality Management System

4.1.1 General

The organization must always plan, set up, record, put into action, and keep up a quality management system in line with this specification’s demands for the product within the organization’s defined scope. Additionally, the organization needs to assess and enhance the effectiveness of this quality management system.

4.1.2 Quality Policy

The organization’s commitment to quality must be clearly outlined, documented, reviewed, and endorsed by top management. The quality policy should:

1. Align with the organization’s goals and guide its strategic path,
2. Serve as a foundation for setting quality objectives,
3. Be effectively communicated, understood, put into practice, and upheld within the organization,
4. Be accessible to relevant stakeholders as determined by the organization, and
5. Include a pledge to meet requirements and consistently enhance the efficiency of the quality management system.

4.1.3 Quality Objectives

Quality objectives, including those necessary to fulfill product and customer needs, must be set at appropriate functions and levels within the organization by management, with approval from top management. These objectives should be measurable, communicated, and aligned with the quality policy.

4.1.4 Planning the Quality Management System

4.1.4.1 General

The planning of the quality management system must be conducted. While planning, the organization must specify the scope of the quality management system, including the products covered and any limitations or exclusions. The organization must recognize external and internal factors relevant to the organization’s long-term objectives and goals. Identify relevant stakeholders and their requirements for the quality management system. The organization must establish the sequence and interaction between the processes of the quality management system. The organization must determine and oversee the criteria and methods necessary for the efficient operation and control of quality management system processes. The organization must set quality objectives, detailing actions, resources, responsibilities, timeframes, and methods for monitoring and evaluation. It must address identified risks. It addresses opportunities for improvement. It must identify key personnel involved in the quality management system.

4.1.4.2 Exclusions

If an organization carries out activities covered by API Q1, whether internally or through outsourcing, it cannot claim exclusion of those activities. Excluding certain activities should not impact the organization’s capability or obligation to deliver products that meet customer and legal standards. If any exclusions are made, the reasoning behind them must be documented. When an organization performs activities addressed by this specification, no claims to exclusion of those activities are permitted. When exclusions are permitted, they are limited to the following sections:

API Q1 Clauses	Sections
5.4	Design
5.6.4	Validation of Processes
5.6.7	Externally Owned Property
5.8	Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)

4.1.5 Communication

4.1.5.1 Internal

The organization must set up internal communication processes. These processes should involve communicating, at appropriate levels and functions within the organization the significance of meeting customer, legal, and other relevant requirements; and the outcomes of data analysis.

4.1.5.2 External Communications

The organization must create and put into action a procedure for communicating with external entities, including customers. This process should cover:

1. Handling inquiries, contracts, or order processing, and any modifications;
2. Understanding and meeting requirements during contract execution and product creation;
3. Providing product details, including any non-conformities;
4. Addressing feedback and customer complaints;
5. Sharing quality plans and any subsequent adjustments; and
6. Communicating changes and associated risks.

4.2 Management Responsibility

4.2.1 General

Top management must show leadership and dedication to setting up, implementing, maintaining, and enhancing the quality management system by endorsing the creation of quality objectives at relevant functions and levels within the organization. Top management must allocate necessary resources for the quality management system. These resources can encompass human resources, specialized skills, organizational infrastructure, financial assets, and technology. Top management must involving and backing personnel in implementing and sustaining the quality management system and designating responsibilities and authorities to ensure that processes achieve intended outcomes.

4.2.2 Responsibility and Authority

The duties, powers, and responsibilities of personnel within the organization’s quality management system must be clearly outlined, documented, and communicated across the organization.

4.2.3 Management Representative

Top management must appoint and retain a member of the organization’s management who, regardless of other duties, holds responsibility and authority that involves guaranteeing compliance of the quality management system with the requirements of this specification. Establishing, implementing, and maintaining processes necessary for the quality management system. Providing reports to top management regarding the performance of the quality management system and any areas requiring improvement. Initiating actions to rectify nonconformities. Ensuring the promotion of awareness of customer requirements throughout the organization.

4.3 Organization Capability

4.3.1 Resources and Knowledge

4.3.1.1 Resources

The organization must identify and allocate the necessary resources to implement, maintain, and enhance the effectiveness of the quality management system.

4.3.1.2 Knowledge

The organization must identify the expertise required to sustain the operation of its processes and ensure the consistent conformity of its products. This knowledge should be preserved and accessible as per the organization’s discretion.

Note: Knowledge may be gained through experience, study, training, lessons learned, best practices, or other means.

4.3.2           Human Resources

4.3.2.1       Personnel Competence

Personnel involved in the organization’s quality management system responsibilities must be competent. The organization should uphold a documented procedure concerning personnel competence. This procedure should cover:

1. Identifying and documenting required competencies.
2. Identifying necessary education, training, experience, or other actions to attain competence.
3. Evaluating the effectiveness of measures taken to acquire competencies.
4. Establishing criteria and methods for assessing, maintaining, and re-assessing competencies.
5. Designating personnel responsible for assessing competency.

Records of personnel competence must be retained.

4.3.2.2  Training

The organization must establish and uphold a training procedure. The organization must identifying the content and frequency of necessary training. The organization must provide training on the quality management system. It must provide job-specific training, including raising awareness among personnel about the significance of their tasks and their contribution to achieving the organization’s quality objectives. It must offer customer-specified or customer-provided training when necessary. It must assess the effectiveness of the training. It must document the required training records. Records of personnel training must be retained.

4.3.3  Work Environment

The organization must identify, furnish, oversee, and sustain the work environment necessary to ensure product conformity. This work environment encompasses:

1. Facilities, workspaces, and related utilities;
2. Process equipment, including both hardware and software;
3. Ancillary services (e.g., transportation, communication, information systems); and
4. Work conditions, covering physical, environmental, or other influencing factors.

4.4 Documentation Requirements

4.4.1 General

The documentation of the quality management system should consist of:

1. An outline of the quality management system’s scope, defining the products covered and providing reasons for any exclusions;
2. Declarations of the quality policy and quality objectives;
3. Listing legal and other relevant requirements that the organization must adhere to in order to ensure product conformity;
4. Explanation of how the quality management system fulfills each requirement outlined in this specification;
5. Identification of processes requiring validation; and
6. Procedures, documents, and records necessary for planning, executing, and controlling processes, as well as for meeting specified requirements.

Note: Traditionally, some of this documentation has been incorporated into a quality manual, but it can take various formats and may be presented as either a single document or multiple documents.

4.4.2 Procedures

Every procedure mandated by this specification must outline the organization’s approach to conducting an activity. These procedures must be documented, put into action, and upheld to ensure ongoing appropriateness.

Note: One procedure can encompass the requirements for one or more documented procedures. Likewise, multiple procedures can fulfill any requirement for a documented procedure.

4.4.3 Control of Internal Documents

The organization must maintain a documented procedure for managing internal documents required by the quality management system and this specification, including revisions, translations, and updates. This procedure must cover:

1. Responsibilities for approval and re-approval;
2. Review and approval for adequacy before issuance and use;
3. Periodic reviews for ongoing suitability and necessary revisions;
4. Identification of changes and current revision status;
5. Ensuring legibility and proper identification of documents;
6. Availability of documents at locations where activities are carried out.

Obsolete documents must be removed from all points of distribution or use, or appropriately marked to prevent unintended usage if retained for any purpose. Procedures, work instructions, and forms mandated by the quality management system must be controlled.

4.4.4 Control and Use of External Documents

The organization must uphold a documented procedure for managing documents from external sources necessary for product realization and use, including API or other external specifications. This procedure should cover:

1. Identifying and documenting the necessary external documents;
2. Managing access to and distribution of required documents, including relevant versions;
3. Incorporating requirements from external documents into product realization and any affected processes;
4. Establishing a process for identifying changes to required documents, such as addenda, errata, and updates;
5. Assessing the impact of changes;
6. Incorporating relevant changes.

Note: Normative references specified within API product or other external specifications, essential during product realization, may also be regarded as external documents.

4.5 Control of Records

Records, including those originating from outsourced activities, must be established and managed to demonstrate conformity to requirements and the organization’s quality management system. The organization must maintain a documented procedure outlining the controls and responsibilities for managing records. This procedure should cover:

1. Identifying records;
2. Collecting records;
3. Ensuring legibility of records;
4. Correcting records when necessary;
5. Storing records securely;
6. Safeguarding records from unintended alteration, damage, or loss;
7. Retrieving records as needed;
8. Determining retention periods;
9. Disposing of records when appropriate.

Records must be retained for a minimum of ten years or as required by customer, legal, and other relevant requirements, whichever is longer.

5 Product Realization

5.1 Contract Review
5.1.1 General

The organization must uphold a documented procedure for reviewing requirements related to product provision. This procedure should cover determining requirements, reviewing requirements, and making changes to requirements.

5.1.2 Determination of Requirements

The organization must identify requirements outlined by the customer, legal regulations, and any other applicable criteria, as well as requirements not explicitly mentioned by the customer but deemed necessary by the organization for providing the product. In cases where the customer hasn’t provided documented requirements, the organization must confirm these requirements and keep records of the confirmation process.

5.1.3 Review of Requirements

The organization must assess the requirements regarding product provision. This assessment must occur before the organization commits to delivering the product to the customer. It should confirm that requirements are identified and documented, resolve any discrepancies from previously identified requirements, and ensure the organization can meet the documented requirements. If contract requirements change, the organization must update relevant documents and inform relevant personnel of the changes. Records of the review outcomes, including any resulting actions, must be kept.

5.2 Planning

The organization must identify and strategize the processes and documents necessary for product realization. During planning, the organization should address the following:

1. Management of required resources and work environment.
2. Product and customer-specified requirements.
3. Legal and other applicable requirements.
4. Design specifications.
5. Contingency planning.
6. Specific verification, validation, monitoring, measurement, inspection, and testing activities for the product, along with acceptance criteria.
7. Management of change (MOC).
8. Records needed to demonstrate that product realization aligns with requirements.

The outcome of this planning must be documented and regularly updated to reflect changes. These plans should be organized in a structure suitable for the organization’s operational.

5.3 Risk Management
5.3.1 General

The organization must maintain a documented procedure for identifying and managing risks related to product delivery and quality. The procedure should cover:

• Techniques for identifying and assessing risks.
• The use of risk assessment tools and their application.
• Criteria for determining the severity of risks, including potential consequences of product failure.
• Actions for mitigating risks.
• Assessing the remaining risks.
• Contingency planning, including when a contingency plan is necessary based on the assessment of remaining risks.

Risk assessment may involve evaluating severity, probability of occurrence, and detectability. It can also be linked to corrective action.

5.3.2 Risk Assessment
5.3.2.1 Product Delivery

Risk assessment related to product delivery must consider factors such as facility and equipment availability, including maintenance, as well as supplier delivery performance and material availability/supply.

5.3.2.2 Product Quality

Risk assessment concerning product quality must encompass factors such as the delivery of nonconforming products and the availability of competent personnel.

5.3.2.3 Changes Impacting Product Quality

If any of the listed alterations have the potential to adversely affect product quality, a risk assessment concerning product quality must be conducted:

1. Changes in the organizational structure;
2. Changes in key personnel;
3. Alterations in the supply chain of critical products, components, or activities;
4. Modifications to the management system scope or procedures; and
5. Adjustments to the organization’s capacity to execute the processes needed for product realization.

Note: Changes may originate internally or externally.

5.3.3 Contingency Planning

If the organization deems it necessary to have a contingency plan due to assessed risks, the plan must, at a minimum, outline actions needed to mitigate the impact of disruptive incidents, assign responsibilities and authorities, and establish controls for internal and external communication. These contingency plans must be documented, communicated to relevant personnel, and revised as necessary.

5.3.4 Records

Records documenting risk assessment and management, including the actions implemented, must be retained.

5.4 Design
5.4.1 General

If the organization is accountable for product design, it must adhere to the requirements outlined in section 5.4. However, these design requirements do not apply if the product is involved in production activities, servicing, storage, distribution, or logistics.

Note: In previous editions, the term “design” was denoted as “design and development.”

5.4.2 Design Planning

The organization must uphold a documented procedure for planning and overseeing the design process. This procedure should cover:

a) Planning, including updates to the plan(s), used for design.
b) Various stages of the design process.
c) Allocation of resources, responsibilities, authorities, and their interactions.
d) Review, verification, and validation activities required for each design stage.
e) Requirements for a final review of the design.
f) Criteria and approval process for design changes.

When design activities are outsourced or carried out at different locations within the organization, the procedure should outline controls to ensure compliance with design requirements. If design activities are outsourced, the organization remains accountable for design and must ensure that the supplier meets outsourcing requirements.

Note: Design review, verification, and validation serve distinct purposes but can be conducted and recorded separately or in any combination, as appropriate for the product and the organization.

5.4.3 Design Inputs

Inputs must be identified and assessed for adequacy, completeness, clarity, and absence of conflicts. Any identified issues must be resolved. Inputs may encompass functional and technical requirements, along with the following, if applicable:

1. Customer-specified requirements;
2. Requirements from external sources, including API product specifications;
3. Environmental and operational conditions;
4. Documentation of methodologies, assumptions, and formulas; e) Historical performance and other data from similar previous designs;
5. Legal requirements; and
6. Potential consequences of product failure, as required by legal mandates, industry standards, customer specifications, or deemed necessary by the organization.

Records of design inputs must be retained.

5.4.4 Design Outputs

The documentation of outputs must enable verification against the requirements outlined in the design inputs. These outputs should:

• Meet the requirements specified in the design inputs.
• Provide information for purchasing, production, inspection, testing, and servicing, as applicable.
• Identify or reference design acceptance criteria (DAC).
• Include identification of, or reference to, products, components, and/or activities considered critical to the design.
• Incorporate the results of relevant calculations.
• Specify the characteristics of the product essential for its intended purpose and safe and proper function.

Records of design outputs must be retained.

Note: Identification of criticality of products, components, and/or activities may be managed separately from the design process.

5.4.5 Design Review

At appropriate stages, evaluations must be conducted to assess the suitability, adequacy, and effectiveness of the outcomes of design stages in meeting specified requirements, and to identify any issues and recommend required actions. These reviews must involve representatives from relevant functions associated with the design stages under review. Records of the review outcomes and any subsequent actions must be retained.

5.4.6 Design Verification and Final Review

To confirm that the design outputs meet the design input requirements, design verification and a final review must be carried out and documented according to the organization’s procedure. Records of design verification, any required actions, and the final review must be preserved.

5.4.7 Design Validation and Approval

The organization’s procedure must include conducting design validation to ensure that the resulting product can fulfill the specified requirements. Whenever feasible, validation must be concluded before product delivery. After validation, the finalized design must be approved by competent individuals other than those who developed the design. Records of design validation, approval, and any required actions must be retained.

5.4.8 Design Changes

Design changes must be identified and subjected to review, verification, and validation as necessary before being approved for implementation. The review of design changes must assess their impact on the product and its component parts at relevant stages of product realization, including already delivered products. Additionally, the review must evaluate whether customer notification is necessary if the changes adversely affect the specified performance capability of the product. All design changes, including modifications to design documents, must adhere to the organization’s procedure. Records of design changes, reviews, and any required actions must be documented and maintained.

5.5 Purchasing
5.5.1 Purchasing Control
5.5.1.1 Procedure

The organization must maintain a documented procedure for purchasing products, components, and/or activities necessary for product realization. This procedure should cover:

1. Identifying critical products, components, and/or activities.
2. Initial assessment and selection of suppliers.
3. Using identified risks to determine the initial assessment method of the supplier’s capability for critical purchases.
4. Determining the type and extent of control applied to the supply chain for critical products, components, or activities. Note: Additional requirements for outsourced activities are specified in section 5.5.1.7.
5. Establishing criteria, scope, frequency, and methods for re-evaluating suppliers.
6. Identifying approved suppliers and defining the scope of approval.
7. Identifying customer-specified suppliers and suppliers limited by proprietary and/or legal requirements when section 5.5.1.3 applies.

5.5.1.2 Initial Supplier Evaluation—Critical Purchases

For critical products, components, or activities, the initial evaluation of suppliers who have not been previously approved must consider the scope of supply and be specific to each supplier. This evaluation must include:

1. Verifying the implementation of the supplier’s quality management system and its conformity to the organization’s specified quality system requirements for suppliers.
2. Verifying the type and extent of control applied by the supplier internally and throughout their supply chain to meet the organization’s requirements.
3. Assessing the supplier’s capability to meet the organization’s specified requirements. This can be done through one or more of the following methods based on identified risks:
   • Conducting an on-site assessment to verify that relevant product realization processes are performed by process controls and effectively achieve conformity to requirements.
   • Conducting a remote assessment to verify that relevant product realization processes are performed using process controls and effectively achieve conformity to requirements.
   • Performing inspection, testing, or verification of relevant characteristics of received products.

For suppliers of critical purchases with high-risk severity, identified by the organization for which an on-site assessment is not conducted, the evaluation of the supplier’s capability must include a remote assessment and inspection, testing, or verification. When conducting a remote assessment, it must include verification of objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology. Additionally, any additions to a supplier’s scope of approval or change from an approved site to a new site of supply must also undergo evaluation as per the requirements outlined in this section.

5.5.1.3 Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited

For critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements that restrict the application of Initial Supplier Evaluation, the initial evaluation process shall involve verifying the implementation of the supplier’s quality management system and its conformity to the quality system requirements specified by the organization and/or the customer’s requirements and identifying how the supplied product, component, or activity conforms to specified requirements. The scope of approval for customer-specified suppliers shall be restricted to the relevant customer contract in cases where an assessment has not been conducted.

5.5.1.4 Initial Supplier Evaluation—Noncritical Purchases

For the procurement of noncritical products, components, or activities that influence product realization or the final product, the organization’s criteria for evaluating suppliers must either meet the requirements of Initial Supplier Evaluation—Critical Purchases or fulfill one or more of the following:

1. Verifying that the supplier’s quality management system aligns with the quality system requirements specified for suppliers by the organization.
2. Assessing the supplier’s ability to meet the organization’s purchasing requirements.
3. Evaluating the product or component upon delivery, or activity upon completion.

5.5.1.5 Supplier Reevaluation

For suppliers previously approved for products, components, or activities, the organization must determine the frequency of supplier reevaluation based on identified risk and supplier quality performance. For the reevaluation of suppliers providing critical products, components, or activities, the provisions of section 5.5.1.2 shall be followed. For the reevaluation of suppliers providing critical products, components, or activities specified by the customer or restricted by proprietary and/or legal requirements, the requirements outlined in section 5.5.1.3 shall be adhered to. For the reevaluation of suppliers providing non-critical products, components, or activities that affect product realization or the final product, the guidelines detailed in section 5.5.1.4 shall be followed.

5.5.1.6 Records

Records of evaluation results, comprising objective evidence and any subsequent actions, must be retained. Additionally, records of approved suppliers, customer-specified suppliers, and suppliers bound by proprietary and/or legal requirements must be kept.

5.5.1.7 Outsourcing

When an organization decides to delegate a process or activity from its quality management system to an external supplier, it must ensure that the supplier meets the relevant requirements of the organization’s quality management system. If an organization opts to outsource a process or activity related to product realization, it must retain accountability for ensuring that the product meets specified requirements, which may include relevant API or other external specifications. Documentation of outsourced activities must be retained, including evidence of conformity.

5.5.2 Purchasing Information

The organization must verify the adequacy of specified purchasing information before transmitting it to the supplier. Purchasing information provided to the supplier must be documented and clearly outline the product, component, or activity to be procured. This documentation should include, as appropriate:

• a) Acceptance criteria;
• b) Requirements for approving the supplier’s procedures, processes, and equipment;
• c) Relevant technical data such as specifications, drawings, process requirements, inspection instructions, and traceability requirements;
• d) Criteria for qualifying the supplier’s personnel;
• e) Requirements related to the quality management system;
• f) Conditions for approving product release; and
• g) If either the organization or its customer intends to conduct verification at the supplier’s premises, the intended verification arrangements.

Note: Applicable specifications may encompass or derive from customer requirements, API specifications, design output, and/or industry standards.

5.5.3 Verification of Purchased Products, Components or Activities
5.5.3.1 General

The organization must uphold a documented procedure outlining the verification needed to ascertain whether purchased products, components, or activities adhere to specified purchase requirements.

5.5.3.2 Critical Purchases

For critical products, components, or activities, the organization’s verification procedure should cover:

1. Reviewing the required documentation provided by the supplier;
2. Ensuring that the correct versions were utilized when specifying specifications, drawings, process requirements, inspection instructions, traceability requirements, and other relevant technical data as outlined in section 5.5.2 item c;
3. Defining the inspection, testing, and/or verification requirements, including methods, frequency, and the responsible party. The organization should determine these aspects based on identified risks and supplier quality performance.

5.5.3.3 Noncritical Purchases

The organization’s documented procedure must verify noncritical products, components, or activities.

5.5.3.4 Records

Documentation of verification activities and evidence demonstrating conformity to specified requirements must be retained.

5.6 Control of Product Realization
5.6.1 General

The organization must uphold a documented procedure outlining controls related to product realization. This procedure should cover:

1. Establishing and applying manufacturing acceptance criteria (MAC);
2. Identifying and documenting critical processes involved in product realization;
3. Executing the quality plan, if applicable;
4. Ensuring compliance with design requirements and associated modifications, if applicable;
5. Utilizing and ensuring the availability of product realization equipment and TMMDE (unless excluded);
6. Following relevant work instructions;
7. Employing process control documents;
8. Maintaining identification and traceability requirements throughout the product realization process;
9. Executing monitoring and measurement activities.

5.6.2 Quality Plan

When stipulated by contract, the organization must create a quality plan delineating the processes of the quality management system, including product realization, and the resources allocated to a product. This plan should cover the following minimum aspects:

1. Description of the product or the quality plan’s scope;
2. Required processes and documentation, encompassing necessary inspections, tests, and record-keeping to ensure compliance with requirements;
3. Identification of outsourced activities and references to their management;
4. Identification of each procedure, specification, or document referenced or utilized in each activity;
5. Specification of the required hold points, witnessing, monitoring, and document review stages.

The quality plan, along with any modifications, must be documented and endorsed by the organization. Additionally, the quality plan and its revisions should be communicated to the customer.

Note: A quality plan may consist of one or more documents and may be known by various terms, such as product quality plan (PQP), inspection and test plan (ITP), manufacturing process specification (MPS), process control plan (PCP), or quality activity plan (QAP).

5.6.3 Process Control Documents

The organization is required to document process controls, which must encompass or make reference to Criteria for verifying compliance with relevant quality plans, API product specifications, customer requirements, and/or other pertinent product standards/codes; Instructions and criteria for processes, tests, inspections, and; When relevant, points designated for the customer’s inspection hold, witnessing, monitoring, and document review.

Note: Process controls may take the form of routings, travelers, checklists, process sheets, or similar controls, and may be electronic or hard copy.

5.6.4 Validation of Processes

The organization is obligated to validate processes in cases where the resulting output cannot be verified through subsequent monitoring or measurement, leading to the detection of deficiencies after product delivery or during its usage. Validation must demonstrate these processes’ capability to achieve planned outcomes. Process validation shall adhere to either of the following:

1. If a product specification specifies particular processes necessitating validation, only those specified processes shall require validation for the relevant product. (Note: The organization may, at its discretion, opt to validate additional processes beyond those outlined in a product specification.)
2. If there is no applicable product specification or the specification does not identify processes requiring validation, processes necessitating validation for the product, if applicable, shall include, at a minimum: nondestructive examination (NDE)/nondestructive test (NDT), welding, heat treating, and coating and plating (when deemed critical to product performance by the product specification or the organization).

The organization must maintain a documented procedure for process validation, detailing the review and approval methods. This procedure should cover required equipment; personnel qualification; specific methods, including defined operating parameters; identification of process acceptance criteria; record-keeping requirements; and revalidation criteria. In cases where the organization outsources a process requiring validation, it must retain evidence confirming compliance with the stipulations outlined in section 5.6.4.

5.6.5 Identification and Traceability

The organization is responsible for establishing and preserving identification throughout product realization, encompassing relevant delivery and post-delivery activities. This entails acknowledging traceability requirements outlined by the organization, the customer, and/or pertinent product specifications. The organization must uphold a documented procedure for identification and traceability while the product remains within its control, covering the following:

1. Methods employed for identification.
2. Necessary information for traceability, if mandated.
3. Criteria for maintaining and/or reinstating identification and/or traceability.
4. Measures to rectify instances of lost identification and/or traceability.

Records documenting traceability must be retained. Please note that “product” may encompass components or raw materials.

5.6.6 Inspection/Test Status

The organization is required to uphold a documented procedure for maintaining the identification of inspection and/or test status throughout product realization, clearly indicating whether the product conforms or exhibits nonconformity.

5.6.7 Externally Owned Property

The organization must uphold a documented procedure for managing externally owned property, including customer property, incorporated into the product while under the organization’s control. This property encompasses intellectual property and non-publicly available data. The procedure should cover identification, verification, safeguarding, preservation, maintenance, and reporting loss, damage, or unsuitability for use to the external owner. Records concerning the control and disposition of externally owned property must be retained.

5.6.8 Preservation of Product

The organization must uphold a documented procedure outlining the approaches employed to maintain the integrity of the product and its component parts during product realization and delivery. This procedure should cover identification and traceability marking, storage procedures (including designated storage areas or stock rooms), periodic condition assessments as specified by the organization, transportation, handling, packaging, and protection. Records of assessment results must be retained.

5.6.9 Inspection, Testing, and Verification
5.6.9.1 General

The organization must maintain a documented procedure for inspecting, testing, and/or verifying the product to ensure that requirements have been met. This procedure should cover:

1. Methods and application of in-process inspection, testing, and/or verification.
2. Methods and application of final inspection, testing, and/or verification.
3. Creation and retention of records.

It’s important to note that in-process and final inspection may be combined into one or more activities, and certain product characteristics may necessitate final inspection/verification during product realization.

5.6.9.2 In-process Inspection, Testing, and Verification

The organization must conduct inspections, tests, and/or verifications of products at predetermined stages as specified by the quality plan, process control documents, and/or documented procedures. Evidence demonstrating conformity with the acceptance criteria must be retained.

5.6.9.3 Final Inspection, Testing, and Verification

The organization must conduct final inspection, testing, and/or verification of the product in accordance with the quality plan, process control documents, and/or documented procedures to ascertain and document conformity of the completed product with the specified requirements. Unless conducted by an automated system, individuals other than those involved in or directly overseeing the product realization process shall carry out final acceptance inspection at scheduled stages of the product realization process.

5.6.9.4 Records

Records documenting all necessary inspection, testing, verification, and final acceptance activities must be preserved.

5.6.10 Preventive Maintenance

The organization must uphold a documented procedure for conducting preventive maintenance on equipment utilized for product realization. This procedure should outline the equipment types subject to maintenance, the frequency of maintenance tasks, and the individuals responsible for carrying them out. Records detailing preventive maintenance activities must be retained.

Note: Preventive maintenance protocols can be devised based on various factors such as risk assessment, system reliability, usage patterns, historical data, industry best practices, applicable regulations, manufacturer recommendations, or other relevant criteria.

5.7 Product Release

The organization must retain a documented procedure concerning the release of products to customers. Product release should not occur until all planned arrangements have been satisfactorily fulfilled. Only products that conform to requirements or have been authorized under concession shall be released by the organization. Records must be kept to facilitate the identification of the individual responsible for authorizing product release.

5.8 Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)

5.8.1 General

The organization must establish the testing, measuring, monitoring, and detection requirements necessary to demonstrate conformity to specified standards. This includes the necessary Test, Measurement, Monitoring, and Detection Equipment (TMMDE). TMMDE, whether owned and maintained by the organization, owned by employees, or obtained from external sources such as third-party vendors, proprietary sources, or customers, must be controlled. Calibration of TMMDE must occur at specified intervals, with documentation of the date of first use when the calibration interval is determined based on this date.

5.8.2 Procedure

The organization must uphold a documented procedure for controlling Test, Measurement, Monitoring, and Detection Equipment (TMMDE). This procedure must encompass specific equipment types and include:

1. Unique identification;
2. Calibration status;
3. Traceability to international or national measurement standards. If such standards are absent, the basis for calibration must be recorded;
4. Calibration method and acceptance criteria;
5. Calibration frequency and the commencement of calibration intervals;
6. Documentation of calibration measurements before and after adjustments, known respectively as ‘as-found’ and ‘as-left’ measurements. If no adjustments are made, ‘as-found’ and ‘as-left’ measurements are the same;
7. Measures to prevent unintended use of TMMDE identified as out-of-calibration, beyond calibration intervals, or out-of-service;
8. Assessment of the validity of previous measurements and actions to be taken on the TMMDE and product if TMMDE is found to be out of calibration, including maintaining records and evidence of customer notification if suspect product has been shipped;
9. Utilization of third-party, proprietary, employee-owned, and customer-owned TMMDE;
10. Maintenance; and
11. Suitability for planned monitoring and measurement activities.

5.8.3 Equipment

TMMDE identified in 5.8.1 must adhere to the following:

1. a) Undergo calibration;
2. b) Have its calibration status identifiable by the user before and during use;
3. c) Be safeguarded from adjustments or modifications that could invalidate the measurement result or calibration status;
4. d) Be protected from damage and deterioration during handling, maintenance, and storage; and
5. e) Be utilized under environmental conditions suitable for the calibrations, inspections, measurements, and tests being performed.

When utilized in testing, monitoring, measurement, or detection to meet specified requirements, the suitability of computer software to fulfill the intended application must be confirmed before initial use and reconfirmed as necessary.

5.8.4 TMMDE Equipment from Other Sources

When utilizing TMMDE that is third-party, proprietary, or customer-owned, the organization must ensure the equipment is calibrated before use. If constrained by customer, contract, or licensing agreement limitations, the requirements outlined in 5.8.2, Item c), 5.8.2, Item d), 5.8.2, Item e), 5.8.2, Item f), 5.8.2, Item j), and 5.8.2, Item k) shall not be applicable.

5.8.5 Records

The organization is required to uphold a registry documenting the TMMDE outlined in 5.8.1, with each piece of equipment assigned a unique identification. Furthermore, the results of calibration as per 5.8.2 must be documented and retained. In cases where calibration of third-party, proprietary, and customer-owned TMMDE is constrained by customer, contractual, or licensing agreements, the organization must uphold records detailing the imposed limitations.

5.9 Control of Nonconforming Product
5.9.1 Procedure
5.9.1.1 General

The organization must uphold a documented procedure that outlines controls, along with the corresponding responsibilities and authorities, for managing nonconforming products throughout product realization and post-delivery.

5.9.1.2 Nonconforming Product During Product Realization

The procedure for handling a nonconforming product discovered during product realization must encompass guidelines for product identification and control to avoid unintended use or delivery, addressing the identified nonconformity, implementing measures to prevent its initial intended use or delivery, and obtaining authorization for its use, release, or acceptance under concession from the appropriate authority and, if necessary, from the customer.

5.9.1.3 Nonconforming Product After Delivery

The procedure for handling a nonconforming product discovered during product realization must encompass guidelines for product identification and control to avoid unintended use or delivery, addressing the identified nonconformity, implementing measures to prevent its initial intended use or delivery, and obtaining authorization for its use, release, or acceptance under concession from the appropriate authority and, if necessary, from the customer.

5.9.2 Nonconforming Product

The organization shall manage nonconforming products by executing one or more of the following actions:

1. a) Conducting repair or rework followed by subsequent inspection to ensure compliance with specified requirements;
2. b) Re-grading for alternative applications;
3. c) Releasing under concession; and/or
4. d) Rejecting or scrapping the product.

5.9.3 Release of Nonconforming Product Under Concession

Nonconforming products that do not meet manufacturing acceptance criteria (MAC) may be released under concession if authorized by the organization’s relevant authority, given that:

1. a) The products still meet the applicable design acceptance criteria (DAC) and customer criteria;
2. b) It is determined that the violated MAC is unnecessary to meet the applicable DAC and/or customer criteria; or
3. c) The DAC has been modified, and the affected products comply with the revised DAC and associated MAC requirements. If the DAC was previously agreed upon with the customer, any changes to the DAC must be authorized by the customer.

The organization is not permitted to release products that do not conform to DAC or contract requirements without authorization from the customer.

5.9.4 Customer Notification of Nonconforming Product

The organization is required to inform customers of any delivered product that does not meet the agreed design acceptance criteria (DAC) or contractual requirements. Records of such notifications must be maintained by the organization.

5.9.5 Records

Records documenting nonconformities must be retained, encompassing details of the nonconformity, actions taken thereafter including any concessions secured, the reasoning behind approving product release under concession, and the pertinent authority involved.

5.10 Management of Change (MOC)
5.10.1 General

The organization is required to uphold a documented procedure for Management of Change (MOC) to ensure the integrity of the quality management system amid changes. This MOC procedure shall cover:

1. a) Description and justification of the change;
2. b) Allocation and availability of resources, including personnel;
3. c) Assessment of potential risks associated with the change;
4. d) Review, approval, and execution of the change;
5. e) Notifications regarding the change;
6. f) Verification of the completion of MOC activities and assessment of their impact on the Quality Management System (QMS).

5.10.2 MOC Application

The organization must utilize Management of Change (MOC) for alterations that could adversely affect the product’s quality.

5.10.3 MOC Notification

The organization must inform pertinent internal staff about the change and its associated risks. If mandated by contract, the organization must also notify the customer of the change and its associated risks. Documentation of MOC notifications is required.

5.10.4 Records

Records of MOC activities must be maintained

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

6.1 General

The organization is responsible for planning and executing the processes for monitoring, measuring, analyzing, and improving the quality management system to ensure compliance with the requirements of this specification and to enhance the system’s effectiveness over time. This includes identifying appropriate methods, including data analysis techniques, and determining their utilization extent.

6.2 Monitoring, Measuring, and Improving
6.2.1 Customer Satisfaction

The organization must have a documented procedure for monitoring customer satisfaction, detailing the frequency and methods for assessing it, along with key performance indicators. Records of customer satisfaction data must be retained.

6.2.2 Internal Audit
6.2.2.1 General

The organization must conduct internal audits to assess the implementation, maintenance, and conformity of the quality management system to both this specification and the organization’s internal quality management system requirements. A documented procedure outlining responsibilities for planning, conducting, and documenting internal audits must be maintained. This procedure should identify audit criteria, scope, frequency, and methods, considering previous audit results, process criticality, and changes to the quality management system. All processes within the quality management system must undergo audits at least once every 12 months, with audits staggered throughout the year if necessary. Critical processes related to product realization must be audited to ensure compliance with requirements, including observation of activities and evaluation of conformity.

6.2.2.2 Performance of Internal Audit

Competent personnel, separate from those involved in or directly overseeing the audited activity, must conduct audits to ensure objectivity and impartiality. Audit records should offer objective evidence of the implementation and maintenance of the quality management system. Note: product specification requirements may be integrated into various quality management system processes and may be audited alongside one or more of these processes.

6.2.2.3 Audit Review and Closure

The organization must define timeframes for responding to identified nonconformities. Management accountable for the audited area must ensure that any required corrections and corrective actions adhere to the specifications outlined in section 6.4.2. Internal audit records must be retained.

6.3 Analysis of Data

The output of data analysis should furnish insights, including trends, regarding:

• a) Customer satisfaction.
• b) Non conformity to product requirements during product realization.
• c) Instances of nonconformities and product failures detected post-delivery or post-use, provided there is accessible product documentation or evidence to facilitate root cause determination.
• d) Process performance.
• e) Supplier performance.
• f) Attainment of quality objectives.

The organization must utilize data to assess areas where continual enhancement of the quality management system’s effectiveness is possible.

6.4 Improvement
6.4.1 General

The organization is required to enhance the effectiveness of the quality management system continuously. This is achieved by assessing, selecting, and implementing improvement opportunities utilizing quality objectives, internal audits, data analysis, corrective actions, and management review.

6.4.2 Corrective Action

The organization must uphold a documented procedure to manage nonconformities, including those arising from customer complaints, and to implement corrective actions both internally and with suppliers. Corrective actions should correspond to the impact of the encountered nonconformity, which can pertain to both quality management system processes and trends in nonconforming products.

The procedure should cover:

1. Criteria for initiating the corrective action process;
2. Reviewing the nonconformity;
3. Determining and implementing corrections;
4. Identifying the root cause of the nonconformity and assessing the need for corrective actions;
5. Implementing corrective action to minimize the likelihood of recurrence;
6. Defining the timeframe and responsible parties for addressing corrections and corrective action;
7. Verifying the effectiveness of the corrections and corrective action taken;
8. Updating risks and opportunities identified during planning;
9. Management of Change (MOC) when corrective actions necessitate new or modified controls within the quality management system; and
10. Assessing similar potential nonconformities and implementing preventive actions as appropriate.

Records of corrective action process activities should be maintained, including activities conducted to confirm the effectiveness of the corrective actions taken.

6.5 Management Review
6.5.1 General

The organization’s management must conduct a review of the quality management system at least once every 12 months (by the end of the same calendar month as the previous year’s review) to assess its ongoing suitability, adequacy, and effectiveness. This review should encompass evaluations of opportunities for improvement, sufficiency of resources, and the necessity for adjustments to the quality management system, including the quality policy and objectives.

6.5.2 Input Requirements

The minimum inputs required for management review shall encompass:

• a) Evaluation of the status and effectiveness of measures taken based on prior management reviews;
• b) Findings from internal audits and audits conducted by external parties.
• c) Identification of potential changes that may impact the quality management system, encompassing alterations to legal and other relevant requirements (e.g., industry standards), as well as shifts in internal and external factors pertinent to the quality management system.
• d) Assessment of customer satisfaction.
• e) Consideration of feedback received from customers and other concerned parties.
• f) Evaluation of process performance.
• g) Review of risk assessment outcomes and the effectiveness of risk mitigation measures. h) Status update on corrective actions.
• i) Analysis of supplier performance.
• j) Examination of product conformity analysis, including post-delivery or post-use nonconformities;
• k) Comparison of actual performance with quality objectives; and
• l) Proposals for improvement.

6.5.3 Output Requirements

The outcomes of the management review must comprise:

1. A concise evaluation of the quality management system’s effectiveness,
2. Any necessary modifications to processes,
3. Determinations and ensuing actions,
4. Essential resource allocations, and
5. Enhancements aimed at better meeting customer needs.

Senior management is responsible for reviewing and endorsing the results of management reviews. Documentation of management reviews is mandatory, and records of such reviews must be retained.

Annex A Use of API Monogram by Licensees

A.1 Scope

The API Monogram® serves as a registered certification mark, owned by API and sanctioned for licensing by the API Board of Directors. Under the API Monogram Program, API grants product manufacturers the authorization to affix the API Monogram to products meeting product specifications and manufactured under a quality management system in compliance with API Q1 requirements. API maintains a comprehensive, searchable record of all Monogram Licensees on the API Composite List website.

Application of the API Monogram and license number on products signifies a representation and guarantee by the Licensee to API and purchasers that, as of the indicated date, the products were manufactured under a quality management system adhering to API Q1 requirements and fully comply with the relevant standard(s) or product specification(s). API Monogram Program licenses are granted following an on-site audit confirming that an organization has implemented and consistently upheld a quality management system meeting API Q1 requirements, and that resultant products meet the specifications of the applicable API product specification(s) and/or standard(s). While any manufacturer may assert that its products meet API product requirements without featuring the Monogram, only those licensed by API can affix the API Monogram to their products.

In conjunction with the stipulations of the API Monogram license agreement, this annex outlines the prerequisites for organizations seeking voluntary API licensing to furnish API-monogrammed products meeting the criteria of the applicable API product specification(s) and/or standard(s), along with API Monogram Program requirements.

A.2 Normative References

API Q1, Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry

A.3 Terms and Definitions

The following terms and definitions apply.

• A.3.1 API monogrammable product: Product that has been manufactured by an API Licensee utilizing a fully implemented API Q1 compliant quality management system and that meets all the API-specified requirements of the applicable API product specification(s) and/or standard(s).
• A.3.2 API product specification: Prescribed set of rules, conditions, or requirements attributed to a specified product that address the definition of terms; classification of components; delineation of procedures; specified dimensions; manufacturing criteria; material requirements, performance testing, design of activities; and the measurement of quality and quantity with respect to materials; products, processes, services, and/or practices.
• A.3.3 API-specified requirements: Requirements, including performance and Licensee-specified requirements, set forth in API Q1 and the applicable API product specification(s) and/or standard(s).
• NOTE Licensee-specified requirements include those activities necessary to satisfy API-specified requirements.
• A.3.4 design package: Records and documents required to provide evidence that the applicable product has been designed in accordance with API Q1 and the requirements of the applicable product specification(s) and/or standard(s).
• A.3.5 Licensee: Organization that has successfully completed the application and audit process and has been issued a license by API.

A.4 Quality Management System Requirements

Any organization affixing the API Monogram to products must establish, uphold, and consistently operate a quality management system in accordance with API Q1.

A.5 Control of the Application and Removal of the API Monogram

Each Licensee is responsible for regulating the application and removal of the API Monogram according to the following guidelines:

1. Products that do not meet API-specified requirements should not display the API Monogram.
2. Each Licensee must establish and uphold an API Monogram marking procedure outlining the monogramming specifications outlined in this annex and any relevant API product specification(s) and/or standard(s). This procedure should:
   • designate the authority responsible for applying and removing the API Monogram;
   • specify the method(s) for applying the Monogram;
   • indicate the location on the product where the API Monogram should be placed;
   • mandate the inclusion of the Licensee’s license number and the product’s date of manufacture alongside the API Monogram;
   • stipulate that the date of manufacture must include at least two digits for the month and two digits for the year (e.g., 05-12 for May 2012), unless specified otherwise in the applicable API product specification(s) or standard(s); and
   • include controls for applying any additional API product specification(s) and/or standard(s) marking requirements, as applicable.
3. Only an API Licensee is authorized to affix the API Monogram and its corresponding license number to API monogrammable products.
4. The API Monogram license is site-specific, and therefore the API Monogram should only be applied at the licensed facility’s designated location.
5. The API Monogram may be applied at any appropriate stage during production, but it must be removed according to the Licensee’s API Monogram marking procedure if the product is later found to be non-conforming with any requirements outlined in the applicable API product specification(s) and/or standard(s) and API Monogram Program.

For specific manufacturing processes or product types, alternative API Monogram marking procedures may be acceptable. Detailed requirements for alternative API Monogram marking can be found in the API Policy, API Monogram Program Alternative Marking of Products License Agreement, accessible on the API Monogram Program website.

A.6 Design Package Requirements

Every Licensee or applicant seeking licensing must uphold an updated design package for all relevant products covered by each Monogram license. The design package should offer tangible proof that the product design aligns with the requirements outlined in the relevant and latest API product specification(s). These design package(s) should be accessible during API audits conducted at the facility. In certain cases, the exclusion of design activities is permissible under the Monogram Program, as elaborated in Advisory #6, which can be found on the API Monogram Program website.

A.7 Manufacturing Capability

The API Monogram Program is structured to recognize facilities that have proven their capacity to produce equipment in accordance with API specifications and/or standards. API reserves the right to decline initial licensing or suspend existing licenses depending on the manufacturing capabilities of a facility. If API deems it necessary to conduct further evaluation, additional audits (at the organization’s cost) may be carried out on any subcontractors to verify their adherence to the requirements outlined in the relevant API product specification(s) and/or standard(s).

A.8 API Monogram Program: Nonconformance Reporting

API requests information regarding products that do not meet API-specified requirements, as well as instances of field failures or malfunctions attributed to specification deficiencies or nonconformities with API-specified requirements. Customers are encouraged to notify API of any issues encountered with API monogrammed products. Nonconformances can be reported using the API Nonconformance Reporting System accessible at http://compositelist.api.org/ncr.asp.