Specification for Quality Management System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industries API SPECIFICATION Q2 FIRST EDITION, DECEMBER 2011 ADDENDUM 1, JUN[.]
Exclusions
Organizations must adhere to all requirements outlined in this document when engaging in relevant activities, including the provision of service-related products, with no claims for exclusion allowed If exclusions are applicable or if service-related products are not provided, the basis for such exclusions must be clearly identified, ensuring they do not compromise the organization's ability or responsibility to meet customer and regulatory requirements Exclusions are restricted to specific clauses within the document.
— Preservation of Service-related Product
— Validation of Service-related Product
— 5.7.8 Preventive Maintenance, Inspection and Test Program
Where claims of conformity are made, exclusions shall be identified in conjunction with these claims.
This document outlines quality management system requirements that enhance service-related standards Informational notes labeled as "NOTE" serve as guidance to help clarify and understand the associated requirements, rather than being mandatory stipulations.
The following referenced document is indispensable for the application of this document For this dated reference, only the edition cited applies.
ISO 9000:2005 1 ,Quality management systems—Fundamentals and vocabulary
1 International Organization for Standardization, 1, ch de la Voie-Creuse, Case postale 56, CH-1211, Geneva 20,Switzerland, www.iso.org.
3 Terms, Definitions, Abbreviations, and Acronyms
Terms and Definitions
This document adopts the terms and definitions outlined in ISO 9000, with the stipulation that when terms are defined in both ISO 9000 and this document, the definitions provided here will take precedence.
Specified limits of acceptability applied to process, service, or product characteristics.
Demonstration through monitoring, evaluation, or measurement that the service or service-related product conforms to specified requirements.
Comparison and adjustment to a standard of known accuracy.
Process of obtaining, assembling, and/or organizing applicable documentation with the intent of meeting the requirements for control or records.
Act or process of satisfying the legal and other applicable requirements of a regulation or regulatory body.
That deemed by the organization or customer as indispensable or essential, needed for a stated purpose or task, and requiring specific action.
Element of service that is essential to achieve goals or stated objectives.
Metric by which an organization measures the manner or quality of the functioning of its processes, service, or service-related product.
Obligation imposed on an organization, including those that are statutory or regulatory.
The governing body of an organization, whether an individual or a group, is responsible for directing and controlling its operations This entity holds fiscal responsibility and is accountable for ensuring compliance with legal and other relevant requirements.
NOTE For some organizations, top management (see ISO 9000) and management may be the same.
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Business function or process which is contracted to an external supplier.
Planned action to minimize the likelihood of causes of equipment failure and unscheduled interruptions to planned events.
Situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.
Performance of an activity by one function or organization for another.
Document that establishes procedures, resources, processes, and any required sequence of activities identifying and controlling the quality requirements.
Materials, equipment, and software used in the execution of a service.
Abbreviations and acronyms
For the purposes of this document, the following abbreviations shall apply.
ISO International Organization for Standardization
PMITP preventive maintenance, inspection and test program
General
The organization shall establish, document, implement, maintain, measure the effectiveness of, and improve upon a quality management system in accordance with the requirements of this document
The organization shall ensure that legal and other applicable requirements with which the organization claims compliance are taken into account in its quality management system
The organization's commitment to quality will be clearly defined, documented, and approved by top management Additionally, top management will regularly review the quality policy to ensure its continued relevance and appropriateness.
4 API S PECIFICATION Q2 organization, is the basis for the development of quality objectives (see 4.1.3), and is communicated, understood, implemented, and maintained at all relevant functions and levels within the organization
Management must establish measurable quality objectives at all relevant functions and levels within the organization to meet service and service-related product requirements These objectives should align with the overall quality policy to ensure consistency and effectiveness.
Management must ensure that the planning of the quality management system aligns with the requirements outlined in this document, while also maintaining the integrity of the system during any planned and implemented changes.
NOTE Additionally, see 5.2, 5.4.1, 5.5, 5.7.2, 6.1 and 6.2.2 for other planning requirements.
Management shall ensure that appropriate communication processes are established within the organization and the effectiveness of the quality management system is communicated.
The organization shall establish processes to ensure that customer and legal and other applicable requirements are communicated at relevant levels within the organization.
The organization shall establish processes to ensure that the results of data analysis (see 6.3) are communicated at relevant levels within the organization.
The organization must establish and document a process for effective communication with external entities to ensure a clear understanding of requirements and proper risk management during contract execution and service delivery This includes handling inquiries, contracts, and amendments, managing service-related information and nonconformities, developing service quality plans and implementing changes, as well as addressing feedback and complaints.
Management Responsibility
Top management shall ensure the availability of resources essential to establish, implement, maintain and improve the quality management system
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NOTE Resources can include human resources and specialized skills, organizational infrastructure, technology and financial resources.
Management demonstrates its commitment to the quality management system by emphasizing the importance of fulfilling customer, legal, and other relevant requirements This includes establishing quality objectives and key performance indicators (KPIs) for effective data analysis, as well as conducting regular management reviews to ensure continuous improvement.
Roles, responsibilities and authorities shall be defined, documented, assigned within, and communicated throughout the organization
The organization's management will designate a management representative with clear roles, responsibilities, and authority to ensure the quality management system is effectively established, implemented, and maintained This representative will also take proactive measures to reduce the risk of nonconformities and will report to management on the quality management system's performance, including suggestions for enhancements.
Organization Capability
The organization shall determine and provide the resources needed to implement, maintain, and improve the effectiveness of the quality management system.
The organization will establish a documented procedure to define personnel competency and identify training needs This procedure will ensure that all personnel receive the necessary training and will include measures to assess the effectiveness of the actions taken to achieve the required competency levels.
Personnel engaged in activities must possess the necessary education, training, skills, and experience to fulfill service and product requirements It is essential to document and maintain evidence of personnel competence.
The organization is committed to implementing a quality management system by providing comprehensive training for its personnel and contractors involved in service execution This includes incorporating customer-specified and customer-provided training as needed, ensuring compliance with legal and applicable requirements regarding training frequency and content Additionally, the organization emphasizes the importance of personnel understanding their roles in achieving quality objectives and identifies necessary legal training Furthermore, it maintains detailed records of education, training, skills, and experience to support these initiatives.
The organization is responsible for establishing and maintaining a work environment that ensures compliance with relevant service and product requirements This environment encompasses various elements, including buildings, workspace, and utilities, as well as process equipment—both hardware and software Additionally, it includes supporting services like transportation, communication, and information systems, along with the physical and environmental conditions under which work is conducted.
Documentation Requirements
The quality management system documentation shall include: a) statements of quality policy and quality objectives; b) a quality manual that addresses each requirement of this document and includes the following:
1) scope of the quality management system,
2) description of the interaction between the processes of the quality management system, including the reference to documented procedures,
3) allowable exclusions and the basis for claiming those exclusions (see 1.2), and
4) identification of legal and other applicable requirements to which the organization claims compliance; c) documented procedures established for the quality management system; and
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Procedures required by this document and the quality management system shall be established, documented, implemented and maintained
NOTE A single document can address the requirements for one or more procedures A requirement for documented procedures can be covered by more than one document.
The organization will establish a documented procedure to identify, distribute, and control all documents necessary for the quality management system, including those sourced externally.
The procedure outlines essential controls to guarantee that all documents required by the quality management system are adequately reviewed and approved before issuance and use It specifies the responsibilities for document approval and re-approval, identifies any changes made to the documents, ensures that they remain legible and easily identifiable, and confirms that the relevant versions of applicable documents are accessible at the locations where activities are conducted.
Obsolete documents shall be removed from all points of issue or use, or otherwise identified to prevent unintended use if they are retained for any purpose.
A master list or equivalent shall be established to identify the current revision status of documents.
Control of Records
The organization shall maintain a documented procedure to define the controls and responsibilities needed for the initiation, identification, collection, storage, protection, retrieval, retention time, and disposition of records
Records, including those from outsourced activities, shall be established and controlled to provide evidence of conformity to requirements and of the effective operation of the quality management system
Records must be clear, identifiable, and easily accessible They should be kept for at least five years or longer if mandated by customer, legal, or other relevant regulations.
5 Realization of Service and Service-related Product
Contract Review
The organization shall maintain a documented procedure for the review of requirements related to the execution of services or provision of service-related products
The organization will identify the following requirements: a) customer-specified needs for service planning, execution, and evaluation; b) relevant legal and regulatory obligations; and c) additional requirements deemed essential by the organization for effective service delivery and related product provision.
Where the customer provides no documented statement of the requirements, the customer requirements shall be confirmed by the organization and records maintained (see 4.5)
The organization will assess the service execution requirements and related products before committing to customer service This assessment ensures that all requirements are clearly defined, any discrepancies from previously identified requirements are addressed, and the organization is equipped to meet these defined requirements.
Where contract requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements
Records of the results of the review, including resulting actions, shall be maintained (see 4.5).
Planning
The organization shall identify and plan the processes and documents needed for service and service-related product realization
In the planning process, the organization must consider customer-specified requirements, including critical success factors, key performance indicators, and legal obligations Additionally, an initial risk assessment should be conducted, along with the management of required resources and the work environment The design of services and service-related products, contingency planning, and change management are also essential Finally, maintaining records to demonstrate compliance with realization processes is crucial.
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Risk Assessment and Management
The organization will implement a documented procedure to manage risks during service execution, which includes identifying potential or actual risks related to services and products, utilizing appropriate risk management tools and techniques, selecting and communicating mitigation or preventive measures to minimize exposure to loss, and informing customers of any remaining risks that could affect the service.
Records of risk assessment and actions taken shall be maintained (see 4.5).
Design and Development
The organization shall maintain a documented procedure to plan and control the design and development of the service, including the use of service-related products.
The procedure will outline the design and development stages, detail the necessary activities for completion, review, and verification of each stage, clarify the interfaces among various groups involved in the design and development process, and define the responsibilities and authorities related to these activities.
When design and development are outsourced, the organization shall ensure the supplier meets the requirements of 5.4 and provide objective evidence that the supplier has met these requirements.
Inputs relating to design of the service shall be determined and records maintained (see 4.5) These inputs shall include: a) customer-specified requirements (see 5.1); b) legal requirements; and c) other applicable requirements including:
1) requirements provided from an external source,
2) requirements for service-related products, including its functional and technical requirements,
4) results from risk assessments (see 5.3), and
5) historical performance and other information derived from previous similar service designs.
The outputs of design and development shall be documented to allow verification against the design and development input requirements
The outputs of design and development must fulfill the specified input requirements, offer guidance for procuring necessary service-related products, establish controls for service execution with permissible variations, incorporate or reference acceptance criteria for service completion, and identify essential service-related products.
The design verification of the service will be conducted according to the established plans to confirm that the outputs align with the input requirements Additionally, records of the verification results will be kept for reference.
5.4.5 Design and Development Final Review and Approval
A comprehensive review and approval of the final design and development outputs will be carried out by individuals who were not involved in the design process Documentation of this review is essential, and records of the results will be maintained as specified in section 4.5.
5.4.6 Control of Design and Development Changes
Changes in the approved design shall be reviewed and verified by the management of change process (see 5.11).
Contingency Planning
The organization will establish a documented procedure for contingency planning that encompasses measures for preventing and mitigating incidents and disruptions This planning will be seamlessly integrated into services and supporting processes involving the organization, its suppliers, and customers.
Effective contingency planning must be documented and shared with relevant operational staff, ensuring it is regularly updated to reduce the risk and impact of service disruptions The plan should be informed by assessed risks and must outline necessary actions to address significant risk scenarios.
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Organizations in the petroleum and natural gas industries must implement actions to mitigate the effects of disruptive incidents, clearly identify and assign responsibilities and authorities, and establish controls for both internal and external communications.
Purchasing
The organization shall maintain a documented procedure to ensure that purchased or outsourced services and service-related products conform to specified requirements
The procedure will focus on determining the criticality of services and service-related products, evaluating and selecting suppliers based on their capability to meet organizational requirements, and applying appropriate control measures based on the criticality of these services and products It will also outline the criteria, scope, frequency, and methods for assessing suppliers, as well as the maintenance of a list of approved suppliers and their respective scopes of approval.
For critical services or service-related products, organizations must establish specific criteria for the initial evaluation and selection of suppliers before initiating a purchase agreement.
1) assessment of the supplier at supplier’s facility to meet the organization’s purchasing requirements, and
2) verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization.
For the re-evaluation and initial assessment of suppliers providing non-critical services or service-related products, organizations must ensure that the supplier meets purchasing requirements, verify the conformity of the supplier's quality management system to specified quality standards, and assess the supplier upon delivery of the product or service.
Records of assessment results and any required actions will be kept, as outlined in section 4.5 If supplier assessments indicate the need for corrective actions, documentation proving the effective implementation of these actions will be maintained in accordance with section 6.4.2.
When documenting purchasing information for suppliers, it is essential to include a detailed description of the services or service-related products being acquired This documentation should outline acceptance criteria, approval requirements for the supplier's procedures and equipment, the relevant specifications and technical data, qualifications for the supplier's personnel, and the necessary quality management system requirements.
5.6.3 Verification of Purchased Services and Service-related Product
The organization must establish a documented procedure to verify that purchased services and related products meet specified requirements Additionally, it is essential to maintain records of all verification activities to ensure compliance.
The organization shall ensure and provide evidence that outsourced services and service-related products conform to specified requirements.
Execution of Service
The organization must establish a documented procedure that integrates key elements into the development of a service quality plan, including personnel training and competence, defined contract requirements, risk assessment and management, detailed information on service characteristics and related products, and the identification of necessary equipment along with its testing and monitoring requirements.
Service execution controls must be documented through routings, travelers, checklists, process sheets, or similar documents, detailing the requirements for verifying compliance with quality plans, procedures, and relevant standards or codes These control documents should encompass or reference instructions, workmanship standards, and acceptance criteria for processes, tests, inspections, as well as any customer inspection hold or witness points.
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The organization shall develop a service quality plan that controls the execution of services or use of service-related products.
NOTE A service quality plan is often referred to as a quality plan or service delivery plan.
The service quality plan must encompass essential elements such as compliance activities and documentation for customer and legal requirements, the designation of responsible functions including external parties, and the management of subcontractors It should also specify the relevant revisions for all procedures and documents involved, outline acceptance inspection requirements with defined review points for both the organization and the customer, and detail the necessary service equipment and monitoring devices Additionally, the plan must address risk identification and controls, highlight critical services and related products, specify required deliverables, and outline necessary record-keeping practices.
The service quality plan shall be updated when any of the plan content changes
Service quality plans and any revisions to them shall be documented and approved by the organization.
When required by contract, the service quality plan and any revisions shall be communicated to the customer.
The organization must establish a documented procedure to ensure the identification and traceability of service-related products This procedure should encompass identification controls throughout all phases of delivery, installation, repair, and redress, as mandated by both the organization and the customer Additionally, it must outline the requirements for the maintenance or replacement of identification and traceability marks, along with the necessary record-keeping.
It is essential to identify service-related products, particularly critical ones, and ensure they are traceable to the preventive maintenance, inspection, and test program (PMITP) records, as well as to the original manufacturer.
The organization shall maintain a documented procedure for the identification of service-related product status.
The organization will implement a documented procedure to identify, verify, store, preserve, maintain, and protect customer property under its control This includes customer-derived intellectual property and specific data Additionally, the organization is responsible for reporting any loss, damage, or inappropriate use of customer-supplied property to the customer.
The organization is responsible for identifying, verifying, and safeguarding customer property used in its services or related products It will maintain records for the control and disposition of customer-supplied property.
5.7.6 Preservation of Service-related Product
The organization will implement a documented procedure to ensure the preservation of service-related products during internal processing and service execution This preservation process encompasses identification, traceability, transportation, handling, packaging, storage, and protection, and it also extends to the individual components of the service-related product.
In order to detect deterioration, the condition of the service-related product or constituent parts in stock shall be assessed at intervals specified in the procedure.
5.7.7 Validation of Service-related Product
Validation of the service-related product shall be completed prior to the execution of the service Records of the results of validation, when performed, shall be maintained (see 4.5).
5.7.8 Preventive Maintenance, Inspection, and Test Program
The organization will implement a documented procedure for establishing a PMITP, which will include requirements for record keeping, as outlined in section 4.5 This procedure will also cover aspects such as inspection, maintenance, redress, repair, make-up, testing, and the acceptance criteria for service-related products.
The PMITP must encompass preventive maintenance actions, comprehensive reports detailing usage history, repairs, modifications, inspections, and testing activities for product reuse verification It should also include a list of critical spare parts as specified by the customer and/or original equipment manufacturer recommendations Additionally, the PMITP must implement controls to ensure that equipment integrity aligns with original performance requirements and design acceptance criteria.
Performance requirements that cannot be fulfilled must follow the Management of Change (MOC) process for ongoing use The Project Management and Implementation Transition Plan (PMITP) may consider factors such as risk, system reliability, usage history, industry best practices, relevant codes and standards, and original equipment manufacturer guidelines.
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Control of Testing, Measuring, Monitoring and Detection Equipment
The organization shall determine the required testing, measurement, monitoring, and detection equipment to be controlled and necessary to provide evidence that service or service-related product meets specified requirements
The organization will implement a documented procedure to guarantee that all testing, measurement, monitoring, and detection equipment is properly calibrated and maintained, ensuring the effective delivery of services and related products.
The procedure will cover equipment traceability, calibration frequency, methods, acceptance criteria, and environmental conditions It will also specify necessary assessments and maintain records when previous results do not meet calibration standards The organization must take appropriate actions regarding affected equipment and services Testing, measuring, monitoring, and detection equipment must be calibrated or verified at specified intervals or before use, adhering to international or national measurement standards If no such standards exist, the calibration basis must be documented Additionally, equipment must have identification to track its calibration status, be protected from adjustments that could compromise measurement results, and be safeguarded against damage during handling, maintenance, and storage.
To ensure that computer software meets its intended application, it is essential to confirm its ability to fulfill specified requirements during testing, measurement, monitoring, and detection This confirmation should occur before the software's initial use and be reconfirmed as needed.
When the equipment is externally provided, the organization shall verify that the equipment is suitable to provide evidence of conformity of service or service-related product to specified requirements.
The organization shall maintain a registry of the required testing, measurement, monitoring, and detection equipment that includes an unambiguous form of identification, specific to each piece of equipment.
Records of the results of calibration and verification shall be maintained (see 4.5).
Service Performance Validation
The organization shall maintain a documented procedure to validate the execution of the service performance to confirm that requirements were achieved
The execution of the service will occur at designated stages, adhering to design requirements and the service quality plan It is essential to maintain evidence of compliance with established acceptance criteria, including key performance indicators (KPIs) and critical success factors.
Records of the service performance validation shall be maintained, including identification of the person(s) accepting the results (see 4.5).
Control of Nonconformities
The organization will establish a documented procedure outlining the controls, responsibilities, and authorities for managing nonconforming service execution and related products The response to any nonconformity will be proportional to its severity and impact on service delivery.
5.10.2 Nonconforming Service Execution and Service-related Product
The organization will address nonconforming service execution or service-related products through a structured approach: first, by taking corrective action to resolve the nonconformity; if that is not feasible, by preventing the service-related product from being used as intended; and if neither of these options is suitable, by obtaining authorization for release or acceptance under concession from a relevant authority or the customer.
For nonconforming service execution, the organization shall take corrective action in accordance with 6.4.2 that is appropriate to the effects, or potential effects, of the nonconformity.
When nonconforming services and/or service-related product are corrected they shall be subject to verification to demonstrate conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.5).
The organization will inform customers if the service provided does not meet the specified design requirements or if any nonconforming service-related products have been delivered or utilized Additionally, the organization will keep records of these notifications.
Management of Change
The organization will implement a documented procedure for managing changes (MOC), ensuring that potential risks associated with these changes are identified and necessary approvals are obtained before any modifications are made.
The organization will implement the MOC process for any changes that could affect service execution, including alterations in the organizational structure and modifications in key personnel whose absence may adversely impact the service.
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Organizations in the petroleum and natural gas industries must be aware of several critical changes that can impact their operations These include alterations in key suppliers that could adversely affect service delivery, modifications to management system procedures stemming from corrective and preventive actions, and updates to original equipment manufacturer specifications or software related to service products Additionally, any changes in approved designs, whether initially agreed upon by the customer or necessitated by legal and other applicable requirements, must be carefully managed.
5.11.3 MOC Evaluation, Notification and Controls
The organization will perform a risk assessment when considering any potential changes and will inform all relevant personnel, including the customer, about the change and any associated residual or new risks Additionally, the organization will update necessary documents and maintain records of Management of Change (MOC) activities.
6 Quality Management System Measurement, Analysis, and Improvement
General
The organization must establish and execute processes for monitoring, measuring, analyzing, and improving its quality management system to ensure compliance and enhance its overall effectiveness continuously.
Quality management system measurement, analysis, and improvement shall include determination of applicable methods, including techniques for the analysis of data, and the extent of their use.
Monitoring, Measuring and Improving
The organization will implement a documented procedure to assess customer satisfaction, focusing on customer feedback, key performance indicators (KPIs), and other relevant data to evaluate the fulfillment of customer requirements Additionally, records of customer satisfaction results will be systematically maintained.
The organization will establish a documented procedure outlining the responsibilities for planning and executing internal audits This planning will take into account the outcomes of prior audits and the criticality of the processes involved.
The organization will establish the audit criteria, scope, frequency, and methods to guarantee that all components of the management system, which assert compliance with this document's requirements, are audited at least once a year.
Outsourced suppliers that impact the quality of services or service-related product, located at the organization’s facility, shall be included as part of the internal audit of the organization
The organization shall conduct internal audits to determine whether the quality management system conforms to the requirements of this document and is effectively implemented and maintained.
Audits shall be performed by competent personnel (see 4.3.2.2) independent of those who performed or directly supervised the activity being audited.
An audit of all elements of the management system shall be conducted prior to claiming conformance to the requirements of this document.
The organization must establish response times for addressing identified nonconformities Management in the audited area is responsible for implementing necessary corrections and corrective actions to eliminate these nonconformities and their root causes Follow-up activities will include verifying the effectiveness of the actions taken Additionally, records of audits and their outcomes must be maintained.
Analysis of Data
The organization must establish a documented procedure for identifying and utilizing data analysis techniques It is essential to determine, collect, and analyze relevant data to assess the suitability and effectiveness of the quality management system, as well as to identify opportunities for continual improvement This process should encompass data obtained from monitoring, measurement, and other pertinent sources.
Data analysis will yield insights into customer satisfaction, adherence to service design requirements, process and service-related product characteristics and trends, supplier performance, and quality objectives.
Improvement
The organization will establish a documented procedure to monitor, evaluate, and enhance the effectiveness of its quality management system processes related to service execution and service-related products.
The organization utilizes its quality policy, objectives, customer feedback, audit results, data analysis, corrective and preventive actions, and management reviews to continuously enhance the effectiveness of its quality management system.
NOTE See ISO 9000 for definitions of correction, corrective action, and preventive action.
The organization will implement a documented procedure to address nonconformities and take corrective actions, both internally and throughout the supply chain, to eliminate their root causes and reduce the chances of recurrence.
The procedure shall define requirements for: a) reviewing nonconformities (including customer complaints),
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Organizations in the petroleum and natural gas industries must identify the root cause of nonconformities and implement necessary corrections It is essential to evaluate the need for corrective actions to minimize the chances of recurrence Additionally, organizations should establish a timeframe and assign responsible individuals for executing these corrections Reviewing the effectiveness of the implemented corrections and actions is crucial, along with maintaining comprehensive records of all corrections and actions taken.
When the corrective action identifies the need for new or changed controls, the procedure shall require that the MOC process (see 5.11) be applied to the proposed action.
The organization will establish a documented process to identify and execute preventive measures, both internally and throughout the supply chain, aimed at eliminating the root causes of potential nonconformities to reduce their likelihood of occurrence.
The procedure outlines the requirements for identifying potential nonconformities and their causes, evaluating the necessity for preventive actions, determining the timeframe and responsible individuals for implementation, reviewing the effectiveness of these actions, and maintaining records of the results.
When the preventive action identifies the need for new or changed controls, the procedure shall require that the MOC process (see 5.11) be applied to the proposed action.
Management Review
The organization's management will conduct an annual review of the quality management system to ensure its ongoing suitability, adequacy, and effectiveness This review will focus on identifying opportunities for improvement and determining any necessary changes to the quality management system, including updates to the quality policy and quality objectives.
The management review input must encompass the effectiveness of actions taken from prior reviews, the outcomes of internal audits, and any changes in legal or other relevant requirements that may impact the quality management system.
In the context of API specification, it is essential to consider customer feedback, evaluate process effectiveness through risk assessment results, monitor the status of corrective and preventive actions, and conduct a thorough review and analysis of failures in service and service-related products.
The management review will provide a summary evaluation of the quality management system's status, highlighting necessary process changes, decisions, actions, required resources, and enhancements to services and service-related products to better meet customer needs.
Top management shall review and approve the output of management reviews Management reviews shall be documented and records of these reviews shall be maintained (see 4.5).
[1] API Specification Q1, Specification for Quality Programs for the Petroleum, Petrochemical, and Natural Gas
[2] OHSAS 18001 2 , Occupational health and safety management systems—Requirements
[3] ISO 9001 1 , Quality management systems—Requirements
[4] ISO 9004, Managing for the sustained success of an organization—A quality management approach
[5] ISO 10005, Quality management systems—Guidelines for quality plans
[6] ISO/TR 10013, Guidelines for quality management system documentation
[7] ISO 10015, Quality management—Guidelines for training
[8] ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000
[9] ISO 19011, Guidelines for quality and/or environmental management systems auditing
[10] ISO/TS 29001, Specification for Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry
[11] ISO 31000, Risk management—Principles and guidelines
2 Occupational Health & Safety Advisory Services, Navy House, King James IV Road, Rosyth Business Park, Rosyth, Fife, KY11 2BJ, England, www.ohsas.org.
3 The Code of Federal Regulations is available from the U.S Government Printing Office, Washington, DC 20402.
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Spec Q1, Specification for Quality Programs for the Petroleum and
Web: www.api.org/monogram
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API Engine Oil Licensing and
Web: www.api.org/eolcs
API Training Provider Certification Program (API TPCP™)
Sales: (+1) 713-964-2662 Service: (+1) 202-682-8075 Fax: (+1) 202-682-8070 Email: tpcp@api.org Web: www.api.org/tpcp
API Perforator Design Registration Program
Sales: (+1) 713-964-2662 Service: (+1) 202-682-8490 Fax: (+1) 202-682-8070 Email: perfdesign@api.org Web: www.api.org/perforators
Service: (+1) 202-682-8192 Fax: (+1) 202-682-8070 Email: exchange@api.org Web: www.api.org/ace
API Diesel Exhaust Fluid Certification Program
Phone: (+1) 202-682-8516 Fax: (+1) 202-962-4739 Email: info@apidef.org Web: www.apidef.org
Sales: (+1) 713-964-2662 Service: (+1) 202-682-8469 Fax: (+1) 202-682-8348 Email: apiworksafe@api.org Web: www.api.org/worksafe
Phone: (+1) 202-682-8053 Fax: (+1) 202-682-8070 Email: training@api.org Web: www.api-u.org
Phone: (+1) 202-682-8499 Fax: (+1) 202-962-4730 Email: apidata@api.org Web: www.APIDataNow.org
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