ANSI/API SPECIFICATION Q1 - ISO TS 29001:2007
(Identical), Petroleum, petrochemical and natural gas industries—Sector specific requirements—Requirements for product and service supply organizations
1 Scope
1.1 General
1.1.1 Field of Application — Supplemental
This Technical Specification defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.
Boxed text is original ISO 9001:2000 text unaltered and in its entirety. The petroleum, petrochemical, and natural gas industry sector-specific supplemental requirements are outside the boxes.
1.2 Application
1.2.1 Application — Supplemental
Where exclusions are made, claims of conformity to this Technical Specification are not acceptable unless these exclusions are limited to requirements within the subclauses listed below in this subclause, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements:
- 7.3 Design and development;
- 7.5.1 Control of service provision;
- 7.5.2 Validation of processes for production and service provision; — 7.5.4 Customer property.
2 Normative references
3 Terms and definitions
3.1 Terms and definitions for the petroleum, petrochemical and natural gas industries
For the purposes of this Technical Specification, the terms and definitions given in ISO 9000:2005 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 complies with specified requirements
3.1.3
calibration
comparison and adjustment to a standard of known accuracy
3.1.4
control feature
organization’s documented method to perform an activity under controlled conditions to achieve conformity to specified requirements
3.1.5
delivery
point in time and physical location at which the agreed transfer of ownership takes place
3.1.6
design acceptance criteria
defined limits placed on characteristics of materials, products, or services established by the organization, customer, and/or applicable specifications to achieve conformity to the product design
3.1.7
design validation
process of proving a design by testing to demonstrate conformity of the product to design requirements
3.1.8
design verification
process of examining the result of a given design or development activity to determine conformity with specified requirements
3.1.9
field nonconformity
product nonconformity that is detected after delivery or use has started
3.1.10
manufacturing acceptance criteria
defined limits placed on characteristics of materials, products, and services established by the organization to achieve conformity to the manufacturing or service requirements
3.1.11
tender
offer made by an organization in response to an invitation to provide a product
4 Quality management system
4.1 General requirements
4.1.1 Outsourced processes and/or services — Supplemental
The organization shall maintain responsibility for product conformance to specified requirements when processes are outsourced.
4.2 Documentation requirements
4.2.2 Quality manual
4.2.2.1 Quality manual — Supplemental
The quality manual shall identify the manner in which the organization addresses each specific requirement of this Technical Specification, including both the requirements of ISO 9001:2000 and the supplemental requirements.
4.2.3 Control of documents
4.2.3.1 Control of documents — Supplemental
A master list or equivalent control feature shall be used to identify the documents required by the quality management system, and their current revision status.
4.2.3.2 Control of document changes — Supplemental
Changes to documents shall be reviewed and approved by the same functions that performed the original review and approval.
4.2.4 Control of records
4.2.4.1 Control of records — Supplemental
The documented procedure shall identify the functions responsible for the collection and maintenance of records.
Records required by applicable industry product standards shall be retained for not less than the period of time specified by the industry standard or five years, whichever is longer. Records required to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be retained for a minimum of five years.
NOTE Collection is the process of obtaining, assembling and/or organizing applicable documentation with the intent of meeting the requirements of 4.2.4.
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.3.1 Quality policy — Supplemental
Top management shall document its approval of the quality policy.
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
NOTE See also 5.6, 7.1, 7.1.1, 7.3.1, 7.5.1, 8.1 and 8.2.2 for other planning requirements.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1.1 General — Supplemental
The management review shall be conducted at least annually.
NOTE 5.6.1.1 includes monitoring of quality objectives as part of the management review.
5.6.2 Review input
NOTE 1 5.6.2 c) in conjunction with 8.4 c) includes trends of product nonconformity.
NOTE 2 5.6.2 f) includes changes to applicable petroleum, petrochemical and natural gas industry standards.
NOTE 3 5.6.2 c) includes reports and analysis of field nonconformities (see 3.1.9), if applicable.
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.2 Competence, awareness and training
6.2.2.1 Training — Supplemental
The organization shall establish control features (see 3.1.4) for identifying training needs and providing for training of personnel who perform activities addressed in the quality management system. The training requirements shall provide for quality management system training and for job training of personnel. The frequency of training shall be defined by the organization.
NOTE 1 6.2.2.1 provides on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel.
NOTE 2 6.2.2.1 includes having a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d)]. Personnel whose work can affect quality should be informed about the consequences to the customer of nonconformity to quality requirements.
6.3 Infrastructure
6.4 Work environment
NOTE 6.4 includes maintaining its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.
7 Product realization
7.1 Planning of product realization
7.1.1 Planning of product realization — Supplemental
When product requirements are provided from external sources, the organization shall define the methods and shall establish control features (see 3.1.4) used to translate these requirements into the product realization process.
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.2.1 Review of requirements related to the product — Supplemental
The organization shall establish control features (see 3.1.4) to review requirements related to the product.
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.1.1 Design and development planning — Supplemental
The organization shall establish control features (see 3.1.4) for the design of the product.
When design and development are outsourced, the organization shall ensure the supplier meets the requirements of 7.3 and provide objective evidence that the supplier has met these requirements.
7.3.1.2 Design documentation — Supplemental
Design documentation shall include the methods, assumptions, formulas and calculations. 7.3.2 Design and development inputs
7.3.2.1 Design and development inputs — Supplemental
The organization shall identify, document and review the product design input requirements. Design and development inputs shall include customer specified requirements (see 7.2.2).
7.3.3 Design and development outputs
7.3.3.1 Design and development outputs – Supplemental Design and development outputs shall be documented.
7.3.4 Design and development review
7.3.4.1 Design and development review — Supplemental
A final design review shall be conducted and documented. Individual(s) other than the person or persons who developed the design shall approve the final design.
7.3.5 Design and development verification
NOTE Design verification activities includes one or more of the following:
a) confirming the accuracy of design results through the performance of alternative calculations;
b) review of design output documents independent of activities of 7.3.4;
c) comparing new designs to similar proven designs.
7.3.6 Design and development validation
NOTE Design validation includes one or more of the following:
a) prototype tests;
b) functional and/or operational tests of production products;
c) tests specified by industry standards and/or regulatory requirements;
d) field performance tests and reviews.
7.3.7 Control of design and development changes
7.3.7.1 Control of design and development changes — Supplemental
Design and development changes including changes to design documents, shall require the same controls as the original design and development, and design documentation.
7.4 Purchasing
7.4.1 Purchasing process
7.4.1.1 Purchasing process — Supplemental
The organization shall establish control features (see 3.1.4) for the purchasing process and supplier selection.
NOTE Purchased products above include all products and services that affect compliance with customer requirements.
7.4.1.2 Criteria for supplier selection, evaluation, and re-evaluation — Supplemental
Criteria for the selection, evaluation and re-evaluation of suppliers shall include one or more of the following.
a) Inspection of supplier’s final product by the organization at supplier’s facility.
b) Inspection of supplier’s final product by the organization upon delivery.
c) Surveillance of supplier’s conformance to the organization’s purchasing requirements.
d) Verification by the organization that the supplier’s quality management system conforms to an internationally recognized quality management system standard/technical specification.
NOTE When there are mergers, acquisitions or affiliations associated with suppliers, consideration includes the organization verifying the continuity of the supplier’s quality management system and its effectiveness.
7.4.1.3 Supplier provided processes that require validation — Supplemental
Where an organization chooses to outsource any process that requires validation, the organization shall require that the supplier comply with the requirements of 7.5.2, as applicable (see 4.1).
7.4.2 Purchasing Information
7.4.2.1 Purchasing information — Supplemental
Purchasing information provided to the supplier shall be documented and shall describe the product to be purchased including, where appropriate, the items in 7.4.2, as well as
a) the type, class, grade or other precise identification, and
b) the title or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data.
7.4.3 Verification of purchased product
7.4.3.1 Verification of purchased product — Supplemental
The organization shall establish control features (see 3.1.4) for the verification of purchased product. The organization shall maintain records of verification activities (see 4.2.4).
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.1.1 Control of production and service provision — Supplemental
The organization shall establish control features (see 3.1.4) that describe the control of production and service activities performed.
7.5.1.2 Process controls — Supplemental
Process controls shall be documented in routings, travellers, checklists, process sheets, or other types of control features (see 3.1.4) and shall include requirements for verifying compliance with quality plans, control features, and reference standards/codes. The process control documents shall include or reference instructions, workmanship and acceptance criteria for processes, tests, inspections, and customer’s inspection hold or witness points.
7.5.2 Validation of processes for production and service provision
7.5.2.1 Validation of processes for production and service provision — Supplemental
The organization shall validate those processes identified by the applicable product specification as requiring validation. If these processes are not identified, or there is no product specification involved, the processes requiring validation shall include, as a minimum, non-destructive examination, welding and heat treating, if applicable to the product.
7.5.3 Identification and traceability
7.5.3.1 Identification and traceability — Supplemental
The organization shall establish control features (see 3.1.4) for identification and traceability of the product by suitable means from receipt and during all stages of production, delivery and installation, as required by the organization, the customer, and the applicable product specifications.
7.5.3.2 Identification and traceability maintenance and replacement — Supplemental
Control features shall include requirements for maintenance or replacement of identification and traceability marks, and records.
7.5.3.3 Product status — Supplemental
The organization shall establish control features (see 3.1.4) for the identification of product status.
7.5.4 Customer property
7.5.4.1 Customer property — Supplemental
The organization shall establish control features (see 3.1.4) for the verification, storage, maintenance and control of customer property.
7.5.5 Preservation of product
7.5.5.1 Preservation of product — Supplemental
The organization shall establish control features (see 3.1.4) describing the methods used to preserve the conformity of product for the activities of 7.5.5.
7.5.5.2 Periodic assessment of stock — Supplemental
In order to detect deterioration, the condition of product or constituent parts in stock shall be assessed at specified intervals.
NOTE 7.5.5.2 includes the possible use of an inventory management system to optimize inventory turn-over time and assure stock rotation, such as “first-in-first-out” (FIFO).
7.6 Control of monitoring and measuring devices
7.6.1 Control of monitoring and measuring devices — Supplemental
The organization shall establish control features (see 3.1.4) to control, calibrate and maintain monitoring and measuring devices. Control features shall include device type, unique identification, location, frequency of checks, check method, and acceptance criteria.
7.6.2 Environmental conditions — Supplemental
The organization shall ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.
NOTE Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment should include
- equipment identification, including the measurement standard against which the equipment is calibrated,
- revisions following engineering changes,
- any out-of-specification readings as received for calibration/verification,
- an assessment of the impact of out-of-specification condition, and
- notification to the customer if suspect product or material has been shipped.
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.2.1 Internal audit — Supplemental
Internal audits shall be scheduled and conducted at least annually by personnel independent of those who performed or directly supervised the activity being audited.
8.2.2.2 Response times — Supplemental
The organization shall identify response times for addressing detected nonconformities. NOTE ISO 19011 has replaced ISO 10011 (all parts).
8.2.3 Monitoring and measurement of processes
NOTE 8.2.3 includes maintaining records of the effective dates of process changes.
8.2.4 Monitoring and measurement of product
8.2.4.1 Monitoring and measurement of product — Supplemental
The organization shall establish control features (see 3.1.4) to monitor and measure the characteristics of the product.
8.2.4.2 Acceptance inspection — Supplemental
Personnel other than those who performed or directly supervised the production of the product shall perform final acceptance inspection (see 3.1.2) at planned stages of the product realization process.
8.3 Control of nonconforming product
8.3.1 Release or acceptance of nonconforming product — Supplemental
The process of evaluation, release and acceptance of nonconforming product shall include one or more of the following.
a) accepting products that do not satisfy manufacturing acceptance criteria provided that — products satisfy the design acceptance criteria,
— the violated manufacturing acceptance criteria are categorized as unnecessary to satisfy the design acceptance criteria, or
— products are repaired or reworked to satisfy the design acceptance criteria or manufacturing acceptance criteria;
b) accepting products that do not satisfy the original design acceptance criteria provided that — the original design acceptance criteria are changed per 7.3.7, and
— the materials or products satisfy the new design acceptance criteria.
8.3.2 Field nonconformity analysis — Supplemental
The documented procedure for nonconforming product shall include requirements for identifying, documenting and reporting incidents of field nonconformities or product failures (see 3.1.9). The documented procedure shall ensure the analysis of field nonconformities, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause.
8.3.3 Customer notification — Supplemental
The organization shall notify customers in the event that product which does not conform to design acceptance criteria (see 3.1.6) has been delivered. The organization shall maintain records of such notifications (see 4.2.4).
8.4 Analysis of data
8.4.1 Analysis of data — Supplemental
The organization shall establish control features (see 3.1.4) for the identification and use of the techniques for the analysis of data.
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.2.1 Corrective action — Supplemental
The organization shall ensure that any corrective action is effective.
8.5.2.2 Response times — Supplemental
The organization shall identify response times for addressing corrective action.
8.5.3 Preventive action
8.5.3.1 Preventive action — Supplemental
The organization shall ensure that any preventive action is effective.
