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The 33 Extra Requirements of API Spec Q1, 7th Edition

The 33 extra quality management system requirements found in API Spec Q1 (when compared to ISO 9001:2000)
Quality Management System Elements
1. Section 4.2.2.1 requires the quality manual to identify the manner in which the organization addresses each specific requirement of API Spec Q1, including both the requirements of ISO 9001:2000 and the supplemental requirements. 2. Section 4.2.3.1 requires the use of a master list (or equivalent) to identify the documents required by the quality management system, and their current revision status. 3. Section 4.2.3.2 requires that changes to documents be reviewed and approved by the same functions that performed the original review and approval. 4. Section 4.2.4.1 requires that records required by applicable industry product standards or to provide evidence of conformity to requirements and of the effective operation of the quality management system be retained for not less than the period of time specified by the industry standard or five years, whichever is longer. 5. Section 5.3.1 requires top management to document its approval of the quality policy. 6. Section 5.6.1.1 requires management reviews to be conducted at least annually. 7. Section 6.2.2.1 requires the organization to establish control features for identifying and providing training and that frequency of traning be defined. 8. Section 7.2.2.1 requires the organization to establish control features to review requirements related to the product. 9. Section 7.3.1.1 requires the organization to establish control features for the design of the product. 10. Section 7.3.1.2 requires that design documentation includes methods, assumptions, formulas, and calculations. 11. Section 7.3.2.1 requires that design and development inputs include customer specified requirements. 12. Section 7.3.4.1 requires that individual(s) other than the person or persons who developed the design approve the final design. 13. Section 7.3.7.1 requires that design and development changes utilize the same controls as the original design and development. 14. Section 7.4.1.1 requires the organization to establish control features for the purchasing process and supplier selection. 15. Section 7.4.1.2 requires that the criteria for the selection, evaluation and re-evaluation of suppliers include one or more of the following: a) Inspection of suppliers final product by the organization at suppliers facility, b) Inspection of suppliers final product by the organization upon delivery, c) Surveillance of suppliers conformance to the organizations purchasing requirements, d) Verification by the organization that the suppliers quality management system conforms to an internationally recognized quality management system standard/technical specification. 16. Section 7.4.2.1 requires that purchasing information provided to the supplier be documented and describe the product to be purchased, including, where appropriate: 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. 17. Section 7.4.3.1 requires the organization to establish control features for the verification of purchased product. 18. Section 7.5.1.1 requires the organization to establish control features for the production and service activities performed. 19. Section 7.5.1.2 requires that process control documents include or reference instructions, workmanship and acceptance criteria for processes, tests, inspections, and customers inspection hold or witness points. 20. Section 7.5.2.1 requires the organization to establish control features for the qualification and validation of special processes. 21. Section 7.5.3.1 requires the organization to establish control features for identification and traceability of the product as required by the organization, the customer, and the applicable product specifications. 22. Section 7.5.3.2 requires that controls include maintenance or replacement of identification and traceability marks, and records. 23. Section 7.5.3.3 requires the organization to establish control features for the identification of product status. 24. Section 7.5.4.1 requires the organization to establish control features for the verification, storage, maintenance and handling of customer property. 25. Section 7.5.5.1 requires the organization to establish control features for the methods used to preserve the conformity of product. 26. Section 7.5.5.2 requires assessment of the condition of the product or constituent parts in stock at specified intervals to detect deterioration. 27. Section 7.6.1 requires the organization to establish control features for the calibration and maintenance of monitoring and measuring devices. 28. Section 7.6.2 requires the organization to ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out. 29. Section 8.2.2.1 requires internal audits to be scheduled and conducted at least annually. 30. Section 8.2.4.1 requires the organization to establish control features for the monitoring and measuring of the characteristics of the product. 31. Section 8.2.4.2 requires that personnel other than the persons who performed or directly supervised the production of the materials or products perform final acceptance and product release. 32. Section 8.3.2 requires that the process of evaluation, release and acceptance of nonconforming product to include one or more of the following: a) Accepting products that do not satisfy manufacturing acceptance criteria provided: i) Products satisfy the design acceptance criteria, or ii) The violated manufacturing acceptance criteria are categorized as unnecessary to satisfy the design acceptance criteria, or iii) 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: i) The original design acceptance criteria are changed within the guidelines prescribed by the technical specifications, and ii) The materials or products satisfy the new design acceptance criteria. 33. Section 8.4.1 requires the organization to establish control features for the identification and use of the techniques for the analysis of data. Definition from Section 3.1.3: Control Feature Organizations documented method to perform an activity under controlled conditions to achieve conformity to specified requirements.

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