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SC18 TG5 Development of a Guidance Document for the implementation of API Specification Q2

SC18 TG5 Development of a Guidance Document for the implementation of API Specification Q2 Objective Create a guidance document for users of the API Specification Q2 document. The guidance document should provide references to establishing a QMS. 1 . Scope

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SC18 TG5 Development of a Guidance Document for the implementation of API Specification Q2

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  1. SC18 TG5 Development of a Guidance Document for the implementation of API Specification Q2 Objective Create a guidance document for users of the API Specification Q2 document. The guidance document should provide references to establishing a QMS. 1. Scope This document is intended to provide guidance to organizations that have an understanding of implementing quality management systems. This is not intended to provide training on the development and implementation of a quality management system. This document will not provide guidance to each section of the API Q2 Specification. This specification does not apply to the API Monogram Program or any product that is identified by license as eligible for marking with the API Monogram. Development Process Slower than the development of the Specification Meeting Monthly with the objective of submitting a draft by the end of 2012.

  2. Development Example • 4. New Sections not found in API Specification Q1 • Below is a list of sections in API Specification Q2 which were not addressed in previous editions of API Quality Management Systems: • Legal Requirements (4.1.1) • Contract Review (5.1) • Risk Assessment and Management (5.3) • Service Design & Development (5.4) • Contingency Planning (5.5) • Execution of Service (5.7) • Validation of Service-related Product (5.7.7) • Preventive Maintenance, Inspection, & Test (5.7.8) • Service Performance Validation (5.9) • Management of Change (5.11)

  3. Example of Supporting Information • Legal Requirements (4.1.1) – There may be different legal, statutory, or regulatory requirements depending on the geographical region. The expectation is that the organization demonstrate due diligence of both investigation and resolution of legal requirements. (Q2 3.1.9) • Statutory legal requirements are mandatory requirements from a governmental body (e.g., International, Country, State, Commonwealth, City, etc.) in the form of legislation. Regulatory Requirements are rules issued by some agency that a government body has given authority to regulate an industry. Both Governmental and Regulatory Agencies can make a Technical Standard or Recommended Practice mandatory. • Statutory legal and regulatory requirements can impact: • Design; some examples: • Use of required Technical Codes & Standards as required by Regulation • Use and or restriction of some substances or chemistry • Restrictions on exporting State of the Art Technology • Manufacturing, Installation & Services • Testing & Inspection • Certifications; such as: • Design, Fabrication, In-process, Personnel & End-Product • Operation for Use, Maintenance, Disposal; some examples: • Safe use, handling, maintenance, & operation of the equipment • Approved methods of disposal/recycling • Additional reference can be found in ISO 14001, and OHS 18001 (ISO?) • Legal requirements may be an input for Contract Review.

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