Q2 Conformity MatrixAPI Q2申请符合性矩阵表

Tier 1 (Quality Manual) Tier 2 (Procedure/Work Tier 3 (Procedure/Work Document Number/ID, Instruction) Instruction) Revision Level, Document Document Number/ID, Document Number/ID, Description Revision Level, Document Revision Level, Document Description Description
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193506324.xlsx
Company: Facility Name/ID: Date:
Reference: API Spec Q2 1st Ed Paragraph Number
4.2.1
Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed in your Quality Management System Documentation. If you are applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes for each requirement being excluded. See Section 1 of Q1 for a list of allowable
Hale Waihona Puke 4.1.44.1.5
Communications
Company: Facility Name/ID: Date:
Reference: API Spec Q2 1st Ed Paragraph Number Reference Requirement
Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed in your Quality Management System Documentation. If you are applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes for each requirement being excluded. See Section 1 of Q1 for a list of allowable
Company: Facility Name/ID: Date:
Reference: API Spec Q2 1st Ed Paragraph Number Reference Requirement
Instructions Please provide a Tier 1 (Quality Manual) reference and/or a Tier 2 (Procedure/Work Instruction) reference where each requirement has been addressed in your Quality Management System Documentation. If you are applying for exclusions to your QMS, please indicate “Excluded” in the Tier 1/Tier 2 boxes for each requirement being excluded. See Section 1 of Q1 for a list of allowable
Reference
Requirement
Organization Structure Management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the organization the importance of meeting customer as well as legal and other applicable requirements; b) ensuring that quality objectives are established including key performance indicators (KPIs) for use in data analysis; and c) conducting management reviews (see 6.5). Responsibility Roles, responsibilities and authorities shall be and Authority defined, documented, assigned within, and communicated throughout the organization. The organization's management shall appoint a specific management representative(s) from within the organization who shall have defined roles, responsibilities and authority for: a) ensuring that the quality management system is established, implemented and maintained in accordance with the requirements of this document; b) initiating action(s) to minimize the likelihood of the occurrence of nonconformities; and c) reporting to management on the performance of the quality management system for review, including recommendations for improvement. Organization Capability Provision of The organization shall determine and provide the Resources resources needed to implement, maintain, and improve the effectiveness of the quality management Human Resources
4 4.1 4.1.1
4.1.2
4.1.3
Quality Management System Requirements General Quality The organization shall establish, document, Management implement, maintain, measure effectiveness of, and System 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. Quality Policy The organization’s policy for its commitment to quality shall be defined, documented, and approved by top management. The organization’s top management shall review the quality policy to ensure that it is appropriate to the 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 Objectives Management shall ensure that quality objectives, including those needed to meet requirements for the service and service-related product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. Planning Management shall ensure that: a) the planning of the quality management system is carried out in order to meet the requirements of this document, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Page 1 of 29 193506324.xlsx