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Iso 9001 & Api Q 1

This document outlines the requirements for an ISO 9001 quality management system and an API Specification Q1 quality management system. Both documents discuss establishing the quality policy and objectives, determining roles and responsibilities, planning for quality management, supporting the system through resources and competence, operating procedures, and ensuring control of externally provided products and services. Some key differences include the API Specification providing more detail around risk management, product design and development, purchasing controls, and contingency planning.

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Marzuk Mudjahid
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0% found this document useful (0 votes)
411 views4 pages

Iso 9001 & Api Q 1

This document outlines the requirements for an ISO 9001 quality management system and an API Specification Q1 quality management system. Both documents discuss establishing the quality policy and objectives, determining roles and responsibilities, planning for quality management, supporting the system through resources and competence, operating procedures, and ensuring control of externally provided products and services. Some key differences include the API Specification providing more detail around risk management, product design and development, purchasing controls, and contingency planning.

Uploaded by

Marzuk Mudjahid
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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ISO 9001 API Specification Q1,

1 Scope.. 1 Scope....................................................................................................
2 Normative references.. 2 Normative references...........................................................................
3 Terms and definitions......................................................... 3 Terms, definitions and abbreviations...................................................
4 Context of the organization................................................ 3.1 Terms and definitions .......................................................................
4.1 Understanding the organization and its context............. 3.2 Abbreviations ....................................................................................
4.2 Understanding the needs and expectations of interested4 Quality Management System Requirements........................................
4.3 Determining the scope of the quality management syste4.1 Qualtiy Management System............................................................
4.4 Quality management system and its processes...............4.1.1 General ..........................................................................................
5 Leadership...........................................................................4.1.2 Quality Policy .................................................................................
5.1 Leadership and commitment........................................... 4.1.3 Quality Objectives ..........................................................................
5.1.1 General......................................................................... 4.1.4 Planning..........................................................................................
5.1.2 Customer focus............................................................. 4.1.5 Communication..............................................................................
5.2 Policy................................................................................ 4.1.5.1 Internal........................................................................................
5.2.1 Establishing the quality policy.......................................4.1.5.2 External........................................................................................
5.2.2 Communicating the quality policy................................ 4.2 Management Responsiblity ..............................................................
5.3 Organizational roles, responsibilities and authorities......4.2.1 Organization Structure...................................................................
6 Planning.............................................................................. 4.2.2 Responsibility and Authority .........................................................
6.1 Actions to address risks and opportunities...................... 4.2.3 Management Representative ........................................................
6.2 Quality objectives and planning to achieve them............4.3 Organization Capability ....................................................................
6.3 Planning of changes......................................................... 4.3.1 Provision of Resources ...................................................................
7 Support............................................................................... 4.3.2 Human Resources...........................................................................
7.1 Resources......................................................................... 4.3.2.1 General .......................................................................................
7.1.1 General......................................................................... 4.3.2.2 Personnel Competence...............................................................
7.1.2 People........................................................................... 4.3.2.3 Training and Awareness .............................................................
7.1.3 Infrastructure................................................................ 4.3.3 Work Environment ........................................................................
7.1.4 Environment for the operation of processes................ 4.4 Document Requirements ..................................................................
7.1.5 Monitoring and measuring resources........................... 4.4.1 General ..........................................................................................
7.1.6 Organizational knowledge............................................ 4.4.2 Control of Documents....................................................................
7.2 Competence..................................................................... 4.4.3 Use of External Documents in Product Realization........................
7.3 Awareness........................................................................4.5 Control of Records.............................................................................
7.4 Communication................................................................5 Product Realization...............................................................................
7.5 Documented information................................................ 5.1 Contact Review .................................................................................
7.5.1 General......................................................................... 5.1.1 General ..........................................................................................
7.5.2 Creating and updating.................................................. 5.1.2 Determination of Requirements.....................................................
7.5.3 Control of documented information.............................5.1.3 Review of Requirements................................................................
8 Operation............................................................................ 5.2 Planning.............................................................................................
8.1 Operational planning and control.................................... 5.3 Risk Assessment and Management ..................................................
8.2 Requirements for products and services......................... 5.4 Design and Development..................................................................
8.2.1 Customer communication............................................ 5.4.1 Design and Develoment Planning ..................................................
8.2.2 Determining the requirements for products and servic5.4.2 Design and Development Inputs ...................................................
8.2.3 Review of the requirements for products and services 5.4.3 Design and Development Outputs.................................................
8.2.4 Changes to requirements for products and services.... 5.4.4 Design and Development Review...................................................
8.3 Design and development of products and services......... 5.4.5 Design and Development Verification............................................
8.3.1 General......................................................................... 5.4.6 Design and Development Validation .............................................
8.3.2 Design and development planning............................... 5.4.7 Design Approval and Release ........................................................
8.3.3 Design and development inputs................................... 5.4.8 Design and Development Changes ................................................
8.3.4 Design and development controls................................ 5.5 Contingency Planning (Business Continuity Management)...............
8.3.5 Design and development outputs.................................5.5.1 General...........................................................................................
8.3.6 Design and development changes................................ 5.5.2 Planning Output.............................................................................
8.4 Control of externally provided processes, products and  5.6 Purchasing.........................................................................................
8.4.1 General......................................................................... 5.6.1 Purchasing Control ........................................................................
8.4.2 Type and extent of control............................................5.6.1.1 Procedure ...................................................................................
8.4.3 Information for external providers............................... 5.6.1.2 Initial Supplier Evaluation ‐ Critical .............................................
8.5 Production and service provision.....................................5.6.1.3 Initial Supplier Evaluation ‐ Noncritical ......................................
8.5.1 Control of production and service provision................ 5.6.1.4 Supplier Re‐evaluation................................................................
8.5.2 Identification and traceability....................................... 5.6.1.5 Supplier Evaluation ‐ Records .....................................................
8.5.3 Property belonging to customers or external provider 5.6.2 Outsourcing....................................................................................
8.5.4 Preservation.................................................................. 5.6.3 Purchasing Information..................................................................
8.5.5 Post‐delivery activities.................................................. 5.6.4 Verification of Purchased Services or Products..............................
8.5.6 Control of changes........................................................ 5.7 Production and Servicing Provision...................................................
8.6 Release of products and services..................................... 5.7.1 Control of Production and Servicing...............................................
8.7 Control of nonconforming outputs.................................. 5.7.1.1 Production and Servicing Procedure ..........................................
9 Performance evaluation..................................................... 5.7.1.2 Process Control Documents........................................................
9.1 Monitoring, measurement, analysis and evaluation....... 5.7.1.3 Product Realization Capability Documentation ..........................
9.1.1 General......................................................................... 5.7.1.4 Validation of Processes for Production and Servicing.................
9.1.2 Customer satisfaction................................................... 5.7.1.5 Servicing Procedure.....................................................................
9.1.3 Analysis and evaluation................................................ 5.7.2 Product Quality Plans ....................................................................
9.2 Internal audit................................................................... 5.7.2.1 General........................................................................................
9.3 Management review........................................................ 5.7.2.2 Plan Content ...............................................................................
9.3.1 General......................................................................... 5.7.2.3 Plan Approval ..............................................................................
9.3.2 Management review inputs.......................................... 5.7.3 Identification and Traceability........................................................
9.3.3 Management review outputs....................................... 5.7.4 Product Status................................................................................
10 Improvement.................................................................... 5.7.5 Customer Property ........................................................................
10.1 General. 5.7.6 Preservation of Product .................................................................
10.2 Nonconformity and corrective action............................ 5.7.6.1 General........................................................................................
10.3 Continual improvement.... 5.7.6.2 Storage and Assessment .............................................................
Annex A (informative) Clarification of new structure, termin5.7.7 Inspection and Testing....................................................................
Annex B (informative) Other International Standards on qua5.7.7.1 General........................................................................................
management systems developed by ISO/TC 176.................. 5.7.7.2 In‐process Inspection and Testing ..............................................
5.7.7.3 Final Inspection and Testing........................................................
5.7.8 Preventive Maintenance................................................................
5.8 Control of Testing, Measuring and Monitoring Equipment for Produ
5.9 Final Product Release .......................................................................
5.10 Control of Nonconforming Product ................................................
5.10.1 General.........................................................................................
5.10.2 Nonconforming Product...............................................................
5.10.3 Release or Acceptance of Nonconforming Product under MAC o
5.10.4 Field Nonconformity Analysis.......................................................
5.10.5 Customer Notification .................................................................
5.11 Management of Change .................................................................
6 Measurement, Analysis and Improvement .........................................
6.1 General..............................................................................................
6.2 Monitoring, Measuring and Improving .............................................
6.2.1 Customer Satisfaction.....................................................................
6.2.2 Internal Audit .................................................................................
6.2.2.1 General........................................................................................
6.2.2.2 Performance of Internal Audit.....................................................
6.2.2.3 Audit Review and Closure............................................................
6.2.3 Monitoring and Measurement of Processes..................................
6.3 Analysis of Data.................................................................................
6.4 Improvement.....................................................................................
6.4.1 General...........................................................................................
6.4.2 Corrective Action ...........................................................................
6.4.3 Preventive Action...........................................................................
6.5 Management Review.........................................................................
6.5.1 General ..........................................................................................
6.5.2 Input Requirements........................................................................
6.5.3 Output Requirements.....................................................................
Annex A (informative) API Monogram Program Requirements..............
Annex B (informative) Comparison to API Spec Q1, 9th Edition.............
Annex C (informative) Comparison to API Spec Q1, 8th Edition.............

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