Professional Documents
Culture Documents
Iso 9001 & Api Q 1
Iso 9001 & Api Q 1
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.............