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QUALITY MANUAL
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Introduction I...................................Description II...................................Quality Manual III..................................Scope of the quality management system IV..................................Quality policy and responsibility V...................................Certification VI .................................Organization chart Quality Management System (QMS) Activities I Quality Management System 1. General Requirements 2. Process Mapping 3. Process Matrix X Normative Elements 4. Diagram of a Customer Oriented Process (COP) II Documentation Requirements 1. Generalities 2. Quality Manual 3. Document Control 4. Control of Quality Records III Management Responsibility 1. Commitment 2. Focus on the Customer 3. Quality Policy 4. Planning 4.1 Quality Objectives 4.2 Quality Management System Planning 5. Responsibility, Authority and Communication 5.1 Responsibility and Authority 5.2 Management Representative 5.3 Internal Communication 6. Critical Analysis by Management 6.1 Generalities 6.2 Critical Analysis Input 6.3 Critical Analysis Output IV Resource Management 1. Resource Supply 1.1. Human Resources 1.1.1 Generalities 1.1.2 Competence, Awareness and Training 1.2 Infrastructure 1.3 Work Environment
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08/09/2010 V Product Execution 1. Product Execution Planning 2. Processes Related to Customers 2.1 Determination of Product Related Requirements 2.2 Critical Analysis of Product Related Requirements 2.3 Communication with Customers 3. Design and Development 3.1 Design and Development Planning 3.2 Design and Development Inputs 3.3 Design and Development Outputs 3.4 Critical Analysis of Design and Development 3.5 Design and Development Verification 3.6 Design and Development Validation 3.7 Control of Alterations in Design and Development 4. Purchasing 4.1 Purchasing 4.2 Information for Purchasing 4.3 Purchased Product Verification 5. Production and Service Supply 5.1 Production Control and Service Supply 5.2 Process Validation and Service Supply 5.3 Identification and Traceability 5.4 Customer Property 5.4a Customer Production Tools 5.5 Product Preservation 5.6 Control of Measurement and Monitoring Devices VI Measurement, Analysis and Improvement 1. Generalities 2. Measurement and Monitoring 2.1 Customer Satisfaction 2.2 Internal Audits 2.3 Process Measurement and Monitoring 2.4 Product Measurement and Monitoring 3. Control of Nonconformance Products 4. Data Analysis 5. Improvements 5.1 Continuous Improvement 5.2 Corrective Actions 5.3 Preventive Actions
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This Quality Manual describes the GE-GEVISA S. A. Quality Management System that reflects the following norm requirements: ISO 9001 Ed. 2008 Quality Management System EN 13980 Potentially explosive atmospheres Application of quality systems GE Energy procedures The following aspects were taken into consideration when structuring the Quality System: Quality Policy and company objectives. Installations and material and human resources. Technical, cultural and own management knowledge. II- QUALITY MANUAL: This Quality Manual describes the GE-GEVISA S.A. Quality Management System, integrating its technical and administrative culture, installations, and material and human resources and is approved by the Ge Energy. The Management Representative elaborates and maintains the Quality Manual, which is approved by the Plant Manager and Quality Control Manager The revision is elaborated, verified and approved in an identical manner as the prior issue. The Manuals situation is controlled by means of its revision index, characterized by alterations in one or more divisions. The Quality Manual is only available in electronic media printed. Copies and distributions are not permitted and controlled. The quality terminology used can be found in ISO 9000/2000 Quality Management System / Fundamentals and Vocabulary. The GE Energy Quality Manual complement the Gevisa Quality Manual and it is attached.
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III SCOPE OF THE QUALITY MANAGEMENT SYSTEM: Design, Manufacture and Service of medium and large motors & generators and Industrial Services BASEEFA SCOPE: Custom 8000 TEAAC induction motors, Ex NII T3 (BS500:part 6) Product list Atex type Examination Certificates
A) EXCLUSIONS For Industrial Services, Requirement 3 of Design and Development does not apply since it is a the customers responsibility.
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IV QUALITY POLICY AND RESPONSIBILITY This policy of GE GEVISA establishes, as a strategic objective, reaching and maintaining a reputation of leadership with respect to the quality of its products and services, continuingly striving to meet and exceed its customers expectations. In accordance with this policy, GE GEVISA recognize that the human factor is fundamental in obtaining total quality, and that all necessary support should be given to people for their full understanding of this premise. Pursuing quality through all existing processes is an endless mission, which is aimed at the continuous improvement of any task, which adds value to the product or service, thus emphasizing a constant participation of each employee and teamwork. Specific activities, which preserve the environment and the individual safety of each contributor, shall be considered a priority and shall have full management support. General prevention is also considered a strategic business point through the permanent search of the continuous improvement process. To implement this policy, the company delegates to each individual contributor his personal commitment, encouraging and facilitating his self-confidence, simplicity and speed in performing any pertinent task. This policy, together with internal procedures and routines, gives support to the quality system applied by the company and described in the quality manual.
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V- CERTIFICATION We certify that this quality manual, together with the internal routines and written procedures, truthfully describes the Quality System applied at the GE - Gevisa plant in Campinas SP.
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VI ORGANIZATION CHART
Sales
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Final test
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GE GEVISA S. A. establishes, documents, implements and maintains a quality management system and continuously improves its effectiveness according to ISO 9001:2008 requirements. GE GEVISA S.A.: a) identifies the necessary processes for the quality management system and for its application throughout the entire organization; b) determines the sequence and the interaction for these processes; c) determines the necessary criteria and methods for ensuring the effective operation and control of these processes; d) ensures the availability of necessary resources and information to support the operation and monitoring of these processes; e) monitors, measures and analyzes these processes, and; f) implements the necessary measures to reach the planned results and the continuous improvement of these processes. These processes are managed by GE GEVISA S. A. in compliance with ISO 9001:2008 requirements. Whenever GE GEVISA S.A. opts to purchase any process externally that may affect product conformity with regard to requirements, GE GEVISA S.A. guarantees the control of these processes. The control of said processes is identified in the quality management system.
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Management
Customer
Responsibility
QM-section C- III
Resource
Measurement, Analysis and e improvement
Requirements
Management
Product Inputs
Execution QM-section C- V
Product
Outputs
Process Mapping
Management Process
Customer (Requirements)
Sales Process
Design Process
Sourcing Process
Manufacturing Process
Expediting Process
COP Process (Customer Oriented Process) This process is being considered in each key process.
COP process (customer oriented process) Process is considered in each key process
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Resources Managment
Customer
QM-section C- IV
QM-section C- VI
Satisfaction
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4.1 General Requirements 4.2.1 Generalities 4.2.3 Document Control 4.2.4 Quality Record Control 5.1 Management Commitment 5.2 Focus on the Customer 5.3 Quality Policy 5.4 Planning 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Critical Analysis by Management 6.1 Resource Supply 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment 7.1 Product Execution Planning 7.2 Processes Related to Customers 7.3 Design and Development 7.4 Purchasing 7.5.1 Production Control and Service Supply 7.5.2 Production Process Validation 7.5.3. Identification and Traceability 7.5.4 Customer Property 7.5.5 Product Preservation 7.6 Measurement and Testing Equipment Control 8.1 Generalities 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Process Measurement and Monitoring 8.2.4 Product Measurement and Monitoring 8.3 Control of Nonconformance Product 8.4 Data Analysis 8.5.1 Continuous Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action
Sales
(*) To QMS Matrix Gevisa x GEE procedures x WI ISMWI see the appendix on page 31.
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PROCESSES
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Final testing
Reference Documents
QMS Routines Routine 2.11 Routine 2.9 / Routine 2.17 Routines 2.6 and 2.16 Routine 2.7 Routine 2.8 Routine 2.9 Routine 2.9 Routine 2.9 Routines 2.6 and 2.16 Routine 2.10 Routine 2.14
Routine 2.12. Routines 2.13 and 2.12 Routine 2.3 Routine 2.12 Routines 2.09 and 2.12 Routine 2.4
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4 COP DIAGRAM
Sales
Production.
Planning
Internal
Audit
Design/Dev.
Expediting
- Quantity
- Period of Time - Logistics Identif. and Packaging and Delivery Req.
Management Process: Performs at interfaces between COPs and interfaces x Customer, through the CRITICAL ANALYSIS BY MANAGEMENT Customer Interface Customer Input Customer Output
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-Product Specifications - Proc. Variab. Reduction -Non Declared Req. Prod. -Cost/Price Reduction -Packaging Requirements
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II DOCUMENTATION REQUIREMENTS 1) GENERALITIES The quality management system documentation includes: a) documented declarations of the quality policy and the quality objectives; b) quality manual; c) documented procedures required by ISO 9001:2008; d) documents required by GE GEVISA S.A. to ensure the effective planning, operation and control of its processes, and; e) quality records required by ISO 9001:2008. 2) QUALITY MANUAL GE GEVISA S.A. elaborates and maintains a quality manual that includes: a) the scope of the quality management system, including details and justifications for any exclusions; b) the documented procedures established for the quality management system, or references to them, and; c) the description of the interaction between the quality management system processes. 3) DOCUMENT CONTROL
The documents required by the quality management system are controlled. Quality records are a special type of document and are controlled in conformance with the requirements set forth in C-II-4. A documented procedure is established to define the necessary controls to: a) approve documents as to their conformance prior to issuance; b) critical analyze and update documents, whenever necessary, and approve them again; c) ensure that alterations and the documents current revision situation are identified; d) ensure that the pertinent versions of applicable documents are available in those areas where they will be used; e) ensure that documents remain legible and readily identifiable; f) ensure that documents with an external origin are identified and that their distribution is controlled, and; g) avoid the unintentional use of obsolete documents and apply the proper identification in those cases whereby they are retained for any reason.
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4)
Quality records are established and maintained to provide proof of conformance with requirements and of the effective operation of the quality management system. Records are kept legible, readily identifiable and recoverable. A documented procedure is established to define the necessary controls for the identification, storage, protection, recovery, retention period and discarding of records. Note: Disposal implies in discarding
III MANAGEMENT RESPONSIBILITY 1) MANAGEMENT COMMITMENT Top management represented by the Quality Committee provides proof of its commitment to the development and the implementation of the quality management system and with the continuous improvement of its effectiveness by means of: a) the communication to the organization of the importance in satisfying customer requirements as well as regulatory and statutory requirements; b) the institution of the quality policy; c) the guarantee that the quality objectives have been established; d) the carrying out of critical analyses by the Quality Committee, and; e) the guarantee of resource availability. 2) FOCUS ON THE CUSTOMER
Top management, through the Quality Committee, ensures that customer requirements are determined and satisfied with the aim of increasing customer satisfaction. In order to confirm that these requirements and their purposes are being satisfied, customer satisfaction surveys are carried out and the results are analyzed by Top Management, through the Quality Committee. 3) QUALITY POLICY
Top Management, through the Quality Committee ensures that the quality policy: a) is appropriate for GE GEVISA S.A. purposes; b) includes a commitment to satisfying requirements and to the continuous improvement of the quality management systems effectiveness;
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c) provides a structure for establishing and critically analyzing quality objectives; d) is communicated and understood throughout the entire organization, and; e) is critically analyzed for maintaining its conformance. 4) PLANNING 4.1) Quality Objectives Top Management, through the Quality Committee, ensures that the quality objectives, including those necessary to satisfy product requirements, are established in the pertinent functions and levels at GE GEVISA S.A.. The quality objectives are measurable and coherent with the quality policy. 4.2) Planning of the Quality Management System
Top Management, through the Quality Committee, ensures that: a) the planning of the quality management system is carried out in a manner to satisfy those requirements cited in 4.1, as well as the quality objectives, and; b) the integrity of the quality management system is maintained when changes in the quality management system are planned and implemented. 5) RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.1) Responsibility and Authority Top Management, through the Quality Committee, ensures that the responsibilities and authorities are defined and communicated at GE GEVISA S.A.. 5.2) Management Representative
Top Management appoints GE GEVISA S.A.s Quality Control Manager, who regardless of other responsibilities, has the responsibility and the authority to: a) ensure that the necessary processes for the quality management system are established, implemented and maintained; b) report to Top Management, through the Quality Committee, concerning the quality management systems performance and any need for improvement, and; c)ensure the fomentation of awareness concerning customer requirements throughout the organization.
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5.3)
Internal Communication
Top Management, through the Quality Committee, ensures that GE GEVISA S.A. establishes the appropriate communication processes and that communication is carried out concerning the effectiveness of the quality management system using, however not being limited to, the following: Informative meetings and other team meetings; Bulletin boards and internal 08/09/2010spapers; Electronic communication media; 6) CRITICAL ANALYSIS BY MANAGEMENT 6.1) Generalities
Top Management, through the Quality Committee, critically analyzes GE GEVISA S.A.s quality management system, at planned intervals, to ensure its continued pertinence, conformance and effectiveness. This critical analysis includes the evaluation of opportunities for improvement and the needs for change in the quality management system, including the quality policy and the quality objectives. Records will be kept of the critical analyses made by Top Management, through the Quality Committee. 6.2) Critical Analysis Inputs
Critical analysis inputs by management include information concerning: a) audit results; b) customer feedback; c) process performance and product conformance; d) situation of preventive and Corrective Actions e) follow-up of measures derived from prior critical analyses made by management; f) changes that may affect the quality management system, and; g) improvement recommendations. 6.3) Critical Analysis Outputs
Critical analysis outputs by management include any decisions and measures related to: a) improvement in the effectiveness of the quality management system and its processes;
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b) product improvement in relation to customer requirements, and; c) resource needs. IV RESOURCE MANAGEMENT 1) RESOURCE SUPPLY
GE GEVISA S.A. determines and provides the necessary resources for: a) implementing and maintaining the quality management system and continuously improving its effectiveness, and; b) increasing customer satisfaction by attending to their requirements. The resources are identified by means of, although not limited to: Critical analysis meetings by Top Management, through the Quality Committee; Training Program; Critical analysis of customer and product requirements; Production Planning; Internal Quality Audits; Requests for Corrective and Preventive Actions. 1.1) Human Resources
1.1.1) Generalities The personnel that carry out activities that affect product quality is competent with regard to education, training, skills and appropriate experience. 1.1.2) Competence, Awareness and Training GE GEVISA S.A.: a) determines the necessary competences for those personnel that carry out jobs that affect product quality; b) provides training or takes other measures to satisfy these competence needs; c) evaluates the effectiveness of measures that have been taken; d) ensures that its personnel is aware of the pertinence and importance of its activities and how they contribute to reaching quality objectives, and; f) keeps the appropriate education, training, skills and experience records (see C-II-4).
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1.2) Infrastructure GE GEVISA S.A. determines, provides and maintains the necessary infrastructure to achieve conformance with product requirements. The infrastructure includes, whenever applicable: a) buildings, work space and associated installations; b) process equipment (materials and equipment as well as computer programs), and; c) support services (such as transportation or communication). 1.3) Work environment
GE GEVISA S.A. determines and manages the work environment conditions required to achieve conformance with product requirements. V) PRODUCT EXECUTION 1) Product Execution Planning
GE GEVISA S.A. plans and develops the necessary processes for product execution. The product execution planning is coherent with the requirements for other quality management system processes. When planning product execution, GE GEVISA S.A. determines the following, whenever appropriate: a) quality objectives and requirements for the product; b) the need for establishing processes and documents and providing specific resources for the product; c) required verification, validation, monitoring, inspection and testing activities that are specific for the product, as well as criteria for product acceptance; d) necessary records to supply evidence that the execution processes and the resulting product attend to the requirements. The output from this planning should be in a format that is appropriate to GE GEVISA S.A. operation methods. 2) Processes Related to Customers
2.1) Determinao dos requisitos relacionados ao produto GE GEVISA S.A. determines: a) the requirements specified by the customer, including the delivery and after delivery activity requirements;
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b) the requirements that are not declared by the Customer, but that are necessary for the specified or intentional use, when known; c) the statutory and regulatory requirements related to the product, and; d) any additional requirement determined by the organization.
2.2)
GE GEVISA S.A. critically analyzes those requirements related to the product. This critical analysis is carried out prior to GE GEVISA S.A. assuming the commitment to supply a product for the customer (for example, presentation of proposals, acceptance of contracts or orders, acceptance of contract or order changes) and ensures that: a) the product requirements are defined; b) the contract or order requirements that differ from those that were previously manifested are resolved, and; c) the organization has the capacity to attend to the defined requirements. Records are kept of critical analysis results and the measures that result from these actions (see C-II-4). When the Customer does not supply a documented declaration of requirements, GE GEVISA S.A. confirms the Customer requirements prior to acceptance. Whenever the product requirements have been changed, GE GEVISA S.A. ensures that the pertinent documents are complemented and that the pertinent personnel are warned about the changed requirements.
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2.3)
GE GEVISA S.A. determines and takes effective measures to communicate with the customers concerning: a) product information; b) handling of consultations, contracts or orders, including amendments, and; g) customer feedback, including their complaints. Several resources are made available by GE GEVISA S.A. in order to make communication with the customer effective, including, although not limited to: 3) Brochures, Catalogs; Internet Fax, letter, e-mail and telephone; Visits. Design and Development
3.1) Design and Development Planning GE GEVISA S.A. plans and controls product design and development. During design and development planning GE GEVISA S.A. determines: a) the stages for design and development; b) the critical analysis, verification and validation that are appropriate for each phase of design and development, and; c) the responsibilities and authorities for design and development. GE GEVISA S.A. manages the interfaces between the different groups involved in design and development in order to ensure effective communication and the clear attribution of responsibilities. Planning outputs are appropriately updated as the design and development progress.
3.2) Design and Development Inputs Inputs related to product requirements are determined and records are kept (see C-II-4). These inputs include: a) operation and performance requirements; b) applicable statutory and regulatory requirements; c) where applicable, information from similar prior projects, and; d) other essential requirements for design and development.
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These inputs are critically analyzed as to conformance. Requirements are completed, without any ambiguities nor any conflicts between them. 3.3) Design and Development Outputs
Design and development outputs are presented in such a way so as to enable their verification with regard to design and development inputs, and are approved before being released. Design and development outputs: a) attend to the design and development input requirements; b) supply appropriate information for purchasing, production and for supplying services; c) tell or reference product acceptance criteria, and; d) specify those product characteristics that are essential for safe and appropriate use. 3.4) Critical Analysis of Design and Development
Systematic critical analyses of design and development are made during appropriate phases according to planned arrangements: a) to evaluate the capacity of design and development results to attend to the requirements, and; b) to identify any problem and propose the necessary measures. Representatives of functions involved with design and development stage(s) that is(are) being critically analyzed are included among the participants in these critical analyses. Records are kept of critical analysis results and of any necessary measures (see C-II-4). Note: These analyses are normally coordinated with the project phases and include the design and development for the manufacturing process. 3.5) Design and Development Verification Verification is carried out according to the planned arrangements (see C.3.1), in order to ensure that the design and development outputs are attending to design and development input requirements. Records are kept of verification results and of any necessary measures (see C-II-4).
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3.6)
Design and development validation is carried out as per planned preparations (see C.3.1), in order to ensure that the resulting product is capable of attending to the requirements for the specified application or intentional use, when known. Whenever practical, validation is concluded prior to product delivery or implementation. Records are kept of validation results and of any necessary measures (see C-II-4). 3.7) Control of Design and Development Changing Design and development changing are identified and records are maintained. The changes are critically analyzed, verified, and validated, as appropriate, and approved prior to their implementation. The critical analysis of design and development alterations includes the evaluation of the effect of said alterations on component parts and on the already delivered product. Records are kept of the critical analyses results of alterations and of any necessary measures (see C-II-4).
4) 4.1)
GE GEVISA S.A. ensures that the purchased product conforms with the specified purchasing requirements. The type and the extent of control applied to the supplier and to the purchased product depend on the effect of the purchased product on the subsequent execution of the product or final product. GE GEVISA S.A. evaluates and selects suppliers based on their capacity to supply products according to GE GEVISA S.A. requirements. Selection, evaluation, and reevaluation criteria are established. Records are kept of the evaluation results and of any necessary measures, derived from the evaluation (see C-II-4).
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4.2) Purchasing Information The purchasing information describes the product to be purchased and it includes, whenever appropriate, the requirements for: a) approval for the product, procedures, processes and equipment; b) personnel qualifications, and; c) quality management system. GE GEVISA S.A. ensures the purchasing requirement conformance specified prior to their communication to the supplier. 4.3) Purchased Product Verification GE GEVISA S.A. establishes and implements inspection or other necessary activities to ensure that the purchased product attends to the specified purchasing requirements. When the organization or its Customer intends to carry out an inspection of supplier installations, GE GEVISA S.A. declares the intended inspection measures and the product release method in the purchasing information. 5) Production and Service Supply
5.1) Control of Production and Service Supply GE GEVISA S.A. plans and carries out production and the supply of services under controlled conditions. Controlled conditions include, whenever applicable: a) the availability of information that describes product characteristics; b) the availability work instruction, whenever necessary; c) the use of appropriate equipment; d) the availability and use of devices for monitoring and measurement; e) the implementation of measurement and monitoring, and; f) the implementation of release, delivery and post-delivery activities.
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5.2)
GE GEVISA S.A. validates any production process and service supply in which the resulting output cannot be verified through subsequent monitoring and measuring. This includes any process where the deficiencies are only apparent after the product has been in use, or the service has been delivered. The validation demonstrates the capacity of these processes to achieve the planned results. GE GEVISA S.A. takes the necessary measures for these processes, including, when applicable: a) the criteria defined for critical analysis and process approval; b) equipment approval and personnel qualifications; c) use of specific methods and procedures; d) requirements for records (see C-II-4), and; e) revalidation. 5.3) Identification and Traceability
GE GEVISA S.A. identifies the product using the appropriate means over the period of product execution. GE GEVISA S.A. identifies the product situation with regard to monitoring and measuring requirements. When traceability is a requirement, GE GEVISA S.A. controls and registers the only product identification (see C-II-4). 5.4) Customer Property GE GEVISA S.A. takes care of customer property when it is under GE GEVISA S.A. control or being used by it. GE GEVISA S.A. identifies, verifies, protects and safeguards customer property supplied for use or incorporation into the product. If any customer property should be lost, damaged or considered inappropriate for use, this shall be informed to the Customer and records will be made (see C-II-4).
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Note: The customers returnable package is included in this clause. 5.4.A) Customer Production Tools Tools for production, testing, inspection, and equipment that belong to a customer shall b e permanently marked so that the owner identity is visually apparent and can be easily determined. 5.5) Product Preservation
GE GEVISA S.A. preserves product conformity during the internal process and its delivery to the intended destination. This preservation includes identification, handling, packaging, storage and protection. Preservation is also applied to the parts that make up the product. 5.6) Control of Measurement and Monitoring Devices GE GEVISA S.A. determines the measurements and monitoring to be carried out and the necessary measurement and monitoring devices to show product conformity with specific requirements (see 4.2.1). GE GEVISA S.A. establishes the processes to ensure that measurement and monitoring can be carried out and are executed in a manner coherent with measurement and monitoring requirements. Whenever it is necessary to ensure valid results, the measurement device is: a) calibrated or verified at specified intervals or prior to use, and compared to traceable measurement standards and international and national measurement standards; when this standard does not exist, the basis used for calibration or verification shall be recorded; b) adjusted or readjusted, whenever necessary; c) identified to allow for the calibration situation to be determined; d) protected against adjustments that would invalidate the measurement result, and; e) protected from damage and deterioration during handling, maintenance and storage. Furthermore, GE GEVISA S.A. evaluates and registers the validity of prior measurement results when to evidence that the device does not conform with the requirements. GE GEVISA S.A. takes the appropriate measure with the device and with any affected product. Records will be kept of the calibration and verification results (see C-II-4). Computer software capacity is confirmed to satisfy the intended application when used in the measurement and monitoring of specified requirements. This is done prior to the initial use and reconfirmed if necessary.
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VI) MEASUREMENT, ANALYSIS AND IMPROVEMENT 1) Generalities GE GEVISA S.A. plans and implements the necessary processes for monitoring, measurement, analysis and improvement to: a) demonstrate product conformity, b) ensure quality management system conformity, c) continuously improve quality management system effectiveness, and This is to include the determination of applicable methods, including statistical techniques and the extent in which they will be used. 2) Measurement and Monitoring 2.1) Customer Satisfaction
As one of the measurements of the quality management systems performance, GE GEVISA S.A. monitors information related to customer perception as to whether GE GEVISA S.A. attended to customer requirements. The methods for obtaining and using this information are determined. 2.2) Internal Audit
GE GEVISA S.A. carries out internal audits at planned intervals to determine whether the quality management system: a) conforms with the planned arrangements, to the ISO 9001:2008 requirements, and to the quality management system requirements established by GE GEVISA S.A., and; b) is maintained and implemented effectively. An auditing program is planned, taking into account the situation and the importance of the processes and areas to be audited, as well as the results of previous audits. The auditing criteria, scope, frequency and methods are defined. The choice of auditors and the execution of the audits ensure objectivity and impartiality in the auditing process. The auditors do not audit their own work. The responsibilities and requirements for audit planning and execution and reporting the results and keep the records (see C-II-4) are defined in a documented procedure. The person responsible for the area to be audited ensures that the actions will be executed, without any undue delay, to eliminate any detected nonconformities and their causes. The follow-up activities include the verification of executed actions and the reporting of the verification results.
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2.3)
GE GEVISA S.A. applies the appropriate methods for monitoring and, when applicable, for measuring quality management system processes. These methods demonstrate the capacity of the processes to achieve the planned results. When the planned results are not achieved, the corrections are carried out and the Corrective Actions are executed, as necessary, to ensure product conformity. 2.4) Product Measurement and Monitoring
GE GEVISA S.A. measures and monitors product characteristics to verify if the product requirements are satisfied. This is carried out in the appropriate stages of the product execution process according to the planned measure. Evidence of conformity with the acceptance criteria is kept. The records appoint the person(s) authorized to release the product (see C-II-4). Product release and service delivery do not continue until all planned measures have been satisfactorily concluded, unless these are approved in some other manner by a pertinent authority and, whenever applicable, by the customer.
3)
GE GEVISA S.A. ensures that products that do not conform with product requirements will be identified and controlled to avoid their unintentional use or delivery. The controls and related responsibilities and authorities to handle nonconforming products are defined in a documented procedure. GE GEVISA S.A. handles nonconforming products in one or more of the following ways: a) carrying out measures to eliminate the detected nonconformity; b) authorizing their use, release or acceptance under concession by a pertinent authority and, when applicable, by the Customer;
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c) carrying out an action to impede their original intended use or application. Records are kept concerning the nature of the nonconformities and any subsequent actions that were carried out, including the obtained concessions (see C-II-4). When the nonconforming product is corrected, it is rechecked to demonstrate conformity with the requirements. When the products nonconformity is detected after delivery or during initial use, GE GEVISA S.A. takes the appropriate measures with regard to the effects, or potential effects, of the nonconformity. 4) Data Analysis
GE GEVISA S.A. determines, collects and analyzes the appropriate data to demonstrate quality management system effectiveness and fitness and to evaluate where continuous improvements of the quality management systems effectiveness can be carried out. This includes the data generated as a result of monitoring and measurement as well as from other pertinent sources. Data analysis supplies information related to: a) customer satisfaction; b) conformity with product requirements; c) characteristics and tendencies of processes and products, including opportunities for Preventive Actions, and; d) suppliers. 5) Improvements 5.1) Continuous Improvement
GE GEVISA S.A. continuously improves quality management system effectiveness through the use of the quality policy, quality objectives, audit results, data analysis, corrective and Preventive Actions and critical analysis by management. 5.2) Corrective Actions GE GEVISA S.A. carries out Corrective Actions to eliminate the causes of nonconformities so as to avoid their repetition. The Corrective Actions are appropriate for the effects of the nonconformities that are found.
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A documented procedure is established to define the requirements for: a) the critical analysis of the nonconformities (including customer complaints); b) the determination of nonconformity causes; c) the evaluation of the need for measures to ensure that the nonconformities will not occur again; d) the determination and implementation of necessary measures; e) the registry of results from measures that were carried out (see C-II-4), and; f) the critical analysis of Corrective Actions that were carried out. 5.3) Preventive Actions GE GEVISA S.A. defines the measures to eliminate the causes of potential nonconformities in order to avoid their occurrence. The Preventive Actions are appropriate for the effects of the potential problems. A documented procedure is established to define the requirements for: a) defining potential nonconformities and their causes; b) evaluating the need for measures to avoid the occurrence of nonconformities; c) defining and implementing necessary measures; d) recording the results of carried out measures (see C-II-4), and; e) critically analyzing Preventive Actions that were carried out.
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Resp.
Comite
Comite Comite
General Requirements (GEEQMS 4.1) Documentation Requirements - General (GEEQMS 4.2.1) Quality Manual (GEEQMS 4.2.2) Document Control (GEEQMS 4.2.3) Record Control (GEEQMS 4.2.4) Management Commitment (GEEQMS 5.1)
QMS ISMWI-MGMT-03 General Requirements QMS ISMWI-MGMT-06 Documentation Requirements - General QMS ISMWI-MGMT-05 Quality System & Manual QMS ISMWI-MGMT-07 Document Control QMS ISMWI-MGMT-08 Record Control
A Mendes/ R Costa/ Customer Focus (GEEQMS 5.2) Fava A Mendes/ R Costa/ Customer Data Standard (GEEQMS 5.2.1) Fava Comite Comite Quality Quality Policy (GEEQMS 5.3) Quality Objectives (GEEQMS 5.4.1) Quality Management System Planning (GEEQMS 5.4.2) Responsibility, Authority and Communication (GEEQMS 5.5) Management Review (GEEQMS 5.6) QMS ISMWI-MGMT-15 Responsibility, Authority and Communication QMS ISMWI-MGMT-04 Management Review QMS ISMWI-MGMT-01 Quality Policy QMS ISMWI-MGMT-02 Quality Objectives
Comite Comite
2.11
Fernanda
2.11
SGQ
Fernanda
Simone
Comite
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2.22 2.09 2.07 2.06/ 2.16 2.07 Nelson Mancia Nelson New Product Introduction GEEQMS 7.0.2 Planning of Product Realization (GEEQMS 7.1) Lifecycle Control Board (GEEQMS 7.1.1)
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A Mendes/ R Costa/ Customer Related Processes (GEEQMS 7.2) Fava Ney Design and Development (GEEQMS 7.3) Technical Design and Development Review (GEEQMS 7.3.4) Design and Development Validation (GEEQMS 7.3.6)
2.07
Ney Ney/ Nelson/ Renato Calipo/ Fonaro Mancia Leite/ Detoni Leite/ Adaias Leite/ Detoni
Product Safety (GEEQMS 7.3.8) Purchasing (GEEQMS 7.4) Control of Production and Service Provision (GEEQMS 7.5.1) Work Instructions (GEEQMS 7.5.1.1) Equipment Maintenance (GEEQMS 7.5.1.2) Validation of Processes (GEEQMS 7.5.2) QMS ISMWI-MGMT-17 Validation of Processes
Identification and Traceability (GEEQMS 7.5.3) Customer Property (GEEQMS 7.5.4) Preservation of Product (GEEQMS 7.5.5) Control of Monitoring and Measuring Devices (GEEQMS 7.6) Measurement, Analysis and Improvement - General (GEEQMS 8.1) Customer Satisfaction (GEEQMS 8.2.1) QMS ISMWI-MGMT-21 Customer Satisfaction Internal Audit (GEEQMS 8.2.2) Monitoring and Measurement of Processes (GEEQMS 8.2.3) Monitoring and Measurement of Product (GEEQMS 8.2.4) QMS ISMWI-MGMT-18 Control of Monitoring and Measuring Devices QMS ISMWI-MGMT-20 Customer Property
2.12
Leite/ Detoni
2.13/ 2.12
Antonio/ Fava
2.03 2.12
QMS ISMWI-MGMT-10 Internal Auditing QMS ISMWI-MGMT-11 Monitoring and Measurement of Processes QMS ISMWI-MGMT-12 Monitoring and Measurement of Product and Services
2.09/ 2.12
Valmir
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2.04 2.12
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Quality at GE Energy
Table of Contents
GE Energy and Quality Visions Our Customer Commitments The Quality Organization and Policy Quality Management System Key Business Processes Quality Control Mechanisms ISO Cross-Reference 2 3-5 6-8 9-11 12-16 17-18 19-22
Growth Values
External Focus Defines success through the customers eyes In tune with industry dynamics sees around corners Clear Thinker Seeks simple solutions to complex problems decisive Focus communicates clear and consistent priorities Imagination Generates new and creative ideas open to change Resourceful displays courage and tenacity Inclusiveness Teamwork respects others ideas and contributions Creates excitement and drives engagement Expertise Domain depth credibility built from experience Continuously develops self loves learning Always with unyielding integrity!
Passives 4 5
Neutral
Promoters 9 10
Extremely likely
% Detractors (0 through 6)
GE Energy conducts two types of NPS surveys: Relationship NPS - Conducted periodically on a sample basis to gauge overall customer satisfaction with GE Energy Transactional NPS Ongoing surveys to gauge customer satisfaction on specific events or projects, such as an outage, part sale, or repair For each type of NPS survey, the Quality teams analyze the results (including comments) to identify key areas for improvement These teams work with regional, functional, and executive leadership teams to develop an integrated action plan to drive impactful improvement Action plans and subsequent results are reviewed routinely at all levels within the organization
Net Promoter is a registered trademark of Bain & Company, Inc., Fred Reichheld and Satmetrix Systems, Inc.
Customer Requirements
GE Energy understands customer requirements associated with its products and services including those associated with their delivery and ongoing support. This understanding will come from what is stated in the contract, defined by applicable statutory and regulatory authorities, and the customers intended use of the product or service. GE Energy has established channels for effective communication of customer requirements as well as changes thereto throughout its organization.
Product Lines
Support Functions
Quality
Quality Policy
Every GE Energy employee must be committed to: Passionately driving customer satisfaction with all products and services we provide, and building long-term loyalty by partnering with customers to help achieve their success. Ensuring strict compliance with laws and regulations pertaining to the quality, safety and performance requirements in every country where GE Energys products and services are offered. Sustaining continuous improvement in the effectiveness of GE Energys Quality Management System. These commitments will be met with the highest integrity, through clearly documented quality objectives, routine quality management reviews and an all-encompassing Quality culture that employs the Lean Six Sigma methodology.
Continuous Improvement
Document Control
With respect to controlled documents, GE Energy defines, establishes, and maintains document control methods to enable users to readily identify and access the current revision of all such documents. Document management systems store current versions of such documents by unique identifier and revision level. Controlled documents need to be: Legible Identifiable Retrievable A documented procedure defines controls for both internal and externally supplied controlled documents that include: Identification Storage Protection Access authorization
The requirements regarding Document Control have been defined in procedure GEEQMS 4.2.3 Document Control.
Auditing
Focus for Internal Audits Compliance with GE Energys Quality Management System requirements Test effectiveness of process: does the process work as intended and are results achieved? Planning based on status and importance of the process as well as results of previous audits Audit results, including timeliness and effectiveness of Corrective and Preventive Actions, are reviewed by management at all levels of the organization Audit Mechanisms Local audits: for high frequency, detailed process assessments Independent internal audits: full-time and volunteer auditors driving cross-organizational learning Customer and registrar audits Audits are performed to several applicable industry standards. Certification details are available upon request.
The requirements regarding Internal Audit have been defined in procedure GEEQMS 8.2.2 Internal Audit.
Continuous Improvement
GE Energy continually improves the effectiveness of its QMS through: quality policy quality objectives collection and analysis of nonconformance data determination of root cause corrective and preventive actions management reviews GE Energy utilizes Lean Six Sigma methodologies and tools along with traditional quality management activities to drive sustainable improvements.
Customer
Business Processes
Sales Manager
New Products
Customer
Partner
Suppliers
Support Request
Support Processes
SECURITY OF PERSONNEL, FACILITIES AND EQUIPMENT QUALITY MANAGEMENT INFORMATION MANAGEMENT
Inquiry-to-Order (ITO)
Opportunity Identification Process Phase Risk Review Opportunity Screening Proposal Development Submission Approval Negotiated Terms Approval Hand-off to OTR
1
R0
2
R1
3
R2
4
R3
Inquiry-to-Order (ITO)
Sales Marketing Commercial Operations Risk Management Pricing Engineering Sourcing Production Quality Finance Contract Management EHS
Owner Contributor
Inquiry-to-Order Process
Inquiry-to-Order (ITO) at GE Energy provides a standard and consistent process for developing commercial opportunities. GE Energy follows a risk review process to balance customer requirements with GE capabilities and the ability to manage any identified risk. The ITO process is divided into 5 phases: Opportunity identification and screening Opportunity screening and bid/no bid decisions Quote and proposal development, submission approval Negotiated price and terms approval Hand-off to the Order-to-Remittance process
Order-to-Remittance (OTR)
Resource Allocation Procurement Product Realization Fulfilment Receipt of Payment
Order-to-Remittance Process
Project Management Engineering Sourcing Production Finance Quality
Owner Contributor
Order-to-Remittance Process
The Order-to-Remittance (OTR) process covers the execution of a sales contract from the time that the order is initiated to the time that final payment is received. The OTR process is divided into 5 phases: Resource allocation - that includes detailed technical definition as well as planning and scheduling of equipment, material and human resources Procurement - of material resources to complete the order Product realization - where in acquired resources are transformed into final product Fulfillment - where in the product is delivered to the customer specified location and the terms of the contract are fulfilled Receipt of Payment Throughout the process, control points are in place to verify and validate whether customer and regulatory requirements are met.
Supplier Quality
GE Energy expects the same high quality standards from our external suppliers as we produce internally. GE Energys Sourcing function has established rigorous processes around supplier quality and oversight to enable and verify this quality level for all sourced components and services.
Mutual Non-Disclosure Agreement Protects proprietary information for both parties Integrity Acknowledgement Suppliers commitment to comply with GEs requirements EHS (Environmental, Health, Safety) Questionnaire Provides basic EHS data for evaluation of EHS practices General Supplier Profile Basic data to support quality, financial viability, and overall risk
Qualification Process
Released for Production Product Compliance Process Capability
Critical hardware requires Characteristic accountability Product quality plan, manufacturing process plan Process risk (FMEA) Team approvals required Supplier quality engineer, design engineer, materials engineer
Surveillance Process
Sustaining Quality Monitoring Auditing
Periodical Surveillance Required Quality systems assessment (if not ISO certified) Product audit - compliance to technical requirements Process audit - compliance to special processes Additional audit/inspection requirements defined by: Customer requirements, risk, supplier performance, defects
The requirements regarding Record Control have been defined in procedure GEEQMS 4.2.4 Record Control.
ISO Cross-Reference
The numbering structure of the procedures in GE Energys Quality Management System follows the ISO 9001 standard. Refer to table 1 for a cross-reference of ISO 9001:2008 sections to corresponding GE Energy QMS procedures.
Table 1
Section 1 Scope 1.1 1.2 2 3 4 Normative Reference Terms, Definitions and Acronyms Quality Management System 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 5 General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records GEEQMS 4.2.1-Documentation Requirements-General GEEQMS 4.2.2-Quality Manual GEEQMS 4.2.3-Document Control GEEQMS 4.2.4-Record Control GEEQMS 4.1-General Requirements General Application GEEQMS 1.0-Scope GEEQMS 1.0-Scope GEEQMS 2.0-Normative Reference GEEQMS 3.0-Terms, Definitions and Acronyms ISO Mandatory Procedure
Management Responsibility
5.1
Management Commitment a. b. c. d. e. GEEQMS 5.5-Responsibility, Authority and Communication; section 4.1.2.d GEEQMS 5.3-Quality Policy GEEQMS 5.4-Planning; section 4.1 GEEQMS 5.6-Quality Management Review GEEQMS 5.5-Responsibility, Authority and Communication section 4.1.2.c GEEQMS 7.2-Customer Related Processes GEEQMS 8.2.1-Customer Satisfaction GEEQMS 5.3-Quality Policy
Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning
Section 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3 6 Resource Management 6.1 6.2 6.2.1 6.2.2 6.3 6.4 7 Product Realization 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7
GEEQM Rev 2.0 October 2011
ISO Mandatory Procedure Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Management Review General Review Input Review Output GEEQMS 5.6-Quality Management Review GEEQMS 5.6-Quality Management Review GEEQMS 5.6-Quality Management Review GEEQMS 5.5-Responsibility, Authority and Communication GEEQMS 5.5-Responsibility, Authority and Communication GEEQMS 5.5-Responsibility, Authority and Communication
Competence, Awareness and Training GEEQMS 6.2.2-Competence, Awareness and Training Infrastructure Work Environment GEEQMS 6.3-Infrastructure and Work Environment GEEQMS 6.3-Infrastructure and Work Environment
Planning of Product Realization Customer Related Processes Determination of Requirements Related to the Product Review of Requirements Related to the Product Customer Communication Design and Development Design and Development Planning Design and Development Inputs Design and Development Outputs Design and Development Review
GEEQMS 7.2-Customer Related Processes GEEQMS 7.2-Customer Related Processes GEEQMS 7.2-Customer Related Processes
GEEQMS 7.3-Design and Development GEEQMS 7.3-Design and Development GEEQMS 7.3-Design and Development GEEQMS 7.3.4-Technical Design and Development Review
Design and Development Verification GEEQMS 7.3-Design and Development Design and Development Validation Control of Design and Development Changes GEEQMS 7.3.6-Design and Development Validation GEEQMS 7.3-Design and Development
Section 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8
ISO Mandatory Procedure Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Validation of Processes for Production and Service Provision Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Devices GEEQMS 7.5.1 - Control of Production and Service Provision GEEQMS 7.5.2-Validation of Processes GEEQMS 7.5.3-Identification and Traceability GEEQMS 7.5.4-Customer Property GEEQMS 7.5.5-Preservation of Product GEEQMS 7.6-Control of Monitoring and Measuring Devices GEEQMS 7.4-Purchasing GEEQMS 7.4-Purchasing GEEQMS 7.4-Purchasing
Measurement, Analysis and Improvement 8.1 General a. b. c. Note determination of statistical techniques and extent of their use 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3 GEEQMS 8.2.4-Monitoring and Measurement of Product GEEQMS 8.2.2-Internal Audit GEEQMS 8.5-Continuous Improvement GEEQMS 8.4-Analysis of Data
Monitoring and Measurement of Processes Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Nonconforming Product Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action. GEEQMS 8.5-Continuous Improvement GEEQMS 8.5-Continuous Improvement GEEQMS 8.5-Continuous Improvement GEEQMS 8.2.1-Customer Satisfaction GEEQMS 8.2.2-Internal Audit GEEQMS 8.2.3-Monitoring and Measurement of Processes GEEQMS 8.2.4-Monitoring and Measurement of Product GEEQMS 8.3-Control of Nonconforming Product GEEQMS 8.4-Analysis of Data