Quality Manual Rev. P

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2 Contents Page 1. Organization Chart 4 2. Quality Organization 4 3. Authority and Responsibility 4 4. Quality Management System General Requirements 4.2 Documentation Requirements General Quality Manual Control of Documents Control of Records 5. Management Responsibility Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning Quality objectives Quality management system planning 5.5 Responsibility, Authority, and Communication Responsibility and authority Management representative Internal communication 5.6 Management Review General Review input Review output 6. Resource Management Provision of Resources 6.2 Human Resources General Competence, awareness, and training 6.3 Infrastructure 6.4 Work Environment I:\Company\Document Control\Document\Level-1\Q-MAN-p.doc 8/9/10 Page 2 of 23

3 Contents Page 7. Product Realization Planning of Product Realization 7.2 Customer-related Processes 7.3 Design and Development Design and Development Planning Design and Development Inputs Design and Development Outputs Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes 7.4 Purchasing Purchasing process Purchasing information Verification of purchased product 7.5 Production and Service Provision 7.6 Control of Monitoring and Measuring Devices 8. Measurement, Analysis, and Improvement General 8.2 Monitoring and Measuring Customer satisfaction Internal audits Monitoring and measurement of processes Monitoring and measurement of product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement Continual improvement Corrective action Preventive action I:\Company\Document Control\Document\Level-1\Q-MAN-p.doc 8/9/10 Page 3 of 23

4 1. Organization Chart The MOR Manufacturing organization chart is defined in the document: MOR-ORG- current date revision. 2. Quality Organization There is no quality department so quality responsibility and accountability are widely dispersed as a shared team effort. Each individual is responsible for checking their own work and verifying their neighbor s work. Primary responsibility for quality rests with the Quality Manager. The quality system is generally administered through the QA Database. 3.0 Authority and Responsibility 3.1 The Management Team is responsible for establishing, implementing, and maintaining the quality system. Specific responsibilities include: formulating the quality policy, defining organization, assigning authorities and responsibilities, appointing a management representative, periodically reviewing the quality system, and making available resources and personnel necessary to maintain the system Resources The Management Team identifies resource requirements for managing, carrying out, and verifying the work. The Management Team assigns resources for appropriate support activities and production and is guided by team schedules. 3.2 President - Establishes quality policy. 3.3 Quality Manager - Drafts and implements quality policy and serves as quality system Management Representative and ISO 9000 Coordinator. The Quality Manager assigns internal audits in an annual audit plan Management Representative - The Quality Manager is the designated quality system Management Representative and ISO 9000 Coordinator. This designation provides the authority and responsibility to ensure that the quality management system is maintained and its efficiency is continuously improved, and that the system complies with the requirements of the ISO 9001: 2008 standard. 3.4 Document Control Prepares MOR Bill of Materials (BOM) from customer data and maintains cross over data base, processes change notices and revisions, updates BOM and Qualified Parts List (QPL), issues documents, and maintains master lists of controlled documents (QA Database). 3.5 Organization - Interrelation of personnel who manage, perform, and verify work affecting quality is defined on the organization chart. Responsibilities, authority, and interrelation are further defined in the table below: Level 2 Operating Procedures and Level 3 Work Instructions define specific responsibilities. I:\Company\Document Control\Document\Level-1\Q-MAN-p.doc 8/9/10 Page 4 of 23

5 ACTIVITY Prevent Nonconformities Primary Responsibility Manufacturing Technicians And Team Leaders All hands Identify/record Problems Team Leaders All hands Provide Solutions Verify Solution Implementations and Close Corrective Action Reports Control Nonconforming Products Corrective Action in response to Customer Complaints Report on Quality Management System performance for Management Team review Management Review of Quality Management System effectiveness Manufacturing Technicians Test Technicians And Team Leaders Quality Manager Team Leaders and Test Technicians Customer Service Managers Quality Manager President All hands Authority Quality Engineer or designated representative All hands Quality Manager, Quality Engineer, or designee Quality Manager Quality Engineer President Quality Manager 3.6 Management Review The Management Team reviews the quality system at least once a year to assess the effectiveness and continuing suitability of the quality system. The Quality Manager is responsible for scheduling, facilitating, and recording the reviews. Specific details for scheduling, conducting, and recording the reviews are provided in Procedure OP , Management Review. 4. Quality Management System 4.1 General Requirements -- The Management Team shall establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with ISO 9001: This shall include: a) determining the processes needed for the quality management system and their application throughout the organization, I:\Company\Document Control\Document\Level-1\Q-MAN-p.doc 8/9/10 Page 5 of 23

6 b) determining the sequence and interaction of these processes, c) determining criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensuring the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitoring, measuring where applicable and analyzing these processes, and f) implementing actions necessary to achieve planned results and continual improvement of these processes. These processes (including processes for management activities, provision of resources, product realization, measurement, analysis and improvement) shall be managed by MOR Manufacturing in accordance with the requirements of ISO 9001: When MOR Manufacturing chooses to outsource any processes needed for its quality management system that affect product conformity to requirements, it will ensure control over such processes. The type and extent of control to be applied to those outsourced processes shall be defined within the quality management system. MOR Manufacturing retains the responsibility for conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by: a) the potential impact of the outsourced process on the organization s capability to provide product that conforms to requirements. b) the degree to which the control for the process is shared c) the capability of achieving the necessary control through the purchasing process. 4.2 Documentation Requirements General quality management system documentation shall include: a) documented statements of quality policy and quality objectives, b) quality manual, c) documented (established, documented, implemented, and maintained) procedures and records required by ISO 9001: 2008, I:\Company\Document Control\Document\Level-1\Q-MAN-p.doc 8/9/10 Page 6 of 23

7 d) documents, including records, determined by MOR Manufacturing to be necessary to ensure the effective planning, operation, and control of its processes Quality Manual This one top-level document is established and maintained by the Management Team and covers four levels of quality management system documentation. a) The scope of the quality management system includes all activities of MOR Manufacturing including PCB assembly (SMT and through hole), cabling assembly, coil winding, box builds, and engineering and design services. All requirements of the ISO 9001: 2008 Standard apply, without exception. Our Quality Manual Level 1 umbrella documentation establishes the framework for overall policy, commitment, and direction. b) Level 2 Operating Procedures further define quality management system responsibilities. Specific work instructions and standards are included in Level 3 documents. Level 4 consists of quality records providing objective evidence of current and historic activities conducted. c) Interaction between the processes of the quality management system is shown in the following flowchart. I:\Company\Document Control\Document\Level-1\Q-MAN-p.doc 8/9/10 Page 7 of 23

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9 Process Sequence and Interaction Customer Requirements Management Responsibility Quality Management System Quality Manual Quality Policy/Objectives Management Review Process Training and Development Communication Measurement, Analysis and Resource Management Improvement Strategic Action Plan Self/Neighbor Inspection Quality Planning Final Test/Inspection Quality Assurance Database Defect Reporting Manufacturing Control System Trend Analysis Corrective/Preventive Action Customer and Supplier Surveys Product Realization Purchasing/Supplier Management Receiving/Receiving Inspection OP Sheets Manufacturing Control System Product ID/Traceability Inputs Assembly Requests for Quotes Preventive Maintenance Drawings, Specs, BOMs Inventory Control Purchase Orders Lean Manufacturing Consigned Material Process Engineering I:\Company\Document Control\Document\Level-1\Q-MAN-p.doc Complaints 4/17/2003 Page 9 Outputs Products Packaging Delivery Customer Satisfaction

10 4.2.3 Control of Documents Documents required by the quality management system shall be controlled. Procedures and Forms are indexed and access controlled in the QA Database, Document Index and Forms Index. Records are a special type of document and shall be controlled according to the requirements of Procedure OP defines the required controls to: a) approve documents for adequacy prior to issue, b) review and update as necessary and re-approve documents, c) ensure that changes and the current revision status of documents are identified, d) ensure that relevant versions of applicable documents are available at points of use, e) ensure that documents remain legible and readily identifiable, f) ensure documents of external origin determined to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and g) prevent unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose Control of Records Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. Records shall remain legible, readily identifiable, and retrievable. Procedure OP defines the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 5. Management Responsibility 5.1 Management Commitment The Management Team 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 MOR Manufacturing the importance of meeting customer as well as statutory and regulatory requirements, b) establishing quality policy (see 5.3), c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. Page 10 of 23

11 5.2 Customer Focus -- The Management Team shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see and 8.2.1). 5.3 Quality Policy The Management Team shall ensure that the quality policy as defined in the document: Quality Policy- current revision : a) is appropriate for the purpose of MOR Manufacturing, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within MOR Manufacturing, and e) is reviewed for continuing suitability. 5.4 Planning Quality Objectives The Management Team shall ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. a) specific product quality objectives are included on the quality/production flowchart when appropriate, and b) general quality objectives are documented each year by the Quality Manager Quality Management System Planning The Management Team shall ensure that: a) planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Page 11 of 23

12 5.5 Responsibility, Authority, and Communication Responsibility and Authority The Management Team shall ensure that responsibilities and authorities are defined and communicated within MOR Manufacturing Management Representative The Management Team has appointed the Quality Manager as a representative who, regardless of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established, implemented, and maintained, b) reporting to the Management Team on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout MOR Manufacturing Internal Communication The Management Team shall ensure that appropriate communication channels are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management Review General The Management Team shall review MOR Manufacturing s quality management system, at least once a year, to ensure its continuing suitability, adequacy, and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy; and quality objectives. Documentation of these reviews shall be filed with internal audit records Review Input -- Input to the management review shall include information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) followup actions from previous management reviews, f) changes that could affect the quality management system, and Page 12 of 23

13 g) recommendations for improvement Review Output -- Output from the management review shall include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 6. Resource Management 6.1 Provision of Resources The Management Team shall determine and provide resources needed to: a) implement and maintain the quality management system and continually improve its effectiveness, and b) enhance customer satisfaction by consistently meeting customer requirements; 6.2 Human Resources General Associates performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experience. Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system Competence, Awareness, and Training -- The Management Team shall: a) determine necessary competence for associates performing work affecting conformity to product requirements, b) where applicable provide training or take other actions to achieve the necessary competence, c) evaluate effectiveness of actions taken, d) ensure that its associates are aware of the relevance and importance of their activities and how they contribute to achievement of quality objectives, and Page 13 of 23

14 e) maintain appropriate records of education, training, skills, and experience (see 4.2.4). 6.3 Infrastructure The Management Team shall determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace, and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport, communication or information systems). 6.4 Work Environment The Management Team shall determine and manage the work environment needed to achieve conformity to product requirements. Work environment relates to those conditions under which work is performed including physical, environmental and other factors such as noise, temperature, humidity, lighting or weather. 7. Product Realization 7.1 Planning of Product Realization Manufacturing Engineering shall plan and develop processes needed for product realization. Product realization shall be consistent with requirements of other processes of the quality management system. Product realization planning shall determine the following, as appropriate: a) quality objectives and requirements for the product as defined in the quality/production flowchart, b) the need to establish processes, documents, and to provide resources specific to the product, c) required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance. d) Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). e) Planning output for each assembly shall be documented in a quality/production flowchart. Page 14 of 23

15 7.2 Customer Related Processes Determination of Requirements Related to the Product The Customer Service Manager and Manufacturing Engineering shall determine: a) requirements specified by the customer, including requirements for delivery and postdelivery activities, b) requirements not stated by the customer, but necessary for specified use or known and intended use, where known, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by MOR Manufacturing. Post delivery activities include, for example, actions under warranty provisions or contractual obligations such as maintenance services Review of Requirements Related to the Product The Quote Team shall review requirements related to the product prior to making a commitment to supply the product to the customer (e.g., submission of quotes, acceptance of contracts of purchase orders, or acceptance of changes to contracts or purchase orders) and shall ensure that: a) product requirements are defined, b) contract or purchase order requirements differing from those previously expressed are resolved, and c) MOR Manufacturing has the ability to meet the defined requirements. Records of review results and actions arising from the review shall be maintained in the product quote file. Where the customer provides no documented statement of a requirement, a signed confirmation of the requirement shall be obtained from the customer before acceptance. Where product requirements are changed, Document Control shall ensure that relevant documents are amended and that relevant associates are made aware of the changed requirements Customer Communication The President shall determine and implement effective arrangements for communicating with customers in relation to: a) product information, Page 15 of 23

16 b) enquiries, contacts or order handling, including amendments, and c) customer feedback, including customer complaints. 7.3 Design and Development Design and Development Planning MOR Manufacturing shall plan and control the design and development of product and shall determine: a) design and development stages, b) appropriate review, verification and validation for each stage, and c) responsibilities and authorities for design and development. Interfaces between groups involved in design and development shall be managed to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as design and development progress. Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization Design and Development Inputs Inputs relating to product requirements shall be determined and records maintained (see 4.2.4), including: a) functional and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. Inputs shall be reviewed for adequacy and requirements shall be complete, clear, and not in conflict with each other Design and Development Outputs Outputs of design and development shall be in a form suitable for verification against design and development input, shall be approved prior to release, and shall: a) meet input requirements for design and development, b) provide appropriate information for purchasing, production, and for service provision, Page 16 of 23

17 c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use. Information for production and service provision can include details for the preservation of product Design and Development Review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1): a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Participants in these reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of review results and necessary actions shall be maintained (see 4.2.4) Design and Development Verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that design and development outputs have met input requirements. Records of verification results and any necessary actions shall be maintained (see 4.2.4) Design and Development Validation Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that resulting product is capable of meeting requirements for specified application or intended use, where known. Wherever practicable, validation shall be completed prior to delivery or implementation of the product. Records of validation results and any necessary actions shall be maintained (see 4.2.4) Control of Design and Development Changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of change review results and any necessary actions shall be maintained (see 4.2.4). 7.4 Purchasing Purchasing Process Purchasing shall ensure that purchased product conforms to specified purchase requirements. Type and extent of control applied to supplier and purchased product shall be dependent on the effect of purchased product on subsequent product realization or the final product. Suppliers shall be evaluated and selected based Page 17 of 23

18 on their ability to supply product in accordance with requirements. Criteria for selection, evaluation and re-evaluation are established in Supplier and Subcontractor Assessment, MOP0601 (or OP ). Records of evaluation results and any necessary actions arising from the evaluation shall be maintained (see 4.2.4) by Purchasing Purchasing Information Purchasing information shall describe the product to be purchased, including where appropriate: a) requirements for product approval, procedures, processes, and equipment, b) requirements for qualification of associates, and c) quality management system requirements. Purchasing shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. Ref: Purchasing MOP0602 (or OP ) Verification of Purchased Product Inventory Control and Quality Engineering shall establish and implement inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where MOR Manufacturing or its customers intend to perform verification at the supplier s premises, Purchasing shall state the intended verification arrangements and method of product release in the purchasing information. 7.5 Production and Service Provision Control of Production and Service Provision Team Leaders, Manufacturing Engineering, and/or Test Engineering shall plan and carry out production and service provision under controlled conditions including, as applicable: a) availability of information describing product characteristics, b) availability of work instructions, as necessary, c) use of suitable equipment, d) availability and use of monitoring and measuring equipment, e) implementation of monitoring and measurement, and f) implementation of product release, delivery, and post-delivery activities. Page 18 of 23

19 7.5.2 Validation of Processes for Production and Service Provision Manufacturing Engineering, Process Engineering, and/or Production Teams shall validate any processes for production and service provision where resulting output cannot be verified by subsequent monitoring or measurement and as a consequence deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. Arrangements for these processes are defined in the process work instructions and/or assembly OP sheets and include, as applicable: a) criteria for review and approval of designated special processes, b) approval of equipment and qualification of associates, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation Identification and Traceability Where appropriate, Production Teams shall identify the product by suitable means and with respect to monitoring and measurement requirements throughout product realization. Where traceability is required, Production Teams shall also control the unique product identification and maintain records (see 4.2.4) Customer Property MOR Manufacturing shall exercise care with customer property (including intellectual property and personal data) while under its control or use. MOR Manufacturing shall identify, verify, protect, and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged, or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4) Preservation of Product Production Teams shall preserve the product during internal processing and delivery to intended destinations in order to maintain conformity to requirements. This shall include identification, handling, packaging, storage, and protection. Preservation shall also apply to constituent product part 7.6 Control of Monitoring and Measuring Equipment Manufacturing Engineering and/or Test Engineering shall determine monitoring and measurement to be undertaken and the equipment needed to provide appropriate evidence of conformity of product to determined requirements. They shall also establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner consistent with monitoring and measuring requirements. Where necessary to ensure valid results, measuring equipment shall be: Page 19 of 23

20 a) calibrated or verified, or both at specified intervals, or prior to use, against measurement standards, where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4); b) adjusted or readjusted as necessary; c) have identification in order to determine its calibration status; d) safeguarded from adjustments that would invalidate measurement results; and e) protected from damage and deterioration during handling, maintenance, and storage. Quality Engineering shall also assess and record validity of previous results when equipment is found not to conform to requirements. Appropriate action shall be taken on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). When used in monitoring and measurement of specified requirements, the ability of computer software to satisfy intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. 8. Measurement, Analysis, and Improvement 8.1 General Manufacturing Engineering and/or Quality Engineering shall coordinate with Production Team Leaders to plan and implement monitoring, measurement, analysis and improvement processes needed to: a) demonstrate conformity to product requirements, b) ensure conformity of the quality management system, and c) continually improve effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. 8.2 Monitoring and Measuring Customer Satisfaction As one measurement of the performance of the quality management system, The Management Team shall monitor information relating to Page 20 of 23

21 customer perception of performance in meeting customer requirements. Methods for obtaining and using this information include service visits, customer surveys, customer returns and complaints. Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, compliments, and product returns Internal Audits MOR Manufacturing shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to planned arrangements (see7.1), to the requirements of 1SO 9001:2008 and the quality management system requirements established by MOR Manufacturing, and b) is effectively implemented and maintained. An audit program shall be planned, taking into consideration the status and importance of processes and areas to be audited, as well as results of previous audits. Audit criteria, scope, frequency, and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. OP , Internal Audits, defines the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of the audits and their results shall be maintained (see 4.2.4). Management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include verification of actions taken and reporting of verification results (see 8.5.2) Monitoring and Measurement of Processes -- The Management Team shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, corrective action shall be taken, as appropriate. When determining suitable methods, MOR shall consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system Monitoring and Measuring of Product Production Teams shall monitor and measure product characteristics to verify that product requirements have been met. This shall be Page 21 of 23

22 carried out at appropriate stages of product realization processes in accordance with planned requirements defined on the quality/production flowchart (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate associate(s) authorizing release of product (see 4.2.4). The release of product and delivery of service to the customer shall not proceed until planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. 8.3 Control of Nonconforming Product Production Teams shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. Controls and related responsibilities and authorities for dealing with nonconforming product are defined in procedure OP Control of Nonconforming Product. Where applicable, nonconforming product shall be dealt with in one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application, and d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use as stated. When nonconforming product is corrected it shall be subject to reverification to demonstrate conformity to requirements. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). 8.4 Analysis of Data Quality Engineering shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. Data analysis shall provide information relating to: a) customer satisfaction (see 8.2.1); b) conformity to product requirements (see 8.2.4); c) characteristics and trends of processes and products including opportunities for preventive action (see and 8.2.4); and Page 22 of 23

23 d) suppliers (see 7.4). 8.5 Improvement Continual Improvement The Management Team shall continually improve the effectiveness of the quality management system through use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review Corrective Action Responsible units shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to effects of nonconformities encountered. OP Preventive/Corrective Action defines requirements for: a) reviewing nonconformities (including customer complaints), b) determining causes of nonconformities, c) evaluating need for action to ensure that nonconformities to nor recur, d) determining and implementing action needed, e) records of results of action taken (see 4.2.4), and f) reviewing the effectiveness of corrective action taken Preventive Action The Management Team shall determine action to eliminate causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of potential problems. OP Preventive/Corrective Action defines requirements for:. a) determining potential nonconformities and their causes, b) evaluating need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) recording results of action taken (see 4.2.4), and e) reviewing the effectiveness of preventive action taken. Page 23 of 23

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