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Document Title: Quality Manual Document No:

ABS Limited
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Revision No: 00

Reviewed by Approved by

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Table of contents ISO 9001:2008 Clause 4.2.3 4.2.2 1.0 2.0 3.0 12.5 10.0 4.1 4.2.1 4.2.3 4.2.4 5 6 7 8 Manual Clause 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 Title Front cover Table of Contents Organizational Profile Revision history Purpose Scope References Terms and definitions Responsibility Records Quality Management System Documentation requirements Control of documents Control of records Management responsibility Resource management Product realization Measurement, analysis and improvement Page 1 2 3 4 5 5 5 6 6 7 7 8 9 10 10 16 18 32

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Organizational Profile Describe your organization briefly for the benefit of readers of this manual, in terms of: a. b. c. d. e. History Products Milestone achievements Vision and mission Etc.

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1.0 Revision History Revision number 00 DAF # Effective date Revision description Initial issue

Legend: DAF # Document Approval Form Number 2.0 Purpose

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This manual describes the elements and processes of the quality management system which is implemented as per the requirements of the ISO 9001:2008 international standard. Relevant documents are referenced in the manual in order to provide users with further guidance on the quality management system. 3.0 Scope and application The quality management system demonstrates the organizations ability to consistently provide products that meet customer and applicable statutory and regulatory requirements and to enhance customer satisfaction through the effective application of the quality management system. . The following clauses of the ISO 9001:2008 standard are excluded from the quality management system due to their non-relevance to the organizations operations: a. [Example: Clause 7.3] State and justify which clauses of the ISO 9001:2008 that do not apply to your quality management system. Exclusions are limited to sections within Clause 7 only. Delete the sections of the manual that are excluded from the quality management system. manual. The scope of the quality management system applies to the following products of the organization: Example, if your organization does not design your products, Clause 7.3 is not applicable. Therefore, delete Clause 7.3 from the

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a. b. 4.0 References

List your products here. List your products here.

These standards serve as references for the quality management system: a. b. c. d. ISO 9001:2008 Quality management systems Requirements ISO 9000:2005 Quality management systems- Fundamentals and vocabulary ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing ISO 9004:2000 Quality management systems Guidelines for performance improvements [Note: You need to buy original versions of these documents at http://www.iso.org/iso/store.htm] 5.0 Terms and definitions For the purposes of this quality management system, the standard terms and definitions given in the current version of the ISO 9000 standard apply. Throughout the text of this manual, wherever the term "product" occurs, it represents either the physical goods or intangible services of the organization. Where appropriate, the specific product is expressly mentioned in order to convey the actual intent of a particular requirement. 6.0 Responsibility The Management Representative is responsible for the operation of the quality management system and review of this document (see Clause 12.5.2)

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7.0 Records Related records are maintained as per Clause 9.2.4. 8.0 Quality Management System The organization documents, implements and maintains a quality management system and continually improves upon its effectiveness in accordance with the requirements of ISO 9001:2008, which is an international standard for quality management systems published by the International Organization for Standardization. The organization ensures that a. the criteria and methods needed to ensure that both the operation and control of all processes within the quality management system are effective; b. c. d. necessary resources and information that are required to support the operation of these processes are made available; the monitoring, measurement, and where applicable, the analysis of the processes are planned and implemented; and necessary actions are taken to achieve planned results and continually improve the quality management system. The quality management system is made up of processes which relate to a. b. c. d. Management responsibility (Clause 12.0), Provision of resources (Clause 13.0), Product realization (Clause 13.0), and Measurement, analysis and improvement (Clause 14.0).

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The QMS Flowchart provides a pictorial representation of the interactions of these elements. 9.0 Documentation requirements The quality management system documentation is made up of documents and records required by the ISO 9001:2008 international standard and the organization. The following documents are required by the ISO 9001:2008 standard: a. b. c. d. e. f. g. h. i. Quality Manual, which describes the elements of the quality management system, Quality Policy, which states the organizational stance with regard to product quality management, Statements of quality objectives of the organization Control of Documents procedure, Control of Records procedure, Internal Audit procedure, Control of Product Nonconformity procedure, Corrective Action procedure, and Preventive Action procedure.

References to other documents which are required by the organization are specified throughout this manual, where relevant. All documents that are used within the quality management system are recorded in the Registry of Documents.

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All records that are maintained within the quality management system are recorded in the Registry of Records. 10.0 Control of documents A Control of Documents procedure has been established to define the controls needed to a. b. c. d. e. f. approve documents for adequacy prior to issue, review and update as necessary and re-approve documents, ensure that the changes and the current revision status of documents are identified, ensure that relevant versions of applicable documents are available at points of use, ensure that documents of external origin are identified and their distribution controlled, and prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. The Document Controller is responsible for the implementation of this process. The following records are maintained for this process: a. Registry of Documents b. c. d. 11.0 Document Approval Form Document Approval Form Log Document Distribution Form

Control of records

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In the operation of the quality management system, records are maintained to provide evidence of conformity to requirements and of the effectiveness of the quality management system. A Control of Records procedure has been established to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. Quality Representatives are responsible for maintaining records in their respective departments to ensure that they remain legible and are readily identifiable and retrievable. The Document Controller is responsible for the implementation of this process. The following records are maintained for this process: a. b. 12.0 12.1 Registry of Records Records Disposal Form Management responsibility The top management of the organization is committed to continually improve the quality management system and this is demonstrated by a. b. c. communicating to the organization of the importance of meeting customer as well as statutory and regulatory requirements, establishing and documenting the Quality Policy, ensuring that quality objectives are established (refer to Quality Objectives Register),

Management commitment

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d. e. 12.2 Customer focus

conducting management reviews, and ensuring the availability of resources (see Clause 13.0).

Top management is focused towards the fulfillment of customer requirements and the enhancement of customer satisfaction. This is achieved by ensuring that customer requirements are determined (see Clause 14.2.1) and customer satisfaction levels are monitored and measured (see Clause 15.2.1). 12.3 Quality Policy Top management has established a Quality Policy to direct the quality management system. The Quality Policy is appropriate to the purpose of the organization and includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, and provides a framework for establishing and reviewing quality objectives. Top management ensures that the quality policy is communicated and understood within the organization, and is reviewed during management reviews for continuing suitability. 12.4 Planning

12.4.1 Quality objectives

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Top management ensures that quality objectives, including those to meet requirements for products, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the Quality Policy and are reviewed during management review meetings. Quality objectives are established to ensure good levels of customer satisfaction, process and product conformities, and suppliers performance. Quality objectives are maintained in the Quality Objectives Register. 12.4.2 Quality management system planning Top management ensures that the planning of the quality management system is carried out to meet all requirements as well as the quality objectives, and the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 12.5 Responsibility, authority and communication Top management ensures that responsibilities and authorities are defined and communicated within the organization. Responsibilities and authorities are described within the QMS Organization Chart and Job Descriptions. 12.5.2 Management Representative

12.5.1 Responsibility and authority

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Top management has appointed a member of the organization's management to be the Management Representative [refer to the QMS Organization Chart] who, irrespective of other responsibilities, is responsible and has the authority in a. b. c. ensuring that processes needed for the quality management system are established, implemented and maintained, reporting to top management on the performance of the quality management system and any need for improvement, and ensuring the promotion of awareness of customer requirements throughout the organization. The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system. 12.5.3 The Management Representative is assisted at the departmental and process level by Quality Representatives. managers and executives. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments. The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel who are appointed by the Quality Representatives. These positions are assumed by the respective

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12.5.4 The Management Representative is also assisted by an appointed Document Controller who is responsible for the effective implementation of the Control of Documents and Control of Records procedures. 12.5.5 Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is defined in the QMS Organization Chart. 12.5.6 Internal communication Top management ensures that appropriate communication processes are established within the organization. The Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is posted by the Management Representative on the Bulletin Board for the benefit of all employees.

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Employees are encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organizations premises. 12.6 Management review Top management reviews the quality management system at planned intervals in order to ensure its continuing suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. The management reviews are chaired by the [CEO/Managing Director] and attended by the Management Representative, Document Controller and members of the Quality Management System Committee. 12.6.2 Review input The Management Representative provides the following inputs for the management review: a. b. c. d. e. f. Results of audit; Customer feedback; Process performance and product conformity; Status of preventive and corrective actions; Follow-up actions from previous management reviews; Changes that could affect the quality management system; g. Recommendations for improvement.

12.6.1 General

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12.6.3 Review output The outputs from the management review include decisions and actions related to the a. b. c. improvement of the effectiveness of the quality management system and its processes, improvement of product related to customer requirements, and resource needs.

Specific management directives are given to the Management Representative on subsequent actions to be taken in consideration of the review outputs. 13.0 13.1 Resource management Provision of resources Resources are determined and made available in order to ensure the effective operation, maintenance and continual improvement of the quality management system and enhance customer satisfaction. Resource requirements are determined and planned during management reviews. 13.2 Human resources The Human Resources Department ensures that all personnel performing work within the quality management system are competent on the basis of appropriate education, training, skills and experience.

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All Department Managers are required to conduct induction sessions for all new employees and transfer personnel. These induction sessions involve briefings, demonstrations and premise tours (where applicable), where inductees are made aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. In order to ensure the competency of personnel within the quality management system, the organization conducts regular competency assessments. This process involves the following activities: a. b. competence, and c. Evaluating the effectiveness of the actions taken. The following records are maintained: a. b. c. d. 13.3 Employee Induction Form Employee Competency Assessment Training Request Form Training Programs Planner Infrastructure The organization determines, provides and maintains infrastructures that are necessary to support the processes of the quality management system and ensure conformity to product requirements. Describe your infrastructures here, such as: Determining the necessary competency requirements, Providing training or taking other actions to achieve the necessary

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a. b. c. d. e.

[Buildings/Work Areas] [Process equipments] [Transportation Vehicles] [MIS/Software] Etc. Note 1: List any maintenance records. Note 2: Please ensure that top management reviews resource requirements during management reviews. Planning of resource management needs to be captured in quality records. Implementation of resource management must be recorded also. Subsequent reviews will serve as continual improvement efforts. 13.4 Work environment The organization determines and manages its work environment under which work is performed, in accordance with its product quality requirements. Describe your work environment and controls that your organization implements, such as the physical environment and other environmental aspects like such as noise, temperature, humidity, lighting and weather, where applicable. Note 1: List any control records. 14.0 14.1 Product realization Planning of product realization

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The organization plans and implements effective processes needed for the creation of its products in order to meet customer requirements and enhance customer satisfaction. Product realization planning involves the considerations of: a. b. c. d. e. f. and g. Records needed to provide evidence that the realization processes and resulting product meet all specified requirements. The following planning documents are maintained: a. 14.2 Product Quality Plan Product requirements; Quality objectives; Resources specific to the product; Processes specific to the product; Required documentation; Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;

Customer-related processes Product requirements are effectively determined by the [Sales & Marketing Department]. This process is controlled by the [Sales & Marketing Procedure] Note: If you dont have a procedure for your sales and marketing processes, delete this section. In its place, you can briefly describe this process here.

14.2.1 Determination of requirements related to the product

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The organization considers these factors in determining the requirements related to the product: a. b. c. d. requirements specified by the customer, including the requirements for delivery and post-delivery activities, requirements not stated by the customer but necessary for specified or intended use, where known, applicable statutory and regulatory requirements related to the product, and any additional requirements considered necessary by the organization. Details of product requirements are documented in the following documents: a. b. [List your records by title here] [List your records by title here]

14.2.2 Review of requirements related to the product Requirements related to the product are reviewed prior to the organization's commitment to supply any product to the customer. These reviews ensure that a. b. c. product requirements are defined, contract or order requirements differing from those previously expressed are resolved, and the organization has the ability to meet the defined requirements.

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Where the customer provides no documented statement of requirements, customer requirements are confirmed before acceptance. Where product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements. 14.2.3 Customer communication The [Sales & Marketing Department] implements and maintains effective arrangements for communicating with the organizations customers, in relation to product information, enquiries, order handling and customer feedback, including product returns. The following records are maintained: a. b. c. d. e. f. 14.3 [Record title 1] [Record title 2] Quotations Customer Complaints Customer Satisfaction Surveys Official Correspondences

Design and development [Note: If your organization does not design its products, delete this section].

14.3.1 Design and development planning In planning and controlling the design and development of a product, the [Design & Development Department] determines a. the design and development stages,

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b. c.

the review, verification and validation that are appropriate to each design and development stage, and the responsibilities and authorities for design and development.

The following document controls this process: a. b. c. d. [Example: Design and Development Procedure] The following records are maintained: [Product Design Record 1] [Product Design Record 2]

14.3.2 Design and development inputs. Inputs relating to product requirements are determined as follows: a. b. c. d. functional and performance requirements, applicable statutory and regulatory requirements, information derived from previous similar designs, and other requirements essential for design and development.

These inputs are reviewed for adequacy to ensure that they are complete, unambiguous and not in conflict with each other. The following records are maintained: a. b. [Example: Review of Design Inputs 1] [Example: Review of Design Inputs 1] 14.3.3 Design and development outputs Design and development outputs are ensured to meet the specified input requirements and are approved by the Quality Representative prior to release.

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The design and development outputs include appropriate information for a. b. product, c. d. product acceptance criteria, and specifications of the characteristics of the product that is essential for its safe and proper use. The outputs are maintained in the following documents: a. b. c. d. [Example: Purchasing Requirements] [Example: Production and Service Provisions] [Example: Product Acceptance Criteria] [Example: Product Specifications] 14.3.4 Design and development review Systematic reviews of design and development are performed in accordance with planned arrangements at suitable stages. These reviews are conducted for the purposes of evaluating the ability of the results of design and development to meet requirements, and identifying any problems and propose necessary actions. Participants in such reviews include representatives of functions concerned with the design and development stages being reviewed. purchasing requirements, production and service provision and details for the preservation of

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The following records of the results of the reviews and necessary actions are maintained: a. b. c. [List your records by title here] [Design and development review 1] [Design and development review 2]

14.3.5 Design and development verification Verification is performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. The following records of the results of the verification and necessary actions are maintained: a. b. c. [List your records by title here] [Design and development verification 1] [Design and development verification 2]

14.3.6 Design and development validation Design and development validation ensures that the resulting product is capable of meeting the requirements for the specified application or intended use. This process is controlled by the [Example: Design and Development Validation] procedure. Wherever practicable, validations are completed prior to the delivery or implementation of the product.

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The following records of the results of validations and necessary actions are maintained: a. b. c. [List your records by title here] [Design Validation Record 1] [Design Validation Record 2]

14.3.7 Control of design and development changes Design and development changes arising from the review, verification and validation activities are identified, reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes includes evaluation of the effect of changes on constituent parts and product already delivered. Records of the review of design and development changes and any necessary action are maintained via the following documents: a. b. 14.4 Purchasing The Purchasing Department ensures that purchased products conform to specified requirements. The type and extent of control applied to the suppliers and the purchased products are dependent upon the effect of the purchased product on subsequent product realization or the final products. [List your records by title here] [List your records by title here]

14.4.1 Purchasing process

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The criteria for selection, evaluation and re-evaluation of suppliers are maintained. The organization evaluates and selects suppliers based on their ability to supply product in accordance with the organizations requirements. Suppliers are included into the Approved Suppliers List only if their first three deliveries do not involve any issues. Approved suppliers are re-evaluated annually, based on both qualitative and quantitative metrics, and they must achieve the minimum score standard to remain in good standings. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained in the following documents: a. b. c. Approved Suppliers List Supplier Selection Form Supplier Performance Evaluation

14.4.2 Purchasing information Purchasing information that is generated from the design and development process describes the product to be purchased, including (where appropriate) a. b. c. requirements for approval of product, procedures and equipment, requirements for qualification of personnel, and quality management system requirements.

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All purchasing information is approved prior to release by the Quality Representative. Records of purchasing information which is released to suppliers are maintained via the following documents: a. [Example: Purchase Order]

14.4.3 Verification of purchased product The [Purchasing Department] inspects and tests all purchased products, where appropriate, in order to ensure that they meet specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier's premises, the organization states the intended verification arrangements and method of product release in the purchasing information. The following document is used to record all verification of purchased products are maintained in the following documents: a. [Example: Purchasing Inspection Form] Note: Use your existing format for this record. All nonconforming products are controlled via the Control of Nonconforming Product procedure (See Section 15.3) 14.5 Production and service operations [You may modify this title to suit your products] The [Production Department] implements production and service provisions under controlled conditions. Controlled conditions include

14.5.1 General

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a. b. c. d. e. f.

the availability of information that describes the characteristics of the product, the availability of work instructions (as necessary), the use of suitable equipments, the availability and use of monitoring and measuring equipments, the implementation of monitoring and measurement, and the implementation of product release, delivery and post-delivery activities.

The following documents support and control the production and service processes: a. b. c. d. e. [List all documentation related to this section by title] [Production procedures] [Work instructions] [Flowcharts] [Drawings]

14.5.2 Validation of processes for production and service provision [If this section is not applicable to your organization, delete it] The organization validates processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. Where applicable, the validation process includes a. b. defined criteria for review and approval of the processes, approval of equipment and qualification of personnel,

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c. d. e.

use of specific methods and procedures, requirements for records, and re-validation.

The following processes are validated: a. b. [List the process here] [List the process here]

The following documents record the methods of validation and their results: a. b. [List your records by title here] [List your records by title here]

14.4.3 Identification and traceability [If this section is not applicable to your organization, delete it] Product status is identified throughout product realization with respect to monitoring and measurement requirements. This process is defined in the following document: a. Work Instruction (Document Title)

Where traceability is a requirement, the organization controls and records the unique identification of the product and maintains appropriate records as follow: a. b. [List your records by title here] [List your records by title here]

14.4.4 Customer property [If this section is not applicable to your organization, delete it]

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The organization reports any customer property that is lost, damaged, or otherwise found to be unsuitable for use, to the customer. Customer properties may include intellectual property and personal data. This process is defined in the following document: a. Work Instruction (Document Title)

14.4.5 Preservation of product [If this section is not applicable to your organization, delete it] All products including their constituents are preserved during internal processing and delivery to the intended destination in order to maintain conformity to requirements. Preservation activities include identification, handling, packaging, storage and protection. Storage requirements are defined in the following document: a. Work Instruction (Document Title)

Transportation and delivery requirements are defined in the following document: a. Work Instruction (Document Title)

14.5 Control of monitoring and measuring equipment [If this section is not applicable to your organization, delete it]

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The organization determines the necessary monitoring and measurement that are to be undertaken and the required equipments needed in order to provide evidence of conformity to product requirements. The Equipments Calibration Register records the equipments that require calibration, including the calibration methods, references, frequencies and responsibilities. In order to ensure valid results, measuring equipments are a. calibrated or verified, or both, at specified interval, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification are recorded; b. c. d. e. adjusted or re-adjusted as necessary; identified in order to determine its calibration status; safeguarded from adjustment that would invalidate the measurement result; and protected from damage and deterioration during handling, maintenance and storage. Records of the previous measuring results are assessed to ensure validity when the equipment is found not to conform to requirements and appropriate actions shall be taken on the equipment and any product affected. Individual records of calibration and verification of each equipment are maintained: a. Equipment Calibration Log

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15.0 15.1

Measurement, analysis and improvement General The organization plans and implements necessary monitoring, measurement, analysis and improvement processes needed in order to a. b. c. demonstrate conformity to product requirements, ensure conformity of the quality management system, and continually improve the effectiveness of the quality management system. These processes include determination of applicable methods, including statistical techniques, and the extent of their use.

15.2

Monitoring and measurement Information relating to customer perception is monitored and measured in order to quantify customer satisfaction levels. Customer Satisfaction Surveys are conducted by the [Sales & Marketing Department] to extract specific customer input towards specific aspects of the organizations products (goods and services). Questionnaires are established by the Quality Management System Committee and are reviewed and improved when necessary.

15.2.1 Customer satisfaction

15.2.2 Internal audit Internal audits are conducted at planned intervals as per the Internal Audit procedure in order to determine whether the quality management system

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a. b. c.

conforms to planned arrangements, conforms to the requirements of the ISO 9001:2008 International Standard, and is effectively implemented and maintained.

The Internal Audit procedure defines the responsibilities and requirements for planning and conducting audits, establishing records and reporting of results. The audit programme is planned accordingly, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Auditors are ensured to be objective, impartial and independent of the area being audited. The Quality Representatives who are responsible for the area being audited ensures that any necessary corrections and corrective are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results. 15.2.3 Monitoring and measurement of processes Suitable methods for monitoring and, where applicable, measurement of the quality management system processes are applied in order to demonstrate the ability of the processes to achieve planned results.

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When determining suitable methods, the organization considers the type and extent of monitoring or measurement appropriate to each of the processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. Relevant processes are monitored and measured by the respective Quality Representatives in terms of their a. b. Quality objectives ; and Conformity to planned arrangements.

When planned results are not achieved, correction and corrective action are taken, as appropriate. Monitoring and measurement data which have been collected are analyzed for continual improvements as per Section 15.4. 15.2.4 Monitoring and measurement of product Product characteristics are monitored and measured in order to verify that requirements have been met. Products are monitored and measured at the following stages: a. b. Verification and inspection of purchased products (Clause 14.4.3); Verification and inspection of in-process products and finished products (Clause 14.5.1);

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The release of product and delivery of service to the customer does not proceed until the planned arrangements for the product have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. The following records that indicate evidence of conformity with the acceptance criteria and person(s) authorizing release of product are maintained: a. 15.3 [List your inspection records by title]

Control of nonconforming product The organization ensures that products which do not conform to product requirements are identified and controlled to prevent unintended use or delivery. Quality Representatives are responsible for the implementation of this process at the relevant stages of control. A Control of Nonconforming Product procedure is established to define the controls and related responsibilities and authorities for dealing with nonconforming product. Where applicable, the organization deals with nonconforming product by the following ways: a. b. c. taking action to eliminate the detected nonconformity; authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; taking action to preclude its original intended use or application;

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d.

taking actions which are appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

When nonconforming product is corrected, it is subjected to re-verification to demonstrate conformity to requirements. The nature of nonconformities and any subsequent actions taken, including concessions obtained, are recorded through the Nonconforming Product Form. 15.4 Analysis of data Types of data for monitoring and measurement activities are maintained in the Data Analysis Register. These data are analyzed by the Quality Management System Committee at specified intervals. The analysis of data is conducted to demonstrate the suitability and effectiveness of the quality management system and evaluate where continual improvement of the effectiveness of the quality management system can be made. These data include data generated as a result of monitoring and measurement and from other relevant sources, as applicable. The analysis of data provides information relating to a. b. customer satisfaction, conformity to product requirements,

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c. d. 15.5

characteristics and trends of processes and products, including opportunities for preventive action, and suppliers.

Improvement The organization is committed to continually improve the effectiveness of the quality manage system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

15.5.1 Continual improvement

15.5.2 Corrective action The organization takes appropriate action to eliminate the causes of nonconformities in order to prevent recurrence. The organization ensures that the corrective actions are appropriate to the effects of the nonconformities encountered. The Corrective Action procedure is established to define requirements for a. b. c. d. e. f. reviewing nonconformities including customer complaints, determining the causes of nonconformities, evaluating the need for action to ensure that nonconformities do not recur, determining and implementing action needed, records of the results of action taken, and reviewing the effectiveness of the corrective action taken.

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15.5.3 Preventive action The organization determines action to eliminate the causes of potential nonconformities in order to prevent their occurrence. The organization ensures that preventive actions are appropriate to the effects of the potential problems. A Preventive Action procedure is established to define requirements for a. b. c. d. e. determining potential nonconformities and their causes, evaluating the need for action to prevent occurrence of nonconformities, determining and implementing action needed, records of results of action taken, and reviewing the effectiveness of the preventive action taken.