SAMPLE COMPANY Page 1 of 11 Revision: Prepared by: _ Effective Date: Approved by: _ QUALITY MANUAL Purpose: The purpose of this quality manual is to outline and state the general policies governing the company's system of quality assurance. These policies cover twenty different sections in accordance with the framework established by ISO 9001. These are the top level policies representing the company's desired objectives or protocol for achieving quality assurance. All departmental or functional policies and procedures written must conform and parallel these policies. Any changes to policies and procedures should be reviewed to ensure that there are no conflicts with these policies stated in this Quality Manual. Distribution: The Quality Assurance Manager will be responsible for approving and preparing updates of this manual and issuing copies to designated personnel or departments. The Quality Assurance Manager will have responsibility for ensuring that all obsolete manuals are retrieved and removed from circulation prior to releasing updates. Holders of this manual are responsible for assuring that access to their manual is available to company personnel. Revisions: Anyone can submit suggestions for revision to these policies to their supervisor or directly to the Quality Assurance Manager. The Quality Assurance Manager will be responsible for reviewing suggestions and must give approval to any revisions to these policies. Table of Contents 1.0 MANAGEMENT RESPONSIBILITY 3 2.0 QUALITY SYSTEM 4 3.0 CONTRACT REVIEW 4 4.0 DESIGN CONTROL 5 5.0 DOCUMENT CONTROL 5 6.0 PURCHASING 6 7.0 CUSTOMER SUPPLIED PRODUCT 6 8.0 PRODUCT IDENTIFICATION AND TRACEABILITY 7 9.0 PROCESS CONTROL 7 10.0 INSPECTION AND TESTING 7 11.0 INSPECTION, MEASURING AND TEST EQUIPMENT 8 12.0 INSPECTION AND TEST STATUS 8 13.0 CONTROL OF NONCONFORMING PRODUCT 9 14.0 CORRECTIVE ACTION 9 15.0 HANDLING, STORAGE, PACKAGING AND DELIVERY 10 16.0 QUALITY RECORDS 10 17.0 INTERNAL QUALITY AUDITS 10 18.0 TRAINING 11 19.0 SERVICING 11 20.0 STATISTICAL TECHNIQUES 11 QUALITY MANUAL Page 3 of 11 1.0 MANAGEMENT RESPONSIBILITY Quality Policy - The Company will continually plan, implement, review and revise a system of "Quality Assurance" so that all transactions and processes undertaken by us achieve and maintain the level of quality of our products as defined by us as a company and our customers' expectations and requirements in a constantly changing marketplace. Organization - The company's personnel will be organized to ensure implementation, maintenance and review of the quality system. The responsibility, authority and interrelationships of personnel in reference to their role in the quality system is described in the company's organization chart and as detailed in individual job descriptions. To avoid conflicts of interest, the Quality Assurance Manager will report directly to the President and will not be directly responsible for production operations. The Quality Assurance Manager has the ultimate authority and responsibility for the quality system. The Quality Assurance Manager will review the company's organization and job descriptions to assure which personnel will: a. initiate action to prevent the occurrence of product nonconformity; b. identify and record any product quality problems; c. initiate, recommend, or provide solutions through designated channels; d. verify the implementation of solutions; and e. control further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. As part of this function, the Quality Assurance Manager will ensure that the company has allocated adequate resources and trained personnel independent of those directly performing production work to verify all facets of the quality system. Management Review - At the beginning of each year, the President, Quality Assurance Manager and Operation Managers will review all internal quality assurance audit reports for the prior year and discuss the quality system in general for its effectiveness and adequacy. The President and Quality Assurance Manager will direct and implement any changes necessary to the system. QUALITY MANUAL Page 4 of 11 2.0 QUALITY SYSTEM The quality assurance system is an integrated effort the encompasses management policies, quality objectives, organization and documentation. It is simply not just a system of inspection and testing but rather a whole company- wide program that includes such areas as product development, design evaluation, component and/or vendor selection, documentation, testing and inspection procedures and equipment, production or process development, reviews and validation, service and employee training. The company will prepare, implement, review and maintain at all times a system for the assurance of quality. The documentation of this system will be achieved through this quality manual, quality records and through the establishment of written operating policies, procedures, and work instructions. 3.0 CONTRACT REVIEW All contracts, requests for proposals and sales orders will be reviewed upon receipt. Standard Models - Orders for any of the company's standard product models will be reviewed for accuracy and conformity in accordance with the "Sales Order Entry" procedure. Custom Orders or Request For Proposals - All requests for nonstandard models or modifications must be reviewed to ensure that the customer's requirements are adequately defined and that the company has the capacity and ability to satisfy these requirements. These requests should be approved according to the "Product Design & Development" and "Preproduction Quality & Planning" procedures. If applicable, the Quality Assurance Manager will delegate the preparation of a quality plan to define and verify the achievement of quality objectives for the contract or custom order. QUALITY MANUAL Page 5 of 11 4.0 DESIGN CONTROL The design phase is the most important phase in the life cycle of a product. The inherent quality, effectiveness, safety and customer satisfaction of a product are established during this phase. To ensure that specified requirements are met, the following areas will be performed: - the design input is to be identified and documented into a product brief; - design activities for product development are to be appropriately assigned; - the design output to be documented in applicable terms to the product consisting of defining the physical makeup and characteristics and performance criteria; - the design will be verified and reviewed against the design criteria; and - control of design changes will be maintained. The procedures specifically relating to implementation of this policy are "Product Design and Development," "Preproduction Quality and Planning" and "Engineering Change Notice." 5.0 DOCUMENT CONTROL Control of documentation including approval, issuance, storage and changes will be maintained to assure the integrity of the quality system. Responsibility and authority for these functions will be as follows unless noted otherwise in that specific documentation. Level I (Quality Manual) - President and Quality Assurance Manager Level II (Operating Procedures) - Department Managers Level III (Work Instructions) - Production Team Leaders Level IV (Forms & Other Documents) - As applicable in conjunction with the above authority levels. Procedures to be specifically followed for implementation of this policy will be "Engineering Change Notice/Document Change Control," "Product Master Record" and "Quality System." QUALITY MANUAL Page 6 of 11 6.0 PURCHASING To ensure that purchased products and materials conform to specified requirements, the company will assess all vendors' capabilities and performance according to our quality requirements. Approved vendors will be maintained on an "Approved Vendor List" and all purchasing of components and materials must be made from an approved vendor on this list. Further, all purchasing documents will clearly and adequately define the components or materials to be purchased in sufficient detail as to describe the following whenever applicable: - the type, class, style, grade, or other precise identification; - the title or other positive identification, and applicable issue of specifications, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel; - the title, number, and issue of the quality system specification to be applied to the product. This purchasing information will be reviewed by the purchasing manager prior to issuance of orders. Procedures to be specifically followed for implementation of this policy will be "Vendor Selection, Files and Inspection" and "Purchasing Procedures." 7.0 CUSTOMER SUPPLIED PRODUCT All products, components and/or materials provided by a customer to be used in the production of their finished products will be received, inspected, marked and stored following the same procedures for other purchased items. Customer supplied items will be adequately segregated from other inventory in storage. In the event of any damage, deterioration, loss or unsuitability of customer supplied items will be recorded and reported to the customer. The procedure "Customer Supplied Product" will be followed for implementation of this policy. QUALITY MANUAL Page 7 of 11 8.0 PRODUCT IDENTIFICATION AND TRACEABILITY Product identification will be provided by using the company's part numbering system to assign unique identification for all components and internally manufactured parts and the engineering bill of materials to describe the assembly of all part numbers. Product traceability will be provided by the use of a serial number system for all completed products. Procedures to be specifically followed for implementation of this policy will be "Bill of Materials," "Part Number Designation" and "Serial Number Designation." 9.0 PROCESS CONTROL Control of production will be provided by detailed planning of all phases including the methods and equipment to be used and workmanship criteria. This detailed planning will be documented for each product in the form of "work instructions." Any special processes required for products, the results of which cannot be subsequently verified through inspection will be delineated in the work instructions with specific information for the method of monitoring or validating the activity while in process. The procedure to be specifically followed for implementation of this policy will be "Work Instructions." 10.0 INSPECTION AND TESTING All parts, components and materials utilized in production of products will be received in an organized manner, inspected for conformance and appropriately tagged prior to stocking or use. Any items or shipments rejected for nonconformance will be properly tagged and quarantined from other inventory items until disposition. Further, as part of the company's total quality assurance program, quality control checks will be performed at various completion levels during production and upon final completion of the product in accordance with specified requirements and/or as outlined in the quality plans. The procedures to be specifically followed for implementation of this policy are "Receiving, Inspection and Stocking of Parts and Materials" and "In-Process and Final Inspection and Testing." QUALITY MANUAL Page 8 of 11 11.0 INSPECTION, MEASURING AND TEST EQUIPMENT All inspection, measuring and test equipment used in production or testing will be properly maintained, control and calibrated as necessary as part of the company's quality assurance program. This includes equipment provided by suppliers, sub-contractors and/or employees. The appropriate level of accuracy or requirements of inspection, measuring and test equipment will be determined in the product plan. Inspection, measuring and test equipment will be stored, handled and maintained as appropriate to assure continued measurements of accuracy giving consideration to environmental and other relevant factors. Further, this equipment will be periodically calibrated against nationally recognized standards or other valid documented standards determined appropriate due to the nature of the piece of equipment. All equipment will be properly identified in such a manner to indicate its calibration status and supporting records will be maintained for calibration activities. The procedure to be specifically followed for implementation of this policy is "Control, Calibration and Maintenance of Inspection, Measuring and Test Equipment." 12.0 INSPECTION AND TEST STATUS To assure that only assemblies or final products that have passed required tests and/or inspections are passed on to the next production phase or final disposition, all products or assemblies will be appropriately labeled, tagged, stamped, or accompanied by check-out sheets and physical location to properly indicate approved or nonconformance status. Required authorization(s) for signing off of inspection documentation and disposition will be outlined in the appropriate product plan or as so indicated on the signature line. The procedure to be specifically followed for implementation of this policy is "Inspection and Test Status of Products." QUALITY MANUAL Page 9 of 11 13.0 CONTROL OF NONCONFORMING PRODUCT All finished product, assemblies or components rejected or found to be in nonconformance to specified requirements will be identified, segregated and documented to prevent their inadvertent shipment or continued use in production operations. All nonconforming items will be evaluated and reviewed by the Quality Control Manager and the Production Supervisor for disposition of the items as follows: - reworked to meet specified requirements; - accepted with or without repair by concession; - re-graded for alternative applications; or - rejected or scrapped. Any items repaired or reworked shall be inspected again under the appropriate procedures. The procedure to be specifically followed for implementation of this policy is "Nonconforming Components and Products." 14.0 CORRECTIVE ACTION The cause for nonconforming product will be investigated by the Quality Assurance Manager. The investigation process will include as appropriate, analyzing all processes, work operations, concessions, quality records, service reports and customer complaints to detect possible reasons for nonconforming product. Appropriate corrective action(s) shall then be taken to prevent and/or eliminate the identified potential causes for the nonconforming product. The Quality Assurance Manager will ensure that the proscribed corrective actions are implemented including changes in the necessary policies and procedures and will follow-up on a subsequent basis to ensure that the corrective action has been effective in eliminating the nonconformance. The procedure to be specifically followed for implementation of this policy is "Corrective Action and Follow-Up." QUALITY MANUAL Page 10 of 11 15.0 HANDLING, STORAGE, PACKAGING AND DELIVERY Product packaging will be designed and constructed to protect the product from alteration or damage during the customary conditions of processing, storage, handling and distribution. Storage of products will be controlled to prevent inadvertent damage and deterioration. Shipping containers and shipping methods will be used that ensure the protection and maintenance of quality during shipping and through delivery to destination. The procedure to be specifically followed for implementation of this policy is "Packaging, Storage and Distribution." 16.0 QUALITY RECORDS All quality records that are used directly or relative to the company's quality assurance system and which demonstrate the effectiveness of the system will be maintained. These quality records are to be retained in an orderly fashion and for the time periods that comply with legal and regulatory requirements and as needed for general operation requirements. The procedure to be specifically followed for implementation of this policy is "Quality Records Retention and Storage." 17.0 INTERNAL QUALITY AUDITS Quality Assurance is an integrated effort or total systems approach to satisfy the quality, performance and safety of each product and usermarket. To evaluate and continually improve "Quality Assurance," periodic and unscheduled audits of completed products, production and product development processes and product flow shall be performed to assure compliance with regulatory and company requirements. Reportings of findings from these audits will be performed and appropriate corrective action will be taken for any deficiencies discovered. The procedure to be specifically followed for implementation of this policy is "Quality Assurance Audits." QUALITY MANUAL Page 11 of 11 18.0 TRAINING Job Descriptions will be prepared for all positions in the company to serve as an organizational aid for identifying experience and/or education requirements, appropriate delegation of responsibilities and coordination of work. Adequate and appropriate training of personnel will be provided to satisfy identified skill or training requirements and as a component of the company's quality assurance system. Training is to be provided to all new employees and on a periodic or "as-needed" basis to experienced employees. The procedures to be specifically followed for implementation of this policy is "Job Descriptions," "Employee Training" and Training/Tuition Reimbursement." 19.0 SERVICING The company will provide adequate and appropriate service for its products during and after the warranty periods. Satisfaction surveys and customer contact will be analyzed to determine if the desired results of the company's quality assurance system have been achieved. Any complaints or operation questions regarding the performance, safety, reliability or quality of the company's products or services will be subject to management review and/or investigation and will result in prompt response and corrective action when indicated. The procedures to be specifically followed for implementation of this policy is "Customer Satisfaction Survey," "Customer Service Contact/Complaint Handling," "Service Satisfaction" and "Post-Sale Customer Follow-Up." 20.0 STATISTICAL TECHNIQUES When appropriate, statistical sampling will be used to effectively verify product acceptability or as an additional component of quality assurance. The procedure to be specifically followed for implementation of this policy is "Statistical Sampling."