Quality Management System Policy Manual

Transcription

1 Quality Management System Burns Engineering, Inc Bren Road East Minnetonka, MN 55343

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3 General Requirements The Quality Manual consists of the quality system policy documents and the quality system procedures, which are located and controlled as defined under documentation requirements, ref Through the Quality Manual, Burns Engineering, Inc.: a. Determines the processes needed for the quality management system and their application throughout the organization b. Determines the sequence and interaction of these processes c. Determines the criteria and methods needed to ensure that both the operation and control of these processes are effective d. Ensures the availability of resources and information necessary to support the operation and monitoring of these processes e. Monitors, measures, and analyses these processes f. Implements actions necessary to achieve planned results and continual improvement of these processes g. Ensures these processes are managed by the organization in accordance with the requirements per the quality management system scope in section 1. h. Ensures control over any outsourced process that affect product conformity to requirements is defined within the quality management system Burns Engineering, Inc.; a privately held company, incorporated in the state of Minnesota. [4.1.1] The quality management system defined in this manual covers all work carried out by the organization within our permanent facility. [4.1.3] 4.2 Documentation Requirements General The documentation of the quality management system includes: a. Quality Policies The Quality Manual contains company quality policies, which assign responsibilities and establish direction of the quality management system. The quality policy statement and the objectives of the quality management system are also contained within the policies. b. Quality Procedures The Quality Manual defines the requirements to be addressed by quality system procedures. Procedures will include, as appropriate, the purpose and scope of the procedure, individual responsibilities, sequence and steps of the process, and resources to be deployed. Procedures are controlled and located on the company fileserver computer system. c. Planning, Operation, and Control The company s quality system includes, but is not limited to, documentation needed to ensure effective planning, operation, control of its processes, and that Ex (Explosion Proof Approved) product documentation is compatible with the Ex Certificate, the schedule drawings and technical documentation associated with the Ex approval. d. Records Where required by the standard or by company business needs, records are identified and defined Quality Manual The ISO Management Representative is responsible to maintain the Quality Manual that includes: a. The scope of the quality management system, reference paragraph 1. b. The documented procedures established for the quality management system. The documented and approved procedures are saved as PDFs and are located in the company fileserver. c. Management maintains a description of the interaction between processes of the quality management system. See Figure 1 below. Page 3 of 23

4 Figure 1 Interaction of Processes Inquiries Applications Engineering Purchasing Customer Requirements Order Entry Job Processing Inventory Control Production Orders or Inquiries Calib Services Mfr d Product Customer Services (Review & Quoting) In process Inspection Calibration & Test Finished Goods Inventory Final Assembly Final Inspection Shipping Customer Customer Satisfaction & Feedback Enabling and Supporting Processes: Document Control Corrective & Preventive Action Competency of Human Resources Nonconforming Material Calibration of Gages Internal Communications Infrastructure & Work Environment Records Control Quality System Improvement Activities: Internal Quality System Audits Customer Satisfaction, Process Monitoring, & Data Analysis Quality System Management Review Definition: Quality Policy Statement Quality Objectives Control of Documents Associated Procedures Document Control Design-Engineering Change Control (ECO) Manufacturing Change Request Configurator Change Control Option Code Change Control Procedure Release and Change Control Quality System Folder Security The ISO Management Representative maintains a documented procedure to define document control, including: a. Approval of documents prior to issue. b. Requirements for review, update, and re-approval of documents. [ b] c. Identification of changes and revision status. d. Availability of relevant versions of documents at points of use. e. Identification and legibility of documents. f. Identification and control of documents of external origin necessary for the quality management system which includes those associated with Ex certificates. g. Identification and preventing use of obsolete documents. Page 4 of 23

5 h. All revision controlled documents are uniquely identified, including as applicable a revision level/issue date, page numbering, the total number of pages, and the issuing authority. [ ] i. Procedures for document control define the controls for authorizing hand-written and/or temporary changes to documents, including the need for changes to be clearly marked, initialed, and dated. Formally revised documents are issued in a timely manner. [ ] j. Trademarked names and/or logos are used in accordance with the trademark owners guidelines. k. Ex product documentation (Explosion Proof) is controlled and conforms to the appropriate schedule drawing Control of Records [ Records Control ] a. The ISO Management Representative ensures pertinent records are established and maintained to provide evidence of conformity to requirements and effectiveness of the quality management system. b. The ISO Management Representative maintains a documented procedure for identification, collection, indexing, storage, protection, retrieval, retention time, and disposal of quality and technical records. c. Quality records include reports from internal audits and management reviews, as well as records of corrective and preventive actions. [ ] d. All records are held secure and in confidence. [ ] e. Management defines methods to protect and back-up records stored electronically and prevents unauthorized access to or amendment of records. [ ] f. Technical Records [4.13.2] i. Records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records, and a copy of each test report or calibration certificate issued, are retained for a defined period. The records for each test or calibration contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records include the identity of personnel responsible for the sampling, performance of each test and/or calibration, and checking of results. ii. Observations, data, and calculations are recorded at the time they are made and shall be identifiable to the specific task. iii. When mistakes occur in records, each mistake is crossed out, not erased or made illegible or deleted, and the correct value entered alongside. All such alterations to records are signed or initialed by the person making the correction. In the case of records stored electronically, equivalent measures are taken to avoid loss or change of original data. 5. Management Responsibility 5.1 Management Commitment The President provides evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a. Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements. b. Establishing the quality policy. c. Establishing quality objectives. d. Conducting management reviews. e. Ensuring the availability of resources Responsibility for Ex Product Compliance The ISO Management Rep and FM Approvals (Approval Body) is responsible for ensuring effectiveness and conformance of all Ex products per the relevant Ex Certificate and schedule drawing. Page 5 of 23

6 5.2 Customer Focus The President ensures customer requirements are determined and met, with the aim of enhancing customer satisfaction. 5.3 Quality Policy The President has established a quality policy that: a. Fits the organization s purpose. b. Includes commitment to meeting requirements and continually improving the effectiveness of the quality management system. c. Provides for defining and reviewing quality objectives. d. Is communicated and understood within the organization. e. Is reviewed for continuing suitability. Refer to section 2 for the quality policy statement. 5.4 Planning Quality Objectives The President ensures that quality objectives, including those needed to meet product requirements, are established at relevant functions and levels of the organization, and that they are measurable and consistent with the quality policy, refer to section Planning The ISO Management Representative ensures the quality management system is planned in order to meet the requirements of the standard, as well as the quality objectives. The ISO Management Representative also ensures the integrity of the system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, Authority, and Communication Responsibilities and Authorities The President ensures responsibilities and authorities are defined and communicated within the organization, through policy and procedure documents, as well as through job assignments. In addition, top management maintains an organization chart which defines the structure and the main positions within the company Management Representative The Quality Manager is top management s appointed ISO Management Representative. The ISO Management Representative has the delegated responsibility and authority to: a. Implement and maintain the processes needed to support the quality management system. b. Provide coordination for Ex products, and liaison with approval bodies associated with the Ex products and quality system verification, and all changes and concessions of Ex products. c. Reports directly to management on the effectiveness of the quality management system and any need for improvement. d. Promote awareness of customer requirements throughout the organization Internal Communication The ISO Management Rep ensures appropriate communication processes are used within the organization, including communicating the effectiveness of the quality management system Conflicts of Interest [4.1.4] In order to prevent potential conflicts of interest, a calibration laboratory Technical Manager is maintained with a reporting relationship to top management separated from production. Page 6 of 23

7 5.5.5 Organization and Personnel [4.1.5] Burns Engineering, Inc.: a. Has managerial and technical personnel who have the authority and resources to carry out their duties to implement, maintain, and improve the management system. All personnel can identify departures from the defined system and procedures, and initiate actions to prevent or minimize such departures. b. Has arrangements to ensure all personnel are free from conflicts of interest or undue pressures that may adversely affect the quality of their work. c. Has procedures to protect our customers confidential information and proprietary rights, including electronic storage and transmission of results. d. Has procedures to avoid involvement in activities that would diminish confidence in our competence, impartiality, judgment, or operational integrity. e. Defines its organization and management structure and the relationships between quality management, technical operations, and support services. f. Specifies the responsibility, authority, and interrelationships of all personnel who manage, perform, or verify work affecting the quality of the calibrations. g. Provides supervision of calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each calibration, and with the assessment of the calibration results. h. Has technical management with overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations. i. Ensures back-ups are in place for all key managerial personnel. 5.6 Management Review General [ Management Review ] The ISO Management Representative maintains procedures to ensure top management reviews the quality management system at least annually to evaluate its adequacy, effectiveness, and continued suitability, and to assess opportunities for improvement and the need for changes, including the quality policy and objectives. The ISO Management Representative ensures records of the reviews are maintained Review Input Inputs for the management review meeting include: a. The suitability of policies and procedures b. Reports from managerial and supervisory personnel c. Results of internal audits d. Status of corrective and preventive actions e. Assessments by external bodies f. The results of interlaboratory comparisons or proficiency tests g. Changes affecting the quality management system, including volume of work h. Customer feedback, including customer satisfaction information i. Process performance and product conformity j. Follow up of actions from prior management review meetings k. Recommendations for improvement l. Other relevant factors, such as quality control activities, resources, and staff training m. Effectiveness of the QMS with respect to products intended for use in Ex atmospheres Review Output Outputs from the review meetings include decisions and actions in regards to: a. Improvements to the quality management system and its processes. b. Improvements to product and/ or related to customer requirements. c. Resource needs. Page 7 of 23

8 The ISO Management Rep ensures records of the reviews are maintained and the actions that arise from them are documented. Top management ensures actions are carried out within an appropriate and agreed timetable. 6. Resource Management 6.1 Provision of Resources The President determines and provides the resources needed to: a. Implement and maintain the quality management system and continually improve its effectiveness. b. Enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources General Quality Manager ensures personnel performing work within the quality management system are competent based on education, training, skills, and/or experience Competence, Training, and Awareness [ Employee Competency and Training ] Quality Manager and Department Supervisor: a. Determines required job competencies. b. Takes action to achieve necessary competence (such as hiring, training, etc.). c. Evaluates the effectiveness of the actions taken. d. Ensures personnel are aware of the impact their work has on the achievement of quality objectives. e. Ensures records are maintained of education, training, skills, and experience. 6.3 Infrastructure Quality Manager and Operations Manager determines, provides, and maintains the infrastructure needed to achieve customer requirements, including, as applicable, buildings, workspace, utilities, process equipment, transportation services, communication/data services, etc. 6.4 Work Environment Operations Manager ensures the work environment is adequate to achieve required results. 7. Product Realization 7.1 Planning of Product Realization Quality Manager and Operations Manager plans and develops the processes necessary for product realization, determining and providing the following, as appropriate and in a form suitable to the organization s method of operations: a. Product quality objectives and requirements. b. Product specific processes, documents, and resources. c. Product acceptance criteria and product specific verification, validation, monitoring, measurement, inspection, and test activities. d. Appropriate records to show evidence that the processes and resulting product meets requirements. 7.2 Customer-related Processes Determination of Product Requirements [ Quote Process ] Customer Service / Applications Engineering ensures customer requirements are determined, including: a. Specified requirements, including delivery and post-delivery requirements. Page 8 of 23

9 b. Implied requirements not stated but necessary for the intended use where known. c. Statutory and regulatory requirements applicable to the product. d. Other requirements necessary to meet customer needs Contract Review [ Order Entry ] Customer Service ensures requirements are reviewed prior to making commitments to the customer to ensure: a. Requirements are adequately defined. b. Requirements differing from those previously expressed are resolved. c. The organization has the ability to meet the defined requirements. d. The calibration method is selected and capable of meeting the customers requirements. [4.4.1.c] Records of reviews and actions taken as a result of the review are maintained, non-documented verbal requirements are confirmed, and customer requirement changes are communicated to relevant personnel and relevant documents are amended. Records include pertinent discussions with the customer regarding the requirements or results of the work. [4.4.2] Customer Communication The Director of Business Development determines and maintains effective methods for communicating with customers relative to: a. Product information. b. Enquiries, contracts, and orders, including changes. c. Customer feedback and complaints. Director of Business Development maintains a procedure for the resolution of complaints received from customers or other parties. Records are maintained of all complaints and of the investigations and corrective actions implemented. [4.8] Customer Service cooperates with customers, or their representatives, to clarify the customer s request and to monitor performance of the work performed, while providing confidentiality to other customers. [4.7.1] 7.3 Design and Development Associated Procedures: Design-Catalog Product Design-Customer Initiated Design- Production Planning Design & Development Planning Engineering Manager assigns personnel to plan and control the design and development of product. During design and development, assigned personnel define: a. Stages of design and development. b. Review, verification, and validation appropriate to each project. c. Responsibilities and authorities for specific design and development activities. d. Any needed interfaces between groups involved in the design and development. e. Changes to plans as design and development progresses and update the plans Design and Development Inputs Sales and Engineering personnel ensure product requirement inputs are determined and recorded, including: a. Functional and performance requirements. b. Statutory and regulatory requirements, where applicable. c. Information derived from previous designs. Page 9 of 23

10 d. Any other requirements necessary for the project. Sales and Engineering personnel ensure these inputs are reviewed for adequacy as part of contract review, so that requirements are clear and do not conflict with each other Design and Development Outputs Design personnel provide outputs in a form that can be verified and validated against the input requirements. Outputs are approved prior to release. Outputs: a. Meet input requirements. b. Provide information for production and suppliers to produce and service the product. c. Provide acceptance criteria. d. Specify characteristics of the product for safe and proper use Design and Development Review Engineering ensures product design reviews are performed at suitable stages during development and planning to: a. Evaluate the product design s ability to meet requirements. b. Identify any issues with the product design and propose improvement actions. Engineering ensures appropriate functional parties concerned with the product design are included in the review process. Engineering maintains records of the results of reviews and any improvement actions Design and Development Verification Engineering verifies product designs per plans to ensure the input requirements of the design are met by the design outputs. Design personnel maintain records of the results of verifications and any improvement actions Design and Development Validation Engineering validates product designs per plans to ensure the resulting product is capable of meeting the requirements of the specified application or intended use. Design personnel maintain records of the results of validation and any improvement actions Control of Design and Development Changes Engineering ensures changes are identified and records are maintained. Design personnel ensure changes are reviewed, verified, and validated as needed prior to implementation, and that the review considers the effect on constituent parts, as well as products in the field. Design personnel maintain records of the results of review of changes and any improvement actions. 7.4 Purchasing Associated Procedures: Purchasing Supplier Qualification Purchasing Process Purchasing personnel: a. Ensure purchased product and services conform to specified requirements. b. Determine the extent and type of control applied to suppliers and purchased product based on the effect the product has on subsequent product realization or the final product. c. Select suppliers based on their ability to supply product in accordance with requirements. d. Establish criteria for selection, evaluation, and re-evaluation of suppliers. e. Ensure records of supplier evaluation and any resulting actions are maintained Purchasing Information Page 10 of 23

11 Purchasing personnel ensure information describes product to be purchased, including where appropriate: a. Requirements for approval of product, procedures, processes, and equipment. b. Requirements for qualification of personnel. c. Quality management system requirements. d. Purchasing documents for items affecting the quality of laboratory output contain data describing the services and supplies ordered. These purchasing documents are reviewed and approved for technical content prior to release. [4.6.3] Purchasing personnel ensure the adequacy of purchase requirements prior to their communication to the supplier Verification of Purchased Product Quality Assurance establishes and maintains verification or other activities necessary for assuring purchased product meets the purchase specification. When verification is intended to be performed at the supplier s premises, purchasing personnel are responsible to state the verification arrangements and method of product release in the purchasing information Calibration Related Consumables and Supplies [4.6.1] Purchasing ensures procedures include requirements for purchasing, receiving, and storage of consumable materials related to tests and calibrations. 7.5 Production Associated Procedures: Production Control Maintenance Control of Production Manufacturing management is responsible for establishing and implementing production under controlled conditions, which include: a. The availability of information that describes the characteristics of the product. b. The availability of work instructions as necessary. c. The use of suitable equipment. d. The availability and use of monitoring and measuring equipment. e. The implementation of monitoring and measurement. f. The implementation of product release, delivery and post delivery activities Validation of Processes Engineering is responsible for establishing and implementing arrangements for validation of production operations to verify the ability of processes to meet planned results. Arrangements include, as applicable: a. Defined criteria for review and approval of the processes. b. Approval of equipment and qualification of personnel. c. Use of specific methods and procedures. d. Records of validation. e. Revalidation methods Identification and Traceability Manufacturing management identifies product and current status with respect to monitoring and measurement throughout product realization. Traceability is maintained when required by customer requirements to ensure the unique identification of the product is controlled and records maintained Customer Property [ Control of Customer Property ] Page 11 of 23

12 Customer property is managed and controlled through the Return Material Authorization (RMA) forms in the business system. Manufacturing exercises care of customer property while it is under the control or being used by the company. Customer property is verified, identified, safeguarded, and protected. If customer property is lost, damaged or found unsuitable for use, this is reported to the customer and records are maintained Preservation of Product Manufacturing management preserves the product during all internal processes and delivery to the intended destination in order to maintain conformity to requirements. Preservation of product includes proper identification, handling, packaging, storage, and protection. 7.6 Control of Monitoring and Measuring Equipment [ Control of Monitoring and Measurement Equipment ] Quality Assurance determines the monitoring and measurement requirements and equipment needed to provide evidence of product conformity, based on customer requirements. Quality Assurance maintains processes to ensure monitoring & measurement can be and are carried out in a manner consistent with the monitoring & measurement requirements. Quality Assurance is responsible to ensure measuring equipment is: a. Calibrated at specified intervals, or prior to use, against measurable standards traceable to international or national measurement standards. Where no standard exists, the basis used for calibration or verification is recorded. b. Adjusted or readjusted as necessary. c. Identified to enable the calibration status to be determined. d. Safeguarded from adjustments that would invalidate the result. e. Protected from damage and deterioration during handling maintenance and storage. Quality Assurance assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements, and takes appropriate action on the equipment and any product affected. Quality Assurance maintains records of the results of calibration and verification. Validation of laboratory computer software is done before it is put in service and after any modifications. Page 12 of 23

13 7.7 Accredited Calibration and Testing Requirements [5.1, ] Note: Numbering of all paragraphs of section 7.7 follow ISO 17025, i.e = 5.1.] General Management controls the factors that determine the correctness and reliability of the tests and calibrations performed. These factors include contributions from: a. Human factors. b. Accommodation and environmental conditions. c. Test and calibration methods and method validation. d. Equipment. e. Measurement traceability. f. Sampling. g. The handling of test and calibration items Management takes these factors into account in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses Personnel Management ensures the competence of: a. All who operate specific equipment, perform tests and calibrations. b. All who Evaluate results, and sign test reports and calibration certificates. c. Trainees, and provides direct supervision. d. Personnel performing specific tasks on the basis of education, training, experience and/or demonstrated skills Management formulates goals with respect to the education, training and skills of the laboratory personnel. Management maintains procedures for identifying training needs and providing training of personnel relevant to the present and anticipated tasks of the laboratory Where contracted and additional technical and key support personnel are used, management ensures that such personnel are supervised and competent, and that they work in accordance with the laboratory s quality management system Management maintains current job descriptions for managerial, technical and key support personnel involved in tests and calibrations Management assigns and authorizes personnel to perform particular types of sampling, tests, and calibrations, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment. Records are maintained of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel. This information is readily available and includes the date on which authorization and/or competence is confirmed Accommodation and Environmental Conditions Management ensures laboratory facilities for testing and calibration, including but not limited to energy sources, lighting and environmental conditions, are adequate to facilitate correct and valid performance of the tests and calibrations. Management provides adequate environmental conditions to ensure valid results and the required quality of any measurement. Procedures are documented defining the technical requirements for accommodation and environmental conditions that can affect the results of tests and calibrations. Page 13 of 23

14 Laboratory personnel monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures and where they influence the quality of the results. Due attention is paid to electromagnetic disturbances, humidity, electrical supply and temperature, as appropriate to the technical activities concerned. Tests and calibrations are stopped when the environmental conditions jeopardize the results of the tests and/or calibrations Management ensures there is effective separation between neighboring areas in which there are incompatible activities to prevent cross-contamination Controls for access to and use of areas affecting the quality of the tests and/or calibrations are based on the measurement requirements Management ensures good housekeeping in all areas, including special procedures where necessary Test and Calibration Methods and Method Validation General Management ensures appropriate methods and procedures are used for all tests and calibrations within our scope. These include sampling, handling, transport, storage and preparation of items to be tested or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test and/or calibration data. Instructions are available on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could jeopardize the results of tests and/or calibrations. All instructions, standards, manuals and reference data relevant to the work of are kept up to date and are made readily available to personnel. Deviation from test and calibration methods are approved by management only when the deviation has been documented, technically justified, authorized, and when necessary accepted by the accrediting body Selection of Methods Laboratory personnel use test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the inspections, test and/or calibrations it undertakes. Where available, those published in international, regional or national standards are used. Laboratory personnel use the latest valid edition of a standard, unless it is not required or possible to do so. When necessary, the standard is supplemented with additional details to ensure consistent application. When the customer does not specify the method to be used, laboratory personnel select methods that have been published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment. Laboratory-developed methods or methods adopted by the laboratory may also be used, if they are appropriate for the intended use and if they are validated. The customer is informed as to the method chosen. Management confirms the laboratory can properly operate standard methods before introducing the tests or calibrations. If the standard method is changed, the confirmation is repeated. Laboratory personnel inform the customer when the method proposed by the customer is considered to be inappropriate or out of date Laboratory-developed Methods Management ensures test and calibration methods developed by the laboratory for its own use are planned and assigned to qualified personnel equipped with adequate resources. Plans are updated as development proceeds and effective communication amongst all personnel involved is ensured. Page 14 of 23

15 Non-standard Methods Non standard methods are not used. Any methods developed are validated before use Validation of Methods Management ensures methods are validated to confirm by examination and the provision of objective evidence that the particular requirements for a specific intended use are met Management ensures all methods used are validated to confirm that the methods are fit for the intended use. Validations are as extensive as is necessary to meet the needs of the given application. The validation record includes the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use The range and accuracy of the values obtainable from validated methods (e.g. the uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences and/or cross-sensitivity against interference from the matrix of the sample/test object), as assessed for the intended use, shall be relevant to the customers needs Estimation of Uncertainty of Measurement Management maintains procedures for estimating the uncertainty of measurement for all calibrations and types of calibrations Management ensures personnel have and apply procedures for estimating uncertainty of measurement. In all cases, the laboratory calculates uncertainties, or at least attempts to identify all the components of uncertainty when the nature of the test method precludes rigorous and valid calculations. Uncertainty calculations use reasonable estimations based on knowledge of the performance of the method, and on the measurement scope, making use of previous experience, validation of data, etc When estimating the uncertainty of measurement, all uncertainty components which are of importance in the given situation are taken into account using appropriate methods of analysis Control of data Management ensures calculations and data transfers are subject to appropriate checks in a systematic manner When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, management ensures that: a. Computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use. b. Procedures are established and implemented for protecting the data; such procedures include, but are not limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing. c. Computers and automated equipment are maintained to ensure proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data Equipment Management furnishes laboratories with all sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data). In those cases where our laboratories use equipment outside our permanent control, management ensures the requirements of ISO/IEC are met. Page 15 of 23

16 Management ensures equipment and its software used for testing, calibration and sampling is capable of achieving the accuracy required and complies with specifications relevant to the tests and/or calibrations concerned. Calibration programs are established for key quantities or values of the instruments where these properties have a significant effect on the results. Before being placed into service, equipment is calibrated or checked to establish that it meets requirements and complies with the relevant standard specifications. All equipment is checked and/or calibrated before use Only authorized personnel operate test and calibration equipment. Instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) are readily available for use by the appropriate laboratory personnel Each item of equipment and its software used for testing and calibration and significant to the result, when practicable, is uniquely identified Records are maintained of each item of equipment and its software significant to the tests and/or calibrations performed. The records include at least the following: a. The identity of the item of equipment and its software. b. The manufacturer s name, type identification, and serial number or other unique identification. c. Checks that equipment complies with the specification. d. The current location, where appropriate. e. The manufacturer s instructions, if available, or reference to their location. f. Dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the due date of next calibration. g. The maintenance plan, where appropriate, and maintenance carried out to date. h. Any damage, malfunction, modification or repair to the equipment Technical instructions define the requirements for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration Management ensures equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, is taken out of service, and is isolated to prevent its use, or clearly marked as being out of service until it has been repaired and shown by calibration or test to perform correctly. Laboratory personnel examine the effect of the defect or departure from specified limits on previous tests and/or calibrations and implement the nonconforming work procedure Whenever practicable, all equipment requiring calibration is labeled, coded, or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration criteria when recalibration is due When, for whatever reason, equipment goes outside the direct control of our operations, laboratory personnel ensure the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks are carried out according to a defined technical instruction Where calibrations give rise to a set of correction factors, laboratory personnel have technical instructions to ensure that copies (e.g. in computer software) are correctly updated Test and calibration equipment, including both hardware and software, are safeguarded from adjustments, which would invalidate the test and/or calibration results. Page 16 of 23

17 Measurement Traceability General Management ensures all equipment used for tests and/or calibrations, including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the test or calibration is calibrated before being put into service. Technical instructions are available for the calibration of measurement and test equipment Specific requirements Calibration Management designs and operates the program for calibration of equipment to ensure that calibrations and measurements are traceable to the International System of Units (SI). Management establishes traceability of the measurement standards and measuring instruments to the SI by means of unbroken chain of calibrations or comparisons linking them to relevant primary standards of the SI units of measurement. The link to SI units is achieved by reference to national measurement standards. When using external calibration services, traceability of measurement is assured by the use of calibration services from laboratories that can demonstrate compliance with the requirements ISO/IEC The calibration certificates issued by these laboratories contain the measurement results, including the measurement uncertainty and/or a statement of compliance with an identified metrological specification All calibrations are made in SI units which are traceable to national or international standards. Where possible, participation in an inter-laboratory comparisons program is conducted Testing [Our laboratory does not perform testing within its scope of accreditation.] Reference Standards and Reference Materials Reference Standards Management maintains a program and procedure for the calibration of its reference standards. A body that can provide traceability as described in calibrates the reference standards. Such reference standards of measurement are used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards is not invalidated. Reference standards are calibrated before and after any adjustment Reference Materials Reference materials are traceable to SI units of measurement, or to certified reference material. Internal reference materials are checked as far as is technically and economically practicable Intermediate Checks Checks needed to maintain confidence in the calibration status of reference, primary, transfer or working standards, and reference materials are carried out according to defined procedures and schedules. Page 17 of 23

18 Transport and Storage Management maintains procedures for the safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and protect their integrity Sampling [Our laboratory does not perform sample calibration.] Handling of Test and Calibration Items Management maintains procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests the customer and the laboratory. Management maintains procedures for identifying test and/or calibration items. The identification is retained throughout the life of the item. Procedures ensure items cannot be confused physically or in records and documents, including control of subgroups of items and the transfer of items within and from the laboratory. Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the test or calibration method, are recorded. When there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, laboratory personnel consult the customer for further instructions before proceeding and record the discussion. Management maintains appropriate facilities and procedures for avoiding deterioration, loss, or damage to the test or calibration item during storage, handling, and preparation. The technical instruction for the specified item also provides any special handling instructions to be followed. When items have to be stored or conditioned under specified environmental conditions, these conditions are maintained, monitored and recorded. Where a test or calibration item or a portion of an item is to be held secure, the item is stored in a locked cabinet to protect the condition and integrity of the secured items or portions concerned Assuring the Quality of Test and Calibration Results Management maintains procedures for monitoring the validity of tests and calibrations. The resulting data is recorded in such a way that trends are detectable and, where practicable, statistical techniques are applied to the reviewing of the results. This monitoring is planned and reviewed and includes participation in inter-laboratory proficiency-testing programs, as well as one or more of the following: a. Regular use of certified reference materials and/or internal quality control using secondary reference materials. b. Replicate tests or calibrations using the same or different methods. c. Retesting or recalibration of retained items; and/or d. Correlation of results for different characteristics of an item. Management and laboratory personnel analyze quality control data. When results are outside predefined criteria, planned actions are taken to correct the problem and prevent incorrect results from being reported Reporting the results General The results of each test, calibration, or series of tests or calibrations are reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods. Results are reported, usually in a test report or a calibration certificate, and include all the information requested by the customer and necessary for the interpretation of the test/calibration Page 18 of 23

19 results and all information required by the method used. (This information is normally that, which is required by , and or ) When there is a written agreement with the customer, the results are reported in a simplified way. Any information listed in to , which is not reported to the customer, is readily available Test Reports and Calibration Certificates Test reports and calibration certificates include at least the following information, unless there is valid reason for not doing so: a. A title (e.g. Test Report or Calibration Certificate ). b. Our name and address, and the location where the test and/or calibrations were carried out, if different from the address of the laboratory. c. Unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate. d. The name and address of the customer. e. Identification of the method used. f. A description of, the condition of, and unambiguous identification of the item(s) tested or calibrated. g. The date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration. h. Reference to the sampling plan and procedures used where these are relevant to the validity or application of the results. i. The test or calibration results with, where appropriate, the units of measurement. j. The name(s), functions(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate. k. Where relevant, a statement to the effect that the results relate only to the items tested or calibrated. l. The page number and total number of pages (i.e.- hard copies). m. A statement specifying the test report or calibration certificate shall not be reproduced except in full, without written approval of Burns Engineering, Inc Test Reports [Our laboratory does not perform testing.] Calibration Certificates In addition to the requirements listed in , calibration certificates include the following, where necessary for the interpretation of calibration results: a. The conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results. b. The uncertainty of measurement and/or a statement of compliance with an identified metrological specification or clauses thereof. c. Evidence that the measurements are traceable The calibration certificate relates only to quantities and the results of functional tests. If a statement of compliance with a specification is made, it identifies which clauses of the specification are met or not met. When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, a record of those results is maintained for possible future reference. When statements of compliance are made, the uncertainty of measurement is taken into account. Page 19 of 23

20 When an instrument for calibration has been adjusted or repaired, the calibration results before and after adjustment or repair, if available, are reported Calibration certificates (or calibration labels) do not contain any recommendation on the calibration interval, except where this has been agreed with the customer or where superseded by legal regulations Opinions and Interpretations When opinions and interpretations are included, the bases upon which the opinions and interpretations have been made are documented. Opinions and interpretations are clearly marked such as in a test report Testing and Calibration Results Obtained From Subcontractors [Our laboratory does not use subcontractors within our scope of accreditation.] Electronic Transmission of Results In the case of transmission of test or calibration results by telephone, facsimile or other electronic or electromagnetic means, all requirements defined above are also met Format of Reports and Certificates The format of each type of test or calibration report or certificate is designed to minimize the possibility of misunderstanding or misuse Amendments to Test Reports and Calibration Certificates Material amendments to a test report or calibration certificate after issue are made only in the form of a further document, or data transfer, which includes the statement: Supplement to Test Report [or Calibration Certificate], serial number [or as otherwise identified], or an equivalent form of wording, and will also meet the above requirements of this manual. When it is necessary to issue a complete new test report or calibration certificate, the certificate or report is uniquely identified and contains a reference to the original that it replicates. Page 20 of 23