ISOIEC 17025质量指南(1).doc

ACB COMPNAY1800 NW 169TH PI, BEAVERTON , OR 97006ISO/IEC 17025 QUALITY MANUALRevision 1Date: 4/16/04UNCONTROLLED COPY CONTROLLED COPY Serial # _Issued To: _ Date: _ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 2 OF 17TABLE OF CONTENTSIntroduction.4Quality Manual Distribution and Approval.4Quality Policy Statement. 5 4.0 Management Requirements.64.1 Organization.64.2 Quality System.84.3 Document Control .84.4 Review of Requests, Tenders, and Contracts.94.5 Subcontracting of Tests and Calibrations .104.6 Purchasing Services and Supplies.104.7 Service to the Customer .114.8 Complaints .114.9 Control of Nonconforming Testing and/or Calibration Work.114.10 Corrective Action.124.11 Preventive Action .124.12 Control of Records.134.13 Internal Audits .144.14 Management Reviews.145.0 Technical Requirements . . .155.1 Technical Requirements General.155.2 Personnel .155.3 Accommodations and Environmental Conditions.165.4 Test and Calibration Methods and Method Validation.175.5 Equipment .205.6 Measurement Traceability.225.7 Sampling .235.8 Handling and Transportation of Test and/or Calibration Items.235.9 Assuring the Quality of Test and Calibration Results . 245.10 Reporting the Results.24ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 3 OF 17INTRODUCTIONABC Company recognizes its responsibility as a provider of quality testing services. To this end, ABC Company has developed and documented a quality management system to better satisfy the needs of its customers and to improve management of the company. The quality system complies with the international standard ISO/IEC 17025, 1999 and ISO 9001:2000. This manual has been prepared to define the quality system, establish responsibilities of the personnel affected by the system, and to provide general procedures for all activities comprising the quality system. In addition, this manual is utilized for the purpose of informing our customers of the quality system, and what specific controls are implemented to assure service quality.QUALITY MANUAL DISTRIBUTION AND APPROVALThis manual will be revised as necessary to reflect the quality system currently in use. It is issued on a controlled copy basis to all internal functions affected by the quality system and on an uncontrolled copy basis to customers and suppliers; although, it can be issued to customers on a controlled copy basis upon customer request. The methods for control and distribution of manuals are explained in Control of MPS Quality Manual, procedure # QA- 001.The Quality Manager and CEO approve changes to the Quality Manual. ABC Company records the revision level, issue date and authorized signatures in the master Quality Manual.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 4 OF 17QUALITY POLICY STATEMENTABC Company is committed to the continuous improvement of processes and products to achieve customer satisfaction. It is therefore our policy to: Consistently provide quality products and services that conform to customer requirements. Deliver our testing services with accurate and quick test results, while maintaining aneconomical value to the customer. Comply with ISO 17025 standards at all times to ensure quality product and testingservices. It is ABC Company goal to encourage active participation of all employees in quality planning and continuous improvement efforts to meet all quality, service and cost objectives._Chuck Weitzel, President / CEODon Harring, Quality ManagerABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 5 OF 174.0 Management Requirements4.1 Organization and Management4.1.1 ABC Company (MPS) is a registered Corporation in the State of Oregon and holds legal responsibility for its operation. 4.1.2 MPS is organized to operate in accordance with the requirements of ISO/IEC 17025. The Quality Manager has the responsibility to maintain the Quality System to operate in accordance with the requirements of ISO/IEC 17025. It is the responsibility of all employees to work in accordance with the quality policies, and to satisfy the needs of our customers. 4.1.3 MPS is organized to operate in accordance with the requirements of ISO/IEC17025, whether carrying out work in its permanent facilities or on location, at customer sites.4.1.4 MPS is not part of an organization performing activities other than testing and/or calibration; therefore, there is no potential conflict of interest amongst its personnel.4.1.5 The organization of ABC Company is illustrated below in Figure 1. Chuck WeitzelPresident/CEODon HarringQuality ManagerJim RogersEngineerMarc JuzkowChief TechnologyOfficerMary PiestrakOffice Manager Figure 14.1.5 cont.a). The Test Engineer is responsible for being familiar with the test methods, procedures, test objectives and the assessment of test results. The Quality Manager has the responsibility to maintain the Quality Management Systems to ISO/IEC 17025 and has the authority to institute corrective action and procedures consistent with these quality goals. The process for updating the Quality Manual, and methods for determining the revision history and responsibilities are detailed in Control of MPS Quality Manual, procedure # QA-001. The Quality Manager reports directly to the Chief Executive Officer. b). Gifts or favors from suppliers, customers or internal activities that may benefit from “in-spec” test results are prohibited to avoid any perception of conflict of interest, see Customer Confidentiality and Code of Ethics, procedure # QA-002.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 6 OF 17 c) Proprietary rights and confidential information for both MPS and its customers are adequately secured (Customer Confidentiality Procedure # QA- 002).d). It shall be the responsibility of all MPS employees to conduct themselves in a manner that does not diminish the confidence in our competence, impartiality, judgment or operational integrity as viewed by both MPS employees and our customers. This responsibility includes activities both in and outside of normal operations at MPS.e). The organizational chart is maintained and stored by the Quality Manager and is part of this manual. MPS is a privately held company, not part of any other company or organization. In the absence of the Quality Manager, the Test Engineer or CEO will assume the duties of the Quality Manager. In the absence of the Test Engineer the Quality Manager or CEO will assume the duties of the Test Engineer. In the event of both the Quality Manager and the Test Engineers absence, the CEO, having knowledge of testing methods and systems for MPS, will assume these necessary management positions until the return of these key personnel.f). Job descriptions will be maintained for all personnel detailing responsibility, authority, and education and training requirements (ref.: Job Description and Training Program, Procedure # QA-003). 4.2.1.1 The Quality Manual is the principal document that defines the quality system at ABC Company. The Quality Manual and all documented procedures are available to all personnel on the Quality Systems Directory. The Quality Systems Directory, managed by the Quality Manager, maintains the Quality Manual andall relevant documents per Document Control Procedure # QA-004 and Control of MPS Quality Manual, procedure # QA-001. 4.2.1.2 Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality. Quality procedures will be readily available to personnel for reference and implementation. The quality document structure contains this Quality Manual, Quality Procedures, Work Instructions, and Quality Records.4.3 Document Control4.3.1 MPS shall establish and maintain procedures to control all documents that form part of its quality system.4.3.1.1 Documents required by the quality system are managed by the Document Control Procedure # QA-004.4.3.1.2 The Document Control Procedure is established to define the means needed to: Approve documents for adequacy prior to use. Assure documents are uniquely identified and approved for use. Review and update as necessary and re-approve documents. Ensure that changes and the current revision status of the documents are identified Ensure that relevant version of applicable documents are available at points of use Ensure that documents remain legible and readily identifiable Ensure that documents of external origin are identified and their distribution managed. Prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 7 OF 174.3.2 Document Changes4.3.2.1 Changes to Documents are controlled by the Document Control procedure # QA-004. Changes to documents shall be reviewed by the same functions that performed the original review unless specifically designated otherwise. Approval functions have access to pertinent information to base their review and approval.4.3.2.2 A description of the change is listed on the document or attachment and the obsolete document is retained in the document history files. 4.3.2.3 Quality system documents shall be uniquely identified to include: Date of issue Revision identification # Page numbering Total number of pages or a mark to signify the end of the document Issuing authorities4.4 Review of Requests, Tenders, and Contracts4.4.1 Contract/order review is an integral part of the quality system at ABC Company. All contracts/orders are reviewed and accepted only if the requirements are clear and understood, and the company has the capability and capacity to assure full customer expectations. The process for contract review is further defined in the Contract Review Procedure, # QA-005.4.4.2 Records of reviews, including any significant changes, are maintained for minimum period of one year.4.4.3 The contract review will also cover any work that is subcontracted out.4.4.4 Communications are maintained with the customer from request/quote through commencement of work. This includes informing the customer of any deviation from the contract.4.4.5 If a contract needs to be amended after work has commenced, the same contract review process shall be repeated and any amendments shall be communicated to affected personnel.4.5 Subcontracting of Tests and Calibrations4.5.1 It is not the policy of MPS to subcontract testing. However, if it should become necessary to subcontract work for some unforeseen circumstance the following policies will apply: Work is only to be placed with a testing facility that complies with ISO 17025, or is approved by MPS Purchasing as an Approved Supplier, unless otherwise specified by customer.4.5.2 MPS will inform its customer in writing of the arrangement to subcontract, and if appropriate, obtain customer approval to subcontract.4.5.3 MPS is responsible for the subcontractors work, except when the customerspecifies the subcontractor.4.5.4 MPS shall maintain a file for all subcontractors and a copy of their “scope of accreditation”, or Approved Supplier record, see Supplier Approval Process # QA-007.4.6 Purchasing Services and Supplies4.6.1 MPS purchasing department maintains approved suppliers for the purchase of supplies and services that have a direct affect on the quality product and testing performed. See Purchasing Services and Supplies Procedure # QA- 006 and Supplier Approval Process # QA-007.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 8 OF 174.6.2 Purchased supplies and consumable materials that affect the quality of tests are not used until inspected to ensure compliance with specified requirements, see Purchasing Services and Supplies Procedure # QA-006.4.6.3 MPS shall evaluate suppliers of critical consumables, and services which affect the quality of calibration and maintain a Approved Supplier list, see Purchasing Services and Supplies procedure # QA-006.4.7 Service to the customer 4.7.1 MPS will do everything possible to assure that its customers receive the best possible service while maintaining the utmost in confidentiality when required. This may include, however is not limited to: Cooperating with customers in the clarification of test requests and the performance of said tests. Affording customers access to the laboratory to witness testing when requested. Prepare, package and dispatch test items and reports as required by our customers for verification purposes. Advise, guide and communicate with our customer in technical matters, opinions and interpretations in regards to testing performed or to be performed. Communicate to our customers any major deviations in testing being performed. Communicate to the customers any delays that may result in the customer not receiving their testing in a timely manner. Customers will be notified of any event that casts doubt onto the validity of results supplied to them.4.8 ComplaintsComplaints, both verbal and written, shall be documented in accordance with Customer Complaint, procedure # QA-008, which covers the methods for documenting, investigating and resolving complaints. 4.9 Control of Nonconforming Testing and/or Calibration Work4.9.1 In the event that a non-conformance is identified with regard to any aspect of testing, or the results of the work do not conform to its own procedures or to the agreed requirements of the customer, the Quality Manager or the Test Engineer will act to contain the non-conformance and initiate corrective action per the Control of Non-Conforming Testing, procedure # QA-009.4.9.2 Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of MPS operations with its own policies and procedures, the Corrective Action procedure # QA-010 shall be followed to identify the root cause(s) of the problem and to eliminate this (these) cause(s).4.10 Corrective Action4.10.1 Corrective Action procedure # QA-010 describes the methods for implementing corrective action and includes a process for the recording of relevant information for Management review.ABC CompanyISO/IEC 17025 QUALITY MANUALREV. 1 DATE: 4/16/04 PAGE 9 OF 174.10.2 The Corrective action procedure must start with root cause analysis.4.10.3 Corrective action shall be selected for anticipated effectiveness of appropriate magnitude, documented, and implemented. 4.10.4 Corrective action shall be monitored for effectiveness. 4.10.5 Where the identification of nonconformance raises doubt on MPS compliance with its own policies and procedures, or with ISO 17025, additional internal audits will be performed to monitor the effectiveness of Corrective Action and the quality system.4.11 Preventative Action4.11.1 MPS has established the following procedures to reduce the likelihood that a non-conformance will occur: Non-conformance Corrective Action Management Review In