QM-Quality manual



QUALITYMANUALISO/IEC 17025:2017<<INSERT THE NAME OF YOUR LABORATORY>>CONTROLLED DOCUMENTAuthor of the original document: LOGC750219 Client: M11502N32QMQM QM Quality ManualControlled Copy No.: <<Insert number of copy or original document>>NamePositionSignatureDatePrepared by:Revised by:Approved by:Location of document: Document Changes StatusDate of IssueRevisionDescription of the performed changesPrepared byRevised byApproved byActiveYYYY-MM-DD0None (original version).AABBCCCONTENTS<<Comment → after this document is completed; insert the page number of each chapter and subchapter. These instructions apply to all documents of the Guide M-17025>>SectionPage1. OBJECTIVE AND SCOPE. 1.1 Objective. 1.2 Scope.2. DEFINITIONS AND NOTATIONS. 2.1 Definitions. 2.2 Notations.3. REFERENCES.4. GENERAL REQUIREMENTS.4.1 Impartiality.4.1.1 Impartial activities.4.1.2 Commitment of top management with impartiality.4.1.3 Pressures to impartiality.4.1.4 Identification of risks to impartiality.4.1.5 Elimination of risks to impartiality.4.2 Confidentiality.4.2.1 Confidentiality of customer information.4.2.2 Release of confidential information.4.2.3 Confidential information from external sources.4.2.4 Responsibility of the personnel with confidential information.5. STRUCTURAL REQUIREMENTS.5.1 Legality of the Laboratory.5.2 Head of the Laboratory.5.3 Scope of activities.5.4 Responsibility for compliance with the standard, customers and authorities.5.5 Organizational structure.5.6 Responsible of the management system.5.7 Responsibility of top management.6. RESOURCE REQUIREMENTS.6.1 General.6.2 Personnel.6.2.1 General.6.2.2 Competence requirements.6.2.3 Evidence of competence.6.2.4 Communication of responsibilities to personnel.6.2.5 Procedure for personnel management.6.2.6 Authorizations for personnel.6.3 Facilities and environmental conditions.6.3.1 Suitability.6.3.2 Documentation of requirements.6.3.3 Control, record and monitoring of environmental conditions.6.3.4 Control of facilities.6.3.5 Activities outside the Laboratory.6.4 Equipment.6.4.1 Access to equipment.6.4.2 Equipment outside its permanent control.6.4.3 Procedure for equipment management.6.4.4 Compliance of equipment requirements.6.4.5 Accuracy of measuring equipment.6.4.6 Calibration of measuring equipment.6.4.7 Calibration program of measuring equipment.6.4.8 Identification of the measuring equipment.6.4.9 Suspicious measuring equipment.6.4.10 Intermediate checks of measuring equipment. 6.4.11 Updating reference values ??and correction factors.6.4.12 Preventing unwanted adjustments to equipment.6.4.13 Equipment records.6.5 Metrological Traceability.6.5.1 Traceability chart.6.5.2 Metrological traceability to the International System of Units.6.5.3 Exception cases of metrological traceability.6.6 External products and services.6.6.1 List of external products and services.6.6.2 Acquisition of external products and services.6.6.3 Communication of requirements to suppliers.7. PROCESS REQUIREMENTS.7.1 Review of requests, tenders and contracts.7.1.1 Procedure for review of requests, tenders and contracts.7.1.2 Inappropriate methods.7.1.3 Conformity assessment.7.1.4 Deviations to the contract.7.1.5 Customer notification.7.1.6 Modifications to the contract during service.7.1.7 Cooperation with the customer.7.1.8 Records of reviews.7.2 Selection, verification and validation of methods.7.2.1 Selection and verification of methods.7.2.1.1 Suitable methods.7.2.1.2 Updating of documents.7.2.1.3 Recent methods.7.2.1.4 Methods suggested to customers.7.2.1.5 Verification of methods.7.2.1.6 Methods developed by the Laboratory.7.2.1.7 Deviations to methods.7.2.2 Validation of methods.7.2.2.1 Validation.7.2.2.2 Changes to validated methods.7.2.2.3 Performance characteristics.7.2.2.4 Records of validation.7.3 Sampling.7.3.1 Plan and sampling method.7.3.2 Sampling method.7.3.3 Records of sampling.7.4 Management of items under testing or calibration.7.4.1 Procedure for item management.7.4.2 Identification of items.7.4.3 Deviation of items.7.4.4 Special conditions for items.7.5 Technical records.7.5.1 Content.7.5.2 Correction to records.7.6 Evaluation of measurement uncertainty.7.6.1 Identification of contributions.7.6.2 Calibration laboratories.7.6.3 Testing laboratories.7.7 Ensuring the validity of results.7.7.1 Procedure for monitoring the validity of results.7.7.2 Inter-laboratory comparisons.7.7.3 Analysis of monitoring data.7.8 Reporting of results.7.8.1 General.7.8.1.1 Revision and approval of results.7.8.1.2 Objectivity of report of results.7.8.1.3 Simplified report.7.8.2 Common requirements for reporting results.7.8.2.1 Information to be contained.7.8.2.2 Responsibility for information in the report of results.7.8.3 Specific requirements for test reports.7.8.3.1 Additional requirements 7.8.3.2 Sampling by the testing laboratory.7.8.4 Specific requirements for calibration certificates.7.8.4.1 Additional requirements.7.8.4.2 Sampling by the calibration laboratory.7.8.4.3 Calibration interval.7.8.5 Specific requirements for sampling.7.8.5.1 Additional requirements.7.8.6 Conformity statements.7.8.6.1 Decision rule.7.8.6.2 Information about conformity statement.7.8.7 Opinions and interpretations.7.8.7.1 Authorizations.7.8.7.2 Report.7.8.7.3 Records.7.8.8 Correction of reports.7.8.8.1 Identification.7.8.8.2 Modifications.7.8.8.3 Substitutions.7.9 Complaints.7.9.1 Process to attend complaints.7.9.2 Access to complaints.7.9.3 Treatment of the complaint.7.9.4 Collecting and verifying information.7.9.5 Customer notification.7.9.6 Customer communication.7.9.7 Closing the complaint.7.10 Nonconforming work.7.10.1 Procedure for nonconforming work.7.10.2 Records of nonconforming work.7.10.3 Actions after nonconforming work.7.11 Management of information and data.7.11.1 Access.7.11.2 Validation of information management systems.7.11.3 Integrity of information management systems.7.11.4 External management systems.7.11.5 Availability of information.7.11.6 Checks to calculations and information transfers.8. MANAGEMENT SYSTEM REQUIREMENTS.8.1 Options.8.1.1 General.8.1.2 Option A.8.1.3 Option B.8.2 Documentation of the management system.8.2.1 Policies and objectives.8.2.2 Content of policies and objectives.8.2.3 Management commitment.8.2.4 Linking of the management system.8.2.5 Access documentation.8.3 Document control.8.3.1 Control.8.3.2 Issuing and updating documents.8.4 Control of records.8.4.1 Readability.8.4.2 Control.8.5 Risks and opportunities.8.5.1 Identification.8.5.2 Planning.8.5.3 Impact.8.6 Improvement.8.6.1 Improvement actions.8.6.2 Customer feedback.8.7 Corrective actions.8.7.1 Implementation of actions.8.7.2 Impact of actions.8.7.3 Records of actions.8.8 Internal audits.8.8.1 General.8.8.2 Audit program.8.9 Management reviews.8.9.1 General.8.9.2 Entries of the review.8.9.3 Outputs of the review.9. ANNEX.9.1 Procedures of the quality management system (see folder PROC)---9.2 Forms for records of the quality management system (see folder FOR)---9.3 External documents of the quality management system (see folder EXT)---9.4 File for Laboratory personnel (see folder PER)---9.5 File for Laboratory measuring standards and equipment (see folder STD)---9.6 Documents for legally of the Laboratory (see folder LEG)---9.7 Records of the quality management system (see folder REC)---1. OBJECTIVE AND SCOPE.1.1 Objective.The overall objective of this quality manual is to describe the documental structure that follows the Laboratory <<Insert name of your Laboratory>> to comply with the technical and managerial requirements of the standard ISO/IEC 17025:2017 [1] in order to demonstrate that it consistently operates a quality system, it is technically competent, it is impartial and it is able to generate technically valid results. 1.2 Scope.a) This document applies for all Laboratory personnel, technical and managerial (administrative). b) This document applies for the services: <<list the general services covered by this quality manual, for example: digital micrometers calibration, water testing, food sampling, etc. Or refer to another document, such as the master list of documents and software>>.c) This document applies for <<Insert places where the document applies, for example: Laboratory and/or customer locations and/or other facilities>>.2. DEFINITIONS AND NOTATIONS.2.1 Definitions.<<Comment→ select, delete or add as required. The number in brackets “[ ]” indicates the bibliographic reference where this definition was obtained (see section 3)>>Audit [2]. Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Audit criteria [2]. Set of policies, procedures or requirements. Audit findings [2].Results of the evaluation of the collected audit evidence against audit criteria. Audit program [2].Set of one or more audits planned for a specific time period and directed towards a specific purpose. Calibration [3]. Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.[…]3. REFERENCES.<<Comment→ Select, delete or add as required. These references are recommended, if some are not consulted or purchased they should be delete>>[1] ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.[2] ISO 9000: 2015 Systems management quality-- Fundamentals and vocabulary.[…] 4. GENERAL REQUIREMENTS.4.1 Impartiality.4.1.4 Identification of risks to impartiality.Laboratory continuously identifies risks to impartiality of its activities, relationships or relationships among its personnel, using the electronic form <<Insert identification and name of the form, e.g. SOFT-001 "Form for risk management">>. This activity is performed at least once every <<Insert period, for example: 12 months, or sooner if necessary>>, and it is led by <<Insert the name of the position, for example: Quality Manager>> and the technique used for the identification of risks is <<Insert technique to use, for example: Brainstorming>>.[…]5. STRUCTURAL REQUIREMENTS.5.1 Legality of the Laboratory.<<Insert name of your Laboratory or organization to which the Laboratory belongs (if it will acquire the legal responsibility of the Laboratory)>> is a company legally incorporated under national laws as recorded in the files <<Insert identification registration, incorporation or similar document>>.<<Comment → If your Laboratory legally dependents of a larger organization, do this clarification>>The legal information identifying the Laboratory is: Company name: <<Insert the official name of your Laboratory or organization to which your Laboratory belongs>>. Legal registration: <<Insert legal registration of your Laboratory or organization to which your Laboratory belongs>>. Official address: <<Insert the official address of your Laboratory or organization to which your Laboratory belongs>>. Main activities: <<Insert the main activities of your Laboratory and/or organization to which your Laboratory belongs >>. Laboratory operation address: <<Insert operation address (if it is different from the official, e.g. temporary address)>>. Phone: <<Insert your phone number for Laboratory operations>>. Web page: <<Insert the web page of your company>>. E-mail: <<Insert your electronic mail for contact>>. <<Insert the name of your Laboratory>> hereinafter referred as "Laboratory" is legally represented by <<Insert the name of the legal representative of your Laboratory>> with professional registration <<Insert number or registration of your legal representative or complementary data, as available>>.<<Insert an image of the legal registration of your Laboratory (if applicable)>><<Insert an image of the legal registration of your Laboratory (if applicable)>>The following documents show the legal responsibility of the Laboratory:<<Comment → Select those who apply, if possible all>>No.DescriptionDocumentLocation1Legal operationDocuments of incorporationFolder “LEG”2AccountingTax payment receiptsAccounting Department3EquipmentPurchase invoicesFolder “STD”4Software Purchase invoicesFolder “STD”5Operation authorizationGovernment authorizationLegal Department6Personnel payments Personnel contractsHR Department7Social SecurityPayment receiptsAccounting Department8Normative standardsPurchase invoicesFolder “LEG”9.........[…]6. RESOURCE REQUIREMENTS.6.2.2 Competence requirements.The Laboratory has job profiles of managerial, technical and key support personnel involved in the services. These profiles are defined and maintained updated, as defined in the procedure <<Insert identification and name of the procedure, e.g. PROC-001 "Procedure for personnel management">>.[…]7. PROCESS REQUIREMENTS.7.2.2 Validation of methods.7.2.2.1 Validation.For methods: a) non-standard, b) developed by the Laboratory, c) modified d) standard used out of range; the Laboratory performs validation according to the following procedure:<<Comment → Select the procedures that apply, depending on the activity of your Laboratory. Remove from this list and from the Guide M-17025 folder the documents which do not use. In the master list of documents and software, set "Not assigned" or similar to that code of document not used (you can use these codes not assigned for further documents)>> <<Insert identification and name of the procedure, e.g. PROC-013 "Procedure for validation of calibration methods">> <<Comment → e.g. Calibration of calipers, gauges, thermometers, scales, etc.>> <<Insert identification and name of the procedure, e.g. PROC-014 "Procedure for validation of physical testing methods">> <<Comment → e.g. Test for tensile, compression, hardness, elongation, etc.>> <<Insert identification and name of the procedure, e.g. PROC-015 "Procedure for validation of analytical testing methods">> <<Comment → e.g. Concentration of x substance in wastewater, chemical composition, etc.>> […]8. MANAGEMENT SYSTEM REQUIREMENTS.[…]8.4.1 Readability.If errors occur in printed records, these are crossed out without being unreadable, not erased, and the new value is written to the margin (for paper records) and is signed by the person making the modification.Example:wrong value 5.189 mmsign 19/08/05correct value 5.198 mm[…]Sample DocumentPurchase the ISO/IEC 17025 full Quality Manual Template, Procedures, Forms and Spreadsheets at Guide for implementing a quality system ISO/IEC17025Metrology and QualityMETRyCALSuccessful Accreditation! ................
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