Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,ISO/IEC 17025:1999,General requirements for the competence of Testing and Calibration Laboratories,Presentation by,B.Sudarsan,Lead Assessor-NABL,1,Contents of ISO/IEC 17025:1999,Scope,Normative References,Terms and Definitions,Management Requirements,Technical Requirements,ISO/IEC 17025:1999,2,1.SCOPE,Specifies requirements applicable to Testing/Calibration laboratories,Notes given in the standard are for guidance and do not contain requirements,Standard is meant for use by laboratories,clients,accreditation bodies etc.,Compliance with the regulatory and safety requirements are not covered by the standard,Compliance with this standard ensures compliance with ISO 9001/9002:1994,ISO/IEC 17025:1999,3,2.NORMATIVE REFERENCES,ISO 9001:1994 Quality Systems Model for Quality Assurance in Design,Development,Production,Installation and Servicing,ISO 9002:1994 Quality Systems Model for Quality Assurance in Production,Installation and Servicing,ISO/IEC Guide 2:General terms and their definitions concerning standardization,VIM:International Vocabulary of basic and general terms in metrology,ISO/IEC 17025:1999,4,3.TERMS AND DEFINITIONS,Terms given in ISO/IEC guide 2 and VIM,are applicable,Also terms given ISO 8402:1994 are,applicable for general definitions,ISO/IEC 17025:1999,5,4.MANAGEMENT REQUIREMENTS,4.1 Organization,4.2 Quality system,4.3 Document control,4.4 Review of requests,tenders and contracts,4.5 Subcontracting of tests and calibrations,4.6 Purchasing services and supplies,4.7 Service to client,4.8 Complaints,ISO/IEC 17025:1999,6,4.MANAGEMENT REQUIREMENTS contd.,4.9 Control of non-conforming testing/calibration,4.10 Corrective actions,4.11 Preventive actions,4.12,Control of records,4.13,Internal audits,4.14,Management reviews,ISO/IEC 17025:1999,7,4.1 ORGANIZATION,4.1.1 Laboratory/organization shall be an,entity that can be held legally responsible,4.1.2 Laboratory to carry out activities to meet the,requirements of this standard,clients,regulatory authorities and organizations,providing recognition,4.1.3 Management system to cover permanent,temporary and mobile facilities,4.1.4 If laboratory is part of an organization,having different activities,responsibility of,key personnel shall be defined,ISO/IEC 17025:1999,8,4.1.5 The laboratory shall have,Managerial and technical personnel,Policies and procedures to ensure personnel are free from undue pressures,Policies and procedures to ensure protection of clients confidential information,Policies and procedures to avoid involvement in any activities that would diminish confidence,Defined management structure,Defined authority and responsibility and inter-relationship of personnel,Adequate supervision of testing/calibration staff,Technical management,Appointment of Quality Manger,Deputies for key Management personnel,ISO/IEC 17025:1999,9,4.2 QUALITY SYSTEM,4.2.1 Establish,maintain and implement Quality,System appropriate to the scope of activities,4.2.2,Quality System Policies and Objectives,shall be defined in Quality Manual.Quality,Policy shall be issued under the authority of,chief executive and shall Contain,Commitment to good professional practices,Statement of laboratorys service,Objectives of Quality System,Requirement that personnel concerned get familiarized with Quality System,Commitment to comply with ISO/IEC 17025:1999,ISO/IEC 17025:1999,10,4.2.3 Quality Manual shall include/refer to,supporting procedures and outline structure,of Quality System,4.2.4 Defined responsibility and authority of,technical management and Quality Manager,ISO/IEC 17025:1999,11,4.3 DOCUMENT CONTROL,4.3.1 GENERAL,Procedure for Document Control,covering,documents of internal and external origin,4.3.2 DOCUMENT APPROVAL AND ISSUE,4.3.2.1 Approval of Documents by authorized,personnel.Maintenance of Master List,4.3.2.2 The procedure shall ensure that,Availability of authorized appropriate documents,Periodic review and revision as needed,Removal of obsolete/invalid documents,Suitable identification of obsolete document retained for knowledge/legal purposes,4.3.2.3,Unique identification:date.Revision status,page number and number pages,ISO/IEC 17025:1999,12,4.3.3,DOCUMENT CHANGES,4.3.3.1 Approval of changes by the same agency as,original issue or authorized otherwise,4.3.3.2 Identification of changes either on the,document or on attachments,4.3.3.3 If manual corrections are permitted define the,same in the procedure,4.3.3.4 If documents are maintained on computer,memory define the controls,ISO/IEC 17025:1999,13,4.4 REVIEW OF REQUESTS,TENDERS AND,CONTRACTS,4.4.1 Establish and maintain documented procedure,for review of requests,tenders and contracts for,testing/calibration.The procedure shall cover,Ensure that the requirements are adequately,defined,documented and understood,b),Laboratory has the capability and resources to,meet the requirements,c),Selection of appropriate