mangement system acl

MANAGEMENT SYSTEMISO/IEC 17025:2005

ISO/IEC 17025:2005

ISO/IEC 17025:2005

It is generally agreed by the WTO that the biggest obstacle to trade is Non Tariff Technical Barriers i.e. (TBTs)

It is in the interest of all to overcome these and to develop a means of recognizing the technical infrastructure and output from one country in another country as being equivalent

ISO/IEC 17025:2005Recognition and Trade

ISO/IEC 17025:2005

Peer Evaluation Process (ISO/IEC 17040)Accreditation Body in country A(ISO/IEC 17011)Accreditation Body in country B (ISO/IEC 17011) Recognition Laboratory in country A (ISO/IEC 17025)Test/Calibration ResultsRecognition of

EquivalenceLaboratory in Country B (ISO/IEC 17025)Test /Calibration ResultsILAC MLA (Mutual Recognition Arrangement) ISO/IEC 17025:2005

ISO/IEC 17025:2005

ISO/IEC 17025 contains the criteria necessary for a laboratory to implement in order for it to perform its test work competentlyAccreditation is independent and formal recognition of the competence a laboratory to perform specific tests etc.The criteria that a laboratory must comply with to be internationally acceptable is ISO/IEC 17025.ISO/IEC 17025:2005What is Accreditation

ISO/IEC 17025:2005

Establish confidence of management and customers on your test results as well as test reports and increase customer trust as well as market share. It will give better image of company as a Quality producer in Global market.Provide hot tips on analysis of data as well as measure uncertainty and perfect record keeping.

BENEFIT OF ISO/IEC 17025ISO/IEC 17025:2005

ISO/IEC 17025:2005

Provide guideline for doing testing and measurement in detail.

Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc.BENEFIT OF ISO/IEC 17025ISO/IEC 17025:2005

ISO/IEC 17025:2005

ISO/IEC 17025Message in 5 lines for Laboratories

Say what you do

Do what you say

Record what you do

Check the difference

Act on the differenceISO/IEC 17025:2005

ISO/IEC 17025:2005

ISO/IEC 17025Message in 1 line

Do right thing, first time, every time to achieve consistent quality

Message in 1 line

Continual improvement is the way of lifeISO/IEC 17025:2005

ISO/IEC 17025:2005

The ISO 17025 standard itself is comprised of 5 elements: Scope 2. Normative References 3. Terms and Definitions 4. Management Requirements 5. Technical Requirements

Elements 4 and 5 contain the actual accreditation requirements.

ISO/IEC 17025 : Management SystemISO/IEC 17025:2005

ISO/IEC 17025:2005

These are the base requirements necessary for a laboratory to be able to implement and operate to demonstrate it is competence:

They are not super requirements

Cost (of compliance and/or Accreditation) is cost of achieving consistently good results

Cost of not having consistently good results could be much higher ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

17025 focus is on: Management requirements and Technical requirements

Annex A Cross reference to ISO 9001

Annex B Guidelines for establishing application for sector fieldsISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

17025 focus is on: 17025 contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent and are able to generate technically valid resultsISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

Management requirementsOrganizationManagement SystemDocument controlReview of requests, tenders and contractsSubcontracting of tests and calibrationPurchasing services and suppliesService to the customerComplaints

ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

Management requirementsControl of non conforming testing and/or calibration workImprovementCorrective actionPreventive actionControl of recordInternal audits Management reviewsISO/IEC 17025:2005

ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.1 Management requirementsLegal entityConflict of interest defined and relationship documented (Part of larger org.)Impartiality (4.1.5 b) and freedom from commercial/financial pressures which might influence judgement for 3rd party activities (Note 2)


ISO/IEC 17025:2005

4.1 Management requirementsHave policies in place to avoid involvement in activities that would negatively effect confidence in its competence, impartiality, judgement or operational integrity. Have Management and Technical staff (sufficient) and with adequate authority and resources to complete there responsibility and duties.ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.1 Management requirements

Define the Organization & management structure of the laboratory.Specific responsibility, authority or interrelationship of all personnels.Technical management has overall responsibility for technical operationAppoint deputies for key managerial operations


ISO/IEC 17025:2005

4.2 Management SystemEstablish, maintain and implement Quality System appropriate to the scope of activities Management 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 practicesStatement of laboratorys serviceObjectives of Management System


ISO/IEC 17025:2005

Requirement that personnel concerned get familiarized with Management SystemCommitment to comply with ISO/IEC 17025:2005Quality Manual shall include / refer to supporting procedures and outline structure of Management SystemDefined responsibility and authority of technical management and Quality Manager


ISO/IEC 17025:2005

4.3 Document ControlProcedure for document control Approval and issue Reviewed and approved by authorized personAvailability of documentPeriodic review & revision as needed & removal of obsolete documentsUniquely identificationDocument changes by original function. Altered text highlighted


ISO/IEC 17025:2005

4.4 Review of requests, Tenders and ContractsHave procedures in place to ensure requirement are defined , documented & understoodCapability & resource to meet the requirementSelection of appropriate calibration methodDifferences resolved before acceptanceRecords of review must be availableCan be oral or documented (contract)


ISO/IEC 17025:2005

4.4 Review of requests, Tenders and ContractsTo inform customer if any deviationAmendment to a contract should be reviewed & communicatedFor review of simple or routine results (date and initials of person doing test sufficient) Note in 4.2.2Repetitive tests Review at initial stage only as long as unchanged ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.5 Subcontracting of calibration

Aimil Calibration Laboratory doesnt go for subcontracting of calibration


ISO/IEC 17025:2005

4.6 PURCHASING SERVICES AND SUPPLIESProcedure for selection and purchasing of services and supplies that affect quality of tests/ calibration Use of purchased materials only after inspection/ verificationReview and approval of purchase documents before release.Evaluation of suppliers and maintenance of records ( for critical materials)


ISO/IEC 17025:2005

4.7 Service to Customer

The laboratory shall obtain feedback from customers and analyze for possible improvement.Protect the confidentiality of other customerTo cooperate with customer for their clarification & request . ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.8 Complaints

Procedure for resolution of complaints from customers and other parties.

Maintenance of records of complaints


ISO/IEC 17025:2005

4.9 Control of non-conforming testing/calibration workPolicies procedures implemented shall include Responsibilities and authorityEvaluation of non conforming work Notification to customer , if neededCorrection taken immediatelyResponsibility for authorizing resumption of work is definedISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.10 Improvements

Shall continually improve effectiveness of its Management System through the use of quality policy, quality objective, audit results , analysis of data , corrective & preventive actions and management review. ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.11 Corrective actionProcedure for implementing corrective action Cause analysis- investigation of root cause Selection and Implementation of corrective Action through a designated authorityShall start with a cause analysis Identify all potential corrective actions (select and implement)Shall monitor corrective actions effectivenessAdditional Audit where neededISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.12 Preventative Actions

Identification & implementation of preventive ActionsProcedure for Preventive ActionNeeded improvements and potential sources of NC shall be identifiedAction plans developed when identifiedISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.13 Control of RecordsProcedure for control the Quality and technical records.Records shall be legibleSecurity of recordsReadily retrievableMistakes can be corrected by the crossing the original observation, not by erasingProtect and back up needed ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.14 Internal auditsCan be performed as predetermined schedule & procedure Done periodical All elements of system Done by trained and qualified auditor where ever permitted by persons independent of activities to be audited


ISO/IEC 17025:2005

4.14 Internal audits

Timely corrective action & notification to the customerRecords of internal AuditFollow up audit to verify effectiveness of corrective action ISO/IEC 17025:2005ISO/IEC 17025 : Management System

ISO/IEC 17025:2005

4.15 Management Review

Predetermined procedures & schedules for management review.Records of management Review & follow up actions.


ISO/IEC 17025:2005

4.15 Management ReviewReview should covera.Suitability of polices & procedureb.Reports from managerial & supervisorsOutcome of internal auditAssessment of external agenciesILC/ PT resultsChanges in volume & type of WorkCustomer feedback / complaints


ISO/IEC 17025:2005

Thank you for your attention !

Any questions ?

ISO/IEC 17025 : Management SystemISO/IEC 17025:2005

ISO/IEC 17025:2005

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mangement system acl

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