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MESSAGE ISO/IECtitle 17025:2017 17025 :2017 Click toFROM edit Master style
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MESSAGE IN 5 LINES FOR LABORATORIES
Click to edit Master text styles Say what you do Click to edit Master text styles Second level Do what you say Second level Third level what you do Record Fourth level level Third Check the difference level » Fifth dif ference Act on the difference Fourth level Fifth MESSAGE IN 1 LINE level •
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Do right thing, first time, every time to Achieve Consistent Quality
MESSAGE IN 1 LINE
Continual improvement is the way of life
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ISO/IEC 17025: 2017 Requirements
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4. General Requirements
5. Structural Requirements
6. Resource Requirements
7. Process Requirements
Click to edit Master text styles 4.1 Click to edit Master text styles 6.1 General Second level Impartiality Second level Third level 6.2 Personnel 4.2 Confidentiality Fourth level Third level » Fifth level Fourth level Fifth level 6.4 Equipment •
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7.1 Review of requests, tenders and contracts
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7.3 Sampling
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6.3 Facilities and environmental conditions
7.5 Technical records
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7.2 Selection, verification and validation of methods
7.4 Handling of test or calibration items 7.6 Evaluation of measurement uncertainty
7.7 Assuring the validity of results
7.8 Reporting of results
7.9 Complaints
7.10 Non conforming work
6.5 Metrological traceability
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8. Management System Requirements 8.1 Options
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.8 Internal audits (Option A)
8.7 Corrective action (Option A)
8.9 Management reviews (Option A)
7.11 Control of data – Information management
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4 TIER DOCUMENT DOCUMENTA ATION STRUCTURE FOR LABORATORY ISO/IEC 17025:2017 Click to editUNDER Master title style
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Click to edit Master Lab text styles Quality Manual Click to edit Master text styles Second level Second level Third level Procedures Fourth level Third level » Fifth level Fourth level Work Instruction/SOP/ test Fifth level standards/Test Methods/other
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documents Forms/Records Sample receipt
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Purchasing
Sampling
Testing
Record preparation
Dispatch
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Personnel & Trg.
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Risk and Opportunit Opportunity y
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Click to edit Master title style The Th e obj bjec ecttiv ive e of thi hiss pr pres esen enttat atio ion n are to app pprrec ecia iatte an and d und nder erst stan and d how Click to edit Master title style an QMS is established in terms of: Click to edit Master textofstyles Four Phases Risk Click to edit Master text styles Second level Risk Analysis Risk Evaluation Second level Third level Intended user Identification Risk acceptability decisions Area wise risk level identification Fourth Third level Risk estimation » Fifth level Fourth level Fifth level
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Risk monitoring and control
OPTION analysis Implementation of measures RESIDUAL RISK evaluation Overall RISK acceptance
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Post test operation information Post-production experience Review of Risk management experienceexperi ence- custo customer mer use Take appropriate actions in MRM 5
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Application for Accreditation
(by
Laboratory)
Accreditation Procedure Acknowledgement & Scrutiny of Application (by accreditation body Secretariat)
Feedback to Adequacy of Quality Manual
(by
Laboratory
Lead Assessor)
Stage 1 audit of Laboratory (Optional)
Final Assessment of Laboratory
(by
Assessment Team)
and
Necessary Corrective Action
Scrutiny of Assessment Report
(by
accreditation body Secretariat)
by Laboratory
Recommendations for Accreditation (by Accreditation Committee)
Approval for Accreditat Accreditation ion
(by
Chairman, accreditation body)
Issue of Accreditation Certificate
(by
accreditation body Secretariat)
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Audit Steps
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1. Audit Plan
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2. Develop Checklists Click to edit Master text styles Click to edit Second level Master text styles 3. Opening Meeting Second level Third level Fourth level Third level 4. Gather level Evidence » Fifth Fourth level Fifth level 5. Record Results
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6. Closing Meeting 7. Audit report 055 /1/21/2 20/12 7017 0 GMG
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ISO/IEC 17025 Accreditation Steps For accredited laboratories
ISO/I O/IEC EC 17 1702 025:2 5:201 017 7 Steps to update existing ISO/IEC 17025:2005 system to revised IS labor lab orato atory ry man manage agemen mentt sy syst stem em (Ex (Exis isting ting acc accred redite ited d lab labor orato atorie ries) s)
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Cond Co nduc uctt aw awar aren enes esss pr prog ogra ram m for re revis visio ion n to ISO ISO/I /IEC EC 17 1702 025: 5:20 2017 17
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Revie Re view w al alll do docu cume ment ntss to me meet et re revi vise sed d IS ISO/ O/IE IEC C 17 1702 025: 5:20 2017 17 re requ quir irem emen ents ts an and d Id Iden enti tify fy ch chan ange ges. s.
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Prom Pr omot ote e th the e us use e of ri risk sk ba base sed d th thin inki king ng an and d de dete term rmin ine e ri risk sk an and d op oppo port rtun unit itie iess
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Rev evie iew w qu qual alit ity y po poli licy cy an and d es esttab abli lish sh qu qual alit ity y ob obje ject ctiv ives es as we well ll as pr prep epar are e ri risk sk sh shee eett
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Revi Re vise se Qu Qual alit ity y Ma Manu nual al an and d pr prep epar are e do docu cume ment ntss as pe perr re revi vise sed d IS ISO/ O/IE IEC C 17 1702 025: 5:20 2017 17..
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Tra rain in int intern ernal al aud audito itors rs fo forr re requi quire remen ments ts of re revis vised ed ISO/ ISO/IEC IEC 170 17025 25:20 :2017 17 st stand andar ard d
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Asse As sess ss th the e sy syst stem em th thro roug ugh h in inte tern rnal al au audi ditt as pe perr re revis vised ed IS ISO/ O/IE IEC C 17 1702 025: 5:20 2017 17 st stan anda dard rd..
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Tak ake e cor corre recti ctive ve act action ionss on ide identi ntifie fied d non non-co -conf nform ormiti ities. es.
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Apply Appl y to re revis vised ed ex exis isti ting ng ce cert rtif ific icat ate e to ISO ISO/I /IEC EC 17 1702 025: 5:20 2017 17 st stan anda dard rd to yo your ur ex exis isti ting ng ac accr cred edit itat atio ion n body.
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Final audit (Either in surveillance audit or special audit by accreditation body on ISO/IEC 17025:2017
Note: Also all accredited laboratories needs to update the system within 3 year of release of standard.
The ISO/IEC 17025:2017 is released in November 2017, the accredited laboratories may may go for Upgradation to to ISO/IEC 17025:2017 before November 2020
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