hamolwan laoviitayanurak iso 17025 micro[1]
DESCRIPTION
ISO 17025TRANSCRIPT
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© 3M 2009. All Rights Reserved.
High Level Importance: ISO 17025 Microbiology complianceThamolwan Laoviitayanurak, 3M FSD Professional ServiceAPEC Regional Workshop, BKK Thailand on Aug 25, 2011
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Topic Outline
Lab Accreditation: ISO/IEC 17025– What is it?– Who Provides Accreditation?– How do you get it?
ISO 17025 Microbiology compliance for Food Safety– Food Safety Challenges– ISO 17025 Microbiology compliance
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Lab Accreditation
As consumers, we want confidence in products
• inspected• tested
Verification that this has been done properly is the job of recognized accreditation bodies
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What is it?
Based on ISO Guide 25
Since December 1999, a standard –ISO 17025– Defined, written procedures
– Document you are following them
“SAY what you do, DO what you say”
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What is it?
Certification of lab:
– Management systems– Personnel– Products– Testing & calibration– Inspection– Quality systems & procedures– Vendors– Complaint handling– Etc.
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• Provides confidence in the results• Public and industry acceptance• Meets purchaser or regulatory specifications• National and International recognition• Increase competitiveness and market share• Assurance to customers of good laboratory practices• Ensures better support in the event of legal challenge• Save money by getting it right the first time
Accreditation: Benefits
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WHO Provides Accreditation?
International Laboratory Accreditation Cooperation (ILAC)
Formed in 1996 – 44 national bodies signed Memorandum of Understanding (MOU)
International cooperation between accreditation schemes
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ILAC
Forum for development of lab accreditation practices
Promotes lab accreditation as a trade facilitation tool
Provides assistance to develop accreditation systems
Recognizes competent global test facilities
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WHO Provides Accreditation?
Each country has own body– KOLAS– A2LA– COFRAC– EMA
Multilateral Agreements are signed between regions– EA– APLAC
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What Is a Multilateral Agreement?
Agreement between cooperatives to recognize & promote equivalence of each other’s:
• Systems• Certificates • Reports
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What Do These Agreements Mean?
Agree on equivalency
Assess each other
Results from one lab can be accepted by another
Can help intl trade - a supplier may need only 1 certificate to satisfy all governments
Can be a competitive advantage
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APLAC EA NA/SA …………
Thailand
(TLAS, BLQS)
Japan Singapore HK
ILAC
ILAC = International Laboratory Accreditation Coordination
APLAC = Asia Pacific Laboratory Accreditation Coordination
Accreditation Bodies
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Accreditation bodies recognise the work of accredited laboratories as equivalent around the world
Regulator are also encouraged to accept local and foreign accredited results
Reduces Technical Barriers to Trade
APLAC and ILAC
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Mutual Recognition Arrangement (MRA- 001)
APLAC member
USACANADAAUSTRALIANEW ZEALAND
SINGAPOREINDONESIAVIETNAM THAILAND
JAPAN CHINA HONG KONG REPUBLIC OF KOREACHINESE TAIPEIINDIA
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BLQS1997
TISI (TLAS,1987)
Engineering / others labs
Health product testing labs.
Medical labs.
National Laboratory Accreditation Bodies
Thai Industrial Standard Institute (TISI)
Thai Laboratory Accreditation Scheme (TLAS)
Bureau of Laboratory Quality Standards (BLQS), DMSc.
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How Are Labs Accredited?
After defining & documenting: • Quality management systems
• Technical requirements for operation
Initiating a 3rd party assessment of competence
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Contents of ISO / IEC 17025 : 2005
1. Scope
2. Normative References
3. Terms and Definitions
4. Management Requirements
5. Technical Requirements
ISO / IEC 17025 : 2005
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Management Requirements (15) Technical Requirements (10)
ISO / IEC 17025 : 2005
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4. MANAGEMENT REQUIREMENTS4.1 Organization4.2 Management System4.3 Document control4.4 Review of requests, tenders and contracts4.5 Subcontracting of tests and calibrations4.6 Purchasing services and supplies4.7 Service to Customer4.8 Complaints
ISO / IEC 17025 : 2005
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4. MANAGEMENT REQUIREMENTS –contd.4.9 Control of non-conforming testing/ calibration4.10 Improvement4.11 Corrective actions4.12 Preventive actions4.13 Control of records4.14 Internal audits4.15 Management reviews
ISO / IEC 17025 : 2005
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Technical Requirements
ISO / IEC 17025 : 2005ISO / IEC 17025 : 2005
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5. TECHNICAL REQUIREMENTS5.1 General5.2 Personnel5.3 Accommodation and environmental conditions5.4 Test and calibration methods and method validation5.5 Equipment5.6 Measurement traceability5.7 Sampling5.8 Handling of test and calibration items5.9 Assuring quality of test and calibration results5.10 Reporting the results
ISO / IEC 17025 : 2005
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Why do it?
Benefits for Labs
Improved systems
More control over testing protocols
Better training & discipline
Fewer repeat analysis
Greater confidence in results
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Why do it?
Benefits to Customers Greater confidence in reliability of
test data
Greater acceptance by government depts.
Calibration standards & testing traceable to national standards
Results accepted nationally & abroad
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Food Safety: Why Should We Care?
25
Every year foodborne pathogens result in an estimated
• 2 billions cases of foodborne illnesses• 1.8 millions needless deaths each year• Economic losses between $ 10-83 billion USD
WHO © 3M 2011. All Rights Reserved.
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Sources of Contamination
• Raw materials (ingredients)• Processing equipment• Food Handlers• Farmers and producers• Packaging material• Animals and insects• Environment: Air, soil, water,
waste, silage
Where do pathogens come from?
© 3M 2011. All Rights Reserved.
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27 © 3M 2011. All Rights Reserved.
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What Are The Challenges?
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What are the issues impacting Food Safety?
Globalization of the food supply Intensification of agriculture and animal husbandry New raw materials, new processes and new foods Changes in well known organisms & emerging microorganisms
i.e. E.coli 0104 outbreak Climate changes Increased regulatory demands Consumer related issues (demographic change, awareness,
behaviors, etc...)
© 3M 2011. All Rights Reserved.
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Establishes minimum competency standards Identifies laboratory’s specific competencies Assures acceptance of data Assurance to meet quality requirements of
consumers Reduced risk Ensure we provide products & services that
support food safety world-wide
What are benefits of ISO 17025 Microbiological Compliance?
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www.themegallery.com
Records, checklist, form
Supporting document
, Test/calibration method
Quality policy statement
Least confidential
Less confidential
confidential
Most confidential
Work instructionStandard Procedure, diagram
Proficiency testCalibration of equipment
Organization chartPlaning,internal audit,SOP
Equipment profileUncertainty,Validation
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• Legal methods approved for testing of product's quality• International recognized standard methods• Customer requirement methods • For test methods that are in-house and adapted from standard method, there shall be validated and record of the data
Microbiological Test Methods
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Proficiency Testing (Pt)
External control to measure a lab’s:– Accuracy
– Competency
Verify lab & technicians are competent
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Proficiency Tests - Microbiology
Samples with known levels of target organisms
Shipped periodically – at least 2x/yr
Follow current methods
Rotate technician participation
Reported results compared to other labs
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Define Measurement of Uncertainty
Currently – some uncertainty!– Repeatability/ reproducibility
The degree of rigor or/ and the need for reporting of uncertainty of measurement depends on:- the requirements of the client- the requirements of the test method- the existence of narrow limits on which decisions on conformance to specification are based
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• Estimation of uncertainty of measurement is not possible in qualitative testing, laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation • Previous validation data can be a support • The standard strains or reference strains that using in testing shall be traceable to the national or international levels
Microbiological testing
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Limitations of Accreditation
Provides assurance – but not a guarantee
Large volumes of food, small volumes tested – so can still miss:– Potential food spoilage– Potential food poisoning
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Conclusion
Lab Accreditation ISO 17025– Establishing quality management
systems & technical requirements for operation
ISO 17025 Microbiology Compliance– required for successful performance
in food safety– critical importance in the risk
assessment process-
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Thank you for your attention