LABORATORY ACCREDITATION AS TOOL FOR COMPLIANCE WITH STANDARDS
LABORATORY ACCREDITATION AS TOOL FOR COMPLIANCE WITH STANDARDS Prof Dr. Adel B. Shehata Chief Executive of the NATIONAL LABORATORIES ACCREDITATION BUREAU NLAB Tersa. St. . . El-Haram, Giza P. O. Box: 136 GIZA, No. 12211 EGYPT Tel : 0020 -2 -3879242 FAX : 0020 -203829446 adelshehata 63@yahoo. com
CONFORMITY ASSESSMENT VOLUNTARY REGULATED SECTOR STANDARDS Specific Technical CUSTOMER Requirement Of REQUIREMENTS Product Or System GOVERNMENT Set Policy , Laws and Technical Regulations CONFORMITY ASSESSMENT SUPPLIER Prove technical requirements Are met CUSTOMER Testing and calibration inspection MEASUREMENTS Underpins testing and calibration through national measurement standards certification ACCREDITATION Conformity assessment model Assures Competence
WTO ISO/IEC/ITU-T Etc REGULATIONS FREE Codex/IOE/IPPC Standards TRADE OIML ILAC/IAF Pattern Accreditation TRACEABILITY TO Approval Conformity SI Certification assessment BIPM system Infrastructure for world free trade
Differences between accreditation and certification • Certification • Means compliance with a standard or specification • • • (e. g. system or product standards). Uses management system auditors who are certified by an independent body as meeting internationally agreed criteria. May be general in the scope of recognition. Considers the total business.
• ACCRADITATION • Is the recognition of specified competence and • • its scope is normally highly specified. Evaluates people skills and knowledge Uses assessors who are recognized specialists in their fields. Evaluates the supporting management systems for a specified activity. Involves practical tests as appropriate ( proficiency testing and measurement audits)
Accreditation in General FOR • CERTIFICATION BODIES. • - Quality management system (QMS) • - Environmental management system (EMS) • - ECO-Management Audit Schemes • - Product • - Personnel
• LABORATORIES. Testing laboratories § - Calibration laboratories § - Sampling laboratories INSPECTION BODIES § - • § - Food § - Engineering products • NOTIFIED BODIES - Assessment Under Various EU Directives
Access to traceable standards of measurement Accreditation For testing And/or calibration Test Laboratory Credible test reports for the end user Framework for a credible testing system Documentary Standards
• Laboratory Accreditation A formal Recognition that a laboratory is Competent to Specified tests or Measurements Previous NEXT
Possible role of accreditation for any economy 1. Governments use testing and calibration for • • Enforcement of safety regulations. Protection of the environment. Enforcement of road traffic legislation. Health services. Control of commerce and trade. Forensic investigation Assessment of quality of goods and services purchased for their own use.
2. Industry and commerce have particular interests in • • • Quality assurance of goods and services. Quality control of manufactured goods. Advertising data. Risk assessment and management. Failure investigation. Resolution of complaints and disputes.
3 - Consumers have particular interests of products 4 -Recipient of the test report needs to reliable in the safety and performance have confidence that the data in it is 5 -Unreliable data is actually more dangerous that the absence of any data. 6 -Laboratory accreditation is the tool to ensure the confidence of laboratory to perform specific test of calibration.
NLAB Scope Accreditation of : • Testing Laboratories ●calibration Laboratories ●Sampling Laboratories
Requirements of ISO/IEC 17025 Administrative Requirements Organization Quality System Document Control Review of Contracts Purchasing Services and Supplies Corrective Actions Preventive Actions Control of Records Internal Audits and Management Review Complaints
Technical Requirements Personnel Test and/or Calibration Methods Accommodation and Environmental Conditions Equipment Measurement Traceability Control of Non-conforming Work Handling of Test and Calibration Items Reporting Results
Brief History of NLAB • Nationally Recognized by the Presidential • • • Decree 166/1996. The first nucleus of expertise was built through an MOU with UKAS. Granted first testing laboratory accreditation in 1998. Granted first calibration laboratory accreditation in 1998. Pre-peer evaluated by ILAC for Testing and accreditation laboratories 2001. Peer evaluated by ILAC for Testing and accreditation laboratories 2004.
• • • Training courses offered by NLAB General awareness on ISO/IEC 17025 Technical assessors training course Estimation of uncertainty budget in measurements • • Preparation of Quality system Internal Audits Quality Control Charts Method Validation
Typical structure and interaction in an accreditation body INCORPORATED ACCREDITATION BODY STAKEHOLDER GOVERNING BOARD ADVISORY GROUP (could be board members) CHIEF EXECUTIVE STAFF ADMINISTRATIVE AND TECHNICAL PROFESSIONAL COMMITTEE(S) ASSESSORS ( COULD BE MEMBERS OF TECHNICAL COMMITTEE(S))
Prerequisites for a laboratory accreditation programme Government Support Reasonable Demand From Local Users Access to Appropriate Traceable Education and training Measurement standards
• ESSENTIAL PREREQUISITES • A need for accreditation by organization (lab , certification bodies and inspection bodies) • Some political and governmental support. • Certain technical requirements.
Schematic of the global measurement system Other NORAMET BIPM APMP National Laboratories EUROMET
MEMBERS OF ILAC MRA NETHERLANDS BELGUM FINLAND SWEDN IRLAND (RVA) BELTEST, BKO-OBE (FINAS) (SWEDAC) (NAB) SPIN (ENAC) FRANCE CANDA (CSC) (COFRAC) United kingdom NERWAY (UKAS) (NA) GERMANY DENMARK (DAP, DACH, DANNAK) PTB, DATach) SWITZERLAND ITALY CZECH REPUBLIC (SINAL, SIT) (CAI) (SAS) JAPAN (JAB, JCSS, JNLA) USA A 2 LA, NVLAP, ICB-ES PR OF CHINA ( CNACL) HONG KONG. CHINA (HKAS) NEWZELANND IANZ)) BRAZIL (INMETRO) SOUTH AFRICA INDIA (NABL) AUSTRALIA (NATA) (SANAS) VITNAM (VILAS-STAMEQ) SINGAPORE (SAC)
Thank you Prof. Dr. Adel B. Shehata Chief Executive of NLAB Tersa St El HARAM P. O. Box: 136 Giza , No 12211 Egypt Tel: 0020 -2 -3879242 Fax: 0020 -203829446 Mobil: 0020 -010 -3779483 E-mail: adelshehata 63@yahoo. com www. nlab. org
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