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Accreditation Service for Food Hong Kong Accreditation Service

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Page 1: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Accreditation Service for Food

Hong Kong Accreditation Service

Page 2: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

HKAS

Are they competent?

Test, Certify, Inspect

Are they acceptable?

Accredit

Start

Page 3: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Accreditation Schemes

17 AccreditedCertification

Bodies

Laboratory TestingHOKLASMay 1985

HKAS

CertificationHKCAS

Nov. 1998

170 AccreditedLaboratories

InspectionHKIAS

Dec. 1999

20 AccreditedInspection

Bodies

Page 4: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

HKAS Objectives

To upgrade the standard of operation of certification bodies, inspection bodies and laboratories

To offer officially recognition to competent certification bodies, inspection bodies and testing and calibration laboratorieswhich meet international standards

to promote the acceptance of data, results, reports and certificates obtained by accredited certification bodies, inspection bodies and laboratories

to establish mutual recognition agreements with overseas accreditation bodies

to eliminate the need for repetition of testing, calibration, certification and inspection in the input of economics and thereby reducing costs and facilitating free trade across borders

Page 5: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Features of HKAS Accreditation

Voluntary

Based on international standards

Rigorous assessment and monitoring

International recognition

Independent and impartial

Page 6: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Assessors (>400)

HKAS Structure

Accreditation Advisory

Board (18)

Certification Bodies

Inspection Bodies

LaboratoriesTask forces (7)Task forces (7)Task forces (16)

Working Parties (18)Working Parties (18)Working Parties (18)

Working Party for Food

HKAS Executive

Page 7: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Scope of ServiceHOKLAS

calibration services

chemical testing

Chinese medicine

construction materials

electrical & electronic products

Environmental testing

Food

Forensic testing

medical testing

miscellaneous

Physical and mechanical testing

textiles & garments

toys & children’s products

Proficiency testing provider

Reference material producer

Page 8: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Scope of accreditation for food

Composition (water, ash, protein, fat, dietary fibre, sugars, fatty acids, cholesterol, salt)

ContaminantsMetals

Pesticide residuesVeterinary drugs residues

PreservativesArtificial sweeteners

HormonesEmulsifiers and stabilisers

Colouring mattersMicroscopic examinationGenetically modified food

Food container toxicological tests

Page 9: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Accreditation Process Flow chart

Accreditation granted

Accreditation Decision

Remedial actions

Full on-site assessment Proficiency testing

Advisory visit

Application submit quality documentation

Monitoring

Page 10: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

International Recognition

• Recognised by 79 accrediation bodies in 63 economies (Feb 2100)•Through multilateral mutual recognition arrangements of ILAC, IAF, APLAC and EA

• Covers testing, medical testing, calibration, inspection, management system certification

• HKAS accreditation recognised internationally

Page 11: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

UNITED KINGDOM英國UKAS

BELGIUM比利時 B E L A C

DENMARK丹 麥 D A N A K

FINLAND芬蘭

FINASFRANCE法國 C O F R A C

IRELAND愛 爾 蘭 I N A B

ITALYACCREDIA義 大 利 C O P A

SPAIN西 班 牙 E N A C

NORWAY挪 威 N A

SWEDEN瑞典 S W E D A C

CZECH REPUBLIC 捷克共和國CAI

ISRAEL以色列 I S R A C

BRAZILCGCRE/巴西 I N M E T R O

INDIA NABCB印 度 N A B L

AUSTRALIA澳大利亞NATA

CHINA, PRC中華人民共和國

CNAS

SINGAPORE新 加 坡 S A C

USAASCLD/LAB美國 A C L A S S

A2LA, IAS, L-A-BIAS, NVLAP, PJLA

VIETNAM越 南 B O A

CHINESE TAIPEI中華臺北 T A F

NEW ZEALAND新 西 蘭 I A N Z

HONG KONG香 港 H K A S

INDONESIA印 尼 K A N

THAILANDONAC泰 國 D S S

DMSc

JAPAN JAB日本 I A J a p a n

VLACMALAYSIA馬來西亞 D S M

PORTUGAL葡 萄 牙 I P A C

AUSTRIA奧 地 利 b m w f j

SLOVAKIA斯洛伐克

SNAS

ARGENTINA阿 根 廷 O A A

EGYPT埃 及 E G A C

POLAND波 蘭 P C A

AUSTRALASIA澳亞 J A S - A N Z

ESTONIA愛沙尼亞 E A K

MEXICO墨 西 哥 E M A

SOUTH AFRICA南 非 S A N A S

NETHERLANDS荷 蘭 R v A

SWITZERLAND瑞 士 S A S

CANADA加 拿 大 S C C

CALA

REP. OF KOREA 大韓民國

KOLAS

TUNISIA突尼斯 T U N A C

TURKEY土耳其TURKAK

GREECE希 臘 E S Y D

CUBA古 巴 O N A R C

ROMANIA羅馬尼亞RENAR

COSTA RICA哥斯大黎加ECA

跨美區域集團Regional

GroupInter-America

GUATEMALA瓜地馬拉 O G A

ILAC/IAF MRA

PHILIPPINES菲 律 賓 P A O

UNITED ARAB EMIRATES阿拉伯聯合酋

長國DAC

LITHUANIA立陶宛

LALATVIA

拉脫維亞

LATAK

PAKISTAN巴基斯坦

PNAC

SLOVENIA斯洛文尼亞SA

亞太區域集團Regional

GroupAsia-Pacific

GERMANY德 國 D A k k S

HUNGARY匈 牙 利

N A T

CROATIA克羅地亞

HAA

RUSSIAN FEDERATION俄羅斯聯邦

ACC Analitica

歐洲區域集團

Regional

GroupEurope

Page 12: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Local Food Testing Labs

• 4 government• 17 private

Page 13: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Technical criteria for Laboratory Accreditation

•HOKLAS 003

•Basis of technical criteria for laboratory accreditation - ISO/IEC 17025 : 2005 General requirements for the competence of testing and calibration laboratories

Page 14: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Technical criteria for Laboratory Accreditation

5.4.2 Selection of methods

When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organisations, or in relevant scientific tests or journals, or as specified by the manufacturer of the equipment. Laboratory-developed methods or methodsadopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated.

Page 15: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Technical criteria for Laboratory Accreditation

5.4.4 Non-standard methods

When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer’s requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use.

Page 16: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

5.4.5 Validation of methods

5.4.5.1 Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

Page 17: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

5.4.5.2 The laboratory shall validate non-standard methods, laboratory-designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application. The laboratory shall record the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use.

Page 18: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

NOTE 1 Validation may include procedures for sampling, handling and transportation.

Page 19: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

NOTE 2 The techniques used for the determination of the performance of a method should be one of, or a combination of, the following:

-calibration using reference standards or reference materials;

-comparison of results achieved with other methods;

-interlaboratory comparisons;

-Systematic assessment of the factors influencing the results based on scientific understanding of the theoretical principles of the method and practical experience.

Page 20: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

NOTE 3 When some changes are made in the validated non- standard methods, the influence of such changes should be documented and, if appropriate, a new validation should be carried out.

Page 21: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

5.4.5.3 The range and accuracy of the values obtainable from validated methods (e.g. the uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences and/or cross- sensitivity against interference from the matrix of the sample/test object), as assessed for the intended use, shall be relevant to the customers’ need.

Page 22: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

NOTE 1 Validation includes specification of the requirements, determination of the characteristics of the methods, a check that the requirements can be fulfilled by using the method, and a statement on the validity.

NOTE 2 As method-development proceeds, regular review should be carried out to verify that the needs of the customer are still being fulfilled. Any change in requirements requiring modifications to the development plan should be approved and authorised.

Page 23: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Method Validation

NOTE 1 Validation is always a balance between costs, risks and technical possibilities. There are many cases in which the range and uncertainty of the values (e.g. accuracy, detection limit, selectivity, linearity, repeatability, reproducibility, robustness and cross-sensitivity) can only be given in a simplified way due to lack of information.

Page 24: Accreditation Service for Food Hong Kong Accreditation Service · 2017. 5. 2. · Accreditation Schemes. 17 Accredited. Certification. Bodies . Laboratory Testing. HOKLAS. May 1985

Thank you