Public Disclosure Authorized HACCP Accreditation Project · HACCP Accreditation Body (IARM) has already been established according to the European ... Grkov Zoran IARM-Accreditation

HACCP Accreditation Project

May 2004

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CONTENTS

1. Introduction................................................................................................................................................ 1

2. Theoretical Background ............................................................................................................................ 3

3. Current Situation ....................................................................................................................................... 4

Local environment ........................................................................................................................................ 4

International environment ............................................................................................................................. 8

4. Recommendations for Further Development and Improvement ................................................................ 13

APPENDIX 1: Proposed Training Programme............................................................................................... 18

APPENDIX 2: Proposed Examination Programme........................................................................................ 20

APPENDIX 3: Criteria, Conditions & Process for the Periodic Assessment of HACCP Assessors – Experts

........................................................................................................................................................................ 21

APPENDIX 4: Proposals for Specific HACCP documentation & Criteria for HACCP CBs to become

Members......................................................................................................................................................... 23

APPENDIX 5: IARM Organization.................................................................................................................. 25

APPENDIX 6: Overview of the EU Accreditation Bodies ............................................................................... 26

APPENDIX 7: Overview of EA/MLA............................................................................................................... 31

APPENDIX 8:Fundamental Elements of a Food Safety Management System ............................................. 33

Note/Abbreviations:

- FSMS=Food Safety Management System

- CB=Certification body

- AB=Accreditation body

- Std=standard

- MoE=Ministry of Economy

- IARM = Institute of Accreditation of FY Republic Macedonia

- EA = European Co-operation for Accreditation

- MLA =Multilateral agreement

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1. Introduction

1.1 Food safety is a dominant critical issue within the food sector. It is the responsibility of the producers

to supply safe food. Therefore, the food companies have to demonstrate that they take all the appropriate

measures to ensure that they effectively control the applicable food hazards. The main instrument for this

demonstration is the reliable application of HACCP principles (including the Good Health practices / GHP

applications), i.e. the establishment of an effective Food Safety Management System (FSMS). Within FYR

Macedonia, the application of a FSMS according to HACCP can serve the needs to:

- ensure public health & consumer protection through safe food;

- comply with the national food law (HACCP is a mandatory requirement by 7/2003);

- comply with the WTO/SPSS agreement and therefore enable food exports;

- comply with the EU law (93/43) and therefore contribute to the future plans to enter EU.

1.2 The effective and reliable operation of a FSMS (complying with HACCP principles) can be

demonstrated only by an accredited body that will certify the system. Thus, HACCP system certification is

an urgent market need. Today, the Ministry of Economy within FYR Macedonia encourages organizations

to improve their quality level and be certified and/or accredited by providing them with a 50% cost funding

program. However, the setup up of a HACCP system can be quite expensive, since the Ministry of

Economy runs the cost funding program only for the ISO 9001:2000 (and not HACCP) standard, whereas to

invite foreign certification or accreditation bodies is the country is unprofitable.

1.3 At the moment, the National Accreditation Institution, that has already been established within FYR

Macedonia, is not well qualified and equipped to accredit local HACCP certifying houses according to the

stated European framework guidelines. This results to a large gap in the market, while local companies find

it difficult to implement and be certified according to HACCP principles in economic and operational terms.

SEED, along with other donor institutions, are striving to fill in this gap by bringing foreign certification

bodies. However, because this is a short-term solution, SEED’s objective is to enable the effective

establishment and setup of a HACCP Accreditation Body (AB) in FYR Macedonia within the framework of

the existing National Accreditation Institution.

1.4 Within this framework, SEED appointed KANTOR to:

• work closely with a local consultant in order to analyse the current environment and recommend the

necessary steps for establishing the HACCP AB;

• identify a HACCP AB located in an EU country which will serve as the best model applicable for the

Macedonian conditions;

• identify the appropriate group of governmental representatives from institutions that are involved in

HACCP issues, in order to recommend their becoming members of the HACCP AB;

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• define the necessary conditions and criteria for individuals that can become HACCP AB members;

• formulate a training programme for the usual induction of the selected individuals within the HACCP

AB;

• identify an examination framework for the continuous evaluation of the selected individuals / future

HACCP AB members;

• establish a process for re-evaluating HACCP AB members’ knowledge in order to “renew” their

membership.

1.5 The project will be implemented in three phases, as follows:

PHASE A: The objective of this Phase was to review the current situation within FYR Macedonia, suggest

the best applicable operational model for the HACCP AB, and recommend the appropriate

representatives to become members of the AB. During the visit in Skopje, it was clarified that a

HACCP Accreditation Body (IARM) has already been established according to the European

specifications for accreditation (EA/MLA). However, improvements can be applied to increase

its performance efficiency and effectiveness. Therefore, the initial project goals are partly

modified in the sense that recommendations should focus on identifying the necessary actions

to improve the operation of the recently established HACCP AB.

PHASE B: The objective of this Phase was to draft recommendations about the basic conditions and criteria

for the individuals to become members of the HACCP AB, as well as to describe a process for

periodically evaluating their capabilities, including the formulation of an exam and a training

programme.

PHASE C: This Phase involves responding to SEED’s comments and the provision of any clarifications

considered necessary.

1.6 As far as PHASE A is concerned, Table 1.1 below describes the meetings that took place during

the Skopje visit.

TABLE 1.1: Meetings that took place during the Skopje visit

NAME ORGANISATION Position

Dr Vladimir

Kakurinov

Ss Cyryl and Methodius University (Faculty of

Agriculture-Skopje)

Ass. Professor (Local

consultant)

Prof. Arsov Ljupco IARM-Accreditation institute President

Grkov Zoran IARM-Accreditation institute General Director

Katerina Orovcanec Ministry of Economy, Department for Attracting FDI Head of Unit

Slobodan Popovski GTZ-Bilateral agreement project Coordinator

Nikos Mouzopoulos RWTUV - SMAQVa project (by EAR) Project leader

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1.7 For the implementation of PHASE B, the findings of the previous phase were reviewed and input

was made by international reference material, the local consultant as well as the Greek Accreditation Body

and general Certification and Standardization HACCP experience.

2. Theoretical Background

2.1 This project has two main concepts combined: “Accreditation” and “HACCP”.

2.2 As far as accreditation is concerned, attention has been given to the fact that standardization,

certification and accreditation are interrelated procedures, all of which interact in order to satisfy market

needs & achieve expectations. A certifiable specification (certification standard), should be selected or

developed with the maximum consensus over the different market stakeholders, and has to be as much

recognized/accepted as possible. Certifiable specifications, which have been published by formal

Standardization Bodies (either National, European or International), are “officially recognized standards”

and follow this characteristic.

2.3 A business firm or an organization can claim conformance with a standard only if an appropriate

certification body (CB), one that follows the proper Certification Procedure, has certified them for

conformance. A proper certification procedure is a procedure followed by a third party/certification body,

which results in a written assurance that a product or a service conforms to specified requirements (i.e. the

certifiable standard).

2.4 An appropriate third party/certification body is a suitable accredited CB, which has passed

successfully the accreditation procedure. The accreditation procedure is the procedure that is followed by

an authoritative body in order to give formal recognition that a body or person is capable to carry out

specific certification tasks. The authoritative body would normally be a national accreditation body

recognized by the government to assess (against internationally agreed standards) organizations that

provide certification, testing, inspection and calibration services. An Accreditation Body (AB) should

represent all of the market stakeholders (including social partners) and operate in a proper way that

provides it with the ability to be signatory & accepted in relevant European or international agreements (e.g.

the EA multilateral agreement). An AB does not carry out assessments itself, but assesses and accredits

CB’s for a predefined scope of accreditation, i.e. relating to specific areas of industry.

2.5 It is not mandatory for CBs to seek accreditation strictly from their national AB. However, one AB is

unable to comment on the way in which an accredited -by other accreditation body- CB carries out its

certification activities, since it has not assessed or accredited this body. Nevertheless, according to the

European and international scheme, all accreditation and certification bodies should conform to the same

standards (relevant standards of series EN45000, ISO17000/ISO/IEC Guides), and are not allowed to offer

consultancy, accreditation and certification as a "one-stop shop" package.

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2.6 Regarding HACCP, attention has been given to the fact that HACCP is both a mandatory

requirement (by law) and a voluntary one (driven by the market or other customer needs). As far as

legislative/regulatory requirements are concerned, public control authorities inspect food companies to

assess whether they comply with HACCP principles according to the particular law requirements. A

successful assessment is a prerequisite for a company to continue to operate.

2.7 Regarding voluntary/statutory requirements, the certification bodies audit food companies to assess

their conformity with a HACCP system (FSMS) standard/specification. Due to the nature of this

assessment, successful assessment is a not a prerequisite for a company to operate, but at least it leads to

a certification (market differentiation) and a documented self-controlling and reliable evidence /

demonstration that the company is doing well regarding food safety.

2.8 Mutual acceptance between the inspection results produced by a public authority and a CB is a

matter of law and/or decision of public authorities. Usually there is not mutual acceptance, since HACCP

certification is based on a voluntary approach / self-control preventive system, whereas public authorities

inspect food companies against specific laws and regulations.

2.9 Another issue regarding the HACCP compulsory inspection is that a public inspection authority

does not need an accreditation to do the inspection (as is the case for a CB). It is up to the public inspection

authorities to decide whether they wish (or not) to be accredited for their services. Accreditation to public

inspection authorities can be used to improve and demonstrate their abilities to perform inspections in a

proper way (e.g. based on EN45004).

2.10 Finally, we emphasize the fact that a certifiable HACCP system needs to comply with all the

characteristics of an effective food safety management system. A FSMS would normally consist of 3 “parts /

levela” as shown in APPENDIX 8:Fundamental Elements of a Food Safety Management System.

Therefore, to claim the effectiveness of a HACCP system and/or to be successfully assessed for adequacy,

there is a need for three-level conformity.

3. Current Situation

Local environment

3.1 Within FYR Macedonia, there is a whole strategy developed in the area of quality and related

issues, implemented through regulatory actions (e.g. the introduction of new laws) and operational actions

(e.g. the setup of new institutions, networking labs & certifications). All of these actions intend to bring

quality issues into public awareness. The implementation of this strategy is underway.

3.2 FYR Macedonia committed itself under the Stabilization and Association Agreement (SAA) signed

in 2000, in order to enable EU harmonization and trade liberation, with priorities in Standardization,

Metrology, Accreditation and Conformity assessment. Until July 2002, the Ministry of Economics had the

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management of metrology, standardization and accreditation matters. Since July 2002, the government

published new laws upon standardization, accreditation (official journal 54/2002) and metrology, thus driving

the establishment of 3 independent legal entities :

1. IMRM (Institute of Metrology FYR Macedonia);

2. ISRM (Institute of Standardization FYR Macedonia);

3. IARM (Institute of Accreditation FYR Macedonia), which was established on the base of the Law for

Accreditation and the Decision of the government (O.J.14/2003). The IARM foundation document

has been approved by the Ministry of Economy in sub legal normative or ordinance (according to

the accreditation law).

3.3 IARM is a separate public institution (not a department within the Ministry of Economy legal entity)

and therefore it is self-budgeted. All matters relating to the way that IARM can receive incoming operating

funds are described within the Institute Foundation document.

3.4 IARM is functioning in accordance with the Law on Accreditation, the Decision of Foundation, the

formal standards, any relevant regulations, as well as the Statute and Council’s act. The IARM system

documentation consists of more than 100 documents. The operational documentation for IARM is based on

the EN45003, EN45010, ISO17011 and EA guidelines. IARM can accredit CBs according to the standards

for ISO17025 (for testing and calibration labs), EN45011 (for products), EN45012 (for systems), EN45013

(for personnel), and EN45004 /ISO17020 (for inspection bodies).

3.5 Until today, IARM undertook all accreditation responsibilities (laboratories for testing and

calibration, CBs for products, CBs for quality systems, CBs for environmental protection systems, CBs for

certifying individuals, and CBs that perform monitoring). Accreditation for HACCP CBs falls into “CBs for

quality systems” category and relevant certification bodies have to operate in conformance with the

EN45012 standard. Also, all food matters are covered within the IARM scope of accreditation (doc. A45).

3.6 The last year IARM achieved several things, including the following:

- Law statute (doc. R01 “Statute of the Accreditation Institute of the Republic of Macedonia”), which

in article 9 specifies the ability to accredit CB for HACCP, and in article 13 declares the 11

members of the management board/council;

- definition of a clear documented mission and vision;

- development of appropriate documentation on the benefits, aims, principles and role of

accreditation;

- definition of an organizational chart;

- definition of an operational & financial/resource plan. There is a plan to recruit 9 people until the

end of year 2004 and 14 people until the end of 2005 (14 people is considered an adequate

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number of personnel for the first period of operation). However financial resources for recruiting

new staff are limited;

- use of a new building for its operation (although there is a plan to move to a new location by early

June 2004). Still, current equipment (including computer infrastructure) and offices are poor;

- formulation of a list of trainee assessors/experts (from about 40 applications received after a public

announcement, 17 people passed, while two of them work within the food sector). IARM planned to

achieve a full list of about 20 assessors at the beginning. At a first step, these assessors are

planned to be trained in June in regard with accreditation issues (as required by relevant

standards), and in a next step to take exams in order to certify their ability to participate in

assessments. Three training sessions are planned to follow, while the last one is planned to take

place within a Slovenian accreditation body. However, so far, no specific training regarding HACCP

certification and food safety issues has been planned. Also, no specific criteria on the necessary

skills and know-how required by the assessors have been established;

- formulation of a management system documentation (including statute - 14 procedures/regulations,

18 directions, several working forms, and several working instructions). This documentation system

covers both the IARM management operation and the operation of the accreditation processes.

Specifically, regulation R03 describes the accreditation procedure in terms of the necessary steps &

parties involved. However there is no guiding documentation specific for the assessment &

accreditation processes for HACCP CBs. Also it has not yet been clarified which certification

normative document / standard will be used for HACCP CBs;

- initiation of procedures for membership of EA/MLA (application to EA for membership, translation of

all IARM documentation in English, etc.).

3.7 The full development of IARM involves three phases of gradual development. At the moment, IARM

is about to end its 1st very important phase of development, which focused in management issues and in

formulating a documentation system for the institute (implemented within the framework of the SMAQVa

project). The 2nd phase of development is going to focus more in training the institute’s personnel (including

assessors and other related staff), in enhancing the capabilities of the assessors (exams, participations in

assessments etc), in developing public awareness/promotion as far as food safety is concerned, and in

developing relationships with relevant /similar European ABs recognized throughout EU. The 3rd phase of

development includes training study-visits at appropriate EU Accreditation Bodies.

3.8 A strategic goal for the agency is to become a signatory to the EA Multilateral Agreement (MLA) for

mutual recognition of testing, calibration, certification and inspection results in all fields of accreditation

(testing, calibration, certification of quality systems, certification of products, certification of environmental

management systems, certification of personnel, inspection).

3.9 HACCP certification is of major importance, due to the importance of the food sector within the local

economy. In the last period agriculture has become the second biggest contributor in GDP for FYR

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Macedonia (10,6%). The food processing sector contributes with 5,4%. Therefore, the food sector

(production and processing) contributes 16% in total. This number demonstrates that the food sector has

become the biggest and the most important sector for the Macedonian economy. The total number of

employees engaged within the food sector is 31.000, allocated as follows:

o 210 people employed within agricultural enterprises and cooperatives;

o 126 people employed within food-processing companies;

o 25 people employed within beverage companies;

o 4 people employed within companies for processing of animal fodder;

o more than 2.000 people employed at restaurants, hotels and other facilities where food is

served.

3.10 The food sector is closely related to a large food trade chain in the country. Food trading involves

about 12.500 trade enterprises that employ about 24.000 people with total value of about USD 250 million

per year.

3.11 However, HACCP is a practice not very well known within FYR Macedonia. An initial study/research

carried out by GTZ shows little true knowledge and understanding of the HACCP principles. The formulation

of relevant information campaigns seems to be an urgent need (past efforts have demonstrated some

positive results). Special attention should be given to redesign all food safety issues, so as to promote

HACCP as a framework for effective food safety rather than as a “marketing tool”.

3.12 As far as food safety inspections are concerned, at the moment there are four companies active in

this field within FYR Macedonia, of which none is still capable to certify HACCP systems. On the other

hand, as far as regulatory – compulsory food safety inspections are concerned, responsibilities are shared

among five ministries (from which 3 have the main responsibilities):

� The Ministry of Agriculture (its main responsibility concerns the primary sector, involving testing &

auditing);

� The Ministry of Health (its main responsibility involves the secondary & tertiary sector to ensure

suitability of products, involving testing and auditing);

� The Ministry of Economics (its main responsibility involves market inspection, i.e. labeling);

� The Ministry of Finance (provides allowance numbers for imports and exports);

� The Ministry of Environment (deals with pesticides, residues, wastes, etc).

3.13 However, it is worth noting that the current food inspections are not carried out in a well structured,

planned and documented way (as relevant certification standards demand). Also, responsibilities are not

always clarified and several overlaps occur between Ministries.

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3.14 Since 2002, a Law for Food Safety and Safety of Products and Materials that come in contact with

food (Official Gazette No. 54/2002 of July 15th, 2002) has become active. This law in particular states:

Article 26. Food producers/processors and traders are obligated to implement HACCP systems;

Article 50. Accredited laboratories, authorized by the Ministry of Health, will perform food

examinations and analyses. Accreditation will be performed according to the regulations for

accreditation;

Article 51. Food producers / processors and traders will be charged for Laboratory costs for

examination and analyses;

Article 52. Food producers / processors and traders can seek inspections from other accredited

laboratories;

Article 56. All food producers/processors are obliged to comply with this law one year from the date

of publishing in the Official Gazette (July 15th 2003). Food producers/processors and traders are

obligated one month before this date to demonstrate that they have implemented HACCP systems

(June 15th 2003).

3.15 According to this law, the Ministry of Health has the main responsibility for performing HACCP

audits. However, until the establishment of the appropriate food safety inspection authority, all Ministerial

inspection bodies will keep doing their own inspections, irrespective if these inspections are close to

HACCP audit or not.

3.16 However, there are signs that the local status is changing and that the above food safety law will be

modified in order to provide a legal base for a unified inter-Ministerial food safety authority to be

established, one that will take full responsibility for regulatory/compulsory HACCP auditing.

International environment

3.17 Reliable national accreditation bodies have to operate under relevant EN45000 and ISO17000

standards and participate in EA/MLA. These national accreditation bodies are members of the European

Co-operation for Accreditation (EA) and have signed a binding multilateral agreement (MLA) on peer

evaluation and mutual recognition of reports and certificates. EA regularly ensures that all members make

uniform requirements on accreditation and regularly evaluate whether their members comply with the

agreed rules.

3.18 A European AB can use the appropriate European Standards in the EN 45000 series standards

(e.g. EN45010, EN45003). These EN standards are in accordance with the requirements of the

corresponding ISO/IEC Standards (17000 series) / Guides (e.g. ISO17010-ISO/IEC G61, ISO17011-

ISO/IEC G58). Thus there are no barriers to the establishment of agreements between EA members and

other countries.

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3.19 Accreditations granted by accreditation body members of the International Accreditation Federation

/ IAF Multilateral Recognition Arrangement (MLA) allow companies with an accredited conformity

assessment certificate in one part of the world to have that certificate recognized everywhere else in the

world. This is because MLA is based on regular surveillance of members in order to assure the conformity

of their accreditation programs. Therefore international trade relies on certificates issued by bodies

accredited by members of the EA/MLA.

3.20 The EA has drawn up interpretative documents (EA guidelines). EA guidelines function as common

guidelines for the accreditation bodies, the accredited laboratories and firms. These guidelines have been

drawn up with a view to a harmonisation of the accreditation criteria in EA. Guidelines of special interest are

EA-3/08 (EA Guidelines on the Application of EN 45010, IAF Guidance on Application of ISO/IEC Guide 61

– Issue 3), EA-2/02 (EA Policy and Procedures for the Multilateral Agreement), EA-2/01 (Rules of

procedures), EA-7/01(Guidelines of the application of EN45012), EA-2/01 (Supplement 1 to EA-2/01Criteria

for Membership), etc.

3.21 These documents are generic in their application. For example, EA-2/02 describes the procedures

that EA has adopted for the evaluation and re-evaluation of nationally recognized ABs, the operation of their

accreditation schemes to be signatories to EA multilateral agreement, etc. These procedures are fully

based on the common ILAC/IAF document for the evaluation of single ABs. The signatories must also

adhere to the document EA-1/06 (Multilateral Agreement).

3.22 According to the EA guidelines (and related EN45000/ISO17000 standards), several issues have to

be considered in the HACCP AB operation (as stated or implied), including:

- The AB members must commit themselves to respect the Articles of Association and Rules of

Procedures of EA;

- Membership of EA is restricted to nationally recognized accreditation bodies which operate the

accreditation as a non profit distributing activity;

- The AB management board and/or accreditation committees have to reflect all the interested

parties (i.e. be composed by all significant parties). EA ABs’ members shall, on a national level,

closely co-operate with all interested parties and be accountable to their stakeholders;

- The EA members need to organize their accreditation activities in such a manner so as to provide

an efficient and quality driven service that meets the needs of the conformity assessment market

(i.e. industry, conformity assessment bodies, public authorities, consumers, etc.);

- In the case that an AB uses a certification normative document other than ISO9001, this document

should be publicly known (e.g. recognized standard). This document should be well understood and

known to all relevant parties. The AB (and related CBs) should have the relevant competence for all

assessment and auditing activities;

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- Because accreditation remains as the last level of control of conformity assessment activities, EA

and its members should perform their activities in such a manner that technical competence,

impartiality and integrity are ensured. EA members commit themselves not to offer any kind of

conformity assessment which is subject to accreditation (this restriction also applies to the AB

personnel);

- The contributions from an AB member to EA shall be proportional to the size and scope of its

activities and competence. Each member must, on a regular basis, be able to demonstrate that it

has met its financial and other engagements towards EA. Besides paying its membership fee, each

EA member is obliged to actively contribute in order to enable EA to achieve its goals in

accordance with the fundamental documents;

- Witnessing is an essential part of the HACCP CB assessment process (in order to be accredited by

AB). Witnessing means that the AB assesses how the CB performs the certification audit in place.

For this reason assessors must have the necessary competence and skills (including auditing

according to the particular certification normative document used);

- Regarding organization (& recruitment activities): the AB shall have a permanent secretariat, a

head of the AB or senior support staff. The AB shall have experience in the operation of an

accreditation system, shall be fully operational, and shall have sufficient experience in all aspects of

its accreditation activities;

- The AB should have carried out a reasonable number of accreditations in at least one of the areas

covered by the MLAs for which signatory status is sought;

- The AB shall have access to an appropriate metrological infrastructure that enables accredited

organizations to make measurements that are traceable to national or international standards of

measurement;

- Nationally recognised ABs that are neither EA members nor EA associate members shall enter into

a contract of cooperation with EA before an evaluation can take place;

- Training of AB assessors need to be programmed regularly (e.g. annually). All assessors have to

be subject to ongoing monitoring;

- Technical Accreditation Committees have advisory function with regard to decisions on technical

accreditation requirements and technical issues on the application of the accreditation system. So

they have to be competent and sufficient according to the scope of AB;

- Documented guidance for assessors and related with accreditation process personnel is

recommended in order to complement their knowledge in the several areas, scope and standards

used in the accreditation.

3.23 Regarding the normative document used for HACCP certification due to the lack of ISO or EN

standard, there are several approaches:

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- some ABs (like Danish DANAK, Greek ESYD and Romanian RENAR) are using officially

recognized standards published by National Standardization bodies.

- some ABs (like Dutch RVA) are using several specifications (e.g. Dutch "criteria for HACCP system

assessment", 93/43, CAC-RPC1997, etc). Although these specifications are published by team of

experts or by public bodies, they do not have the characteristic of a standard (i.e. the consensus

between all the market stakeholders);

- some ABs (like British BSI) are using “economic sector” specification (e.g. BRC specification, which

has been published by British Retailers). Although these specifications are beneficial for

commercial transactions, they do not have the characteristic of a standard (i.e. the consensus

between all the market stakeholders).

3.24 An AB can choose any kind of HACCP specification, as long as this standard is complete (in terms

of food safety management system specification). Of course, the AB has to be competent according to this

specification.

3.25 An international FSMS standard (with the code ISO22000) is being discussed in the relevant ISO

technical committee (TC). However, this standard is still underway (ISO DIS22000), and will be discussed

within the ISO TC at end June 2004. It is therefore anticipated to become a standard within 2005.

3.26 National food authorities control the application of the regulatory requirements about HACCP (e.g.

93/43/EU). In some countries successful inspections of food businesses by national authorities result in

HACCP confirmations. However, these confirmations do not have the characteristics of a formal certificate

since they comply with a voluntary scheme of control and last for a specific time period. Mutual recognition /

acceptance between compulsory inspections and voluntary certifications is not very common.

3.27 Although many national accreditation bodies are members of the European Co-operation for

Accreditation (EA), and have already signed a binding multilateral agreement (MLA), (see APPENDIX 7:

Overview of EA/MLA), only few of them are accrediting HACCP CBs (e.g. Greek ESYD, Dutch RVA, Danish

DANAK, Romanian RENAR, Finnish FINAS, German DAR, Czech SAS, etc.). All these accreditation bodies

are operating in the same way, since their management system conforms to the same relevant

EN45000/ISOIEC GD and EA Guidelines (in particular with regard to system certification - as in case of

HACCP EN45010/ISO/IEgud61 and EA-3/08).

3.28 The differences between HACCP ABs are identified in the following:

1. Normative documents used for HACCP certification (i.e. whether the document is an “officially

recognized standard” or not, and also the geographical relation of AB with the country

originating the normative document);

2. Reputation & experience in accrediting HACCP certification bodies (regarding the “fame” of the

AB, the completed works/accreditation of the HACCP CB, etc.);

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3. Country/people characteristics (regarding culture/mentality, geographical location,

communication abilities, society organisation with respect to food safety issues, e.g. food safety

authority, consumer movement, etc);

4. Structure/organization (smoothly operation, independence-impartiality, participation of all

interested parties, incl. consumers, and adequacy of recruitment).

3.29 One or two of the above HACCP ABs could be used as models for improvements in the IARM of

FYR Macedonia. To identify these, the 5 main accreditation bodies are chosen (due to their work on

accreditation of HACCP CB and/or similarities with FYR Macedonia), and have been qualitatively evaluated

with regards to the 4 categories/criteria mentioned above. The chosen ABs are Danish DANAK, British

UKAS, Dutch RVA, Greek ESYD and Romanian RENAR. Brief information related to these ABs is provided

in APPENDIX 6: Overview of the EU Accreditation B. The evaluation considers all the criteria as equally

weighted, giving the following results:

TABLE 3.1: Evaluation of model HACCP ABs for FYR Macedonia

Organisation Criteria 1 Criteria 2 Criteria 3 Criteria 4 Total

DANAK 3 3 1 3 10

UKAS 1 2 1 3 7

RVA 2 3 1 3 9

ESYD 3 2 3 2 10

RENAR 2 2 1 2 7

1=lowest, 2=middle, 3=highest

3.30 According the above – mentioned evaluation Danish DANAK and Greek ESYD appear potential

models for IARM accreditation HACCP CB, followed closely by RVA. Both DANAK and ESYD could serve

as best model for the Macedonian conditions. However, DANAK is superior to ESYD in relation to history in

food safety matters, experience and normative standard used (Danish DS3027 was the base for Greek

ELOT1416). On the other hand, ESYD is superior to DANK in relation of country similarities (e.g. HACCP

public authorities now being developed, low power of consumer movement, level of economy,

culture/mentality of management, geographical distance, etc). Greek ESYD has therefore been used for

some of the recommendations following, primarily due to country similarities with FYR Macedonia.

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4. Recommendations for Further Development and Improvement

4.1 Taking into account the local and the international current situation, we observed that exceptional

steps have been made towards the establishment and effective operation of the IARM. Taking into account

the limited resources (only 3 active employees - 1 secretary), the level of organisation achieved declares

the passion of the employees to develop an effective IARM. During the meetings, the leading people of

IARM demonstrated high knowledge and internal motivation towards this important institute. IARM has

already constructed the basis for future acknowledgement / membership by EA/MLA and recognition by the

internal market stakeholders.

4.2 However, regarding to the accreditation of HACCP CBs, several improvement opportunities have

been identified. These improvements are not related so much with requirements of EA/MLA, but mainly with

the increase of effectiveness and credibility of the IARM in the area of food safety. Food safety becomes a

big issue and an urgent need in the FYR Macedonia society both for public health and economic interest

(as long as the food sector is a vital sector of the economy). IARM is aiming to “regulate the voluntary food

safety inspectors” (i.e. HACCP CB), so it is crucial for its future to be at the very beginning of its operation

as more capable / equipped in the area of HACCP/FSMS as could be. This will increase its reputation /

credibility in the market, something that is very important for such an important new organization.

4.3 Reviewing IARM organisation & management system, we observed that:

- The Council consist of 11 members (5 of them from relevant ministries, 1 from ISRM, 1 from the

Metrology Bureau, 1 from the Chamber of commerce, 2 from University, 1 from IARM – the

manager of its certification & inspection department). We note the absence of representatives of

social groups such as those that represent consumer interests, although we have been informed

that there is a plan to include these in the future;

- The Accreditation board (which has final opinion on the accreditation decision) and compliance

committee comprise of 3 members each. However, these members are not permanent and they are

appointed mainly by the President. Documented guidance for their selection could be helpful.

Especially, it has to be ensured that in the case of food safety at least one member must be

experienced in the particular subject area;

- The same remark is valid for the very important technical committee (which develops the

proficiency testing scheme and provides input to the whole Body), as well as the personnel

evaluation committee. A specific technical committee for foodstuffs equipped with food safety

experts as staff / members could be very beneficial;

- Procedure-regulation R09.2 provides guidance to the functions of Director, quality manager and of

the technical department. Other regulations guide the assessors and experts function, technical

committees function and personnel evaluation committee. All these regulations could be reviewed

so as to incorporate any necessary HACCP / food safety issues (e.g. specific technical committee

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for foodstuffs, specific examinations and evaluation of personnel and assessors dealing with

HACCP, etc.).

4.4 Special attention must be given to the new IARM financial status. Currently, there is limited financial

dependence / support from the Ministry of Economics. At this very important starting period this status

could cause problems to IARM, because resources are limited and the development plan could not be

easily monitored. In particular, resources and infrastructure are a big problem (due to IARM’s self budgeting

financial character). There are currently only 3 full time staff instead the planned 14. Donations or other

similar financial actions could possibly provide a short-term solution, but at the same time could also

jeopardise IARM’s impartiality (depending on the donating source).

4.5 In total, based on the above-mentioned improvement concepts related to food safety / HACCP, the

following recommendations are made:

1. According to accreditation body standards, all significant / interested parties in accreditation should

compose the council. Although satisfactory in size (11 members), the current council does not have

any contribution from social partners, and most important from the food safety point of view, also no

participant from the side of end users (i.e. consumers). Therefore, such participation should be

encouraged.

2. In order to improve similarity between future compulsory (by public authorities) and voluntary (by

CBs) HACCP assessment, possible changes in the council and/or in committees (or other involved

persons / positions) could be considered. These changes should focus on the need for better

involvement of Macedonian government representatives related to food safety / HACCP issues

(e.g. at the time being from the Ministry of Health or from the future national food safety authority).

These food safety government officials should work on the establishment / operation of the HACCP

CB accreditation part of the IARM operation.

3. The HACCP normative document to be used by CBs (accredited by IARM) should be decided. Of

course this issue will not be valid when the ISO22000 standard is published (expected in 2005).

The decision about the standard is necessary in order to plan future documentation improvements

and training needs / provisions.

4. Documentation of the IARM management system has already taken place. The relevant officials of

IARM are convinced of its suitability (according to EA/MLA requirement), and are planning to submit

this to EA. However, improvements of documentation related to HACCP could be introduced in at

least the following areas:

a. guidance for assessors (e.g. specific working instruction development), since there are not

specific provisions related to the assessment of HACCP CBs;

b. committee operation, when these committees are dealing with food safety / HACCP

aspects (e.g. at least one of the participants should be a food safety / HACCP expert, and

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preferably also from the particular sector). Members of the committees should be

appointed on the basis of clear criteria related with their food safety knowledge and their

ability to perform their tasks within the committee. Also, the establishment of a technical

committee specific to foodstuffs and experienced in food safety and HACCP issues is

recommended;

c. written criteria for food safety / HACCP CB assessor evaluations, monitoring and periodic

reevaluation of capabilities.

5. IARM should have sufficient experience & workable knowledge in all aspects of its accreditation

activities (including HACCP). Therefore, besides the written / documented guidance (mentioned in

points 4a and 4b above) and suitable assessors (based on point 4c above), extensive training of

personnel must take place (following the forthcoming June trainings already planned). This training

should be specific to food safety, and it has to be repeated regularly (e.g. on an annual basis) and

updated as necessary. Specific examinations to HACCP CB assessors should be developed (see

APPENDIX 2: Proposed Examination Programme). In some of these trainings, government officials

related to HACCP could participate along with other interested parties (e.g. consumers, CBs). This

will help common understanding to be established between different sectors of food safety

surveillance, and subsequently facilitate future communication between them. Also, communication

between interested parties which will take place during the trainings will assist future cooperation

between them, and will increase the respectability of IARM (by other food safety stakeholders).

6. Besides the organizational, operational or other statutory improvements proposed above, the IARM

should be involved with other stakeholders (e.g. Ministry of Economics, Ministry of Health) in large

campaign / promotional activities, in order for the society to understand HACCP principles,

concepts, benefits and applicable procedures for accreditation and certification. Also, any potential

involvement in activities that support development of relative organizations (e.g. technical

committee of foodstuffs within ISRM, network of Labs, market surveillance schemes / authorities,

etc.) should be considered

7. Also, as soon as the HACCP/food safety law starts to be practically applied and HACCP

official/compulsory inspection schemes are determined and organized, the relation between

accredited HACCP certificates and official inspection results should be defined. In particular, there

has to be discussion between IARM and related Ministries / authorities on this subject (otherwise in

future the certification market could possibly loose credibility, if for example a company has a

HACCP certificate and during an official HACCP inspection it is revealed that this HACCP system is

deemed unsatisfactory by inspecting officials). Depending on the decision taken, this relation could

vary from mutual recognition to common notification schemes.

8. Last, but not least, the resources needed for appropriate IARM personnel and infrastructure should

be made available. This is a prerequisite for satisfaction of all the above remarks.

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4.6 It must be noted that although the Ministry of Economics (MoE) has a minor HACCP official

inspection role, compared with the role of the Ministry of Agriculture or that of the Ministry of Health, it has a

vital role in the food market, since it is the only body which practically has the authority to close down a food

company (due to unfair or unhealthy practices). So since MoE is the founder and main partner of IARM, it

can be the sponsor and organizer of the training, as well as for gathering / coordinating all public officials

regarding HACCP auditing and other issues discussed above (including the public campaign).

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APPENDICES

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APPENDIX 1: Proposed Training Programme

TITLE OF

TRAINING CONTENT PARTICIPANTS DURATION

IARM accreditation

process for HACCP

certification

organisation

- Why Food safety & hygiene (needs)

- Food safety & hygiene concepts and

terms

- Regulatory & statutory framework

(national, European & international,

including legislation, authorities,

standards, other specifications etc)

- Basic food microbiology & chemistry

- Basic food technology (areas to be

covered, e.g. vegetable, meat, etc.)

- HACCP prerequisite –GHP

(requirements for establishment,

buildings, facilities etc + Basic hygiene

rules incl. docs, personnel hygiene,

cleaning & sanitation etc)

- HACCP principles

- Steps to apply HACCP principles

- Requirements of a certifiable-

standardized HACCP system

(according to what the IARM decide to

use)

- Organising the GHP & HACCP system

audits

- Methods & techniques for GHP

auditing

- Methods & techniques for HACCP

system auditing

- Non conformities (criteria,

documentation etc)

- IARM staff esp.

assessors,

experts,

committees, other

members

- Corporate food

safety

teams/personnel

- Consumers

representatives

- HACCP Auditors

- Public Food

inspectors (public

authorities incl.

MoE, MoH, MoA)

8 days (40 hours) –

groups of 16 trainees

at maximum.

Group of trainers to

be used should be

appropriate qualified

and

- Experienced in

delivering HACCP

training and in

particular HACCP

auditors trainings

- Experienced in local

food safety issues

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TITLE OF

TRAINING CONTENT PARTICIPANTS DURATION

- Auditor behaviour

- Auditor code of conduct/ethic

- Other related issues (e.g. continuous

improvement of auditors & processes

etc)

- Case studies

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APPENDIX 2: Proposed Examination Programme

It is recommended that training is followed by exams (at least for assessors and for members of the food

technical committee and for food expert member of the accreditation committee). A proposed scheme for

the examination is the following:

- The exam questions should be based upon the final training syllabus.

- To pass the exams the examinee has to answer successfully the 70% of the exams questions.

Alternatively a minimum 50% could be considered, in case that it is decided an abstraction of

points to take place for wrong answers

- Examination questions/contents could include several multiple choice questions (e.g. 20), several

“open” questions (eg 10) and several case study questions (e.g. 5). The examiner should made

modular answers of the final chosen questions

- Case studies would be 2 types (and both of them they have to cover the areas of vegetable, fruit,

milk, meat and animal feeding stuff products):

o The first type: to include a brief description of a food company (e.g. description of

infrastructure, organization and procedures, processes followed and record keeping).

According to this description the examinee should assess the company FSM system

regarding HACCP specification conformance and food safety effectiveness.

o The second type: to include brief description of a food company (e.g. description of

infrastructure, organization and procedures, processes followed and record keeping) and

a brief description of a certification body audit execution on this company (e.g. reports

made, witnesses during certification audit, non conformities arised). According to these

descriptions, the examinee should assess the certification body capabilities to audit the

company FSM system regarding HACCP specification conformance and food safety

effectiveness.

- 1/3 of the multiple-choice questions and of the open questions could be related with food

microbiology & food chemistry matters related to food hazards (e.g. applicable pathogens

bacteria producing intoxication).

- 1/3 of the multiple-choice questions & of the open questions and ½ of the case studies

descriptions could be related with GHP practices (requirements for location, buildings, facilities &

equipments and basic hygiene requirements like cleaning & sanitation, personnel hygiene, waste

management, pest & insect control etc)

- 1/3 of the multiple-choice questions & of the open questions and ½ of the case studies

descriptions could be related with HACCP specification (requirements for HACCP study, for

HACCP plan, for Hazard analysis, for method to identified critical/significant hazards etc).

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APPENDIX 3: Criteria, Conditions & Process for the Periodic

Assessment of HACCP Assessors – Experts

IARM could incorporate in its existing guiding documentation of the accreditation system some of the

following requirements (if appropriate). Within this framework, procedures/regulations & guidelines related

to assessors and experts could be reviewed, in order to incorporate requirements for the assessors

and/or experts to be:

- aware of their scientific & professional skills, as required for an assessor/expert position

- guaranteed that they have all the technical skills to carry out assessments, to reply on relevant

questions etc

- not related with CBs (free from any relation which effect negatively the impartiality &

independence)

- well trained (according the guidelines of IARM) in addition to their scientific background, in

subjects related with accreditation assessment criteria and with other issues related to the

HACCP CBs accreditation. This has to be done before execution of assessments

- capable to demonstrate discreetness

- conformed with all requirements related with food personal hygiene (when witnessing CBs audits

in place) and with occupation health & safety provisions

- conformed with requirements of EN30011-2 (criteria of skills for QMS assessors)

- technically capable and also to achieve “state of the art” in knowledge of standards, of methods

and of other specifications and skills required in subjects related to FSMS (HACCP & GHP)

development, implementation and auditing/assessment (especially in the areas where critical

knowledge is necessary eg hazard analysis).

- With good Communication skills (oral and writing)

- capable to demonstrate the Knowledge and experience to be leaders and/or effective members of

an assessment team

- (for Assessors) with a personal evaluation grade above a minimum specified grade based on a

predefined evaluation rate/catalogue (e.g. min 8, min 1 in knowledge and 6 in experience). The

predefined evaluation rate should consider the Food related university degree as obligatory, and

could take into account Food safety oriented university degree (e.g. 2 points), post graduate food

safety degree (eg 1), Food safety working experience (e.g. 1 for every year), FSMS auditing

experience, HACCP CBs assessment experience etc. In general the evaluation will take under

consideration

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o The knowledge & understanding of the relevant standards and accreditation procedures

(at least IARM procedures, EN45012, EA guidelines, HACCP normative document

chosen by IARM)

o Working Knowledge and Ability on methods and techniques of making questions,

executing audits/assessment, evaluating audit reports (& related documents), preparing

& submitting reports etc

- (for Lead assessors) should have higher evaluation grade (e.g. min 10, min 2 in knowledge & 7 in

experience) and in addition to the assessor’s knowledge and capabilities should have

o The combination of capabilities, skills and necessary experience to operate as assessor

team leaders

o Detailed knowledge of FSMS & their application

o Detailed knowledge of criteria, regulation etc of accreditation

o Skills in the assessment methods & techniques and in identification and monitoring of

corrective actions, and surveillance monitoring

o Very well education in current food safety issues

o Participated in a minimum number of assessments (e.g. 2 in last 3 years with 1 in the last

year)

- All the data, that demonstrate assessors/experts knowledge & skills, should be kept in detailed

records by IARM

- Technical abilities of assessors should be related with EN45012 per EA section

Regarding Reevaluation/Monitoring: this should be based on the continues satisfaction of all the

above criteria. So documented guidance should clarify

- the methods for monitoring the assessors conformity

- the continuous achievement of the required minimum level of knowledge according the “state of

the art”.

This reevaluation should be taken place before any HACCP CB assessment assignment.

To prove updated knowledge, the assessor should follow both any EA & IARM information/evolutions

applied in his assessment scope and any HACCP/food safety evolutions.

Reevaluation/monitoring results should be recorded and appropriately communicated to the

assessors. Assessors have to take immediately the necessary actions as proposed by the monitoring

results.

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APPENDIX 4: Proposals for Specific HACCP documentation & Criteria

for HACCP CBs to become Members

The documentation (e.g. in the form of direction or working instruction) should specify the IARM

processes in the case of HACCP CBs accreditation. Perhaps, at a minimum, this involves incorporation

into the existing IARM documentation, necessary specifications regarding:

- accreditation committee, complains committee, technical committees etc;

- processes of assessments of HACCP CBs (e.g. guidelines for assessors and for interested

HACCP CBs).

Regarding committees, there could be documented clarification regarding member status and how this

status demonstrates updated skills and knowledge regarding HACCP CBs assessments (e.g.

definition/criteria for minimum participating food safety experts). Also in the case of a specific food

technical committee, its operation should be clearly defined in relation with HACCP/food safety aspects

including testing methods etc.

Regarding guidance for assessors and for interested HACCP CBs, the following criteria / conditions /

specification could be noticed:

- Normative document / standard to be used in the FSMS certification should be defined (e.g.

ELOT1416, DS3027 or other similar, as accompanied with regulatory or statutory docs e.g.

legislation, GHP)

- HACCP CB should conform with EN45012, with the necessary adaptations (e.g. FSMS instead of

QMS, HACCP normative document instead of ISO9001, HACCP guiding documentation instead

of quality manual etc)

- HACCP CB should demonstrate documented knowledge of the HACCP standards and other

related statutory documents, including sampling method, food control methods and other issues,

which are compulsory for the company-under certification

- HACCP CB should regularly identify & satisfy Food safety /hygiene training needs (for its

personnel)

- HACCP CB should follow food safety evolutions, including evolution of HACCP normative

document and food legislation, and also has to update its system (as appropriate)

- HACCP CB should give appropriate time for auditing (at least the same as in the case of

ISO9001). In case of simultaneously certification audit for ISO9001 & HACCP, this necessary

HACCP audit time could not be reduced.

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- Members of HACCP CB audit team should:

o demonstrate documented knowledge of the legislative requirements applying in the food

company under certification,

o have food oriented university degree members (capable for the specific sector technology

food safety and hazard analysis)

o have additional training of at least 30-40 hours regarding HACCP, normative document

and methods to audit companies according this standard

o have practical knowledge in GAP or GMP or G�P, proved by works made as researcher,

as personnel, as consultant, as auditor or with other appropriate way

- Accreditation scopes would have as basis NACE codes (Reg. E.U.761/93). Main business

activities/categories applicable in HACCP certification should be identified (e.g. Agricultural and

Veterinary sector, Food & Drink Industry, Wholesalers/trade of agricultural products & animals,

Wholesalers/trade of food & drinks, Retailers, Hotels/bar/restaurants etc.) For every business

category, the HACCP CB should demonstrate that it has experienced & knowledgeable team of

auditors, and that it is executing 1 certification audit per year at least.

- The above-mentioned activities should be considered every time training sessions for IARM

HACCP assessors are planned.

- Witnessing during the assessment of the HACCP CB is vital, in order to assess effectively the

knowledge and the methodology employed by the HACCP CB audit team. So IARM could

develop specific guiding documentation on this subject (e.g. appropriate check-list form)

- Reevaluation-Monitoring of CBs by AB: It includes the periodic evaluation of the HACCP CB

o whether all the above are satisfied (updated as necessary)

o whether all the intermediate audits carried out by CB conformed with the above

mentioned principles.

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APPENDIX 5: IARM Organization

Government

Accreditation Board

Appeals Committee

IARM

Testing and Calibration Laboratories Department

Testing Laboratories Section

Calibration Laboratories Section

Administration Section

Financial Control Board Council

Technical Committees

Quality Manager Assessors and experts pool

Certification and Inspection Bodies Department

Certification Bodies Section

Inspection Bodies Section

Personal evaluation Committiee

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APPENDIX 6: Overview of the EU Accreditation Bodies

1) DANAK

DANAK is the Danish body. The legislative basis for DANAK is contained in the Act on Development of

Trade and Industry and in Statutory Orders from the National Agency for Enterprise and Housing. In

addition, DANAK has drawn up a number of technical regulations with general and specific requirements

to be fulfilled by accredited laboratories or firms. The standards, legal basis, technical regulations,

guidelines and EA guidelines, serve as DANAK's basis for granting accreditation. The main normative

document used for HACCP is Danish standard DS3027 (edition 1998 is supplemented with CAC/RCP

ed1969/rev.1997 for GHP).

2) UKAS

UKAS (United Kingdom Accreditation Service) is recognised by government to assess, against

internationally agreed standards, organisations that provide certification, testing, inspection and

calibration services. Accreditation by UKAS demonstrates the competence, impartiality and performance

capability of these evaluators. UKAS is a non-profit-distributing company, limited by guarantee, and

operates under a Memorandum of Understanding with the Government through the Secretary of State for

Trade and Industry. UKAS is a company limited by guarantee, having Members instead of shareholders.

The Members represent those who have an interest in all aspects of accreditation - national and local

government, business and industry, purchasers, users and quality managers (eg The Secretary of State

for Trade and Industry, The Association of British Certification Bodies, British Measurement and Testing

Association, Confederation of British Industry, Federation of Small Businesses, Local Authorities

Coordinators of Regulatory Services, The Chartered Institute of Purchasing and Supply, The Institute of

Quality Assurance, The Safety Assessment Federation, Secretary of State for Environment, Food and

Rural Affairs, Food Standards Agency, Defence Procurement Agency, Health and Safety Executive,

Public Health Laboratory Service, British Retail Consortium

Although the company aims to be - and is – profit-making, all profits are ploughed back into the business.

Previous profits are the main sources of funding for new areas of accreditation.

The management board is supported in the day-today running of these activities by an Executive drawn

from senior UKAS staff.

The company takes advice on policy matters from a Policy Advisory Committee and on technical matters

from a series of Technical Committees. The PAC meets three times a year, and the TCs meet as and

when necessary. The internal technical expertise held within UKAS is supplemented by a number of

Technical Advisory Committees whose role is to provide advice on technical matters related to the

development and operation of UKAS activities. The committees are advisory and non-executive, and

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provide a forum for input from various bodies and individuals with an interest in UKAS activities, for

example, professional bodies, accredited organisations, customers, and regulatory bodies. A Technical

Advisory Committee normally comprises invited members capable of providing technical advice from the

perspective of:

• UKAS assessors

• UKAS accredited bodies

• Customers of UKAS accredited bodies

• Independent specialists

• Governmental specialists

• Academia

• Government regulators

• Relevant professional institutes

• UKAS staff

UKAS may seek advice from these committees on a number of specific technical issues, including:

• The formulation and review of specific technical criteria to facilitate effective and consistent

application of UKAS’ activities

• The acceptability of particular procedures as a basis for accreditation

• The identification of potential assessors and sources of assessors

• The need for and conduct of proficiency testing and inter-laboratory comparisons

• The impact of European and other international initiatives

• The need for the establishment of specialist task forces

The UKAS Technical Director (Operations) appoints the Chairman of the Technical Advisory Committee

and UKAS formulates the membership in conjunction with the Chairman. Service on a committee is by

personal invitation of UKAS.

Committees only meet as required. The Chairmen of all the Technical Advisory Committees meet on an

annual basis (normally in September) to review the main issues discussed in individual committees during

the year, and to agree any changes to their future operation.

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One committee is related with foodstuffs (1 out of 14). Details of the Technical Advisory Committees

currently formed, together with contact details of the committee secretaries are given below. Further

committees may be formed as required to meet new technical challenges.

UKAS has signed a number of international agreements, which help to lower barriers to trade by ensuring

international acceptance of certificates issued under the umbrella of UKAS accreditation. In particular,

UKAS is a signatory to the EA (European co-operation for Accreditation), mutual recognition agreements.

Maintenance of mutual recognition status is subject to regular peer evaluation, to accepted international

standards.

3) RVA

For government, businesses, and consumer organisations, the RVA supervises institutions in the public

and private sector that judge the quality of products, work processes, and measuring instruments.

If requested to do so, the RVA can investigate such an organisation (e.g. certification body or laboratory)

on the basis of predetermined criteria. If the institution proves to be competent, the RVA can grant

accreditation. An overview of the accreditations granted is recorded and published on this site.

In addition, the RVA works to establish and maintain an environment of mutual trust and confidence with

all interested parties. These are not just Dutch institutions, companies and their customers. By working

together with sister organisations in Europe (EA = European Cooperation for Accreditation) and

elsewhere (ILAC/IAF = International Laboratory Accreditation Cooperation/International Accreditation

Federation), the RVA also encourages the equivalence of quality certificates in an international

framework. This increases mutual trust in companies that do business outside their country's borders.

The manner in which the RVA conducts investigations is described in some detail in the Regulation for

Accreditation.

4) ESYD

The Hellenic Accreditation System S.A., under the distinctive title ''ESYD'', is a private liability company

operating in the favour of the public interest with the responsibility of the management of the accreditation

system in Greece. The share capital of the company has been undertaken and fully paid up by the Greek

State. It is foreseen however, that shares up to 40% are transferable to legal entities of the public or of

the private sector, the scope of activities of which is related to quality issues. Within the Organs of the

Company (Managing Board and Hellenic Accreditation Council) a well balanced representation of

Ministries, scientific associations and professional and social unions is provided, safeguarding

independence and impartiality in its activities.

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ESYD has been established in 2002 and succeeded the Hellenic Accreditation Council, which under the

same distinctive title, operated within the Ministry of Development since 1994. It is member of EA/MLA.

After a period devoted to the organization and the preparation of the system, ESYD has started to accept

applications for accreditation on the 1.1.2000.The first accreditation certificate was issued in Jun. 2000.

Since then, accreditations have continued at a yearly pace of approx. 50 certificates and a large number

of extensions of the scopes.

ESYD is supported at its tasks by a managerial unit, and by a number of General and Sectoral Technical

Committees, the members of which are experts in particular industry sectors. ESYD employs external

assessors and experts. The assessors are selected and trained according to strictly defined criteria and

procedures and they must comply with specific regulations concerning their independence, integrity and

confidentiality.

There are 6 technical committees. The one of them is dedicated to Food & Drinks.

ESYD management system documentation consist of

- Accredidation regulations (KAD)

- Assessment & Accreditation procedures(DDE, DD)

- Assessors regulations (KANAX)

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- Lab accreditation criteria (KRITE)

- Assessors criteria Procedures (KRITA)

- Regulation of Technical committees operation (KANTE)

- Guiding working instructions (incl. HACCP CBs)

- Forms etc

5) RENAR

RENAR is the Romanian Accreditation Association. It is the unique accreditation body for testing /

analysis / metrological calibration laboratories, inspection and certification bodies (quality / environment

management systems, products/services, and personnel). It supports the governmental authorities where

it comes to meters regarding accreditation, conformity assessment and quality

Represents Romania in similar international forum and signs bilateral and multilateral recognition

protocols for accreditations and certifications performed in Romania and for certificates issued by the

Romanian accredited bodies aiming to achieve the free circulation of products and services on the

internal and international market

Many info could be found in RENAR website. Contents of WEB of RENAR: http://www.renar.ro/

�� RENAR News

�� General presentation (the presentation of the association, RENAR statute, RENAR managing

staff, RENAR policies, RENAR technical committees, membership in other governmental and

non-governmental organisations and structures)

�� Specific steps needed for the accreditation and the relevant costs (accreditation, surveillance,

levy, renewal).

�� Lists of the accredited/suspended/ withdrawn laboratories, certification and inspection bodies.

�� RENAR members (including accredited CBs)

�� CFPA (Training Centre for Accreditation– Courses Programme)

�� International affaires (Membership to similar international organisations, participation to EA and

ILAC technical committees, EA, ILAC and IAF General Assemblies agenda)

�� RENAR publications (Catalogues, Bulletin)

�� Legislation in the field of accreditation and related fields

RENAR uses for accreditation of HACCP CBs the DS3027.

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APPENDIX 7: Overview of EA/MLA

The MLA

EA members can apply for peer-group evaluation of their activities. Members having succeeded in the peer

evaluation may sign the appropriate multilateral agreement for certification body, for laboratory, or for

inspection body accreditation under which they recognise and promote the equivalence of each other’s

systems and of certificates and reports issued by bodies accredited under these systems.

EA promotes the recognition and acceptance in all the MLA countries of certificates and reports issued by

organisations accredited by national accreditation bodies who have signed the MLA.

Through the MLA a uniform level of competence of the accredited bodies involved is assured and the need for

multiple assessments is diminished or eliminated. This means that a supplier will only need one certificate or

report to satisfy the entire European market and all governments.

MLA Signatories

The mechanism by which IAF implements its objective is the IAF Multilateral Recognition Arrangement (MLA).

Accreditation body members of IAF are admitted to the MLA only after a most stringent evaluation of their

operations by a peer evaluation team which is charged to ensure that the applicant member complies fully with

both the international standards and IAF requirements. Once an accreditation body is a member of the MLA it

is required to recognize the certificates issued by certification/registration bodies accredited by all other

members of the MLA.

The first fourteen members to join the IAF Multilateral Recognition Arrangement (MLA) IAF Multilateral

Recognition Arrangement (MLA) signed the Arrangement in Guangzhou, China on 22 January 1998. There is

now a total of thirty IAF Members who are signatories to the IAF MLA. IAF is encouraging more of its members

to join the MLA, as soon as they have passed a rigorous evaluation process, to ensure that their accreditation

programs are of world standard.

IAF has also granted Special Recognition to two Regional Accreditation Groups, European co-operation for

Accreditation (EA) and the Pacific Accreditation Cooperation (PAC), on the basis of the acceptance of the

mutual recognition arrangements established within these organizations. Membership of the IAF MLA is

recognized as being satisfied by membership of either the EA MLA or the PAC MLA and IAF members who

are also signatories of these regional MLAs are automatically accepted into the IAF MLA.

The consequence of joining the IAF MLA is that ISO 9001 conformity assessment certificates issued by

certification/registration bodies accredited by any one of the members of the MLA will be recognised in

the world wide IAF program. For a list of Certification Bodies accredited by a Member of the IAF MLA

please go to the website of the individual member, as listed below.

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Signatories of the MLA for Testing

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APPENDIX 8:Fundamental Elements of a Food Safety Management

System

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Public Disclosure Authorized HACCP Accreditation Project · HACCP Accreditation Body (IARM) has already been established according to the European ... Grkov Zoran IARM-Accreditation

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