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Operative Manual of IFOAM standards

Approved by CC Ed. 01 Rev.: 12 on 24/09/2019

Verified RAQ Writing RAQ Page 1

Operative Manual

of the certification

process

OM_02

Certification scheme:

Agricultural products and alimentary

commodities obtained by the agricultural

Organic method according to the IFOAM

standards

AWARDEE OF CONTROLLED COPY Assigned copy:

Function:

Copy N° Issued: Provided by the responsible for the distribution:

24/09/2019 12 01 IOAS finding-Granting Derogations

03/01/2019 11 01 How to determines the number of new group members to be re-inspected

26/04/2018 10 01 The revision of the document has become necessary in order to satisfy the witness audit criteria for SFG.

21/09/2016 09 01 The revision of the document has become necessary in order to satisfy the NC and MI – IOAS Revision of some topics to be incompliance with new IFOAM norms 2014 ( group certification, certification procedure and sanction system)

30/03/2016 08 01 Complete revision

12-09-2012 07 01 Revision of par.9.11 (added par. 9.11.1 – Renewal o certification) - IOAS MI 11)

11/04/2012

06

01

The revision of the document has become necessary in order to satisfy the IFOAM Accreditation Criteria check list; the revision includes a section for Inputs Approval and Group Certification.

Data/Date

Rev.

Ed.

MOTIVO DELLA REVISIONE/REASON FOR REVISION

This manual is property of BioAgriCert srl. Every transfer of contents to a third party must be authorized in

writing by the BioAgriCert




Index 1 FOREWARD .................................................................................................................. 4

2 MOTIVE FOR REVISION ................................................................................................... 4

3 FIELD OF APPLICATION ................................................................................................... 4

4 LAWS AND DOCUMENTS OF REFERENCE ............................................................................... 5

5 DEFINITIONS AND ABBREVIATIONS ................................................................................... 6

6 SPECIFIC REQUIREMENTS FOR IFOAM ACCREDITATION .......................................................... 10

6.1 LEGAL STRUCTURE .......................................................................................................................................................................... 10

6.2 RESPONSIBILITY, IMPARTIALITY AND OBJECTIVITY - DIVISION OF FUNCTIONS AND TECHNICAL

STRUCTURE ....................................................................................................................................................................................................... 10

6.2.1 Certification committee (CC) - Organo deliberante la certificazione ................................................................................. 12

6.2.2 BAC Appeals Commette (CRI) ...................................................................................................................................................... 12

6.2.3 Impartiality and Objectivity ........................................................................................................................................................ 13

6.2.3.1 Structure of the safeguard committee impartiality (CSI) ............................................................................................. 14

6.2.3.2 Consulting and advising ............................................................................................................................................................ 15

6.2.3.3 Conflict of interest .................................................................................................................................................................. 15

6.3 FINANCIAL AND PERSONNEL RESOURCES ............................................................................................................................... 15

6.3.1 Financial stability ........................................................................................................................................................................... 15

6.3.2 Civil responsibility (TORT LIABILITY) ..................................................................................................................................... 16

6.3.3 Personnel .......................................................................................................................................................................................... 16

6.3.4 Staff competence and training.................................................................................................................................................... 16

6.4 OUTSOURCING ................................................................................................................................................................................... 18

6.5 ACCESSIBILITY AND SCOPE : POLICIES AND PROCEDURES .............................................................................................. 19

6.5.1 Accessibility .................................................................................................................................................................................... 19

6.5.2 Certification Scope and the Chain of Custody ......................................................................................................................... 20

6.5.3 Certification Scope and Subcontracted Production or Processing ...................................................................................... 20

6.6 QUALITY SYSTEM FOR CERTIFICATION .................................................................................................................................. 21

6.6.1 Quality Documentation .................................................................................................................................................................. 22

6.6.2 Internal audit (VII) ....................................................................................................................................................................... 22

6.6.3 Management review and Performance review ........................................................................................................................... 23

6.6.4 Complaints and contentious cases ............................................................................................................................................... 24

6.6.5 Corrective and preventive actions .............................................................................................................................................. 25

6.6.6 Confidentiality provisions ............................................................................................................................................................. 26

6.6.7 DOCUMENTATION AND DOCUMENT CONTROL................................................................................................................. 26

6.6.7.1 Public Access to Information ................................................................................................................................................. 26

6.6.7.2 Document control ...................................................................................................................................................................... 27

6.6.7.3 Records ....................................................................................................................................................................................... 28

6.6.7.4 Registrations In The Bioagricert Software (for Operators) ......................................................................................... 28

7 APPLICATION AND INSPECTION PROCEDURES ...................................................................................................................... 29

7.1 Application Procedures ........................................................................................................................................................................ 29

7.1.1 OPERATORS’ DOCUMENTATION AND REGISTRATION .................................................................................................. 30

7.1.2 Management of recordings ........................................................................................................................................................... 39

7.2 PRELIMINARY VISIT ........................................................................................................................................................................ 40

7.3 Review and acceptance of application .............................................................................................................................................. 40

7.4 Preparation for Inspection ................................................................................................................................................................. 41

7.5 Visit Procedures ................................................................................................................................................................................... 42

8. INITIAL INSPECTION VISIT ........................................................................................................................................................ 42

9. SAMPLING AND TESTING ............................................................................................................................................................... 45

10. INSPECTION REPORT ....................................................................................................................................................................... 46

11. CONVERSION PERIOD ...................................................................................................................................................................... 48

12. CERTIFICATION PROCEDURES ...................................................................................................................................................... 50

12.1 Generalities on the certification system .................................................................................................................................. 50

12.2 Certification process phase ......................................................................................................................................................... 51

12.3 Final evaluation and certification decisions .............................................................................................................................. 52

12.3.1 Operator acceptance into the control system ......................................................................................................................... 52

12.3.2 Enrolment in the Licensee List (LdL) and certification granting .................................................................................... 52

13. CERTIFICATION DOCUMENTS ...................................................................................................................................................... 53

13.1 Certificate of conformity ............................................................................................................................................................. 53




13.2 Conformity declarations granted by the licensee ................................................................................................................... 54

13.3 Packaging labels .............................................................................................................................................................................. 54

13.4 Documents of transaction (DT) ................................................................................................................................................... 57

14. SURVEILLANCE AND MONITORING ACTIVITY ....................................................................................................................... 59

14.1 INSPECTOR ROTATION ............................................................................................................................................................. 59

14.2 ANNUAL CONTROL PLAN ........................................................................................................................................................... 60

14.3 MONITORING OF THE ANNUAL CONTROL PLAN .............................................................................................................. 61

14.4 SURVEILLANCE INSPECTIONS ................................................................................................................................................ 61

14.4.1 Types of inspection ........................................................................................................................................................................ 62

14.4.2 Producers’ inspection ............................................................................................................................................................... 63

14.4.3 Inspection Of Small Farmers Group - SFG ......................................................................................................................... 64

14.4.4 Inspection Of The Processors ............................................................................................................................................... 64

14.4.5 Mixed Companies and Importers Inspections .................................................................................................................... 65

14.4.6 Documental Evaluation ............................................................................................................................................................. 65

15. CROSSED CONTROLS WITH OTHER ODCs AND EXCHANGE OF INFORMATION ........................................................ 66

16. UPDATING OPERATORS’ INFORMATION ................................................................................................................................... 66

17. LICENCE EXTENSION ....................................................................................................................................................................... 66

18. RENEWAL OF CERTIFICATION ..................................................................................................................................................... 66

19. USE OF LICENSES, CERTIFICATES AND CERTIFICATION MARKS .................................................................................. 67

20. LICENCE SUSPENSION, WITHDRAWAL AND CANCELLING OF LICENCE ....................................................................... 69

20.1.1 LICENCE SUSPENSION .............................................................................................................................................................. 69

20.1.2 WITHDRAWAL AND CANCELLING OF LICENCE ........................................................................................................... 70

21. NON-CONFORMITY AND SANCTION SYSTEM ........................................................................................................................ 71

21.1 NON CONFORMITY ...................................................................................................................................................................... 71

21.2 CONTROL AREAS .......................................................................................................................................................................... 72

21.3 PROCEDURE FOR THE MANAGEMENT OF NOT-CONFORMITIES AND SANCTIONS ............................................. 72

21.4 SUPPRESSION OF THE ORGANIC INDICATIONS ............................................................................................................. 73

21.5 SUSPENSION OF THE CERTIFICATION ............................................................................................................................... 73

21.6 EXCLUSION OF THE OPERATOR.............................................................................................................................................. 73

21.7 ADDITIONAL ACTIVITIES FOLLOWING SANCTIONS ................................................................................................... 73

21.8 NOTICES ......................................................................................................................................................................................... 73

21.8.1 Internal Notice ............................................................................................................................................................................... 73

21.8.2 External Notice ......................................................................................................................................................................... 74

22. APPEAL ................................................................................................................................................................................................... 74

23. MODIFICATION OF REQUIREMENTS FOR CERTIFICATION ............................................................................................. 74

24. RISK REDUCTION BETWEEN CERTIFICATION BODIES ....................................................................................................... 75

25. ACCEPTANCE OF OTHER PRODUCT CERTIFICATION ............................................................................................................. 75

26. INSPECTION AND CERTIFICATION FOR SPECIFIC CIRCUMSTANCES OR SCOPE ...................................................... 77

o INPUTS CERTIFICATION ................................................................................................................................................................ 77

27. GROUP CERTIFICATION .................................................................................................................................................................. 78

27.1 SFG – Inspection of small farmer group – SFG ............................................................................................................................. 79

27.2 Growergropu sanction system ………………………………………………………………………………………………………………………………………………………….80 28. BAC REGISTRATIONS AND DOC LIST ........................................................................................................................................ 81




1 FOREWARD

The present Operative Manual (OM) describes the requirements and procedures for the certification process of

agricultural-Organic products in conformity with IFOAM standard.

The certification process of agricultural-Organic products in conformity with IFOAM Standard is part of a

regulated product certification scheme which imposes the compliance with EC Reg. 834/2007 (and Accreditation

Criteria ISO 17065) and the BAC procedures for IFOAM certification.

For the IFOAM certification Bioagricert directly applies the Ifoam Standard 2014; the Bioagricert Ifoam

certification cover the Operators who are certified in compliance with EC Reg. 834/2007 and that asking for

IFOAM certification also.

If an operator requires only certification IFOAM, it must anyway submit all documents required for the EC Reg.

834/2007 and the specific documents for Ifoam.

2 MOTIVE FOR REVISION

The revision of the Manual has become necessary in order to satisfy the IFOAM Standard version 2014 and

IFOAM Accreditation Criteria 2014 ; the revision includes also integrations that occurred over time, due to

upgrade o to IFOAM Standard version 2012, NC, MI and observations received from IOAS during the witness

and surveillance audit and from BAC internal audit.

3 FIELD OF APPLICATION

The present Operative Manual (OM) is part of BAC Quality System; it is linked to the BAC Quality Manual

current version, related Procedures and other documents: certification regulation; operative instructions,

registration forms and specific BAC/Ifoam documents. The present Operative Manual (OM) describes the

requirements and procedures provided by BAC for the certification process of agricultural-Organic products in

conformity with IFOAM Norms: 2014 and for the following categories of operations:

- Food sector: Crop production; Wild products; Grower Groups; Livestock; Aquaculture; Beekeeping; Processing

and handling

- No food sector: Input manufacturing




4 LAWS AND DOCUMENTS OF REFERENCE

NORME QUADRO

Norma Descrizione

UNI EN ISO 9000:2005 Sistemi di gestione per la qualità - Fondamenti e vocabolario

UNI EN ISO 9001:2008 Sistemi di gestione per la qualità - Requisiti

UNI EN ISO/IEC

17000:2005

Valutazione della conformità - Vocabolario e principi generali

UNI EN ISO 19011:2003 Linee guida per gli audit dei sistemi di gestione per la qualità e/o gestione ambientale

UNI EN ISO 45020:2007 Normazione ed attività connesse – Vocabolario generale

UNI CEI 70015:1997

Rapporti committente/cliente-fornitore. Questionario per la raccolta dati ed

informazioni ai fini della valutazione di un fornitore

NORME DELL’ORGANISMO

Norma Descrizione

UNI CEI EN ISO/IEC

17065:2012

Requisiti per organismi che certificano prodotti, processi o servizi

UNI EN ISO 17000:2005 Valutazione della conformità – Vocabolario e principi generali

UNI EN ISO 17021:2006 Valutazione della conformità - Requisiti per gli organismi che forniscono audit e

certificazione di sistemi di gestione

UNI 70018:2009 Valutazione della conformità - Guida all'utilizzo di un sistema di gestione per la qualità di

una organizzazione nella certificazione di prodotto

UNI 70017:2008

ISO Guide 67:2004

Valutazione della conformità - Elementi fondamentali della certificazione di prodotto

UNI 70006:2008 Regole generali per un sistema tipo di certificazione di prodotti da parte di un organismo

indipendente.

EA 6-02:2007 Guidelines on the Use of EN 45 011 and ISO/IEC 17021 for Certification to EN ISO

3834

IAF GD 5:2006 Guidelines on the application of ISO/IEC Guide 65:1996

UNI EN ISO 17050-1:2005 Valutazione della conformità - Dichiarazione di conformità rilasciata dal fornitore -

Parte 1: requisiti generali

UNI EN ISO 17050-2:2005 Valutazione della conformità - Dichiarazione di conformità rilasciata dal fornitore -

Parte 1: documentazione di supporto

UNI 70007:1990 Guida relativa ai provvedimenti che un organismo di certificazione deve adottare nel caso

di uso non corretto del suo marchio di conformità

UNI 70009:1990 Guida per l' indicazione della conformità alle norme nei sistemi di certificazione da parte

di terzi.

UNI EN ISO 17020:2005 Criteri generali per il funzionamento dei vari tipi di organismi che effettuano attività di

ispezione

EA/ILAC-IAF A4:2004 Guidance on the Application of ISO /IEC 17020

UNI 70014:1992 Requisiti per la redazione delle norme da utilizzare per la certificazione dei prodotti

NORME DEI LABORATORI DI PROVA

Norma Descrizione

UNI EN ISO 17025 :2005 Requisiti generali per la competenza dei laboratori di prova e di taratura

NORME STATISTICHE

Norma Descrizione

UNI ISO 3534-1:2000 Statistica – Vocabolario e simboli - Probabilità e termini statistici generali

UNI ISO 3534-2:2000 Statistica – Vocabolario e simboli - Controllo statistico della qualità

UNI ISO 2859-1:2007

Procedimenti di campionamento nell'ispezione per attributi - Parte 1: Schemi di

campionamento indicizzati secondo il limite di qualità accettabile (AQL) nelle ispezioni

lotto per lotto




EXTERNAL DOC.

Ente/Documento Descrizione

EC Regulation EC Regulation N. 834/2007 of June 28, 2007

IFOAM Accreditation Criteria

2014

IFOAM Norms

IFOAM – version 2012 IFOAM Norms

IFOAM – version 2014 IFOAM Norms

IOAS

IOAS Operating Manual for the IFOAM Accreditation Programme – current

version

IOAS IOAS – Official Notices

5 DEFINITIONS AND ABBREVIATIONS (in the present Manual)

Definition or acronym Description

CA

CA Competent Authorities of vigilance of the control system and

maintenance of the registers of Organic operators. They are

represented by: MiPAF

(Competent National Authority) for the maintenance of the Registers of

Importers; Regional Administrators and Provincial Administrations, in

their competent territories and for the maintenance of the Registers of

Producers and Preparers.

Documento Giustificativo (DG) access request to obtain the release of Proof Document (DG) in

accordance with Article 29.1 of Reg. 834/07, Annex XII Reg. 889/08

which allows the inclusion of the company in the BAC control system, for

the specific activity notified and registration in the Registers of organic

operators

Evaluation Activity Documented exam and/or inspection and/or test carried out by

BioAgriCert for Certification.

BAC Bioagricert srl, Headquarters in via Dei Macabraccia, 8 - Casalecchio di

Reno (BO)

CC BioAgriCert Certification Committee: technical body which has the

competence to deliberate certification

Sector Manager (RS) Member of the Certification Committee who has the competence to

decide on certification

CSI Comitato di Salvaguardia dell’Imparzialità (CSI), separated from the

management structure and structured to guarantee the exclusion of

predominant interests; in this committee are equally represented:

consumer associations, agricultural producers associations, transformer

associations and technical scientific Bodies.

CRI Appeals Committee , independent of the management structure

Conformity Certificate EC Reg.

834/2007

The Conformity Certificate is the sole document which links the

products for which the licensee is authorized by BAC to grant

conformity declarations under EC Reg. 834/2007 (Licence certificate).

The conformity declarations granted by the licensee are represented by

the packaging labels for products destined for consumption and by

transaction documents for products destined to other controlled

operators.

Conformity Certificate IFOAM

Standard

The Conformity Certificate is the sole document which links the

products for which the licensee is authorized by BAC to grant

conformity declarations under IFOAM Standard (Licence certificate).

The conformity declarations granted by the licensee are represented by

the packaging labels for products destined for consumption and by

transaction documents for products destined to other controlled

operators.




Commercialization The detention and exposition for sale, the sale, the distribution or any

other means of commercial introduction.

Licensee or Licensed Company Operator to whom BAC has granted or maintains in validity to the

Conformity Certification of agricultural Organic products.

LdL Licensee list. A list of licensees and relative products indicating the

conformity norms to which they are certified. The LdL is available upon

request at the BAC Headquarters

Definition or Acronym Description

BAC guidelines

Documentation of the applications of the norms which defines

production rules, process characteristics and agricultural-Organic

products.

MiPAAF Ministry of Agricultural and Forestry Politics

OM Operative Manual of the Certification Process

Non - Conformity

Lacking satisfaction of one or more requirements (UNI EN ISO

9000:2000). Based upon the Community Law, for agricultural-Organic

products, there are two levels of nonconformity: irregularities and

infractions, to which immediate sanctions are made, the type of which is

determined by the ability to compromise or not the safety of the

control system.

OdC/ CB Certification and control body

IFOAM International Federation of Organic Agricultural Movements

IOAS International Organic Accreditation Service

Operator

A person of physical or legal status who produces, prepares or imports

from third parties products under EC Reg. 834/2007, who have the

responsibility to guarantee that the products for which certification is

requested satisfy the requirements under which the certification is

based, and, in general, every other request of applicable law.

Danger Potential that an operator commercialises products not conformed to

the agricultural- Organic norms, causing a damage

Operative Manual and Procedures Prescribed documents used and managed in a controlled manner by

BioAgriCert.

BAC sector Manager A member of the BioAgricert certification Committee who is able to

grant certifications.

Risk Evaluation of a probable and eventual danger

Certification scheme

Certification system related to determined products and processes, to

which are applied the same norms, the same particular rules and the

same procedures.

Accredia National Certification System, responsible for accrediting, certification

bodies and their subscription to a Register.

Sub-licensee Sub-contracted operator who works for a licensee.

Biological, Bio Organic

SFG Small Farmer Group

Contractor Operator that processes/produces products on behalf of another

certified operator

Subcontracted Production or

Processing

The utilization by the certified operator of third parties for performing

specific production or processing tasks on behalf of that operator

Other IFOAM – IAC - Definitions




IAC - DEFINITIONS - OTHER DEFINITIONS TAKEN FORM IFOAM ACCREDITATION REQUIREMENTS FOR BODIES CERTIFYING ORGANIC PRODUCTION AND PROCESSING -

VERSION 2.0 OF JUNE 2014

The following definitions apply within the context of these requirements:

Acceptance of other product certification: The procedure by which a certification body accepts the

certification of a product by another certification body, thereby enabling the use of, or further processing by,

the certification body’s own operators.

Accreditation: Procedure by which an authoritative body gives a formal recognition that a body is competent to

carry out specific tasks.

Appeal: Request by an operator for reconsideration of any adverse decisions made by the certification body

related to its desired certification status.

Certificate of Conformity: Document issued by a certification body, declaring that an operation is in conformity

with the organic production or processing standards.

Certification: The procedure by which an operator or a group of operators receives written and reliably

endorsed assurance that a clearly identified process has been methodically applied in order to assess that the

operator is producing specified products according to specific requirements or standards. In the context of the

IFOAM Accreditation Requirements, “certification” is to be understood as “third party certification”.

Certification Body: The body that conducts certification.

Certification Mark: A certification body’s sign, symbol or logo which identifies product(s) as being certified to

the requirements of a program operated by that certification body.

Certification Program: A system with defined requirements, procedures and management operated by a

certification bodyfor carrying out certification of conformity to a particular standard.

Certification Scope: The parameters defining the certification granted including the process, product or

product types certified, the applicable standards, and certification program.

Chain of Custody: The channel through which products are distributed from their origin to their end use,

including primary production, processing, handling, storing, trading, and transportation stages.

Complaint: An objection to the policies, procedures or performance of the certification body. A complaint may

also be an objection concerning the compliance of a certified party lodged with the certification body by a third

party.

Conflict of Interest: A set of circumstances that creates a risk that professional judgment or action regarding

certification will be unduly influenced by a secondary interest.

Consultancy: Services or advice customized to a particular operator’s request in order to achieve compliance

with certification requirements.

Conversion Period: The time between the start of the organic management and the certification of crops and/or

animal husbandry as organic.

Corrective actions: Improvements to an organization’s processes taken to eliminate causes of non-conformities

or other undesirable situations.

Evaluation: Systematic assessment based on all relevant information obtained in order to make the certification

decision.

Exception: Permission granted to an operator by a certification body to be excluded from the need to comply

with requirements.

Genetic Engineering: A set of techniques from molecular biology (such as recombinant DNA) by which the

genetic material of plants, animals, microorganisms, cells and other biological units are altered in ways or with

results that could not be obtained by methods of natural mating and reproduction or natural recombination.

Techniques of genetic engineering include, but are not limited to: recombinant DNA,

cell fusion, micro and macro injection, encapsulation. Genetically engineered organisms do not include organisms

resulting from techniques such as conjugation, transduction and natural hybridization.

Genetically Modified Organism (GMO): A plant, animal, or microbe that is transformed by genetic engineering.

Input/Output Reconciliation: An audit that assesses the output of organic product against the supply of

ingredients or in the case of trading operations, the volume of sales against the volume of purchases.

Inspection: An on-site visit to verify that the performance of an operation is in accordance with the

requirements.




Inspection Body: An organization that performs inspection services.

Inspector: A person qualified to perform the inspection of an operation.

Internal Audit: A systematic periodic review and assessment of the objectives and performance of a program

that is undertaken by the certification body itself.

Internal Control System: Part of a documented quality assurance system that allows the external certification

body to delegate the annual inspection of individual group members to an identified body/unit within the

certified operation.

License: An agreement or contract that grants a certified operator the right to use certificates or certification

marks in accordance with the requirements of that program.

Multiple Certification: Certification of an operation by more than one certification body.

Non-Conformity: An instance where a particular standard or requirement is not being met.

Operator: An individual, organization, or business enterprise, responsible for ensuring that production meets,

and continues to meet, the requirements on which the certification is based.

Parallel Production: Any production where the same unit is growing, breeding, handling or processing the same

products in an organic system and in a non-organic system. A situation with “organic” and “in conversion”

production of the same product is also parallel production. Parallel production is a special instance of split

production.

Precedent: A certification decision concerning a new situation or set of circumstances that may serve to guide

future decisions.

Preventive actions: Proactive improvements to an organization’s processes taken to eliminate causes of potential

non-conformities or other undesirable situations.

Production/Sales Reconciliation: An audit that assesses the sales of organic product against the production

volume.

Quality System: Documented procedures that are established, implemented, and periodically audited to assure

that production, handling, management, certification, accreditation and other systems meet specified

requirements and outcomes by following standardized protocols.

Re-inspection: external inspection of individual group members carried out by the certification body inspector

in the context of group certification.

Sanctions: Measures taken against operators who have failed to comply with the standards or other

requirements of the certification body.

Split Production: Where only part of the farm or processing unit is organic. The remainder of the property can

be (a) non-organic; or (b) in conversion. Also see parallel production.

Standard: Norm that specifies how a product should be produced and processed. For the purposes of this

document a standard is used to define organic production practices.

Subcontracted Production or Processing: The utilization by the certified operator of third parties for

performing specific production or processing tasks on behalf of that operator.

Surveillance: Ongoing monitoring of an operator’s compliance with standards and certification requirements.

Trace Back Audit: Verification that a product or its ingredients can be tracked to the original suppliers.

Transaction Certificate: Document issued by a certification body or by the operator, declaring that a specified

lot or consignment of goods is certified.




6 SPECIFIC REQUIREMENTS FOR IFOAM ACCREDITATION

Ref. Doc: IFOAM Accreditation Requirements for Bodies Certifying Organic Production and Processing Version 2.0

- Approved by the IFOAM Genera Assembly through electronic vote in July 2014

6.1 LEGAL STRUCTURE (IAC 1)

BioAgriCert (from now on identified as BAC) is a Srl Company (based on limited responsibility) constituted on

January 29, 1999 and that runs an activity of control and certification of products. Constitutive act is described

in the Annex 1.

BAC is registered at the Camera di Commercio Industria Artigianato and Agricoltura (Chamber of Commerce) of

Bologna with the number 01951701208 and at the R.E.A. n° 401449 for the exercise in associated form of the

control and certification activity, codified by specific norms, of the agro-industrial productions obtained with

organic method, of the eco-compatible productions and of the quality products (Certificato di iscrizione alla

CCIAA - Annex 1).

BAC Organisation is described in Annex 1.

BAC, to run the activity, has got authorisations and crediting reported in the Doc. DocSAA01_ list of the

certification, authorisation and crediting schemes - Annex 1.

6.2 RESPONSIBILITY, IMPARTIALITY AND OBJECTIVITY - DIVISION OF FUNCTIONS AND

TECHNICAL STRUCTURE

BAC assumes and maintains the responsibility for all activities operated, the subcontracted activities and of the

decisions about the granting, maintenance, extension, suspension and withdrawal of the certification.

BAC is organised in order to guarantee the reliability and the credibility of the certificates issued. In particular

the BAC guarantees:

• responsibility of the decisions on the certification, concerning the issue, maintenance, extension,

suspension and withdrawal of the same;

• a structure of the Comitato di Salvaguardia dell’Imparzialità (CSI), separated from the management

structure and structured to guarantee the exclusion of predominant interests;




decision

proposal

Bioagricert organisation is summarized in the following chart.

Inspectors (TI)

Board

CdA

Commette Safeguarde of

Impartiality CSI (*)

Certification Committee CC(**)

Composition: RAC + Responsabibles of Sector (RS): Agricultural Farms (AA) Processing Farms (AP) Certification Office (UC) Foreign Affairs Office (UE)

SCHEME SCHEME

Certificate of

Product

SCHEME

Test Report Inspection

Report

Licensees

Request of Certification

Evaluators (TV/RDP)




(*): involved parts

(**): technical competence

(*) interested parts

(**) technical competence

6.2.1 Certification committee (CC) - Organo deliberante la certificazione

BAC has formal rules and structures for the appointment and operation of the certification committees

involved in the certification process.

Certification committee (CC):

* Guarantee that all the control and certification activities are carried out respecting the

Certification Scheme;

* Decisions regarding the certification. Deliberation about the Operators’ enrolment in the LdL and

about the certification, under indication of the Sector Managers, in case of non-conformity (serious

violations) that involve suspensions, rejections and/or exclusion of the Operator from the

certification and control system

* Inflicting the sanctions to the licensees, requiring the corrective actions and being sure they are

respected in case of a serious non-conformity that involves the suspension and/or the exclusion of

the Operator from the control and certification system;

* Approving the control plans and the documentation of the system, except the MQ

* Carrying out the test, the inspection, the evaluation and the certification;

* Authorisation to committees or people to carry out activities for BAC and in particular the

constitution of technical committees to write technical norms;

* Granting derogations (exceptions) to requirements for certification (already indicated by the

technical norms – Ifoam standard and IAC).

The members of the CC are the BAC Sector Managers (RS).

The CC has a technical-administrative secretary service (SCC) which has the following responsibilities:

* Writing the agenda and convoking, under direction of the Sector Manager, the meetings.

* preparing the useful documentation for the meeting;

* be present at the meetings and write the registers;

* Communicating the decisions and the requests of the CC to the licensees, the technician inspectors

and for knowledge to the Competent Authorities.

* Communicating through circular letters to the licensees, the legislation modifications, which may

influence the product conformity.

The CC carries out periodical technical meetings to which the regional referents and coordinators and the

evaluators take part. Such meetings are useful to compare and exchange information between the headquarter

and the other seats/offices, about the following topics:

* Instruments for the continuous development and improvement of the certification programme;

* Screening of the activity of control/surveillance;

* Training needs;

* Local needs and problems.

6.2.2 BAC Appeals Commette (CRI)

BAC Policies and procedures aim to ensure constructive and timely resolution of appeals; the procedure provides

the opportunity for the applicant to formally present the case and the existence of an independent element

capable of ensuring the impartiality of the process of Appeal.

Test laboratories




Operators can appeal against the decisions of BAC within 15 days from the receipt, detailing the reasons of the

disagreement and requesting a review of the decision.

Appeal must be submitted to the BAC Appeal Committee (CRI), at BAC head office.

The CRI has three external members of the sectors concerned in the certification and with proven

qualifications in the sectors subject to certification, to guarantee impartiality and independence of judgment,

appointed directly by the President of BAC.

The composition of CRI is detailed in the Doc. OB01 – Organisation: Seats, personnel and suppliers

Upon receipt of the appeal, the SCR convene the CRI which meets and examines the relevant documentation,

comparing the motivations of the operator and those of the CC of BAC that issued the decision under appeal.

Once it has evaluated the appeal, the CRI issues a document which is sent to the appeallant operator and to BAC,

containing results of the appeal with the reasons of the decisions within 30 days starting from date of

notification of the decision to the operator (according to the methods, procedures and deadlines described in

doc. Pro_003 the Appeals Committee Activities).

Any justified reasons (eg. waiting for response about AC or other operators /certification bodies) may delay the

decision of the CRI for a period of up to 30 more days. The receipt of the appeal does not stop, however, the

enforceability of the adopted sanctions, until further pronouncement of CRI. In case of non-acceptance the

appeal, decision is definitive Expenses shall be beared by the losing party.

BAC ensures that any staff, who have performed evaluation of certification, consulting activity, or employed by

the appeallant during the two year previous to the opening of the complaint, doesn’t take part to the decision

about the result of the appeal.

6.2.3 Impartiality and Objectivity

BAC is organised in order to guarantee the reliability and the credibility of the certificates issued.

To guarantee the respect of impartiality BAC has adopted the following dispositions for all the organisation

levels, included the committees and other external staff which operate for it:

• impartiality and independence, BAC doesn't supply any advice any consultancy services (directly or

indirectly). BAC funds come exclusively from the payment of the shares related to the control and to

the certification, by the firms which ask for that.

• BAC guarantees the participation of all the parties involved in the certification activity without the

predominance of single interests; it has an independent staff free of conflicts of interest -

SAFEGUARD COMMITTEE IMPARTIALITY (CSI) Comitato di Salvaguardia dell’Imparzialità (CSI),

separated from the management structure and structured to guarantee the exclusion of predominant

interests;

* The technicians, the members of the committees, the internal and external staff, have to subscribe

documents which involve the pledge of privacy and the declaration of conflicts of interest, before the

beginning of the activity;

* People who have different roles have to subscribe the pledge of privacy and the declaration of conflicts

of interest for all the roles they cover;

* Each member has the duty to declare possible conflicts of interests with companies subjected to the

control and in case he/she has such conflicts, he/she can’t join any kind of discussion, work or decision

connected with that Companies. Moreover, he/she can’t join the vote for the certification deliberation

that he/she proposed, or he/she has joined the inspection and/or the evaluation

* Everyone who has declared conflicts of interest with the licensee can’t take part in the activity of

inspection, evaluation and vote, both of the CC and the CSI, for that specific company;

* all staff involved in the control and certification process subscribes a contract or another document for

the pledge of working in agreement with the rules established by BAC and in particular:




* Don’t take part in the evaluation activity if he/she carried out the inspection;

* Don’t deliberate about the certification if he/she carried out the inspection and/or the evaluation;

* no substantial gift or favor is accepted by personnel - ref. Deontological code

the fee for certificationare defined by Doc. TB BioAgriCert Fees, elaborated and approved by the

Administrative Council (CdA) and validated by the CSI.

Only the President, on delegation of the CdA, can make discounts if this simplifies the activity of control.

BAC provide its certification service based on Protocol agreement (M 37), signed by the Operator and BAC

before the inspection.

Information regarding IFOAM certification are offered to all applicants/operators in a non-discriminatory

manner and are limited to explanation of the standards or certification requirements.

To manage the risk of familiarity between the BAC inspection staff and operators, is defined as the maximum

number of years (4 consecutive years) for which the inspector may inspect the same operator. The continuity is

interrupted by at least one complete inspection performed by a different inspector. If the comparison of the

results of the two inspectors did not emerge significant differences, the former inspector may be appointed for

a new cycle of inspections the operator.

6.2.3.1 Structure of the safeguard committee impartiality (CSI)

The CSI is the body established by section 5.2 of the UNI EN ISO 17065, is the member of the guarantor of

impartiality, which ensures the equitable representation of the parties involved in certification. At the CSI

participates President BAC, without voting rights, as a connecting link with the CC. At the CSI may attend the

AC representatives of supervision, without the right to vote. The CSI also plays an advisory role of the Board, in

particular to provide guidance on strategies and policy directions of the CB. There is close cooperation between

the CSI and the Board as regards information, comments and proposals to safeguard the impartiality and the

development and improvement of the system of certification and the SQ. Such exchange of information is

carried out through joint meetings of the two bodies and through the annual report of the CSI on its activity.

The CSI for the activities to safeguard impartiality is largely independent.

If the CC is not apply the decisions of the CSI, the latter may take action including possible information of the

CA and Accreditation Bodies, in compliance with confidentiality requirements for BAC and operators. Similar

steps can be taken if they are not supplied to the CSI information about the decisions and actions on the

certification, including those relating to the selection of industry leaders involved in certification.

The Board of Directors of BAC may decide, keeping registration and reasons for that decision, to not follow

advice from the CIS that were in conflict with the operating procedures of BAC or other mandatory

requirements.

CSI is consulted and the right to express their opinion on:

- policies and the principles of impartiality BAC;

- any tendency on the part of BAC to allow commercial or other considerations prevent the consistent

supply and impartial activity of certification;

- aspects that influence the impartiality and confidence in certification, including openness.

BAC ensures that the CSI has access to all the information necessary to ensure the performance of its

functions.




The activity of the CSI is detailed in the document Pro_002 Activities Committee for the Protection of

impartiality.

To ensure impartiality, BAC establish and keep updated the document Analysis of risks to impartiality

approved by the CSI - RISK ANALYSIS RELATED TO THE IMPARTIALITY - 15/06/2011 APPROVAL OF THE

CSI

The composition and representativeness of the CSI is detailed in document Doc. OB01 Organization BAC:

Locations, Human Resources and Suppliers (Annex 7 to MQ).

6.2.3.2 Consulting and advising

IAC 1.4

BAC doesn't supply any advice any consultancy services (directly or indirectly). BAC funds come exclusively from

the payment of the shares related to the control and to the certification, by the firms which ask for that.

Information regarding IFOAM certification are offered to all applicants/operators in a non-discriminatory

manner.

Specific advice given to operators are limited to explanations of the Standards or certification

requirements. This information is offered without Additional fees and not prescribe solution.

Pre-assessment (Preliminary visit) not include advice on how to overcome the non-conformities identified.

Specific advice given to operators are limited to explanations of the standards or certification requirements.

6.2.3.3 Conflict of interest

IAC 1.5 All staff involved in the control and certification activity subscribes the following documents:

✓ M_039 Engagement letter;

✓ M_040 Declaration of Interests;

✓ M_041 Protocol of assignment;

✓ Confidentiality declaration

Declaration of Interests - The M_040 Declaration of Interests has to be submitted by:

* People who have different roles have to subscribe the declaration of conflicts of interest for all the

roles they cover;

* The technicians, the members of the committees (CC and CSI), the internal and external staff;

* Each member of the Certification Committees has the duty to declare possible conflicts of interests

with companies subjected to the control and in case he/she has such conflicts, he/she can’t join any

kind of discussion, work or decision connected with that Companies. Moreover, he/she can’t join the

vote for the certification deliberation that he/she proposed, or he/she has joined the inspection

and/or the evaluation

* Everyone who has declared conflicts of interest with the licensee can’t take part in the activity of

inspection, evaluation and vote, both of the CC and the CSI, for that specific company.

6.3 FINANCIAL AND PERSONNEL RESOURCES

IAC 1.6

6.3.1 Financial stability

BAC, as a Company based on limited responsibility, has got balances deposited at the Chamber of Commerce.

BAC funds come exclusively from the payment of the shares related to the control and to the certification, by

the firms which ask for that.




The Pro 007 “administrative management " details the sources of the finance, the fee policy, the contract and

the management of the insolvency. To guarantee financial stability anticipatory balances for the following three

years are written annually.

6.3.2 Civil responsibility (TORT LIABILITY)

Regarding to the civil responsibility, BAC refers to the actual legislation and to certification procedures and to

the agreement protocol signed by the parts (Operators). The controversies concerning the contract, as affirmed

in the protocol of agreement, are solved through the ritual arbitration at the Arbitrational Chamber of the

CCIAA in Bologna.

To guarantee a bigger covering of the civil responsibility and to face the damages requests coming from the

certification activity, BAC has signed a special insurance (Annex 1).

6.3.3 Personnel

BAC is organised in order to guarantee the reliability and the credibility of the certificates issued. In

particular, BAC guarantees adequacy of resources.:

- qualified staff with adequate qualification and in continuous updating to guarantee competence and

knowledge relevant to the location and type of processing facilities for which the certification is issued

- an adequate number of inspectors, evaluators and laboratories which respect ISO/IEC -17025;

The whole BAC staff:

- has got documented and updated instructions, manuals and procedures on their roles and

responsibilities;

- is competent and responsible for the functions that has to develop;

- is interested in reaching the aims established by the Company policy. This represents the main task of

the whole staff and it concerns its responsibilities and competence

All staff involved in the control and certification activity subscribes a contract or another document for the

pledge of working in agreement with the rules established by BAC and respect of deontological code and

secrecy, maintaining the best professional secrecy possible regarding all the information and the data acquired

during the activity.

BAC maintain up-to-date records on staff involved in the certification scheme.

The names and qualifications of the organisation members are reported in the following documents:

DocOB01_Organizzazione (Annex 1).

6.3.4 Staff competence and training

All BAC staff is competent for the functions they must carry out. Requirements common to all the

functions regard aspects of discretion and independence.

In order to guarantee that the inspection, the evaluation and the certification are carried out in an effective

and uniform way, BAC has defined the minimum competence levels of the staff, for every meaningful function.

FUNCTION MINIMUM QUALIFICATION REQUIREMENTS

Quality Assurance Manager

Technical-scientific degree. Curriculum declaring a three years experience in the following

sectors: Quality Assurance, Food Quality Control. At least a 24 hours course on the

internal audit in the Food Sector with Final Qualification. Training with Evaluator of

Quality Systems for at least three inspections.

Internal Inspections Manager

Technical Inspector Qualification. Curriculum declaring at least a three years experience

in the Food sector. At least a 24 hours course on the internal audit in the Food Sector

with Final Qualification. Training with RAQ by carrying out at least three inspections

CSI Member Representative of one of the following categories: farmers associations, associations of




operators working in the sector submitted to certification, consumers’ associations,

technical-scientific bodies of general interest.

Knowledge in the field of productions submitted to certification Authority in his/her own

job field and high personal integrity.

CC Member Control Activity Manager, Sector Manager

Certification and control manager Sector Manager Qualification. Curriculum declaring full experience in the certification and

control sector, at least of three years.

Sector Manager (RS) Technical Inspector and Evaluator Qualification.

Curriculum declaring at least a three years experience in the specific sector.

Foreign Affairs Manager

Senior Technical Inspector Qualification. Curriculum declaring at least a three years

experience in the specific sector. Flowing speaking of English.

Coordinator and Regional

Referent

To have carried out technical senior inspector activity for at least one year.

Function Minimal Qualification Requirements

Technical Inspector

(Responsible for dossier

which proposes

certification

Evaluators / RDP)

In order to access qualification the technical evaluators must possess at least

one of the degrees required for technical inspector activity. On the basis of

the specific competences (curriculum, education and practical training), technical evaluators are

qualified for the evaluation activity within the sectors of vegetable production, animal production,

food preparation. In order to extend their qualifications into other sectors they must have

conducted evaluations of at least 10 company dossiers with positive evaluation from their tutor

(expert evaluator).

Minimal vocational training: participation in a 24 hour course on “Evaluation Techniques in Organic

Agriculture,” passing the final exam.

Minimal training: at least one year of evaluation activity observed by the tutor who must also

provide positive feedback. The tutor is a qualified evaluator, who verifies the evaluation activity of

the aspiring evaluator and proposes the certification.

Senior Technical

Inspector

Qualified as a Junior Technical Inspector and having carried out at least 30 inspection visits with

positive feedback from the tutor. In order to extend qualifications to other sectors one must have

conducted at least 10 inspections

within the specified sector and have received positive feedback from the tutor.

Junior Technical

Inspector

In order to access qualification, technical inspectors must possess at least one of the following

degrees: agricultural science, forestry, foodstuffs science and technology, animal production

science, chemistry, biology, veterinarian, or possess an expert diploma in agriculture, agro-

technician, chemistry, dietician or equivalent. On the basis of their specific competences

(curriculum, training and practical training), technical inspectors are qualified for inspection

activity in the following sectors: vegetable production, animal production, food preparation.

Minimal vocational training: participation in a 16 hour course “Control Techniques in Organic

Agriculture,” passing of final exam.

Minimal training: at least 2 inspection visits with a Senior Technical Inspector for each sector of

qualification.

BAC defined the modality of staff management in the procedure: Pro_004 Education, Training and

Performance Assessment.

Work instructions All of BAC’s staff has work instructions, documented and updated, relating to their roles and responsibilities.

In particular the inspectors are provided with:

- Technical Inspectors Operative Manual containing the present version of OM, procedures,

operative instructions, modules and technical norms;

- Basic informative program for consultation of company data;

- identity card and a stamp with their identification code;

- materials necessary for collecting and sending samples;

- BioAgriCert software;




- control plan approved by the CC, which specifies the operators to be inspected, number, type and

period (trimester) in which to effectuate inspections and the samples collecting;

- results of non conformities contested to the company during the previous inspections in order to

evaluate the treatment and application of corrective actions;

- list of product certifications released to the operator, for the vigilance on the correct use of

conformity certification.

Records of staff qualifications

Bioagricert keeps all staff documents both in paper form that in computer form on BAC database:

✓ CV;

✓ copy of diploma or university degree;

✓ copy of training course certificates;

✓ M_039 Engagement letter;

✓ M_040 Declaration of Interests;

✓ M_44 Evaluation form - qualification of inspectors

✓ M_041 Protocol of assignment;

✓ M_046: evaluation of staff performances;

✓ Communications sent to and from the technician.

All useful information (BAC code, name, surname, date and place of birth, address, telephone number, e-mail

address, kind of qualification etc.) are registered on BAC software.

BAC staff is also listed in the Qualified Suppliers’ List with the following information: name, surname, kind of

diploma or degree, code, qualification level, date of hiring, sector .

BAC maintain up-to-date documents describing the respective responsibilities of assigned personnel.

The names and qualifications of the organisation members are reported in the following documents: DocOB01

(Annex 1).

6.4 OUTSOURCING

IAC 1.7

BAC assumes and maintains the responsibility of the subcontracted activities and of the decisions about the

granting, maintenance, extension, suspension and withdrawal of the certification.

- BAC guarantees that the structures and the people to which she gave the subcontract, respect BAC

policies and procedures, have proper competence and requirements of impartiality.

- BAC ensure that performance of the persons or bodies subcontracted for the work are regularly

monitored.

- BAC notifies the subcontracted activities to the Operators, asking their written approval.

Subcontracted tests laboratories

BAC uses test laboratories with which subscribes a convention that includes the following minimum

requirements:

- the laboratory accrediting for the tests foreseen by the certification scheme of the ISO/IEC 17025 norm

and/or other specific norms of the certification system;

- Analytical limits should be less than or equal to 0.010 mg/kg for tests concerning phytosanitary aids and 0,01%

for GMO

- the laboratory participation to ring tests;

the validation of the test methods in conformity with ISO/IEC 17025;

✓ Training of BAC personnel, on test analysis;

✓ the analysis performance, defining the transportation method and the samples stocking, the reply

times, test methods, limits of determination, test repetitions in case they are positive;

- the results presentation in a test report having the Accreditation Body trademark, in which should be




defined: researched active substances, the method used, the measure of the uncertainty of the data, the

measure or the measures if the test is repeated.

- to guarantee the discretion about the information;

- to agree to receive BAC operators’ inspections;

Bac maintains the updated list of Subcontracted tests laboratories.

Performance evaluation of laboratories is done by as described in Pro_004 Education, Training and


Subcontracted Inspection activity

Inspection activity are carried out by professional men/women (BAC Technical Inspectors) or it is

subcontracted by BAC to Inspection and/or Certification Body qualified by BAC in agreement with the norm

ISO 17020 and/or ISO 65.

BAC inscribes in the DocOB01 the technical inspectors engaged and the Inspection Company, values their

performances through the VII and the evaluation of the inspective reports.

Performance evaluation of inspection staff is done by as described in Pro_004 Education, Training and


Challenge/refuse

Operators have the chance of challenge/refuse the technical inspectors (except for the non-announced

inspections), sending a written motivated communication to the CC, who, if it accepts the motivations will provide

to substitute the technical inspector.

The refusal can be accepted when are contested: independence and equity (interest conflicts), competence and

discretion, low deontology, demand of requirements non-included in the reference norms, expression of

subjective opinions, advice proposals or remunerations of any kind, bad behaviour and threatening behaviours.

Operators can refuse also the laboratories and ask that the tests are carried out in laboratories different from

the ones settled by BAC, on condition that the requirements above indicated are respected.

6.5 ACCESSIBILITY AND SCOPE : POLICIES AND PROCEDURES

6.5.1 Accessibility

Policy

BAC guarantees:

- free access to the certification scheme to all whose activity pertains to the field of application of

certification and possess applicable requirements.

- no discrimination of whatever kind and in particular: conditions of financial or debts of any nature;

evaluation and certification access is not conditioned by the dimensions of the operator or membership to

particular associations or groups;

- equality regarding treatment of applicants and in particular the evaluation of access to applications

follows the protocol numbering in entrance and the rejected requests are submitted to the validation of the

CSI.

The fees charged to the certification applicant are defined by Doc. TB BioAgriCert Fees, elaborated and

approved by the Administrative Council (CdA) and validated by the CSI.

Certification Regulation is approved by CSI.

Only the President, on delegation of the CdA, can make discounts if this simplifies the activity of control.

BAC provide its certification service based on Protocol agreement (M 37), signed by the Operator and BAC

before the inspection.




BAC ensures that the Certification, inspections and decisions are confined to the scope of the certification

requested by the applicant.

If BAC believes it is not able to certify the operator, due to the field of application, the location or any other

particular reason as the language used, it communicates to the Operator that his application request is rejected,

according to Bioagricert Regulation.

For the other countries (except Mexico), Bioagricert requires that there would be a qualified person in the

staff of the company who speaks English and local language.

6.5.2 Certification Scope and the Chain of Custody

IAC 2.2

BAC ensures that the issuance of Certificate of conformity and certification documents are based on the

results of inspection and evaluation activities; evaluation activities ensure the verification of the organic

integrity in all entities/units/activities (production; processing; packaging or labelling; contracted production;

transport - unless the transport is not already certified in their own; storage, including port facilities).

In order to check if the organic integrity is maintained, in the technical report (OSP) and Specific BAC

Operator documents for Ifoam to be submitted by the applicant for certification, there is a section dedicated

to the shipping of product, transport (unless the transport is not already certified in their own), storage

(including port facilities) and protection of the products; these documents facilitate the collection of

information needed to assign the class of risk to operators and therefore the number and type of inspections to

be carried out.

The risk rating is assigned according to the criteria defined in the following documents: IO_12_Valutazione

Rischio and Pro 008 WORKING PROCEDURE OF NATIONAL AGENCIES.

Furthermore, the class of risk is assessed during the inspection, confirmed and if necessary updated.

In the technical report (OSP) to be submitted by the applicant for certification, there is a section dedicated to

the shipping of the product, in order to check if the organic integrity is maintained in the shipping process.

Where steps in the production chain have been certified by other certification bodies, the criteria specified in

Section 25.

For certified product not in its final packaging and sold to an operator certified by a different entity the

criteria specified in Par. 13.4 are applied (Transaction document).

6.5.3 Certification Scope and Subcontracted Production or Processing

IAC 2.3

Definition

Subcontracted Production or Processing

The utilization by the certified operator of third parties for

performing specific production or processing tasks on behalf of

that operator.

Subcontracted Production or Processing The utilization by the certified operator of third parties for

performing specific production or processing tasks on behalf of

that operator

Subcontracted Production

when a certified entity (or applicant) has subcontracted

production to an operation that is not certified. For example, a

certified processor or trader has subcontracted producers which

is not certified in its own right

when a certified entity (or applicant) has subcontracted




Subcontracted Processing

production to an operation that is not certified. For example, a

certified processor subcontracts with a storage, handling, or

processing facility which is not certified in its own right.

The activities carried out by third parties (Subcontracted Production or Processing), are subject to the

control system.

The performer of the activity (subcontracted company) is not a licensee with its own certificate of organic

products and cannot take title and marketing the certified products ( These provisions do not prohibit the

subcontracted party from applying for certification in their own right).

The performer of the activity (subcontracted company) must comply with the rules of organic farming and

organic productions and it should subject its activity to control system, based on the written contract between

the licensee and the performer of the activity (Master 20 Ifoam).

Therefore, the licensee which subcontracts some activities to third parties shall:

- describes this activity in its Organic System Plan

- Include a list of the subcontractors with a description of their activities and certification bodies which

they are controlled;

- include the contract of subcontracted activity which shall be subjected to control (Master 20 Ifoam).

In case that the outsourced company is subject to control under the regulation on organic farming, the licensee

will have to save the certificate of the subcontracted (provider) organic products. In this case, certification

granted by another certification body can be accepted provided that it falls under the scope of an IFOAM

accreditation program with the same standard.

In other cases, BAC shall inspect the subcontracted party.

The duties of subcontracted operations and certified operator (licensee which subcontracts some activities to

third parties) are detailed in the Master 20 Ifoam.

6.6 QUALITY SYSTEM FOR CERTIFICATION

IAC 3

The BAC Quality Manual (MQ) defines the SQ basic structure and it represents its reference for the

application, the activation and the maintenance. The MQ contains the quality objects, the organisation structure,

the management modalities and the SQ evaluation instruments.

The application field of the MQ is extended to all the control and certification activity managed by BioAgriCert.

The BAC Quality Manual (MQ) has the aim of:

- spreading inside and outside the organisation the policy for the quality;

- describing the way by which Bioagricert makes its activity conform to the reference norm;

- formalising, with the procedures and the connected documentation for every certification scheme, the

quality system;

- supplying the structure and acting as a referent for the application of the quality system and the

certification system.

The QM is drawn up by the RAQ at first experimental edition and a limited number of copies, distributed to

members of the CdA and the CC, to evaluate the operational applicability. Verification is conducted by the RAQ,

as the guarantor of CB compliance to UNI CEI EN ISO 17065 and the CIS as the guarantor of CB impartiality.

Make any necessary changes, the MQ is approved by the Board. The same procedure will be followed for

revisions.




The MQ is distributed in a controlled way within the Organization to the CdA, CSI and CC members, to the

RVII, regional referents and coordinators (CR) and evaluators (TV); outsides it is distributed to the

Accreditation Bodies and to the Competent Authorities.

Complete MQ is Attached to OM (Annex 1)

6.6.1 Quality Documentation

IAC 3.3

The MQ describes the:

- policy for the quality;

- legal status;

- organisation chart, the hierarchic chart, the responsibilities and the division of the functions;

- qualifications, experience and tasks of staff working in the activity of certification;

- operative and functional tasks and the services regarding the quality;

- suppliers approved, including subcontractors, and the procedures for the evaluation, the recording and

the control of the linked competence;

- policy and procedure to treat appeals, complaints and disputes;

- policy and procedure to conduct the control of the documentation;

- procedures for the recruitment, the selection, the training and the control of the staff’s performances;

- procedures to manage the non-conformities;

- procedures to make internal inspecting controls based on the prescriptions of the norm UNI EN 19011;

- Policy and procedures to manage the re-examination of the Direction.

The procedures for the evaluation of the products and manage the Ifoam certification process, including the

conditions for the issue, maintenance, extension, suspension and withdrawal of the certification documents, are

specified this Operative Manuals.

6.6.2 Internal audit (VII)

IAC 3.4

The implementation and effectiveness of the SQ BAC is verified through VII. The scope of implementation of

the VII covers all the functions and responsibilities at each level of the organization.

The VII are intended to verify:

• that the SQ and the activities are in compliance with the specifications in the standards of reference,

in the MQ, the Operating manuals and related documentation;

• that activities agree with what is specified by the reference norms, in the MQ, in the Operative

Manuals and in the related documentation;

• the implementation of planned activities;

• the realization of the program to improve the quality of service provided to customers;

• the status of corrective actions and / or preventive activated;

• the respect of the tasks indicated by the Accreditation Bodies and the Competent Authorities;

• the performance of the staff.

The main joints of the Organization subject to VII, according to the factors listed above, are:

• headquarters (subject to audit at least twice a year with coverage of all four "processes" that

determine the SQ);

• branch offices;

• inspectors;Technical evaluators and technical evaluators of inspections

• laboratories.




The Annual plan has the dual purpose of submitting to VII of the most critical areas and to ensure that all QMS

procedures are subject to VII; in particular, VII at the headquarters apply for "processes approach, through

"horizontal audits”.

The frequency of VII is established in each OM single scheme, based on the requirements defined by the owner

of the scheme and on the basis of performance evaluation.

Frequency of VII - Ifoam scope:

To meet the IAC criteria, the following frequency of internal audits will be carried out:

- 1 audit/year at BAC Head office (schemes: IFOAM Food; IFOAM inputs)

- At least 1 audit during a cycle of accreditation at the office in Mexico (the only office where activities

of pre-evaluation on IFOAM inputs are carried out).

- At least 1 audit during a cycle of accreditation at the office in Thailand (IFOAM).

The WII are led by RVII and RAQ, or inspection staff with at least 5 years of experience, who has received

the due 19011 education and training to the witness (at least 2 VII as an observer and 1 as conductor, with

tutor); for the area of the RAQ, VII are conducted solely by RVII.

Every year, by February, the RAQ submits to the CdA the Annual Programme of the VII. Once the approval is

obtained, the RAQ schedules the activities and verifies that the programme is carried out.

The VII results are recorded in the Reports of IIV, which copy is granted to the Manager of the Area

submitted to verification and which original is granted to the Direction that, after the evaluation, submit them

to the RAQ.

These reports are part of the useful information to Direction for review of the SQ.

If during the VII, non-conformities were found, they will be formalised in the internal non-conformity report.

The non-conformities connected with the inspectors will be sent to RAQ and RAC for their management.

Further details about the VII activity are described in the Pro. 001 “Re-examination of the Direction,

Internal Inspective Controls, Monitoring and improvement plans of the quality system”

6.6.3 Management review and Performance review

IAC 3.5; IAC 3.6

The Management Review is the responsibility of the Board (CdA).

The Board performs periodic reviews of compliance of the BAC activities and policies, to the criteria set out in

ISO 17065 , with the minimum frequency of a review per year.

The topics considered in the review are as follows:

• issues form the previous review;

• deviations between targets and actual indicators of the parameters of SQ;

• Reports and communications of Accreditation Bodies, Competent Authority and CSI;

• Results of the VII since the last review;

• Results of External Inspections (regulatory and accreditation) since the last review;

• Monitoring Results on the variability of the behavior of inspectors;

• complaints and appeal received and the analysis of causes;

• Among the elements in output from the review are found

• Possible need for changes to the SQ and its programming;

• Future plans and estimates for new jobs, added staff, new equipment, etc..;

• training of new staff and update the existing one;

• analysis of the adequacy of resources.

• elements of improving the effectiveness of the certification system;




• Improvement of BAC in fulfilling the ISO 17065 requirements

The review is formalized in a document entitled Management Review. For the information necessary the conduct

of the review, the Board relies on the documentation produced by RAQ, which has the responsibility for

submitting reports of VII for the various elements of SQ and to highlight the degree of compliance with the

standard.

Additional information for the management review are derived from the findings of CSI and

the joint meetings between the CSI and the Board.

It is the responsibility of the Board to decide any changes to the system, resources available and approve any

corrective action and / or preventive measures to the system to achieve the quality objectives.

If the review shows th