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Timestamp: 2019-10-20 17:43:22
Document Index: 83948321

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art.\n2']

f Ssc 22000 Changes Oktober | Food Safety | Audit
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Fssc 22000 Brief
Certification scheme for food safety systems in compliance with ISO 22000: 2005 and technical specifications for sector PRPs
This document contains a complete certification scheme for food safety systems which are in compliance with the publicly available food safety management systems standard ISO 22000: 2005 Requirements for any organisation in the food chain and technical specifications for sector PRPs (published as e.g. PASxyz or ISO 22002-x documents)
Verwijderd: It is intended Verwijderd: PAS 220:2008
As of February 2010 it is a Global Food Safety Initiative approved scheme. The Foundation for Food Safety Certification (here after the Foundation) retains the ownership and the copyright and the license agreements for certification bodies. Due to the dynamic content of this document the user of this document should always verify if the correct version is held. Future revisions of this document will always be published under the same name. In all cases the English version of the FSSC 22000 certification scheme is leading. Cornelie Glerum Secretary Board of Stakeholders and Foundation for Food Safety Certification
for the certification of food safety systems of food manufacturers that process or manufacture perishable animal products, perishable vegetal products, products with a long shelf life at ambient temperature and (bio)chemical manufacturing like additives, vitamins and bio-cultures.
Gorinchem, October 2011 Copyright October 2011, Foundation for Food Safety Certification, Board of Stakeholders All rights reserved. No part of this publication may be reproduced and/or published in any form, by means of printed matters, photocopy, microfilm, recording or any other method or technology, without written approval by the Board of Stakeholders (here after the Board). Foundation for Food Safety Certification Board of Stakeholders P.O. Box 693 4200 AR Gorinchem, The Netherlands t: +31-183 645028 f: +31-183 621161 Website: http://www.fssc22000.come mail: info@fssc22000.com
CONTENT ....................................................................................................... 3 INTRODUCTION.............................................................................................. 4 FEATURES OF THE SCHEME ............................................................................. 6 REQUIREMENTS AND REGULATIONS................................................................ 9 Part I - Requirements for organizations that require certification............... 9 Part II - Requirements and regulations for certification bodies................... 9 Part III - Requirements and regulations for providing accreditation............ 9 Part IV - Regulations for the Board of Stakeholders .................................... 9 LIST OF DECISIONS BY THE BOARD OF STAKEHOLDERS ................................ 10 REFERENCE DOCUMENTS .............................................................................. 11 TERMS AND DEFINITIONS ............................................................................. 12
Food safety is a global concern, not only because of the importance for public health, but also because of its impact on international trade. Globalisation of food production and procurement makes food chains longer and more complex and increases the risk of food safety incidents. Effective and harmonized food safety systems shall manage and ensure the safety and suitability of food in each link of the supply chain. For this reason ISO developed the standard for food safety management systems ISO 22000, which applies to all organizations in the food chain and thus ensures integrity of the chain. Parallel to this development there is an increasing need for harmonized certification of the food safety systems in order to create justified confidence that all necessary measures are taken to ensure food safety in previous links of the chain. In this context ISO developed the technical specification ISO/TS 22003 that contains requirements for bodies providing certification of the food safety management systems. These developments were triggered by the increasing need of organizations in the food chain for a generally accepted food safety certificate that meets the requirements of the customers in the chain and may incorporate the requirements of the different certification schemes of the retail organizations. As a follow up FoodDrinkEurope took the initiative to develop a technical specification that specifies the requirements for good practices in food manufacturing and that meets customer requirements. Implementation of these good practises is an essential part of the food safety system and creates confidence in trade. The British Standard Institution, BSI issued these requirements as the publicly available specification BSI-PAS 220. As a next step FoodDrinkEurope initiated the development of a certification scheme for food safety systems of organizations in the food chain that incorporates the standards ISO 22000, BSI-PAS 220 and guidance on the application of ISO 22000, ISO/TS 22004. The aim of this scheme is to harmonize the certification requirements and methods for food safety systems in the food chain and to ensure the issue of trustworthy food safety certificates that are comparable as regards content and scope. The Foundation was commissioned by FoodDrinkEurope to develop this scheme and retains the legal ownership and the license agreements for the certification bodies. In this text this certification scheme is referred to as the scheme. The scheme meets
Foundation for Food Safety Certification October 2011 Page 4 of Verwijderd: CIAA Verwijderd: CIAA Verwijderd: food manufacturers Verwijderd: the Confederation of the Food and Drink Industry of the EU (CIAA) Verwijderd: food manufacturers
This certification scheme outlines the requirements for certification bodies (CBs) to develop, implement and operate a system for the assessment and certification of food safety systems of organizations in the food chain and to guarantee its impartiality and competence. The certificate indicates that the organizations food safety system is in conformance with the requirements which are given in this scheme and that the organization is able to maintain conformance with these requirements. It is however not a guarantee of the organization continuous food safety performance. The value added to an organization with a certified food safety system lies in the efforts made by the organization to maintain that system and its commitment to continuously improve its performance.
Verwijderd: food organizations
This scheme is intended for the audit and certification of the food safety system, , which ensure the safety of products during manufacturing of: perishable animal products (i.e. meat, poultry, eggs, dairy and fish products) perishable vegetal products (i.e. packaged fresh fruits and fresh juices, preserved fruits, packaged fresh vegetables, preserved vegetables) products with long shelf life at ambient temperature (i.e. canned products, biscuits, snacks, oil, drinking water, beverages, pasta, flour, sugar, salt) (bio)chemical manufacturing (food ingredients i.e. vitamins, additives and biocultures) but excluding technical and technological aids Food Packaging manufacturing (i.e direct, indirect contact with the food)
Verwijderd: food manufacturing organizations Verwijderd: of food manufacturers that manufacture:
The scheme consists of an introductory part and four separate parts in which requirements and/or regulations for the actors in the process of certification have been laid down. These actors are: the organization in the food chain, the certification body (CB), the accreditation body (AB) and the Board of Stakeholders (Board). The introductory part contains a description of the scheme and information on the background, definitions and reference documents.
Foundation for Food Safety Certification October 2011 Page 6 of Verwijderd: Furthermore it contains the running list of decisions by the Board. Verwijderd: food manufacturing
The three following main sections contain the normative documents for: the organization in the food chain (Part I), the CB (Part II) and the AB (Part III).
Verwijderd: food manufacturing
These normative documents are indicated in the scheme as Requirements. Guidance on the application of these requirements is included if deemed necessary. Apart from this the main sections contain: guidance for the organization in the food chain to obtain and maintain a FSSC 22000 certificate (Part I), regulations of the Foundation concerning the conditions for the use of the scheme and for providing certification and accreditation by the CB and AB (Parts II and III) Finally, Part IV contains the regulations for the Board which deals with the requirements and regulations of this scheme. In figure 1 an outline of scheme is presented
Figure 1 - Plan of certification scheme FSSC 22000 NOTE: the figure does not show the guidance which is included in the normative documents
Organization in the food chain
Accreditation body Section 2 Section 3
This certification scheme has been developed by project teams and steering committees comprising of food safety experts of representative international organizations in the food chain, experts of a number of international certification bodies, a representative of the confederation of the food and drink industry of the EU and sector experts. The scheme is approved by and will be maintained by the Board of Stakeholders. Within the board the interests of all involved parties are represented. As of February 2010 it is a Global Food Safety Initiative approved scheme.
Verwijderd: food manufacturers Verwijderd: a
The Foundation aims to prepare a certification scheme, with a broad acceptance adding particular value to the relationship between the certified organization in the food chain and those around it (the government, customers). In order to achieve this, the Board of the Foundation consists of representatives of trade and industry, authorities and other parties concerned.
Verwijderd: e Verwijderd: food organizations Verwijderd: and suppliers
The Board has at least three meetings per year to maintain the certification scheme. During every meeting major and/or minor changes are decided on. These decisions will be directly published in a current list on the Foundation website. Revisions of all relevant documents of the scheme are published annually on the Foundation website and communicated with the licensed CBs and ABs. If the Board considers it necessary that requirements or regulations should be amended or added on shorter notice than one year, the Board can issue a directive that will be effective from a given date. These directives will be communicated with the licensed CBs and ABs and will be published on the Foundation website. The Board will have an overall review of the certification scheme at intervals not exceeding three years and any amendments arising from the review will be published by the Foundation and made available to all stakeholders.
By entering into an agreement with the Foundation accredited CBs are authorized to provide certification in accordance with this scheme. Accreditation shall be gained in conformance with this scheme by an associated AB that complies with the regulation for ABs (Part III). Licensed CBs are obliged to adhere strictly to this scheme.
LIST OF DECISIONS BY THE BOARD OF STAKEHOLDERS
In the list all decisions of the Board of Stakeholders are included. The decisions which affect the associated certification bodies as well as the certificate holders are an integral part of the requirements for certification. After every meeting of the Board an updated list is published on the website www.fssc22000.com.
Verwijderd: The Current list of decisions by the Board of Stakeholders will be attached to this document.
This scheme is based on the following documents and their future versions: GFSI Guidance Document, Sixth Edition, January 2011 IAF Mandatory Document for duration of QMS and EMS audits; 2009 (Issue 1, IAF MD 5: 2009) and all other relevant IAF Mandatory Documents ISO 9000: 2005, Quality management systems Fundamentals and vocabulary ISO 9001: 2008, Quality management systems Requirements ISO 19011: 2202, Guidelines for quality and/or environmental management systems auditing ISO 22000: 2005, Food safety management systems Requirements for any organisation in the food chain ISO/TS 22002-1: 2009, Prerequisite programmes for food safety. Where ISO/TS 22002-1 is stated, BSI-PAS 220 can be read. ISO/TS 22003: 2007, Food safety management systems Requirements for bodies providing audit and certification of food safety management systems ISO/TS 22004: 2005, Food safety management systems Guidance on the application of ISO 22000: 2005 ISO/IEC 17000: 2004, Conformity assessment Vocabulary and general principles ISO/IEC 17011: 2004, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies ISO/IEC 17021: 2006, Conformity assessment Requirements for bodies providing audit and certification of management systems BSI-PAS 96: 2008, Defending food and drink - Guidance for the deterrence, detection and defeat of ideologically motivated and other forms of malicious attack on food and drink and their supply arrangements BSI-PAS 220: 2008, Prerequisite programmes on food safety for food manufacturing BSI-PAS 223: 2011, Prerequisite programmes and design requirements for food safety in the manufacture and provision of food packaging
Foundation for Food Safety Certification October 2011 Page 11 of Verwijderd: Fifth Verwijderd: September 2007
For the purpose of this document the terms and definitions given in the standards and technical specifications which are listed in the reference documents apply. The following terms and definitions also apply: Audit: systematic, independent, documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements are fulfilled.
Verwijderd: <#>BSI-PAS
Board of Stakeholders or Board: a group of representatives of key interests within the scope of the certification scheme including experts on food safety.
220: BSI-PAS 220: 2008, Prerequisite programmes on food safety for food manufacturing (Publicly Available Specification of the British Standards Institution). Where BSI-PAS 220 is stated, ISO/TS 22002-1 can be read.
Certification system: rules of procedure and management for carrying out conformity assessment leading to the issuance of a certification/registration document and its subsequent maintenance.
Food: Any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of food but does not include cosmetics or tobacco or substances used only as drugs
Food processing: see definition of food manufacturing. Foundation: The Foundation for Food Safety Certification. General principles of food hygiene of the Codex Alimentarius: Recommended International code of practice - General principles of food hygiene, CAC/RCP
1-1969, Rev. 4 (2003) of the Joint FAO/WHO Codex Alimentarius Commission. Guidelines for drinking-water quality of the WHO: Guidelines for drinking water quality, Third edition, Volume 1, Recommendations, WHO, Geneva 2008. Major nonconformity: A nonconformity, as referred to in ISO/IEC 17021 clause 9.1.15b, that: 1) represents failure to fulfil one or more requirements of the management system standard or 2) a situation that raises significant doubt about the clients system to achieve its intended outputs. Minor nonconformity: Other nonconformities as indicated in ISO/IEC 17021, clause 9.1.15c. Normative document: normative documents are indicated in the scheme as Requirements. Organization in the food chain: The party that is responsible for ensuring that products meet and, if applicable, continue to meet, the requirements on which the certification is based. Standard: A document against which something can be measured, judged or evaluated. "Document" is to be understood as any medium with information recorded on or in it. Risk: The probability of causing an adverse health effect caused by the likelihood of occurrence and by the possible severity of the adverse health effect of a particular hazard in food when prepared and consumed according to its intended use.
Verwijderd: <#>ISO/IEC 17011: Standard ISO/IEC 17011: 2004, Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies. <#>ISO/IEC 17021: Standard ISO/IEC 17021: 2006, Conformity assessment Requirements for bodies providing audit and certification of management systems. Verwijderd: N Verwijderd: Verwijderd: Supplier
1. INTRODUCTION 2. SCOPE 5
3.1 Food safety management system.......................................................... 6 3.2 Prerequisite programmes...................................................................... 6 3.3 Additional requirements ....................................................................... 6 3.4 Guidance............................................................................................... 6 Appendix I A: Additional requirements 9 10
This part of the scheme contains the requirements for organizations in the food chain to gain certification. They shall be used by the organization to assess, develop, implement and improve its food safety system and to apply for certification. The requirements of the food safety system also serve as the normative requirements for certification of the organization. They shall as such be used by the certifying body to assess the continuous compliance of the food safety system that is developed and implemented by the organization. Guidance is also given to the CBs and the organizations on the application process for certification.
For the greater part the requirements are based on the standard ISO 22000. ISO 22000 was developed by the International Organization for Standardization (ISO) and fulfils the need of: a worldwide food safety standard that is developed and owned by an independent international organization; international harmonization of the requirements of food safety systems; integration of the technological (i.e. Good practices, HACCP, traceability) and legal food safety requirements in the quality management system requirements of standard ISO 9001; a food safety standard that is applicable to the whole supply chain and that requires any organization in the chain to take into account the hazards of the final product of the chain. Based on this ISO 22000 is considered the most appropriate standard for the food safety management system to be included in this scheme.
An important prerequisite for ensuring food safety is that organizations in the food chain maintain the conditions for hygienic environment and production. ISO 22000 requires in clause 7.2 that organizations shall select and implement specific Prerequisite programmes (PRPs) for these basic hygiene conditions and shall consider and utilize appropriate information when selecting the program (e.g. the requirements as prescribed in the General principles of food hygiene of the Codex Alimentarius, specific codes of practices of the Codex Alimentarius, food safety legislation and possible customer requirements). It does not specify these requirements as the standard is applicable to the whole food chain and the basic
Foundation for Food Safety Certification October 2011 Page 3 of Verwijderd: food manufacturing
Part I Requirements to obtain certification hygiene requirements may vary considerably between sectors. In order to create explicitness on the requirements for PRPs and to allow for a benchmark of ISO 22000 certification schemes by customers (i.e. Global Food Safety Initiative of the Consumer Goods Forum (GFSI)). Stakeholder organizations have developed detailed technical specifications covering sector PRPs. These technical specifications can be used in addition to ISO 22000 to provide further detail for chapter 7.2 of ISO 22000. FSSC 22000 provides a certification scheme for sectors where such a technical specification for sector PRPs has been realised as described in the scope (see also chapter Scope of the scheme).
Verwijderd: the British Standards Institution (BSI) developed in close Verwijderd: Foundation of CIES
To meet the needs of the key stakeholders and to ensure an adequate control of food safety, specific requirements for the food safety system are included in this scheme. These may be elaborations of the clauses in ISO 22000 and technical specifications for sector PRPs or additional requirements and are included in the section Additional requirements (Part I, Appendix IA). When it appears from the three year review of the scheme by the Board or when the Board decides in one of its three annual meetings that the requirements given in the standards need to be amended or appended, these changes are also included in this section.
cooperation with the Confederation of the food and drink industries of the EU (CIAA), a specification of these requirements for food manufacturers (BSI-PAS 220). This specification is developed in compliance with the General principles of food hygiene of the Codex Alimentarius, the Guidelines for drinkingwater quality of the WHO, the specification BSI-PAS 96 and the Key element Good manufacturing practices of the GFSI guidance document (fifth edition; section 6.2). Verwijderd: The BSI-PAS 220 is therefore considered most suitable to be included in this scheme in conjunction with the requirements of clause 7.2 of ISO 22000. Verwijderd: BSI-PAS 220
The requirements in this document are set out for the assessment of food safety systems (see also chapter Features of the scheme):
Verwijderd: , which ensure the safety of foodstuffs during manufacturing of
Categroy codes ISO/TS 22003 C
Applicable PRP Technical Specification
i.e. meat, poultry, eggs, dairy and fish products i.e. packed fresh fruits and fresh juices, preserved fruits, packaged fresh vegetables, preserved vegetables
ISO/TS 22002-1 / PAS 220 ISO/TS 22002-1 / PAS 220
food ingredients i.e. vitamins, additives, and biocultures but excluding technical and technological aids
The requirements are applicable to organizations in the food chain regardless of size and complexity, whether profit-making or not and whether public or private.
The requirements for the development, implementation and maintenance of the food safety management system are laid down in the standard ISO 22000: 2005 Food Safety management systems - Requirements for any organization in the food chain.
3.2 Prerequisite programmes
When establishing, implementing and maintaining the Prerequisite programmes (PRPs) in accordance with clause 7.2 of ISO 22000, the organization shall in addition of ISO 22000 requirements consider and utilise the requirements of technical specification for sector PRPs. Apart from these requirements, other appropriate information shall be considered and utilised especially: regulatory requirements, recognized sector or product group codes of practises and guidelines, customer requirements.
Verwijderd: on PRPs for food manufacturing which are laid down in the technical specification BSIPAS 220: 2008.
Additional requirements for the food safety system are laid down in Part 1, Appendix IA.
1. ISO/TS 22004 Guidance on the application of requirements of the food safety management system is provided for in the Technical Specification ISO/TS 22004. Reference: ISO 22000, various clauses 2. Definition food safety In the requirements, food safety is defined as the concept that the food will not harm the consumer when it is prepared and/or eaten according to its intended use. Organizations in the chain are therefore required to take into account the food safety hazards of their operation for the final product in the chain when establishing prerequisite and HACCP programmes. Reference: ISO 22000, clauses 3.1 and 3.3, note 4
Part I Requirements to obtain certification 3. Chain approach As is stated in chapter 2 of ISO/TS 22004, ISO 22000 promotes the adoption of a food chain approach when developing, implementing and improving the effectiveness and efficiency of a food safety management system. In this regard the organization is required to consider the effects of the food chain prior and subsequent to its operations when developing and implementing its food safety management system. However, some food safety hazards which originate in the food chain may not or cannot be controlled by the organization itself. In order to ensure that these hazards are also controlled, the organization shall identify organizations in the chain that may have an impact on the food safety of the products of the organization (upstream), of which the food safety of the operations may be affected by characteristics of the products of the organization (downstream). The organization shall than establish, implement and maintain effective arrangements for communication with these organizations, so that the relevant hazards are known and can be controlled. In section 5.6 of ISO/TS 22004, the requirements for external communication and arrangements with organizations in the chain are elaborated. The requirement for communication on food safety aspects and hazards in the chain is an essential criterion in the evaluation and selection of suppliers and relevant partners. Reference: ISO 22000, clauses 1.d and 4.1.a and b 4. Inventory of applicable regulations It is pointed out that the organization in the food chain shall make an inventory of: the national, and if applicable foreign, regulatory and statutory requirements on food safety which are applicable to the organization and which should be implemented including the raw materials and services that are provided and products that are manufactured and delivered, applicable codes of practice related to food safety, customer requirements related to food safety, any other additional requirements on food safety determined by the organization. The food safety system of the organization shall ensure and demonstrate conformity with these requirements Reference: ISO 22000, clause 4.2.1, 5.6.1, 7.3.1 and 8.4.2
Guidance on the process of the application for certification is given in Appendix I, B. Reference: ISO/TS 22003, clause 9.2.1(information to be provided by the applicant organisation). ISO/IEC 17021, clause 5.1.2 (certification agreement), clause 8.6.1 (information to be provided by the CB), clause 8.6.1.d. (conditions to be included in the agreement), clause 9.2.1 (information to be provided by the applicant organisation,) clause 9.2.2.1 (review of application) and clause 9.5.1
Foundation for Food Safety Certification October 2011 Page 7 of
1. Specifications for services The organization in the food chain shall ensure that all services (including utilities, transport and maintenance) which are provided and may have an impact on food safety: shall have specified requirements, shall be described in documents to the extent needed to conduct hazard analysis, shall be managed in conformance with the requirements of technical specification for sector PRPs. Reference: ISO 22000, clauses 7.2.3.f and 7.3.3 2. Supervision of personnel in application of food safety principles The organization in the food chain shall ensure the effective supervision of the personnel in the correct application of the food safety principles and practices commensurate with their activity. Reference: ISO 22000, clause 6.2.2 Note: If an additional requirement refers to a subject that also is addressed in one or more of the standards mentioned in the sections 3.1 and 3.2 of Part I, the applicable clause(s) of these standard(s) is/are indicated in the reference at the end of the section with the additional requirement.
Verwijderd: BSI-PAS 220, clause 9, Verwijderd: food manufacturing
According to this scheme, organizations are certified upon completion of a satisfactory audit and a positive certification decision from a CB. The CB in turn shall have been assessed and judged as competent by an accreditation body. The process for accreditation of CBs and certification of organizations is outlined in Figure 1. In order to receive a valid certificate, the organization shall select a CB which is approved and licensed by the Foundation. The Foundation stipulates detailed requirements that a CB shall meet in order to gain approval. As a minimum, the CB shall be accredited in accordance with the requirements and regulations in Part II of this scheme.
Selection of certification body It is essential that the organization is assessed against the current issue of the scheme and that the scheme is available throughout the certification process. The current issue of the scheme is available from www.fssc22000.com. The scheme should be read and understood and a preliminary self assessment shall be conducted by the organization against the requirements and guidance in the section 3 of Part I of this scheme. Any areas of nonconformities shall be addressed by the organization. Once the self-assessment has been completed and nonconformities addressed, the organization must select a CB. The Foundation cannot advise on the selection of a specific CB, but the Foundation lists FSSC 22000 approved certification bodies on http://www.fssc22000.com. Certification agreement A contract shall exist between the organization and the CB, detailing the agreed scope of the audit including reference to the FSSC 22000 scheme requirements. This contract shall be formulated by the CB. It is the responsibility of the organization to ensure that adequate and accurate information is given to the CB to enable the CB to select (an) auditor(s) with the required skills to undertake the audit (see Part II). The CB shall require completion of an official application form, signed by a duly authorized representative of the applicant.
Verwijderd: <sp>
Select an approved Certification Body . Approved certification bodies can be found on www.FSSC22000.com
Closing meeting and confirmation of any nonconformities Initial audit corrections and corrective action completed Corrections and corrective action evidence assessed by certification body by documented evidence or revisit . Successful close out documented
Following issue of the certification ongoing pre planned surveillance audits take a minimum of once per year
This part of the scheme stipulates the requirements for certification bodies (CBs) and their personnel and the way they shall perform assessments and certification. It shall be used by the CB that wishes to grant certificates in conformance with this scheme. It consists of: the requirements for the CB and the certification process and the regulations and rules for the assignment and authorization of the CB to offer certification against the criteria of this scheme.
The normative requirements for the organization to gain certification are the food safety management system requirements of ISO 22000, the detailed requirements of technical specification for sector PRPs and a number of additional requirements as specified in section 3 of Part I. Food safety management systems should, like other quality management systems, be certified by certification bodies that operate management system certification in a competent, consistent and impartial manner in accordance with ISO/IEC 17021 requirements for bodies providing audit and certification of management systems. To promote the harmonized certification of food safety management systems, ISO developed the Technical Specification ISO/TS 22003. This TS elaborates on ISO/IEC 17021 and contains additional requirements to be applied by certification bodies to make the food safety management system certification credible. Therefore, ISO/TS 22003 and ISO/IEC 17021 are considered to be the appropriate standards to apply for certification in accordance with this scheme. The requirements for assessment and certification according to ISO/TS 22003 also includes the assessment of PRPs.
Verwijderd: Verwijderd: food manufacturing Verwijderd: for the prerequisite programs (PRPs) for food manufacturing of BSIPAS220
To meet the needs of the key stakeholders and/or to ensure an adequate and uniform assessment and certification of the food safety systems, specific requirements for certification are included in this scheme. These may be elaborations of the clauses in ISO/TS 22003 and ISO/IEC 17021 or additional requirements and are included in the section Additional requirements (Part I, Appendix IA). When it appears from the review of the scheme by the Board or when the Board decides that the requirements need to be amended or appended, these changes are also included in this section.
Foundation for Food Safety Certification October 2011 Page 3 of 33
Evaluation of conformance The certification body shall take all steps required to evaluate conformance with the standard and fully comply with other associated requirements of the certification scheme. Criteria for providing certification The normative requirements for providing certification are specified in Part I, section 3.
Additional requirements for the development and implementation of the certification system are specified in Appendix IIA. The GFSI requirements as indicated in Appendix IIC are explicitly to be met. Future changes to this addendum will be valid. Most requirements in this addendum are in line with ISO/IEC 17021 requirements; other are explicitly included in this scheme. GFSI Requirements that are implicitly met by the scheme and ISO/IEC 17021, however may require attention to guarantee full accordance, are specified in the appendix.
The CB shall have an accreditation in the applicable Food Chain Category (ref. Part I, chapter 2: scope) according to ISO/IEC 17021 and the additional requirements as specified in the sections 2.1 and 2.2 and ISO/TS 22003. The certification body shall ensure that accreditation is provided by an accreditation body meeting the requirements specified in Part III.
3. REGULATIONS FOR CERTIFICATION BODIES
When applying for association with the Foundation, the certification body (CB) must specify the required category or categories and sector(s), related to its competence and experience. The applicant CB will agree to meet all applicable requirements of this scheme. The CB will be given written authorization enabling it to use the scheme for certification.
A contract with the CB will only be signed up after it has been accredited. The CB shall be accredited in accordance with the requirements of the scheme FSSC 22000. CBs which have applied for accreditation or for extension of their scope of accreditation to this scheme may certify within the applied scope for a maximum of one year without being accredited, subject to a provisional contract with the Foundation. The application for accreditation or for extension of their scope of accreditation shall be demonstrated with a written confirmation of the accreditation body (AB).
An application fee has to be paid to the Foundation before this authorization will be given.
The design of the certificate will be similar to the certificates that are issued by the awarding CB. Notwithstanding this, the certificates shall include the following information: name and address of the organization (site) which food safety system is certified; period of validity; initial, reissue and valid until relevant signatures and positions of signatories; scope, expressed in terms of categories, sectors, production processes, products and sites; logo of the accreditation body; date of the certification decision
Verwijderd: date of the certificate
Part II Requirements and regulations for providing certification Furthermore, the certificate shall contain the following standard text: The food safety management system of (name and place) has been assessed and complies with the requirements of: FOOD SAFETY SYSTEM CERTIFICATION 22000: 2010 Certification scheme for food safety systems including ISO 22000:2005, name of applicable technical specification for sector PRPs and additional FSSC 22000 requirements This certificate is applicable for (scope). This certificate is provided on the base of the FSSC 22000 certification scheme. The certification system consists of an annual audit of the food safety management systems and an annual verification of the PRP elements and additional requirements as included in the scheme and name of applicable technical specification for sector PRPs.
Organizations may not display the FSSC 22000 certification logo or mention possession of a FSSC 22000 certificate on their products. The logo (copyright) is allowed to be used on the issued certificates if the certification is conducted in accordance with all requirements of this scheme. Reference: Conditions for the use of the logo
In the event of the relevant documents in the FSSC 22000 scheme being changed, the Board will give an appropriate period of grace for the organizations to adapt to the implementation of the new requirements, unless the legal regulations stipulate a different transition period.
Changes in the certification scheme
New information or changes with regards to the requirements in the FSSC 22000 scheme shall be communicated by the CBs to those parties involved, such as certificate holders and auditors (auditors and experts), within a period of 2 months.
The CB shall have arrangements for appeals and complaints. Clauses 9.7 and 9.8 of ISO/IEC 17021 apply.
The certification body shall clearly document and make known to its employees all requirements in ISO/IEC 17021 related to personnel.
Full application of the FSSC 22000 certification scheme
The certification bodies are responsible for the full application of the certification scheme and have to observe the regulations and directives issued by the Board.
Annual fee for certified organizations
Organizations certified against this scheme will be charged by the CB for an annual fee to the Foundation. The CB will address this obligation in the certification agreement with the organization. The Foundation will decide annually on the amount of this fee. The CBs will be charged at least annually by the Foundation for the total amount of fees of all certificates they have under contract per 31 December of each year.
Verwijderd: Verwijderd: (in the Month January)
The maximum validity of the certificate is three years. Reassessment has to take place in time to ensure that recertification is granted before the expiry date of the certificate (clause 9.4 of ISO/IEC 17021).
Register of certified organizations
The Foundation will keep a register with the names and certification information of the certified organizations. This register will be made publicly available on the website of the Foundation. The CBs will submit the following information to the Foundation in a format as agreed in the contract between the Foundation and the CB: name and location of the certified organization scope of the certification date of the initial certification
October 2011 Page 7 of 33 Verwijderd:
Part II Requirements and regulations for providing certification expiry date of the certificate in case of suspension or withdrawal; the date of suspension or withdrawal
The content of audit reports is to be treated confidentially by the CB. At discretion of the contracted client audit reports may be made available to authorized parties, however the ownership of the audit report and determination of details made available and authorization for access remain with the contracted client.
At least once per year, the CBs are obliged to provide the Board with all relevant information relating to the application and the functioning of the FSSC 22000 scheme. This information shall be made anonymous so that confidentiality with respect to organizations is assured.
Verwijderd: The information of the preceding year is provided to the Board in Verwijderd:
The CBs are required to ensure that the regulations which are decided by the Board are included in their existing system documentation within a period of two months. Certification bodies are required to control these documents according to their own document control procedures.
Noncompliance with FSSC Scheme Requirements
In cases where a CB fails to comply with the requirements set out in the scheme documents, detailed information will be gathered for review by the Board of Stakeholders. The review will normally take place at the next scheduled BoS meeting. If
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Appendix II A1
Note: if an additional requirement refers to a subject that is also addressed in one or more of the standards mentioned in section 2.1 of Part II, the applicable clause(s) of these standard(s) is/are indicated in the reference at the end of the section with the additional requirement.
1. Work experience of auditors
Concerning the requirements on work experience of the auditors in ISO/TS 22003, clause 7.2.2.4, the following is added: The five years full time work experience in a food chain related industry, shall be in the food related industry in the areas of processing, technology, raw materials and /or products; The two years of full time work in quality assurance or food safety functions shall be in the food related industry; The allowance to reduce the required five years of total work experience with one year if the auditor has completed appropriate post secondary education, is not applicable; The competence of auditors shall be reestablished every 3 years. Reference: ISO/TS 22003 clause 7.2.4.4 and ISO 19011 clause 7.3.2
Training program A training program for each auditor will incorporate: an assessment of knowledge and skills for each field and sub field and assignment of fields of evaluation; an assessment of knowledge of food safety, HACCP, PRPs and to have access to, and be able to apply relevant laws, regulations and codes; a period of supervised training to cover the assessment of food safety management systems, PRPs and HACCP, specific audit techniques and specific category knowledge; For extension of auditor scope for new categories the requirements of ISO/TS 22003, clause 7.2.4.5 apply; a documented sign off of the satisfactory completion of the training program by the appointed supervisor; a plan for continued training to keep the auditors up to date with the best practices and relevant regulatory and statutory developments in the sector(s) where they perform audits. In order to maintain category and scheme
Foundation for Food Safety Certification October 2011 Page 10 of 33 Verwijderd: , Verwijderd: Verwijderd: . Verwijderd: , Verwijderd: Verwijderd: ,
Part II Requirements and regulations for providing certification knowledge, auditors shall be required to carry out a minimum of 5 on-site audits at different organizations each year;. instructions for the auditor to maintain written records of all relevant training undertaken. Reference: ISO/TS 22003, clause 7.2.4 and ISO/IEC 17021, clause 7.2.8 Food safety training The training in HACCP principles, hazard assessment and hazard analysis shall have a duration of at least 2 days/16 h. The food safety management training shall also include specific elements of the sector(s) in which the auditor conduct audits like raw materials, processes, products, risks and legislation and prevailing code(s) of hygiene. Reference: ISO/TS 22003, clause 7.2.4.2 Audit training The training prescribed in section 7.2.4.3 of ISO/TS 22003 shall also cover: audit techniques for food safety systems as described in Part I of this scheme; the content of this scheme including the standards and technical specification to which is referred. The training in audit techniques shall have a duration of at least 1 week/40h. Reference: ISO/TS 22003, clauses 7.2.6 and 7.2.4.3
For qualification the requirements of ISO/TS 22003 apply. In addition to ISO/TS 22003 auditors need to have knowledge of the delivery requirements of FSSC and knowledge of the content of the technical specification for sector PRPs. The certification body shall define how to ensure that this requirement is met. The total supervised training against this scheme shall include a successful completion of supervised training in practical assessment of this standard through 10 audits or 15 audit days at a number of different organizations. Previous experience in ISO 22000 audits is considered to be applicable for meeting the practical assessment training requirements. Reference: ISO/TS 22003, clause 7.2.4.5
4. Defining the scope of the certification
When defining the scope, the CB shall indicate for each location the name of the food chain category and the specific sector as specified in Annex A of ISO/TS 22003 and clause 2 of Part 1. Reference: ISO/TS 22003, clause 9.1.1 and FSSC 22000 guidance document on
Foundation for Food Safety Certification October 2011 Page 11 of 33 Verwijderd: C, D, E or L
5. Duration of audit and audit reporting
In addition to the onsite audit time and preparation and reporting time as stipulated in ISO/TS 22003, clause 9.1.4. and Annex B, the CB shall depending of the size of the organization add half to one day for the audit and reporting of the establishment and implementation of the PRPs as stipulated in section 6 of this appendix. This additional time is as well required for an initial, surveillance and renewal audit. Details of the duration of the audit shall be incorporated In the audit report. Reference: ISO/TS 22003, clauses 9.1.2 and 9.1.4 and Annex B
Verwijderd: Verwijderd:
6. Requirements for audit of PRPs
The CB shall assess whether the organization has established and implemented and maintains the necessary PRPs according to the requirements of section 3.2 of Part I. Of all requirements it shall be assessed to what extent the requirements are fulfilled. The specific requirements for which the necessary PRP is not established or is not effective in controlling the introduction of food safety hazards (as specified in clause 7.2.1 of ISO 22000) shall be identified. In order to verify if the PRPs are met a plant tour shall be part of the audit. Reference: ISO/TS 22003 clauses 9.2.3.1.1 and 9.2.3.1.2, 9.2.3.1.4, 9.2.3.1.5 and 9.2.3.2
General Additional to the items for the audit and certification reports as stipulated in ISO/TS 22003, clauses 9.1.7 and ISO/IEC17021, clauses 8.2.3, 9.2.3.1.2, the audit and certification report shall identify the following: Name and description of the company to which the organization belongs to (name, legal entity and address of headquarters); Date of previous audit and name of CB conducting the previous audit Details of existing certificates; Overview of relevant changes to documentation, requirements, processes and products since the last audit; Registered complaints on Food Safety and reports to concerning government; List of key personnel present at the audit; Names and signatures of the audit team members; Names, function and signatures of the representatives of the auditee; Description of the assessment of the identification by the organization of the food safety hazards to be controlled and the selection of the appropriate (combinations of) control measures for relevant hazards in the operational
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Part II Requirements and regulations for providing certification PRPs or in the HACCP plan; The audit of the PRP requirements (specified in Part I, section 3.2) shall be reported separately according to the requirements in section 8 Audit report of PRPs in this Annex and attached to the audit report; Results and the conclusions of the audit per clause of the normative standard or technical specification (specified in Part I, section 3.1) and per additional requirement (specified in Part I, section 3.3); Overview of nonconformities and minor nonconformities together with the corresponding clause number of the normative standard or technical specification (specified in Part I, section 3.1 and 3.2) or the number of the additional requirement (specified in Part I, section 3.3); Expiry date of the certificate. The Board may decide on more specific requirements for reporting. In the result section of the report conformance of compliance or noncompliance shall be indicated. In case of nonconformance details shall be provided. Non applicable clauses shall be motivated. In the summary section positive evidence of confirming compliance shall be provided. Reference: ISO/TS 22003, clauses 8, 9.1.7 and 9.2.3.1.4 and ISO/IEC 17021, clauses 8.2.3, 9.2.3.1.2 and 9.2.5.1
Verwijderd: Verwijderd: Verwijderd: Verwijderd:
Audit report format The audit report shall cover all elements described in the format as indicated in Part II, appendix IIB (ISO 22000, PRPs and additional requirements) in order to confirm that all requirements are assessed and reported.
8. Criteria for nonconformities and certification decision
The CB is required to establish and maintain criteria as a reference against which a nonconformity and minor nonconformity is determined, in accordance with the definitions in this scheme. Food organizations can only qualify for granting certification on the basis of this scheme if: the CB has not revealed any outstanding nonconformities and the CB has reviewed and accepted the planned corrections and corrective actions for minor nonconformities. Reference: ISO/IEC17021, clause 9.1.9, 9.1.15 and 9.2.5.2 and ISO 19011, clause 6.2.2.
9. Requirements for initial certification
Stage 1 includes all requirements of 9.2 of ISO/TS 22003 and shall be performed at the client premises in order to evaluate the preparedness of the organization for stage 2. During the initial certification audit (stage 1 and 2) all requirements of this scheme shall be evaluated. This includes ISO 22000, the applicable technical specification for sector PRPs and additional FSSC requirements (clause 3.3 of Part I). Stage 2 includes a comprehensive site tour and shall cover a representative number of product lines, categories and sectors covered by the scope. The site tour shall include the review of implementation of all CCPs and Operational PRPs and shall include a representative sampling of the PRPs. The tour shall include all areas that might influence food safety. Where comparable activities / processes take place it is allowed to sample. Reference: ISO/TS 22003, clause 9.1.2
Verwijderd: Verwijderd: Verwijderd: Verwijderd: PAS 220
10. Requirements of the surveillance audits
During the surveillance activities and surveillance audit the effectiveness of the food safety management system and the compliance with the requirements of ISO 22000, technical specification for sector PRPs and the additional requirements of this scheme (section 3.3 of Part 1) will be reviewed. This shall include an examination of the food safety management system documentation on the registration of changes and of the internal communication of changes in the production process, the (origin of) raw materials, the products and product characteristics or in the context in which the food safety system is operating (e.g. changes in legislation, codes of practices, customer requirements) in the period after the previous audit. If any changes are identified by this examination or otherwise, the surveillance audit shall include a full assessment and reporting of the assessment of: the documentation requirements, specifically clauses 4.2.1. and 7.3.1 of ISO 22000 and clause 1 of Section 3.3 (Appendix I A) of Part I of this scheme; the establishment and implementation of the PRPs; the hazard analysis and the operational PRPs and CCPs.
Verwijderd: , Verwijderd: Verwijderd: , Verwijderd: e Verwijderd: Verwijderd: Verwijderd: PAS 220
During surveillance audits it is allowed to sample activities and a number of product lines, categories and sectors covered by the scope. The sampling shall result in a representative review of the scheme implementation. Reference: ISO/IEC 17021, clauses 9.3. 11. Notification of factors affecting the certification The CB shall have arrangements in place with certified organizations for the timely notification in the event that the organization becomes aware of legal proceedings with respect to product safety or legality, or in the event of a product recall. The
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13. Requirements for recertification
All requirements given in ISO/IEC 17021 clause 9.4 apply. The recertification shall include a full assessment and reporting of all requirements (see Part II, chapter 9).
Appendix II A2
Additional requirements Packaging
1. Auditor competence
A primary qualification, a degree or higher certificate in packaging technology and a relevant certificate recognised by the scheme owner in food technology, food hygiene or related science subject OR a primary qualification in food technology, food safety/ hygiene or related science subject and a certificate in packaging technology that is recognised by the scheme owner. Experience is required in the specific sectors of packaging manufacture: plastics paper and board metal glass
For the requirements for general information in the audit report see ISO/IEC 17021, clause 8.2.3 and relevant items Appendix II A, section 7 Requirements for the audit reports In the audit report of PRPs reference can be made to corresponding information in the main audit report.
Client address: Assessor:
Reference: ISO 22000
Provide a summary for each ISO 22000 requirement below 4 Food Safety Management System Summary: 4.1 4.2 5 General requirements Documentation requirements Management responsibility Summary: 5.1 5.2 Management commitment Food safety policy
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Part II Requirements and regulations for providing certification 5.3 5.4 5.5 5.6 5.7 5.8 6 Food safety management system planning Responsibility and authority Food safety team leader Communication Emergency preparedness and response Management review Resource management Summary: 6.1 6.2 6.3 6.4 7 Provision of resources Human resources Infrastructure Work environment Planning and realization of safe products Summary: 7.1 7.2 7.3 7.4 7.5 7.6 7.7 General Prerequisite programmes (PRPs) Preliminary steps to enable hazard analysis Hazard analysis Establishing the operational PRPs Establishing the HACCP plan Updating of preliminary information and documents specifying the PRPs and the HACCP Plan 7.8 7.9 7.10 Verification planning Traceability system Control of nonconformity
Verwijderd: Verwijderd: Verwijderd:
General Validation of control measure combinations Control of monitoring and measuring Food safety management system verification Improvement
Appendix IIB2 Results and conclusion of the audit of PRPs Information on assessment per item.
The number of the items refer to the sections of the applicable technical specification for sector PRPs. For each item shall be referred to the requirements of technical specification for sector PRPs and to the requirements of applicable legislation, recognized sector codes and customer requirements. + = assessed; OK - = assessed; nonconformity or minor nonconformity. Indicate: NC = nonconformity MNC = minor nonconformity NA = not applicable Result Identification of specific requirement which is not fulfilled Details of NC or MNC
Verwijderd: BSI-PAS Verwijderd: BSI-PAS 220 Verwijderd:
Appendix IIB2.1: BSI-PAS 220
4. Construction and layout of buildings 4.1 General requirements 4.2 Environment 4.3 Locations of establishments Summary Construction and layout of buildings:
5. Layout of premises workspace 5.1General requirements 5.2 Internal design, layout and traffic patterns 5.3 Internal structures 5.4 Location of equipment 5.5 Laboratory facilities 5.6 Temporary/mobile premises and vending machines 5.7 Storage of food, packaging
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6. Utilities air, water, energy 6.1 General requirements 6.2 Water supply 6.3 Boiler chemicals 6.4 Air quality ventilation 6.5 Compressed air and other gases 6.6 Lighting Summary Utilities air, water, energy:
8. Equipment suitability, cleaning and maintenance 8.1 General requirements 8.2 Hygienic design 8.3 Product contact surfaces 8.4 Temperature control and monitoring equipment 8.5 Cleaning plant, utensils and equipment 8.6 Preventive and corrective maintenance
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Appendix IIB2.2: BSI-PAS 223
4. Establishments 4.1 General requirements 4.2 Environment 4.3 Locations of establishments Summary Establishments:
7. Waste 7.1 General requirements 7.2 Containers for waste 7.3 Waste management and
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Reference: FSSC part 1 appendix 1A Inventory of applicable regulations
The food organisation shall have an inventory of: The national and, if applicable foreign, regulatory and statutory requirements on food safety which are applicable to the organisation and which should be implemented including the raw materials and services that are provided and products that are manufactured and delivered 1.2 Applicable codes of practice related to food safety, customer requirements related to food safety, any other additional requirements on food safety determined by the organisation. 1.3 The food safety system shall ensure and demonstrate conformity with these requirements 2 Specifications for services The organization shall ensure that all services (including utilities, transport and maintenance) which are provided and may have an impact on food safety 2.1 2.2 Shall have specified requirements. Shall be described in documents to the extent needed to conduct hazard analysis. 2.3 Shall be managed in conformance with the requirements of technical specification for sector PRPs.
Verwijderd: BSI-PAS 220, clause 9 Foundation for Food Safety Certification October 2011 Page 29 of 33
Part II Requirements and regulations for providing certification 3 3.1 Supervision of personnel in application food safety principles The organization shall ensure the effective supervision of personnel in the correct application of food safety principles and practices commensurate with their activity.
Introduction This appendix shows the additional requirements from the global food safety initiative for Certification bodies and Scheme owners who choose accreditation according to ISO/IEC 17021 and ISO/TS 22003. Most requirements in this addendum are in line with ISO/IEC 17021 requirements; other issues are explicitly included in this scheme. GFSI Requirements that are implicitly met by the scheme and ISO/IEC 17021, however may require additional explanation to guarantee full accordance, are specified below: requirement general 4. IX XII Explanation Where the term Quality Management System is used this may be read as Management System, as used in ISO/IEC 17021. A quality manual shall be available. In practice this may be a documented system either on paper or in electronic form. Records shall be available showing the names of subcontractors who are contracted and qualified for delivering the audits There shall be policy and procedures for appeals, complaints and disputes. The explicit inclusion of disputes is additional to the wording as used in ISO/IEC 17021. Additional GFSI requirements As specified in GFSI Part 1 Annex 1: Additional requirements for Certification Bodies and scheme owners choosing accreditation according to ISO/IEC 17021 and ISO /TS 22003
1. The scheme owner and certification body will recognize the definition of supplier as; the party that is responsible for ensuring that products meet and, if applicable, continue to meet, the requirements on which the certification is based. 2. The certification body shall take all steps required to evaluate conformance with the standard and fully comply with other associated requirements of the of the certification scheme. 3. The certification body shall operate an effective and fully implemented quality system. The quality system shall be fully documented and used by all relevant certification body staff. Within the certification body there shall be a designated member of staff responsible for the quality systems development, implementation
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Part II Requirements and regulations for providing certification and maintenance. This designated member of staff will have a reporting role to the organizations executive and shall also have the responsibility for reporting on the performance of the quality system for the basis of management review and subsequent system improvement. 4. The required quality system shall be fully documented within a quality manual, which in turn will contain all necessary procedures for compliance. As a minimum, the quality manual shall contain: I. A quality policy statement II. A description of the legal status of the organization, including ownership, and an organizational structure including named individuals their job titles and description of responsibilities. The organizational structure shall include a chart listing each job title and how these functions interrelate through a management structure. Changes in the legal status, management personnel or constitution of the CB shall be notified to the Foundation in a timely manner. III. A list of named individuals employed by the organization which includes their qualifications and full details of their experience. Changes in personnel which may impact the operational effectiveness of the CB shall be notified to the Foundation in a timely manner. IV. A description of the management of the certification process including its committee structure, terms of reference and procedures. V. Details of management review policy and procedures. VI. Procedures in relation to documentation control VII. Details of operational and functional responsibilities pertaining to quality defining an individual limits of responsibility and accountability VIII. Recruitment procedures, i.e. selection, initial training, ongoing training and performance assessment for all relevant certification body personnel. IX. A list of all subcontractors and a detailed procedure for their appointment, assessment and their ongoing management X. Procedures for actions in response to nonconformities the effectiveness of agreed corrective and preventative actions taken XI. Procedures in relation to the use of the certificate and in the event of the requirement to withdraw or suspend certification the actions taken by the certification body. XII. Policy and procedures relating to appeals, complaints and disputes XIII. Procedures for conducting internal audits and corrective actions arising from internal audits 5. In the event of significant change which could affect the safety of product, changes to the requirement of the certification scheme standard, change of ownership or management of the supplier or the certification has reason to believe there could be compliance issues in relation to certification, the certification body shall reevaluate the supplier(s) to assess compliance with the certification scheme standard. Such cases shall be notified to the Foundation in a timely manner.
Foundation for Food Safety Certification October 2011 Page 32 of 33 Verwijderd:
Part II Requirements and regulations for providing certification 6. The certification body shall make available the following information at all times: I. Authority under which the organization operates II. Statement in relation to its certification system, including information on rules and procedures for granting, maintaining, extending, suspending and withdrawing certification of its clients. III. Evaluation procedures and certification process in relation to the certification scheme IV. Details of the means of obtaining financial support and fees charged to clients V. Details of the rights and requirements of applicants and clients such as the use of logo and marks and the way in which a client can use information in relation to certification VI. Details of complaints, appeals and disputes procedures VII. A comprehensive list of all certificated clients against the scope of the certification schemes standard 7. The certification body shall require all staff involved with the certification process to sign a contract or agreement which clearly commits them to I. Complying with the rules of the organization, with particular reference to confidentiality and independence from commercial or personal interests II. Declaring any issues in relation to personal conflicts of interest. The certification body shall clearly document and make known to its employees all requirements in ISO 17021 related to personnel. 8. The certification body shall hold and maintain records regarding qualifications, training and experience of all staff involved in the certification process. All records shall be dated. The above information regarding auditor qualification shall be made available to the Foundation to facilitate the maintenance of a register of auditors. The information shall be updated periodically [minimum annually]. The information shall include as a minimum: I. Name and address II. Organisation affiliation and position held III. Educational qualification and professional status IV. Experience and training in the relevant fields of competence in relation to the certification schemes requirements V. Details of performance appraisal
This part of the scheme contains the requirements for the accreditation process for certification bodies (CBs) that wish to apply for accreditation in conformance with this scheme. It consists of: the requirements for accreditation and the regulations for the assignment of accreditation bodies.
Standards, guidelines and IAF membership
As indicated in Part II, the CBs shall operate a certification system which is in compliance with the requirements of the standard ISO/IEC 17021 and with the complementary requirements of ISO/TS 22003. The assessment of the CB by the AB shall therefore be conducted against these requirements with reference to the normative requirements for the organizations which are granted certification. The latter are outlined in section 3 of Part I and are in compliance with ISO 22000 and the applicable technical specification for sector PRPs and a number of additional requirements. In order to ensure that the ABs operate to a high standard of competence and probity and that they apply the standards in a consistent and equivalent manner, they shall be member of the International Accreditation Forum (IAF) and a signatory to the IAF Multilateral Recognition Arrangement.
Verwijderd: Verwijderd: BSI-PAS 220 Verwijderd:
To meet the needs of the key stakeholders and/or to ensure adequate control of food safety and certification, specific requirements are included in this scheme. They may be an elaboration of the clauses in the standards and technical specifications of the food safety system and certification system or additional requirements and are included in the sections Additional requirements of Part I and II. These requirements shall be included or implemented in the certification system and shall also be assessed in the accreditation process. They are therefore included in the section Additional requirements of this Part. Also it may be necessary to elaborate clauses in the standard for the accreditation system ISO/IEC 17011 or to add requirements to these criteria. When this appears from the three yearly review of the scheme by the Board or when the Board takes decisions in this area in one of its three yearly meetings, these specific requirements are also included in the section Additional requirements of this Part.
2. REQUIREMENTS FOR ACCREDITATION
2.1 Requirements Accreditation system
ABs that provide accreditation to CBs that wish to offer certification in conformance with this scheme shall meet the requirements of ISO/IEC 17011 and shall be a member of the International Accreditation Forum, IAF and a signatory to the IAF ISO/IEC 17021 (QMS/EMS) multilateral recognition arrangement.
Criteria for providing accreditation
The CBs shall be accredited in compliance with: ISO/IEC 17021 and ISO/TS 22003 the additional requirements as specified in the sections 2.1 and 2.2, and specifically the requirements as included in the appendices (IIA, IIB and IIC) these sections refer to. The CB shall have a provisional contract with the Foundation to certify whitin the applied scope for a maximum of one year without being accredited. A contract between the CB and the Foundation will only be signed up after it has been accredited.
The scope of accreditation shall be precisely defined and indicated on the certificate of accreditation with reference to: this scheme FSSC 22000 the normative requirements for providing certification in the sections 3.1, 3.2 and 3.3 of Part I the category as indicated in Annex A of ISO/TS 22003.
2.2 Additional requirements Accreditation system
Accreditation bodies shall act conform the requirements of ISO/IEC 17011 and GFSI Requirements on the Application of ISO/IEC 17011:2004.
No guidance as yet.
This part of the scheme contains the regulations for the Board of Stakeholders. The Board has been established to function as an advisory body - with discretionary powers to the certification bodies (CBs) that have been authorized to offer certification against the criteria of the scheme FSSC 22000. This Board deals with the requirements and regulations of the scheme. The Board does not review the actual impartiality of the CBs which remains the task of Committee of safeguarding impartiality of the CBs. (Ref. ISO/TS 22003, clause 6.2). The Board offers parties which have an interest in international food safety system certification the possibility to participate in the development of the certification scheme FSSC 22000 as well as in the functioning of the scheme. The Board meets three times a year to discuss all relevant subjects concerning the scheme. The decisions of the Board may affect the associated CBs as well as the certificate holders. The Board is legally represented by the Foundation. A list of the members of the Board of Stakeholders is published on www.fssc22000.com
2. REGULATIONS FOR THE BOARD OF STAKEHOLDERS
The Board consists of representatives of the food categories covered by the FSSC 22000 scope including relevant stakeholders like, trade, retail, CBs, authorities as well as of independent experts. The Board invites the relevant organizations to make binding nominations. The Board appoints its members and ensures that the composition is balanced and manageable in size. The Board may only reject a nominee if this is in the interest of the Board or the functioning of the scheme and in such a case the reasons shall be explained. If the nominee is rejected, the organization involved is given the opportunity to make a new nomination. Members are appointed in consultation with the Foundation. The Foundation may reject a nominee if the rejection is based on interests which the Foundation looks after. Membership is terminated if the member relinquishes the capacity for which he or she was nominated and if the organization concerned indicates a wish to terminate this membership. The Board can appoint independent experts as members, as advisers or as temporary advisers. In doing so, the Board can determine to what extent the adviser has voting powers. The chairperson is appointed by the Board in his or her capacity and is not an individual appointed from the ranks of the organizations which are represented in the Board. In the absence of the chairperson the Board shall appoint a deputy chairperson. The (re) appointment of the chairperson and the independent experts takes place every three years. In the event of prolonged absences of a member, the organization concerned shall be asked to make a new appointment.
Verwijderd: as follows: <#>representatives of food and food ingredient manufacturers organizations <#>representatives of food and food ingredient trade organizations <#>representatives of retailer organizations <#>representatives of the CBs <#>3 members of different Verwijderd: and food ingredients industry
countries, <#>representatives of product safety authorities and/or governmental regulatory bodies <#>agenda members <#>independent experts <#>an independent chairperson <#>a secretary Representative(s) on behalf of accreditation bodies (ABs) may also attend the meetings of the Board. The representative will be added to the Board as an observer. Verwijderd:
The Board is responsible for the content and functioning of the certification scheme FSSC 22000 within the scope of the scheme. The Board organises co-ordination activities in the field of certification on the basis of the scheme and evaluates these in view of developments desired by interested parties, as well as with respect to other relevant (e.g. technical) developments. The Board has the possibility to provide recommendations - on request or otherwise - to the associated CBs with respect to the FSSC 22000 certification scheme.
Part IV Regulations for the Board of Stakeholders In any event, the Board is required to provide advice and to take decisions in the following areas: The nature, content and functioning of the FSSC 22000 scheme; The establishment and implementation of a procedure to vet and approve personnel employed by the scheme to ensure their professional integrity, competence and impartiality; Arrangements to cover any liabilities which may arise from the activities of the scheme owner; Establishment and oversight of an internal audit programme to assure continuing compliance of the scheme with GFSI requirements. The review of scheme operation carried out at the Board meeting 3 times per year shall be included in the audit; The scope of certification; The establishment of requirements and the methods of investigation, which underpin the certification scheme, and establishment of the period of validity for the certification scheme; Reviewing cases where CBs have failed to comply with scheme requirements, and determining appropriate measures to address identified noncompliance; The establishment of the frequency of surveillance assessments in order to ensure that stipulated requirements are continuously met; Overseeing the effective operation of the complaints procedure described in the scheme documents; The FSSC 22000 certificate template; The competence of auditors; including maintaining a register of approved auditors based upon information provided by the relevant CBs; The approval of accreditation bodies in accordance with the Regulations for Accreditation Bodies in section 3 of Part III of this scheme; Overseeing the scheme conformity assessment programme FSSC Integrity Program described in the scheme documents; The full review of the FSSC 22000 certification scheme every 3 years.
In order to effectuate the responsibilities specified in section 2, the Board convenes at least three times a year, and whenever the chairperson or three members of the board make a request to do so. The secretarial work for the Board is carried out by an agency or company or individual, which is nominated by the CBs and approved by the Board. The secretary or his or her deputy attends the meetings. He or she has an advisory vote in the meeting. The secretary provides the Board with all the information (if required in coded form) which the Board seems necessary for the effectuation of its responsibilities. The chairperson can impose confidentiality on the Board if the board receives confidential information necessary for carrying out its responsibilities. To accomplish the tasks specified in section 2, the secretarys office (possibly by outsourcing) is responsible for formulating drafts after consultation with the involved parties. Any opinions on the part of the involved parties that differ from the draft shall be submitted to the Board.
The Board aims to make decisions on the basis of consensus, including all participants, also those with no voting rights. In any event, two-thirds of the number of those members entitled to vote is required to be present or to have been balloted. Those entitled to vote are the members, with the exception of the representatives of the CBs. Decisions can either be made in the meeting or by written consultation. Written consultation can be carried out by means of correspondence, i.e. by letter, fax or e-mail. In the case of written consultation, those votes are counted which are received by the secretarys office within two weeks following a request to do so. In the event of the written procedure, all participants in the Board can request verbal consultation in a meeting.
In the event of written consultation, decisions are made by consent: those opposing a motion can indicate whether to accept the majority position or remain opposed in principle. In case half or less vote for the motion, or if at least one person votes against the motion on principle, the proposal is required to be dealt with in a meeting or an amended motion is required to be submitted. When decisions are made in a meeting, recommendations are accepted by a simple majority of votes. In the event of a tie, the issue is dealt with again and a vote taken. If a new vote is required, the final motion shall be sent to the members entitled to vote within two weeks following the tie, to which a reply must be submitted within two weeks in writing. Split recommendations can be made in the event that the associated CBs are not required to integrally accept or reject the recommendations. The Board shall validate changes in the scheme preceding the implementation with regards to the following aspects: Feasibility, Effectiveness (with regards to the intended effect), Compliance with the relevant standards which apply to the scheme.
Once every year the CBs shall participate in a harmonization meeting. Expertise requirements can be stipulated for these representatives. In the harmonization meetings the following topics are addressed: co-ordination and harmonization with respect to the delivery process of the audits and the certification of the scheme FSSC 22000; proposals for items on the agenda for meetings of the Board; preparing recommendations for the Board; evaluation of practical cases with respect to FSSC 22000 certification; organization of harmonization workshops for auditors.
Verwijderd: with respect to the commercial ownership
Recording of meetings and resolutions
The secretary is responsible for the minutes of the meetings of the Board. The draft minutes, including a list of draft resolutions, is sent to the members of the Board within three weeks following the meeting. If applicable, members are required to submit their comments with respect to the minutes and the list of resolutions to the secretary in writing within 14 days. If no comments are received, the chairperson authorizes the minutes and list of resolutions to be finalised. The list of resolutions
Part IV Regulations for the Board of Stakeholders is sent to the associated CBs. The list is also published on the website. If recommendations or decisions imply alterations of one of the relevant documents of the scheme, the list shall state the alteration and be valid as long as the alteration has not been processed and published. All associated CBs shall be informed of the publication. For the subsequent meeting, the list of resolutions is sent out again as a document received. In case the secretary receives comments, the draft report shall be dealt with and finalised at the subsequent meeting.
The secretary shall draw up reports of the activities of the Board. These reports are made available to the participants and the advisers on the Board and to the associated CBs which are not represented on the Board. In addition, the assigned ABs are entitled to have access to the reports. The Board shall notify all associated CBs with regards to all binding recommendations that have been issued and shall provide the necessary documents. The certification bodies are required to respond to the recommendations issued within two months. In order to fulfil its responsibilities, the Board is required to receive information at least once a year from the secretary and the associated CBs. This information must relate to the nature, content and functioning of the scheme and shall include at least the following; the frequency and the results of the audits (if necessary, in code) conducted by the associated CBs; complaints with respect to the FSSC 22000 certification; the number and nature of appeal procedures with respect to FSSC 22000 certification with the ABs and the CBs; reports on the periodic assessments by the ABs with relevance to those sections which are important for the functioning of the FSSC 22000 scheme; applications and agreements for FSSC 22000 certification as well as certificates granted, suspended or withdrawn. The mentioned information may provide a source of discussion for the Board in respect of possible changes to the FSSC 22000 scheme. All information made available shall be treated in confidentiality by the Board. The secretary, in order to ascertain that the duties of the Board are conducted correctly, shall be responsible to ensure that the documents and information provided to the Board do not contain any commercially sensitive information.
Verwijderd: The CBs are required to provide the information requested by the Board in respect of the previous year in writing, no later than 1 March.
The Board is entitled to ratify and amend these regulations. This requires the approval of all the members of the Board. Ratification and amendments also require the approval of the associated CBs.
In cases not covered by these regulations, the Board of Stakeholders shall make the final decision. The Board of Stakeholders approved these requirements on October 2011.
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