PART 2

REQUIREMENTS
FOR
ORGANIZATIONS
TO BE AUDITED

CONTENTS PART 2 REQUIREMENTS FOR
ORGANIZATIONS TO BE AUDITED
1 Purpose
2 Requirements
2.1 General
2.2 ISO 22000
2.3 ISO 9001
2.4 Prerequisite programs
2.5 FSSC 22000 Additional Requirements

1 PURPOSE

This part describes the Scheme requirements against which licensed Certification Bodies shall
audit the Food Safety Management System (FSMS) or FSMS and Quality Management System
(QMS) of the organization in order to achieve or maintain certification for FSSC 22000 or FSSC
22000-Quality respectively.本部分描述了獲得許可的認證機構應遵守的方案要求 審核食品安全管理體系 (FSMS) 或 FSMS 和質量管理體系

2 REQUIREMENTS

2.1 GENERAL

Organizations shall develop, implement, and maintain all the requirements outlined below and
will be audited by a licensed Certification Body in order to receive a valid certificate.
組織應制定、實施和維護以下概述的所有要求和 將由獲得許可的認證機構進行審核，以獲得有效證書。

The audit requirements for FSSC 22000 certification consist of:

1 ) ISO 22000:201 8 food safety management system requirements;ISO 22000:201 8食品安全管理體係要求

2) Sector specific prerequisite program (PRPs) requirements (ISO/TS 22002-x series or other
specified PRP standard) and;行業特定先決條件計劃 (PRP) 要求（ISO/TS 22002-x 系列或其他指定的PRP 標準）

3) FSSC 22000 Additional requirements.附加要求

The audit requirements for FSSC 22000-Quality certification consist of:FSSC 22000-質量認證的審核要求包括：

1 ) ISO 22000:201 8 food safety management system requirements;食品安全管理體係要求

2) ISO 9001 :201 5 quality management system requirements;質量管理體係要求

3) Sector specific prerequisite program (PRPs) requirements (ISO/TS 22002-x series or other
specified PRP standard) and;行業特定先決條件計劃 (PRP) 要求（ISO/TS 22002-x 系列或其他指定的PRP標準）

4) FSSC 22000 Additional requirements.附加要求

The Board of Stakeholders (BoS) Decision list is a document which contains decisions applicable
to FSSC 22000 Scheme. The decisions overrule or provide further clarification on existing Scheme
rules and have to be implemented and applied within the defined transition period. The decision
list is dynamic and can be adjusted by the BoS when deemed necessary.
利益相關者委員會 (BoS) 決策列表是包含適用決策的文件 FSSC 22000 計劃。這些決定否決或進一步澄清現有計劃規則，必須在規定的過渡期內實施和應用。決定列表是動態的，BoS可以在認為必要時對其進行調整。

2.2 ISO 22000

For both FSSC 22000 and FSSC 22000-Quality certification, the requirements for the development,
implementation and maintenance of the Food Safety Management System (FSMS) are laid down
in the standard ISO 22000:201 8 “Food safety management systems - Requirements for any
organization in the food chain”.
利益相關者委員會 (BoS) 決策列表是包含適用決策的文件 FSSC 22000 計劃。這些決定否決或進一步澄清現有計劃 規則，必須在規定的過渡期內實施和應用。決定 列表是動態的，BoS 可以在認為必要時對其進行調整。

2.3 ISO 9001

For FSSC 22000-Quality certification, the requirements for the development, implementation, and
maintenance of the Quality Management System (QMS) are laid down in the standard ISO
9001 :201 5 “Quality management system - Requirements”.
對於 FSSC 22000-質量認證，制定、實施和實施的要求 質量管理體系 (QMS) 的維護在標準 ISO 中規定 9001 :201 5 “質量管理體系 - 要求”

2.4 PREREQUISITE PROGRAMS 先修課程

The Scheme specifies mandatory application of technical specifications detailing the pre-requisite
programs (PRPs) as referenced in clause 8.2 of ISO 22000:201 8. These PRP requirements are
specified in the ISO/TS 22002-x series and/or the BSI/PAS 221 standards.
該方案規定了技術規範的強制應用，詳細說明了先決條件 ISO 22000:201 第 8.2 條中引用的程序 (PRP) 8. 這些 PRP 要求是 在 ISO/TS 22002-x 系列和/或 BSI/PAS 221 標準中指定。

2.5 FSSC 22000 ADDITIONAL REQUIREMENTS

2.5.1 MANAGEMENT OF SERVICES AND PURCHASED MATERIALS 服務和採購材料的管理

a) In addition to clause 7.1 .6 of ISO 22000:201 8, the organization shall ensure that where
laboratory analysis services are used for the verification and/or validation of food safety,
these shall be conducted by a competent laboratory (including both internal and external
laboratories as applicable) that has the capability to produce precise and repeatable test
results using validated test methods and best practices (e.g. successful participation in
proficiency testing programs, regulatory approved programs or accreditation to
international standards such as ISO 1 7025).
除 ISO 22000:201 8 的條款 7.1 .6 外，組織應確保 實驗室分析服務用於食品安全的驗證和/或驗證， 這些應由合格的實驗室（包括內部和外部 有能力進行精確和可重複測試的實驗室（如適用） 使用經過驗證的測試方法和最佳實踐的結果（例如成功參與 能力測試計劃、監管批准的計劃或認證 國際標準，例如 ISO 1 7025）

b) For food chain categories C, D, I, G and K, the following additional requirement applies to
ISO 22000:201 8 clause 7.1 .6:對於食品鏈類別 C、D、I、G 和 K，以下附加要求適用於ISO 22000:201 8 第 7.1 .6 條

The organization shall have a documented procedure for procurement in emergency
situations to ensure that products still conform to specified requirements and the supplier
has been evaluated.
對於食品鏈類別 C、D、I、G 和 K，以下附加要求適用於 ISO 22000:201 8 第 7.1 .6 條： 組織應有緊急採購的文件化程序 確保產品仍然符合規定要求和供應商的情況 已被評估

c) In addition to ISO/TS 22002-1 :2009 clause 9.2, the organization shall have a policy for the
procurement of animals, fish and seafood that are subject to control of prohibited
substances (e.g. pharmaceuticals, veterinary medicines, heavy metals and pesticides);
除了ISO/TS 22002-1 :2009 第 9.2 條，組織還應制定政策 採購受禁止管制的動物、魚類和海鮮 物質（例如藥物、獸藥、重金屬和殺蟲劑）

d) For food chain categories C, D, I, G and K, the following additional requirement applies to
ISO/TS 22002-1 clause 9.2; ISO/TS 22002-4 clause 4.6 and ISO/TS 22002-5 clause 4:
The organization shall establish, implement, and maintain a review process for product
specifications to ensure continued compliance with food safety, legal and customer
requirements.
對於食品鏈類別 C、D、I、G 和 K，以下附加要求適用於 ISO/TS 22002-1 第 9.2 條； ISO/TS 22002-4 第 4.6 條和 ISO/TS 22002-5 第 4 條： 組織應建立、實施和保持產品評審過程 規範，以確保持續遵守食品安全、法律和客戶 要求。

2.5.2 PRODUCT LABELLING 產品標籤

In addition to clause 8.5.1 .3 of ISO 22000:201 8, the organization shall ensure that finished
products are labelled according to all applicable statutory and regulatory requirements in the
country of intended sale, including allergen and customer specific requirements.
除了 ISO 22000:201 8 的條款 8.5.1 .3，組織應確保完成 產品根據所有適用的法律法規要求貼上標籤 預期銷售國家/地區，包括過敏原和客戶特定要求。
Where product is unlabeled, all relevant product information shall be made available to ensure
the safe use of the food by the customer or consumer.
如果產品未貼標籤，則應提供所有相關產品信息以確保 顧客或消費者安全使用食品

2.5.3 FOOD DEFENSE 食品防衛

2.5.3.1 THREAT ASSESSMENT 威脅評估

The organization shall have a documented procedure in place to:
組織應有一個文件化的程序來

a) Conduct a threat assessment to identify and assess potential threats;
進行威脅評估以識別和評估潛在威脅

b) Develop and implement mitigation measures for significant threats.
針對重大威脅制定並實施緩解措施

2.5.3.2 PLAN 計劃

a) The organization shall have a documented food defense plan specifying the mitigation
measures covering the processes and products within the FSMS scope of the organization.
組織應有文件化的食品防護計劃，詳細說明緩解措施 涵蓋組織 FSMS 範圍內的過程和產品的措施。

b) The food defense plan shall be supported by the organization’s FSMS.
食品防護計劃應得到組織 FSMS 的支持

c) The plan shall comply with applicable legislation and be kept up to date.
該計劃應符合適用法律並保持更新

2.5.4 FOOD FRAUD MITIGATION 食品欺詐緩解

2.5.4.1 VULNERABILITY ASSESSMENT 脆弱性評估

The organization shall have a documented procedure in place to:
組織應有一個文件化的程序來

a) Conduct a food fraud vulnerability assessment to identify and assess potential
vulnerabilities;
進行食品欺詐脆弱性評估，以確定和評估潛在的 漏洞

b) Develop and implement mitigation measures for significant vulnerabilities.
針對重大漏洞制定並實施緩解措施

2.5.4.2 PLAN 計劃

a) The organization shall have a documented food fraud mitigation plan specifying the
mitigation measures covering the processes and products within the FSMS scope of the
organization.
組織應有文件化的食品欺詐緩解計劃，規定 緩解措施涵蓋FSMS範圍內的過程和產品 組織

b) The food fraud mitigation plan shall be supported by the organization’s FSMS.
食品欺詐緩解計劃應得到組織 FSMS 的支持

c) The plan shall comply with the applicable legislation and be kept up to date.
該計劃應符合適用的法律並保持更新

2.5.5 LOGO USE 標識使用

a) Certified organizations, Certification Bodies and Training Organizations shall use the FSSC
22000 logo only for marketing activities such as organization's printed matter, website,
and another promotional material.
獲證組織、認證機構和培訓機構應使用 FSSC 22000 標識僅用於營銷活動，如組織的印刷品、網站、 和另一份宣傳材料

b) In case of using the logo, the organization shall comply with the following specifications:
使用標誌時，組織應符合下列規範

Use of the logo in black and white is permitted when all other text and images are in black and
white. 當所有其他文本和圖像均為黑色和白色時，允許使用黑色和白色徽標 白色的。

c) The certified organization is not allowed to use the FSSC 22000 logo, any statement or
make reference to its certified status on:獲證組織不得使用FSSC 22000標識、任何聲明或 參考其認證狀態

i. a product; 一個產品
ii. its labelling; 它的標籤
iii. its packaging (primary, secondary or any other form); 其包裝（初級、次級或任何其他形式）
iv. in any other manner that implies FSSC 22000 approves a product, process, or service.
以暗示 FSSC 22000 批准產品、流程或服務的任何其他方式

2.5.6 MANAGEMENT OF ALLERGENS (FOOD CHAIN CATEGORIES C, E, FI, G, I & K)
過敏原的管理（食物鏈類別 C、E、FI G, I & K)

The organization shall have a documented allergen management plan that includes:
組織應有書面的過敏原管理計劃，其中包括
a) Risk assessment covering all potential sources of allergen cross-contamination and;
涵蓋所有潛在過敏原交叉污染源的風險評估
b) Control measures to reduce or eliminate the risk of cross-contamination
減少或消除交叉污染風險的控制措施

2.5.7 ENVIRONMENTAL MONITORING (FOOD CHAIN CATEGORIES C, I& K)環境監測（食品鏈類別 C、I 和 K)

The organization shall have in place:組織應具備

a) Risk-based environmental monitoring program;基於風險的環境監測計劃

b) Documented procedure for the evaluation of the effectiveness of all controls on
preventing contamination from the manufacturing environment and this shall include, at
a minimum, the evaluation of microbiological and allergen controls present;
評估所有控制措施有效性的書面程序 防止製造環境的污染，這應包括： 至少，存在對微生物和過敏原控制的評估

c) Data of the monitoring activities including regular trend analysis.
監測活動的數據，包括定期趨勢分析。

2.5.8 FORMULATION OF PRODUCTS (FOOD CHAIN CATEGORY D)產品配方（食物鏈類別 D）

The organization shall have in place procedures to manage the use of ingredients that contain
nutrients that can have adverse animal health impact.
組織應制定程序來管理含有以下成分的成分的使用 可能對動物健康產生不利影響的營養素

2.5.9 TRANSPORT AND DELIVERY (FOOD CHAIN CATEGORY FI)運輸和交付（食品鏈類別 FI）

The organization shall ensure that product is transported and delivered under conditions which
minimize the potential for contamination.
組織應確保產品在以下條件下運輸和交付： 盡量減少污染的可能性

2.5.10 STORAGE AND WAREHOUSING (ALL FOOD CHAIN CATEGORIES)儲存和倉儲（所有食品鏈類別）

a) The organization shall establish, implement, and maintain a procedure and specified stock
rotation system that includes FEFO principles in conjunction with the FIFO requirements.
組織應建立、實施和保持程序和規定的庫存 包括 FEFO 原則和 FIFO 要求的輪換系統

b) In addition to ISO/TS 22002-1 :2009 clause 1 6.2, the organization shall have specified
requirements in place that define post-slaughter time and temperature in relation with
chilling or freezing of the products.
除了 ISO/TS 22002-1:2009 條款 1 6.2，組織還應規定 規定與以下相關的屠宰後時間和溫度的要求 冷藏或冷凍產品

2.5.11 HAZARD CONTROL AND MEASURES FOR PREVENTING CROSS-CONTAMINATION (FOOD CHAIN CATEGORIES C & I)
危害控制及預防措施 交叉污染（食物鏈類別 C 和 I）

a) For food chain category I, the following additional requirement applies to ISO 22000:201 8
clause 8.5.1 .3:對於食物鏈類別 I，以下附加要求適用於 ISO 22000:201 8

• The organization shall have specified requirements in place in case packaging is
used to impart or provide a functional effect on food (e.g. shelf life extension).
組織應制定具體要求，以防包裝被損壞。 用於對食品賦予或提供功能性影響（例如延長保質期）

b) For food chain category CI, the following requirement apply in addition to ISO/TS 22002-
1 :2009 clause 1 0.1 :對於食品鏈類別 CI，除 ISO/TS 22002 外，還適用以下要求

• The organization shall have specified requirements for an inspection process at
lairage and/or at evisceration to ensure animals are fit for human consumption;
組織應對檢查過程有規定的要求 存放和/或取出內臟以確保動物適合人類食用

2.5.12 PRP VERIFICATION (FOOD CHAIN CATEGORIES C, D, G, I & K)
PRP 驗證（食品鏈類別 C、D、G、I 和 K）

For food chain categories C, D, G, I and K, the following additional requirement applies to
ISO22000: 201 8 clause 8.8.1 :ISO22000: 201 8 第 8.8.1 條
對於食物鏈類別 C、D、G、I 和 K，以下附加要求適用於

• The organization shall establish, implement, and maintain routine (e.g. monthly)
site inspections/PRP checks to verify that the site (internal and external),
production environment and processing equipment are maintained in a suitable
condition to ensure food safety. The frequency and content of the site
inspections/PRP checks shall be based on risk with defined sampling criteria and
linked to the relevant technical specification.
組織應建立、實施和維護例行程序（例如每月一次） 現場檢查/PRP 檢查以驗證現場（內部和外部）， 生產環境和加工設備保持在一個合適的 確保食品安全的條件。網站的頻率和內容 檢查/PRP 檢查應基於具有定義抽樣標準的風險和 鏈接到相關的技術規範

2.5.13 PRODUCT DEVELOPMENT (FOOD CHAIN CATEGORIES C, D, E, F, I& K) 產品開發（食品鏈類別 C、D、E、F、I 和 K）

A product design and development procedure shall be established, implemented, and maintained
for new products and changes to product or manufacturing processes to ensure safe and legal
products are produced. This shall include the following:
應建立、實施和維護產品設計和開發程序 對於新產品和產品或製造過程的變化，以確保安全和合法 產品被生產出來。這應包括以下內容

a) Evaluation of the impact of the change on the FSMS taking into account any new food
safety hazards (incl. allergens) introduced and updating the hazard analysis accordingly
考慮任何新食品，評估變更對 FSMS 的影響 引入安全隱患（包括過敏原）並相應更新危害分析

2.5.15.1 – Central function 中心功能

a) The management of the central function shall ensure that sufficient resources are
available, and that roles, responsibilities and requirements are clearly defined for
management, internal auditors, technical personnel reviewing internal audits and other
key personnel involved in the FSMS.
中央職能的管理應確保有足夠的資源 可用，並且明確定義了角色、職責和要求 管理層、內部審計師、審查內部審計的技術人員和其他 參與 FSMS 的關鍵人員。

2.5.15.2 - Internal Audit Requirements 內部審計要求

a) An internal audit procedure and program shall be established by the central function
covering the management system, central function, and all sites. Internal auditors shall
be independent from the areas they audit and be assigned by the central function to
ensure impartiality at site level.
中央職能部門應制定內部審計程序和計劃 涵蓋管理系統、中心功能和所有站點。內部審計師應 獨立於他們審計的領域，並由中央職能部門指派 確保站點級別的公正性

b) The management system, centralized function and all sites shall be audited at least
annually or more frequently based on a risk assessment.
管理體系、集中職能和所有場所應至少接受審核 根據風險評估每年一次或更頻繁地進行一次。

c) Internal auditors shall meet at least the following requirements, and this shall be assessed
by the CB annually as part of the audit:
內部審核員至少應滿足以下要求，並對其進行評估 作為審核的一部分，每年由 CB 執行

Work experience: 2 years’ full-time work experience in the food industry including at least
1 year in the organization.
工作經驗：至少2年食品行業全職工作經驗 在組織工作 1 年。

Education: completion of a higher education course or in the absence of a formal course,
have at least 5 years work experience in the food production or manufacturing, transport
and storage, retailing, inspection, or enforcement areas.教育：完成高等教育課程或在沒有正式課程的情況下， 在食品生產或製造、運輸方面有至少5年的工作經驗 和存儲、零售、檢查或執法區域

Training:訓練

i. For FSSC 22000 internal audits, the lead auditor shall have successfully completed a FSMS, QMS or FSSC 22000 Lead Auditor Course of 40 hours.對於 FSSC 22000 內部審核，主任審核員應成功完成 40 小時的 FSMS、QMS 或 FSSC 22000 主任審核員課程。

ii. Other auditors in the internal audit team shall have successfully completed an
internal auditor course of 1 6 hours covering audit principles, practices, and
techniques. The training may be provided by the qualified internal Lead Auditor
or through an external training provider.
內部審計團隊中的其他審計員應已成功完成 1 6 小時的內部審計員課程，涵蓋審計原則、實踐和 技巧。培訓可由合格的內部首席審計師提供 或通過外部培訓機構

iii. FSSC scheme training covering at least ISO 22000, the relevant prerequisite
programs based on the technical specification for the sector (e.g. ISO/TS 22002-x;
PAS-xyz) and the FSSC additional requirements – minimum 8 hours.
FSSC 計劃培訓至少涵蓋 ISO 22000，相關先決條件 基於行業技術規範的程序（例如 ISO/TS 22002-x； PAS-xyz) 和 FSSC 附加要求——至少 8 小時

d) Internal audit reports shall be subject to a technical review by the central function,
including addressing the non-conformities resulting from the internal audit. Technical
reviewers shall be impartial, have the ability to interpret and apply the FSSC normative
documents (at least ISO 22000, the relevant ISO/TS 22002-x; PAS-xyz and the FSSC
additional requirements) and have knowledge of the organizations processes and
systems.
內部審計報告應由中央職能部門進行技術審查， 包括解決內部審核產生的不符合項。技術的 審查人員應公正，有能力解釋和應用 FSSC 規範 文件（至少 ISO 22000、相關的 ISO/TS 22002-x；PAS-xyz 和 FSSC 附加要求）並了解組織的流程和 系統。

e) Internal auditors and technical reviewers shall be subject to annual performance
monitoring and calibration. Any follow-up actions identified shall be suitably actioned in
a timely and appropriate manner by the Central function.
內部審核員和技術審核員應受制於年度績效 監測和校準。確定的任何後續行動應適當地採取行動 由中央職能及時、適當地處理。