PART 4
REQUIREMENTS FOR CERTIFICATION BODIES

CONTENTS PART 4 REQUIREMENTS FOR
CERTIFICATION BODIES
1 Purpose
2 Relation with the Foundation
2.1 Licensing
2.2 Engagement
2.3 Integrity Program
3 Competence
3.1 General
3.2 Certification decision maker
3.3 Technical expert
3.4 Witnessor
3.5 Auditor qualification process

1 PURPOSE 目的

This Part contains the requirements for licensed certification bodies (CBs) who wish to provide
Scheme certification services to organizations.
本部分包含對希望提供的許可認證機構 (CB) 的要求 為組織提供計劃認證服務。

Where reference to FSSC 22000 requirements is made, this is also applicable for FSSC 22000- Quality unless stated otherwise.
Where the term “Scheme Requirements” is used, this refers to the FSSC 22000 Scheme requirements, ISO/IEC 1 7021 -1 , ISO/TS 22003, and Board of Stakeholders (BoS) decision list.在提及 FSSC 22000 要求的地方，這也適用於 FSSC 22000- 質量除非另有說明。
使用術語“方案要求”時，指的是 FSSC 22000 方案 要求、ISO/IEC 1 7021 -1、ISO/TS 22003 和利益相關者委員會 (BoS) 決策列表。

2 RELATION WITH THE FOUNDATION 與基金會的關係

2.1 LICENSING 許可

1 ) As a prerequisite for the license application, the CB shall hold a valid ISO/IEC 1 7021 -1 :201 5
accreditation including ISO/TS 22003:201 3.
作為許可申請的先決條件，CB應持有有效的ISO/IEC 1 7021 -1 :201 5 認證包括 ISO/TS 22003:201 3

2) For the Scheme Requirements, the accreditation shall cover the applicable food chain
categories and sub-categories in which it supplies its FSSC 22000 certification services. The
CB shall provide the Foundation with information and documentation related to its
accreditation to the Scheme when requested.對於方案要求，認可應涵蓋適用的食品鏈 它提供 FSSC 22000 認證服務的類別和子類別。這 CB 應向基金會提供與其相關的信息和文件 應要求對計劃進行認證

3) The Foundation is entitled to request information from the Accreditation Body related to
the CB accreditation.基金會有權要求認證機構提供與以下相關的信息 CB 認可

4) The CB may hold more than one accreditation for the main location which shall be covered
by a single license. In case the CB has multiple locations holding their own accreditation, a
separate license is required for each location. CB 可能持有多個主要地點的認可，這些認可應涵蓋 通過單一許可證。如果 CB 有多個地點持有自己的認可，一個 每個位置都需要單獨的許可證

2.1.1 LICENSE APPLICATION PROCESS 許可申請流程

1 ) CBs shall apply for obtaining a license with the Foundation to be eligible to perform valid
and recognized FSSC 22000 Scheme certification activities. Licenses are issued for
specified CB office location(s) as requested in the license application form. In case of
outsourcing of any certification related activities this shall also be described in the
application.CB 應向基金會申請獲得許可，才有資格執行有效的 並認可 FSSC 22000 方案認證活動。許可證頒發給 按照許可證申請表中的要求指定 CB 辦公地點。的情況下 外包任何與認證相關的活動，這也應在 應用。

2) A license may cover multiple Food Chain Categories for FSSC 22000 and/or FSSC 22000-
Quality certification services.一份許可證可能涵蓋 FSSC 22000 和/或 FSSC 22000 的多個食品鏈類別- 質量認證服務。

3) With the application, the CB commits themselves to the implementation of all Scheme
requirements and any other obligations outlined in the license agreement.
通過申請，CB 承諾實施所有方案 許可協議中列出的要求和任何其他義務。

2.1.2 LICENSES 許可證

2.1.2.1 LICENSE AGREEMENT (PROVISIONAL STATUS) 許可協議（臨時狀態）

1 ) The CB shall submit an application to the Foundation specifying the food chain categories
and sub-categories which they wish to provide certification services. As part of the
application the CB shall submit the documentation required by the Integrity Program as
part of the on-boarding process. CB 應向基金會提交申請，指定食物鏈類別 他們希望提供認證服務的子類別。作為的一部分 申請 CB 應提交誠信計劃要求的文件作為 入職流程的一部分。

2) Upon review of the information and successful completion of the applicable stages of the
Foundation’s Integrity Program, the CB shall be granted a license with provisional status
and be listed as provisionally approved in the CB list on the FSSC 22000 website.
在審查信息並成功完成適用階段後 基金會的誠信計劃，CB 應獲得臨時狀態的許可證 並在 FSSC 22000 網站的 CB 列表中列為臨時批准

3) The CB shall then apply for accreditation with an AB accepted by the Foundation and
submit the written confirmation of acceptance of the application to the Foundation.
 然後，CB 應向基金會接受的 AB 申請認可，並且 向基金會提交接受申請的書面確認。

4) The provisional status allows a CB to use the Scheme for unaccredited certification once
authorization has been received from the Foundation as per the Integrity Program on-
boarding process requirements. Unaccredited certificates shall be registered in the Portal.
After accreditation is achieved, these unaccredited certificates may be replaced with an
accredited certificate either immediately or following the next certification audit. If
accreditation status is not achieved, the provisional license will be terminated and already
issued certificates shall be withdrawn.臨時狀態允許 CB 使用 Scheme 進行一次未認可的認證 已根據誠信計劃收到基金會的授權- 登機流程要求。未經認可的證書應在門戶中註冊。 獲得認可後，這些未經認可的證書可能會被替換為 立即或在下一次認證審核後獲得認可的證書。如果 未達到認可狀態，臨時許可證將被終止，並且已經 已發證的，予以撤銷。

5) The provisional status of the license is valid for twelve (1 2) months from the date of
signature by the Foundation and within this period of time the CB shall:
執照的臨時狀態自頒發之日起十二 (1 2) 個月內有效 由基金會簽名，在此期間內，CB 應：

a) Achieve accreditation from an AB accepted by the Foundation for the categories and
sub-categories covered in the license agreement. For FSSC 22000 requirements on the
accreditation process see Part V of the Scheme;
 獲得基金會接受的 AB 的類別認證和 許可協議中涵蓋的子類別。對於 FSSC 22000 的要求 認證程序見方案第五部分；

b) Have at least five (5) audited organizations registered in the Portal.
至少有五 (5) 個已審核組織在門戶網站上註冊

c) Successfully complete the applicable stages of the Integrity Program on-boarding process.
成功完成入職誠信計劃的適用階段 過程

2.1.2.2 LICENSE AGREEMENT (FULL STATUS)許可協議（完整狀態）

After the criteria under 2.1 .2.1 have been met the CB shall submit to the Foundation:
在滿足 2.1 .2.1 下的標准後，CB 應向基金會提交：

a) A copy of its accreditation certificate covering the categories and sub-categories in the
license agreement;涵蓋類別和子類別的認可證書副本 許可協議；

b) A copy of its AB assessment reports (office and witness assessments).
Upon successful completion of the applicable Integrity Program stages, the Foundation shall issue
and/or modify the status of the license agreement of the CB listed on the FSSC 22000 website and
in the Portal.一份 AB 評估報告（辦公室和見證評估）。 在成功完成適用的誠信計劃階段後，基金會將發布 和/或修改 FSSC 22000 網站上列出的 CB 許可協議的狀態，以及 在門戶中。

2.1.3 LICENSE MAINTENANCE 許可證維護

In order to maintain its license, the CB shall:為了維持其許可，CB 應：

a) Have at least fifty (50) certificates registered in the Portal with a minimum of one for each
licensed food chain category. For new CBs, this shall be achieved as follows after receiving
the full license: fifteen (1 5) certificates within 1 2 months, thirty-five (35) certificates within
24 months and fifty (50) certificates within 36 months.至少有五十 (50) 個證書在門戶中註冊，每個證書至少有一個 特許食品連鎖類別。對於新的 CB，這應在收到後按如下方式實現 完整執照：1 2 個月內十五 (1 5) 個證書，三十五 (35) 個證書 24 個月和三十 (50) 個月內的三十張證書。

b) Comply with all the requirements of the FSSC 22000 certification Scheme for CBs;
遵守 FSSC 22000 認證方案對 CB 的所有要求；

c) Meet the financial obligations to the Foundation.履行對基金會的財務義務。

2.1.4 LICENSE EXTENSION 許可證延期

1 ) The CB shall submit an application to the Foundation specifying the food chain sub-
categories (or category if no subcategory) for which it requests an extension of the existing
license.CB 應向基金會提交申請，指定食物鍊子 它請求擴展現有類別的類別（或類別，如果沒有子類別） 執照

2) The CB shall be granted a provisional status for the new sub-category (or category if no
subcategory) following a review and registered in the Portal and displayed in the approved
CB list on the FSSC 22000 website. The CB shall share with the Foundation the written AB
confirmation of acceptance to start the accreditation process. CB 應被授予新子類別（或類別，如果沒有 子類別）經過審查並在門戶中註冊並顯示在批准的 FSSC 22000 網站上的 CB 列表。 CB 應與基金會共享書面 AB 確認接受以啟動認證過程。

3) The provisional status allows a CB to issue unaccredited certification for the new sub-
category (or category if no subcategory). Unaccredited certificates shall be registered in the Portal. After accreditation, these certificates may be replaced with an accredited certificate.
 臨時狀態允許 CB 為新的子機構頒發未經認可的認證 類別（如果沒有子類別，則為類別）。未經認可的證書應在門戶中註冊。認可後，這些證書可能會被認可的替代 證書。

4) The provisional status of the license is only valid for 1 2 months from the date of signature
by the Foundation and within this period of time the CB must achieve accreditation from
an AB accepted by the Foundation for the categories and sub-categories covered in the
license agreement. For FSSC 22000-Quality the accreditation shall cover ISO 9001 .
許可證的臨時狀態僅在簽署之日起1 2個月內有效 由基金會和在此期間內，CB 必須獲得來自 基金會接受的 AB 涵蓋的類別和子類別 許可協議。對於 FSSC 22000-質量，認證應涵蓋 ISO 9001。

5) At least one certificate shall be listed in the Portal for the new category within the timelines
defined.至少應在時限內在新類別的門戶中列出一個證書 定義

2.1.5 SUSPENSION, TERMINATION AND REDUCTION 暫停、終止和縮減

The Foundation has the right to suspend, terminate or limit the scope of the CB’s license
agreement. Reasons could be, amongst others:基金會有權暫停、終止或限制 CB 的許可範圍 協議。原因可能包括

1 ) Accreditation not achieved within one year;一年內未取得認可的

2) Termination of the accreditation;認可終止

3) Not meeting the minimum number of certificates specified by the Foundation;未達到基金會規定的最低證書數量

4) Sanction committee decision;制裁委員會的決定

5) No payment of the fee to the Foundation;不向基金會支付費用

6) Repetitive noncompliance with the Scheme requirements;屢次不符合方案要求

7) Noncompliance with the Integrity Program or components there-of.不遵守誠信計劃或其組成部分

2.1.5.1 SUSPENSION 暫停

1 ) When a CB’s license is suspended by the Foundation, the Foundation will determine to
which extent the CB will be allowed to maintain its auditing and certification activities for
a defined period of time. The Foundation will publish suspensions on the FSSC 22000
website, and the Accreditation Body will be notified.當 CB 的許可證被基金會暫停時，基金會將決定 CB 將被允許在何種程度上維持其審核和認證活動 一段規定的時間。基金會將發布關於 FSSC 22000 的暫停 網站，並將通知認可機構

2) The Foundation will restore the suspended license when the CB has demonstrated that
the issue which resulted in the suspension has been resolved and the conditions for lifting
the suspension have been met.當 CB 證明 導致暫停的問題已經解決，解除條件 暫停已經滿足

3) Failure to resolve the issues that resulted in the suspension in a time established by the
Foundation shall result in termination or reduction of the scope of the license as per the
Integrity Program and Sanction Policy.未能在規定的時間內解決導致暫停的問題 基金會應根據 誠信計劃和製裁政策

2.1.5.2 TERMINATION終止

1 ) When a CB’s license is terminated by the Foundation, the CB is cannot apply for a new
license within the time frame communicated by the Foundation.當 CB 的許可被基金會終止時，CB 不能申請新的 在基金會通知的時間範圍內獲得許可。
2) The CB shall agree with the Foundation the transfer of its certified organizations following
the requirements outlined in the license agreement. 2) CB 應與基金會同意在以下情況下轉移其認證組織許可協議中列出的要求


2.2 ENGAGEMENT 參與

2.2.1 COMMUNICATION 通訊

1 ) The CB shall appoint a FSSC 22000 contact person who is competent in the Scheme
requirements and maintains contact with the Foundation.
CB 應任命一名 FSSC 22000 聯繫人，該聯繫人有能力參與該計劃 要求並與基金會保持聯繫

2) This person shall be accountable for all aspects of Scheme implementation and ensure
that the following responsibilities are defined and implemented within the CB:
此人應對方案實施的各個方面負責，並確保CB 定義並實施了以下職責

a) Appoint a contact person for the FSSC 22000 IT systems;指定 FSSC 22000 IT 系統的聯繫人

b) Appoint a responsible person for managing the Integrity Program;任命一名負責人來管理誠信計劃

c) Appoint a representative to attend the Harmonization Conference;指定一名代表出席協調會議

d) Keep up to date with the Scheme developments including IT developments;及時了解計劃的發展，包括 IT 發展；

e) Managing of other additional information required by the Foundation;管理基金會要求的其他附加信息

f) Communicate new information or changes regarding the requirements in the Scheme
to those parties involved within one month unless specified otherwise by the Foundation.
傳達有關計劃要求的新信息或變更 除非另有規定，否則在一個月內向有關各方 基礎。

3) The CB shall assign responsibility for the development, implementation and maintenance
of the CBs quality system relating to the FSSC Scheme. This designated employee shall also
have the responsibility for reporting on the performance of the quality system for the
purposes of management review and continuous improvement.CB 應分配開發、實施和維護責任 與 FSSC 方案相關的 CB 質量體系。該指定員工還應 有責任報告質量體系的績效 管理評審和持續改進的目的。

The CB shall communicate the following to the Foundation:CB 應向基金會傳達以下信息：

1 ) Changes on the FSSC 22000 accreditation status: e.g. scope extension or scope reduction,
suspension, or withdrawal, together with a written communication to the Foundation
about the circumstances leading to this and any delays in obtaining accreditation that
could impact the licenseFSSC 22000 認證狀態的變化：例如範圍擴展或範圍縮小， 暫停或退出，並向基金會發出書面通知 關於導致這種情況的情況以及獲得認證的任何延誤 可能會影響許可證

2) Any significant changes in its ownership, legal status, management personnel, structure,
or constitution that (potentially) impact the CB management of the Scheme in a timely
manner;其所有權、法律地位、管理人員、結構、 或章程（可能）及時影響計劃的 CB 管理 方式;

3) Any possible conflict or problem which could result in bringing the Foundation or GFSI into
disrepute; 3) 任何可能導致基金會或 GFSI 進入的衝突或問題 聲名狼藉；

4) Any public recall of a certified organization resulting in death and/or hospitalization or
generating significant media coverage, within three days of the recall being notified to the
CB; 4) 任何導致死亡和/或住院的獲證組織的公開召回或 在召回通知通知後三天內引起媒體的廣泛報導 斷路器；

5) Situations and/or serious events where the integrity of the FSSC 22000 certification is
compromised as described in Part 3. 5) FSSC 22000 認證完整性受損的情況和/或嚴重事件 如第 3 部分所述受到損害。


2.2.2 RESPONSIBILITIES 職責

1 ) The CB shall cooperate with all requests from the Foundation to report information
regarding all aspects in the performance and integrity of the Scheme.CB應配合基金會的所有要求報告信息 關於該計劃的性能和完整性的所有方面。

2) In case the range of CB certification services offered is wider than those accredited, the CB
shall ensure that the limits and scope of the accreditation shall be made clear and publicly
available while any ambiguity in relation to the scope of services offered by the CB for the
Scheme shall be resolved with the Foundation and certification services that are outside
the scope of the accreditation shall be distinguished from those that are accredited.
2) 如果提供的 CB 認證服務範圍比認可的範圍更廣，則 CB 應確保認可的限制和範圍明確並公開 可用，而 CB 為 Scheme 應與外部的基金會和認證服務一起解決 認可的範圍應當與被認可的範圍區別開來。
3) The CB is responsible for the full application of these Scheme requirements and shall be
prepared to demonstrate compliance at any time with all these requirements.
3) CB 負責全面應用這些方案要求，並且應 隨時準備證明符合所有這些要求。
4) The CB shall attend the annual Harmonization conference and share the information to all
relevant staff. 4) CB 應參加年度協調會議並將信息分享給所有 相關人員。

5) The CB shall participate in the Integrity Program. 5) CB 應參與誠信計劃。

6) The CB shall inform its AB(s) on any changes in the license status (e.g. reduced, extended,
suspended, etc.) made by the Foundation.6) CB 應將許可狀態的任何變化（例如減少、延長、 暫停等）由基金會製作。

7) The CB shall share information concerning the certified organization with the Foundation,
GFSI and governmental authorities when required by law.7) CB 應與基金會共享有關獲證組織的信息， 法律要求時的 GFSI 和政府機構。
8) The CB shall take appropriate steps to assess the situation and have procedures in place
to ensure the integrity of certification is maintained after a serious event and/or food
safety incident notification and maintain records to support the decision made.
8) CB 應採取適當的步驟評估情況並製定適當的程序 確保在發生嚴重事件和/或食品後保持認證的完整性 安全事件通知並保存記錄以支持所做的決定。

9) The CB shall ensure that all Scheme related data in Portal is complete, up to date, correct
and meets the Scheme requirements.CB 應確保門戶中所有方案相關數據完整、最新、正確 並符合方案要求。

1 0) Where the CB uses the FSSC 22000 logo, they shall comply with the requirements in Part
2 and are entitled to use it only when the CB has a signed license agreement.
認證機構使用 FSSC 22000 標識的，應符合第 1 部分的要求 2 並且只有在 CB 簽署許可協議時才有權使用它。

1 1 ) An annual performance report shall be submitted by the CB to the Foundation with the
minimum content as specified by the Foundation.CB 應向基金會提交年度績效報告，並附上 基金會指定的最低含量。

2.3 INTEGRITY PROGRAM 誠信計劃

1 ) The CB shall participate in the Integrity Program which is the Foundation’s system of
ongoing monitoring. This program covers all activities of its licensed CBs to ensure
compliance with all Scheme requirements. The CB shall provide any documentation
requested by the Foundation for the Integrity Program. CB 應參與誠信計劃，這是基金會的系統 持續監測。該計劃涵蓋其許可的 CB 的所有活動，以確保 遵守所有方案要求。 CB 應提供任何文件 誠信計劃基金會要求

2) The monitoring activities include but are not limited to:監測活動包括但不限於：

a) Desk reviews of audit reports and additional information on the audit process;審計報告的案頭審查和審計過程的附加信息

b) Auditor assessment and registration;審核員評估和註冊

c) Office assessments;辦公室評估

d) Witnessed audits;見證審核

e) Monitoring of agreed key performance indicators. 監測商定的關鍵績效指標

Further information can be found in the Integrity Program and Sanction Policy.更多信息可以在誠信計劃和製裁政策中找到

2.3.1 NONCONFORMITY 不合格

1 ) The Foundation’s Integrity Program defines a “nonconformity” as any breach of Scheme
requirements.基金會的誠信計劃將“不合格”定義為任何違反計劃的行為 要求。

2) Nonconformities (“NCs”) requiring a response from the CB shall be raised by the
Foundation in response to:2) 需要 CB 做出回應的不合格（“NC”）應由 CB 提出 基金會回應：

a) Any discrepancy raised by the Integrity Program;a) 誠信計劃提出的任何差異；

b) Feedback from users of the Scheme; b) 計劃用戶的反饋；

c) Feedback from Certified organizations; c) 獲證組織的反饋；
d) Feedback from Accreditation Bodies; d) 認可機構的反饋；

e) Feedback from Governmental authorities;e) 政府當局的反饋；

f) Feedback from the media; and f) 媒體反饋；和

g) Any other feedback deemed credible. g) 任何其他被認為可信的反饋。

2.3.2 FOLLOW-UP 跟進

1 ) When a nonconformity is received, the CB shall: 當收到不合格品時，CB 應：

a) Record and manage the nonconformity in its internal system, a) 在其內部系統中記錄和管理不符合，

b) Respond in the set timeframe and act to: b) 在設定的時間範圍內做出回應並採取行動：

i. Restore conformity (i.e. implement corrections); 恢復一致性（即實施糾正）；

ii. Investigate to identify the causal factors;調查以確定原因；
iii. Perform an impact analysis;進行影響分析；

iv. Provide a documented Corrective Action Plan (CAP) detailing the nonconformity,
grading, cause analysis, correction, planned corrective action, responsible person,
due date, measures of effectiveness, date closed.提供詳細說明不符合項的書面糾正措施計劃 (CAP)， 分級、原因分析、整改、整改計劃、責任人、 截止日期、有效性措施、截止日期。

2) Then:然後：

a) take corrective actions to manage the identified causal factors so that the risks
exposed by recurrence are reduced to an acceptable level, provide objective evidence;
a) 採取糾正措施來管理已識別的致病因素，以便風險 復發暴露降低到可接受的水平，提供客觀證據；
b) use the opportunity to investigate how else and where else a similar nonconformity
could occur; b) 利用這個機會調查類似的不合格是如何以及在哪裡發生的 可能發生；

c) take preventive action to manage these causal factors so that the risks exposed by
occurrence are similarly reduced to an acceptable level. c) 採取預防措施來管理這些因果因素，以便暴露的風險 發生率同樣降低到可接受的水平。

3) Failure to meet the deadlines for nonconformities will result in the Integrity Program and
Sanction Policy being initiated.未能在最後期限前完成不合格將導致誠信計劃和 正在啟動制裁政策。

2.3.3 SANCTIONS 制裁

1 ) CBs that persistently fail to conform to the requirements of the Scheme or put the integrity
of the Scheme at risk shall be investigated by the Foundation as per the Integrity Program
and Sanction Policy.持續不符合方案要求或將完整性 該計劃的風險應由基金會根據誠信計劃進行調查 和製裁政策。

2) Sanctions against non-compliant CBs could include:2) 對不合規 CB 的製裁可能包括：

a) Suspension of the license to issue certifications under the Scheme until discrepancies
have been satisfactorily corrected; a) 暫停根據該計劃頒發證書的許可，直到出現差異 已得到令人滿意的糾正；

b) Termination of the license to issue certifications under the Scheme. b) 終止根據該計劃頒發證書的許可。
The CB shall respond to the sanctions as indicated in the sanction notification.
Details are provided in the Integrity Program and Sanction Policy. CB 應按照制裁通知中的指示對製裁做出回應。 誠信計劃和製裁政策中提供了詳細信息。

3 COMPETENCE 能力

3.1 GENERAL 總則

1 ) The CB shall follow the requirements described in Annex C of ISO/TS 22003 for defining
the competences required to conduct the activities of application review, audit team
selection, audit planning activities and certification decision. 認證機構應遵循 ISO/TS 22003 附錄 C 中描述的要求來定義 進行申請審查活動所需的能力，審計小組 選擇、審核計劃活動和認證決定。


2) There shall be a documented process for initial and ongoing competency review of all
these functions. Records of training and competency reviews shall be maintained. 2) 應有一個文件化的過程，用於對所有人員進行初始和持續的能力審查 這些功能。應保存培訓和能力審查的記錄。

3.2 TECHNICAL REVIEWER AND CERTIFICATION DECISION MAKER 技術審查員和認證 決策者

3.2.1 TECHNICAL REVIEWER 技術審查員

The technical reviewer shall meet the same requirements as set out below for the certification
decision maker with the exception of 3.2.2 – 1 c. The technical review and certification decision
functions may be separate, or the technical review and certification decision may be made by the
same individual where the competency requirements are being met.技術審查員應滿足以下認證要求 決策者，3.2.2 – 1 除外 c.技術審查和認證決定 職能可以分開，或者技術審查和認證決定可以由 滿足能力要求的同一個人。

3.2.2 CERTIFICATION DECISION MAKER 認證決策者

1 ) Those making the decision to issue, maintain, extend, or reduce scope, suspend, or
withdraw a certificate for registration in the FSSC 22000 Register of certified organizations
shall have the following demonstrable competencies;
做出發布、維護、擴展或縮小範圍、暫停或 撤銷證書以在獲證組織的 FSSC 22000 註冊簿中註冊 應具有以下可證明的能力

a) Meet the requirements of Annex C of ISO/TS 22003:201 3; 滿足ISO/TS 22003:201 3附錄C的要求

b) Knowledge of Scheme requirements; 方案要求的知識

c) Knowledge of food safety management systems and ability to assess them. 食品安全管理系統的知識和評估它們的能力

2) In case of FSSC 22000-Quality the certification decision maker shall have knowledge of ISO 9001 .
對於 FSSC 22000-質量，認證決策者應了解 ISO 9001。

3.3 TECHNICAL EXPERT技術專家

1 ) When deemed necessary a technical expert can be assigned to the audit team.
在認為必要時，可以指派一名技術專家加入審核組。
2) The CB shall have in place a procedure for approval of technical experts who shall have
demonstrable experience in the subcategory supporting the scope of the audit. The
technical expert shall operate always under the direction of a qualified FSSC 22000 auditor.
CB 應制定批准技術專家的程序，這些專家應具有 在支持審核範圍的子類別中具有可證明的經驗。這 技術專家應始終在合格的 FSSC 22000 審核員的指導下工作。
3) Where a technical expert is used, the CB shall ensure that at least one auditor in the team
has a qualification in the category. 如果使用技術專家，CB 應確保團隊中至少有一名審核員 具有該類別的

3.4 WITNESSOR 證人

1 ) Witnessed audits shall be undertaken by an auditor qualified for a GFSI recognized
certification program that can demonstrate competence in the FSSC 22000 Scheme
requirements, or by a CB FSSC 22000 technical certification person of equivalent
competence and experience. Witnessors shall be assessed and qualified by the CB as
suitable to undertake witnessed audits. 見證審核應由有資格獲得 GFSI 認可的審核員進行 可以證明 FSSC 22000 計劃能力的認證計劃 要求，或由 CB FSSC 22000 技術認證人員等效 能力和經驗。見證人應由 CB 評估和鑑定為 適合進行見證審核。

2) The witnessor has received training in witness audit techniques見證人接受過見證審核技術方面的培訓。.

3) The witnessor plays no active part in the audit.見證人沒有積極參與審核。

4) Witnessors shall have, as a minimum, the equivalent competency of the function being evaluated (see ISO/TS 22003:201 3 Annex C). 證人至少應具有與被執行職能相當的能力 評估（見 ISO/TS 22003:201 3 附錄 C）。

5) A witness audit performed by the CB can only be substituted by an Accreditation Body (AB)
witnessed audit if it is the first witnessed audit under a provisional license. CB 進行的見證審核只能由認可機構 (AB) 代替 如果這是臨時許可證下的第一次見證審核，則為見證審核。


3.5 AUDITOR QUALIFICATION PROCESS 審核員資格認證過程
CB shall have a system and documented procedures for selecting, training, evaluating, (re)
qualification and maintenance of qualification of the auditor. CB 應有用於選擇、培訓、評估、（重新） 審核員的資格和資格的維護。

3.5.1 INITIAL TRAINING AND EXPERIENCE 初始培訓和經驗
The CB shall ensure that trainee auditors or auditors transferring from other CBs are meeting the
following initial training and experience requirements:CB 應確保實習審核員或從其他 CB 轉來的審核員滿足 以下初始培訓和經驗要求：

1 ) Work Experience工作經歷

a) Experience in the food or associated industry including at least 2 years’ full-time work
in quality assurance or food safety functions in food production or manufacturing,
retailing, inspection or enforcement or the equivalent. 食品或相關行業的經驗，包括至少 2 年的全職工作 食品生產或製造中的質量保證或食品安全功能， 零售、檢查或執法或同等的。

2) Education 教育

a) Education: A degree in a food related or bioscience discipline or, as a minimum, has
successfully completed a food related or bioscience higher education course or equivalent.
教育：食品相關或生物科學學科的學位，或者至少具有 成功完成食品相關或生物科學高等教育課程或 相等的。

3) Training 培訓
a) Lead Auditor Course for FSMS or QMS – minimum 40 hours including exam;
FSMS 或 QMS 主任審核員課程——至少 40 小時，包括考試；

b) HACCP training – minimum 1 6 hours including exam; HACCP 培訓——至少 1-6 小時，包括考試；

c) ISO 22000 Standard – minimum 8 hours including exam (if not included as part of Lead Auditor Training Course);
ISO 22000 標準——至少 8 小時，包括考試（如果不包括在 Lead 中） 審核員培訓課程）；
d) Food defense training covering food defense threat assessment methodology and possible mitigation measures (including exam); 食品防護培訓，涵蓋食品防護威脅評估方法和 可能的緩解措施（包括考試）；

e) Food fraud training covering food fraud vulnerability assessment methodology and possible mitigation measures (including exam); 食品欺詐培訓，涵蓋食品欺詐脆弱性評估方法和 可能的緩解措施（包括考試）；

f) Standards - all relevant Scheme requirements (including exam); ISO/TS 22003 (Annex C), ISO 1 901 1 and ISO/IEC 1 7021 -1 (as applicable to the auditing processes of the CB including exam);標準——所有相關的方案要求（包括考試）； ISO/TS 22003（附件 C)、ISO 1 901 1 和 ISO/IEC 1 7021 -1（適用於 CB 的審核過程 包括考試）；

g) Training in the relevant PRP standard (including exam). 相關 PRP 標準的培訓（包括考試）。

4) Other 其他

a) Audits: a minimum of ten (1 0) audit days consisting of at least five (5) third-party food
safety audits that cover elements of FSMS, HACCP and PRP requirements in the relevant industry sector. The five (5) audits shall include at least two (2) FSSC 22000 audits under supervision of a FSSC qualified auditor and one (1 ) FSSC 22000 witness audit. Where an already qualified FSSC 22000 auditor moves from another CB, the two (2) audits under supervision are not required, only the FSSC 22000 witness audit. 審核：至少十 (1 0) 個審核日，包括至少五 (5) 個第三方食品 涵蓋 FSMS、HACCP 和 PRP 要求要素的安全審核 相關行業部門。五 (5) 次審核應包括至少兩 (2) 項 FSSC 22000 在 FSSC 合格審核員和一 (1) 名 FSSC 22000 見證人的監督下進行審核 審計。如果已經合格的 FSSC 22000 審核員從另一個 CB 調動，則兩個 (2)監督審核不需要，只需FSSC 22000見證審核。

b) For Category I: a primary qualification, a degree or higher certificate in packaging technology and a relevant certificate 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 training (minimum 30 hours) plus certificate in packaging technology that meets the requirements defined by WPO Packaging. This training shall include the following topics as a minimum:
對於 I 類：包裝方面的初級資格、學位或更高證書 技術和食品技術、食品衛生或相關方面的相關證書 科學科目或食品技術、食品安全/衛生方面的初級資格或 相關科學科目和培訓（至少 30 小時）以及包裝證書 符合 WPO 包裝規定要求的技術。本次培訓應 至少包括以下主題：
i. Basics of packaging principles and concepts;包裝原則和概念的基礎知識；

ii. Packaging legislation, standards, and regulations; 包裝立法、標準和法規；

iii. Packaging materials manufacturing; 包裝材料製造；

iv. Specifics to packaging of food/feed products; 食品/飼料產品包裝的具體規定；
v. Quality/food safety control and testing; 質量/食品安全控制和檢測；

vi. Printing processes and printing inks; 印刷工藝和印刷油墨；


vii. Packaging recycling and 包裝回收與

viii. Design of packaging materials. 包裝材料的設計。

c) FSSC 22000-Quality: be a qualified auditor for ISO/IEC 1 7021 -1 accredited ISO 9001 certification according to ISO/TS 22003 categories and ISO 9001 Food Sector codes. FSSC 22000-質量：成為 ISO/IEC 1 7021 -1 認可的 ISO 9001 合格審核員 根據 ISO/TS 22003 類別和 ISO 9001 食品行業規范進行認證。

3.5.2 INITIAL ASSESSMENT AND APPROVAL 初步評估和批准

1 ) The CB shall:認證機構應：

a) provide supervised training in food safety audits; 提供食品安全審核的監督培訓；

b) conduct a FSSC 22000 witnessed audit of the auditor to confirm competence is attained; and
對審核員進行 FSSC 22000 見證審核，以確認其具備能力；和

c) document the sign-off of the satisfactory completion of the training program and witnessed audit.
記錄圓滿完成培訓計劃和見證審核的簽字

2) The supervised training and the witnessed audit shall be conducted by an FSSC 22000 qualified auditor or a FSSC 22000 technical certification person of equivalent competence and experience.監督培訓和見證審核應由 FSSC 22000 合格審核員或具有同等能力和經驗的 FSSC 22000 技術認證人員進行。

3) Already qualified FSSC 22000 auditors moving from another CB shall always be subject to
a witness audit by the new CB as part of the approval process. Where the new CB deems
remote witnessing to be sufficiently robust, the new CB may use ICT to conduct the witness
audit remotely to approve the FSSC 22000 auditor. Refer to Annex 9 for more information.
從另一個 CB 轉來的已經合格的 FSSC 22000 審核員應始終受到 作為批准過程的一部分，由新 CB 進行的見證審核。新 CB 認定的地方 遠程見證足夠穩健，新的 CB 可以使用 ICT 進行見證 遠程審核以批准 FSSC 22000 審核員。有關更多信息，請參閱附件 9。
4) All FSSC 22000 auditors (including auditors in training) shall be registered in the Portal in accordance with the instructions of the Foundation. 所有 FSSC 22000 審核員（包括培訓中的審核員）應在門戶網站上註冊 按照基金會的指示。

3.5.3 ASSIGNMENT OF SUBCATEGORIES (INITIAL AND EXTENSION) 子類別的分配（初始和擴展）
1 ) After the initial approval auditors shall be approved/qualified per subcategory (see Part 1
table 1 ). In order to assign subcategories to an auditor, the CB shall demonstrate that the
auditor complies with the following requirements: 初步批准後，審核員應按子類別獲得批准/合格（見第 1 部分 表格1 ）。為了將子類別分配給審核員，CB 應證明 審核員符合以下要求：

a) Experience: 經驗：


i. Six (6) months’ work experience in the subcategory (where food safety or quality consultancy work is used to demonstrate work experience, the amount of man-days shall add up to six months) OR 六 (6) 個月的子類別工作經驗（如果使用食品安全或質量諮詢工作來證明工作經驗，則工作日的總和應為六個月）或

ii. Five (5) audits against a GFSI approved or recognized standard, Dutch HACCP or ISO 22000 in the subcategory as a qualified auditor OR作為合格審核員在子類別中根據 GFSI 批准或認可的標準、荷蘭 HACCP 或 ISO 22000 進行五 (5) 次審核或

iii. Five (5) audits against a GFSI approved or recognized standard, Dutch HACCP or ISO 22000 in the subcategory as a trainee under the supervision of a qualified auditor for the subcategory OR.根據 GFSI 批准或認可的標準、荷蘭 HACCP 進行五 (5) 次審核 或 ISO 22000 在子類別中作為受訓人員在 子類別的合格審核員或

iv. A combination of the above 以上的組合

b) demonstrated specific competence in the subcategory在子類別中表現出特定的能力

c) meeting the CB’s own competency criteria for the subcategory滿足 CB 自己的子類別能力標準

2) The CB shall have defined competency criteria for each subcategory to ensure knowledge
of products, processes, practices and applicable laws and regulations of the relevant
subcategory. Competence across the whole subcategory shall be demonstrated. Where
the CB further split up subcategories, it shall be clear for which parts of the subcategory
the auditor is qualified. CB 應為每個子類別定義能力標準以確保知識 產品、過程、實踐和適用的法律法規 子類別。應展示整個子類別的能力。在哪裡 CB進一步細分子類，應該明確子類的哪些部分 審核員是合格的。

3.5.4 MAINTENANCE OF AUDITOR QUALIFICATION 審核員資格的保持

3.5.4.1 AUDITS 審核


1 ) Each auditor shall perform at least five (5) FSSC 22000 audits at different organizations each calendar year, either as a lead or co-auditor. In this context, stand-alone stage 1 audits and special audits do not count. 每位審核員應在不同的組織中至少執行五 (5) 次 FSSC 22000 審核 每個日曆年，作為牽頭審計員或聯合審計員。在這種情況下，獨立階段 1 審計和特殊審計不算數

2) In the event when the requirement in (1 ) cannot be met, the CB shall ensure that the auditor has performed at least five (5) audits against an approved GFSI scheme (post-farm gate only except for food chain category A) of which at least one (1 ) FSSC 22000 audit either as a lead or co-auditor. The CB shall mark this auditor in the Portal as working under a temporary exemption arrangement with an appropriate justification. An exemption can be applied in the following cases:如果無法滿足 (1) 中的要求，CB 應確保 審核員已針對批准的 GFSI 計劃（農場後）進行了至少五 (5) 次審核 僅食品鏈類別 A 除外）其中至少一 (1) 次 FSSC 22000 審核 作為牽頭人或聯合審計員。 CB 應在門戶中將此審核員標記為在 有適當理由的臨時豁免安排。豁免可以 適用於以下情況

a) long term sickness of the auditor; 審核員長期患病；

b) extended leave (e.g. maternity, paternity, sabbatical); 延長假期（例如產假、陪產假、休假）；

c) lack of clients in the region/country* 該地區/國家缺乏客戶*


d) due to a serious event 由於嚴重事件

* For lack of clients the temporary exemption cannot be applied more than one year for the same auditor.
* 由於缺乏客戶，臨時豁免不能申請超過一年 同一個審計師。

3) In case an auditor has demonstrated he/she performed FSSC 22000 audits for another CB, these are also allowed to be included. In the event of point 2 or 3 above, the CB shall upload evidence of the audits in the Portal. 如果審核員證明他/她為另一個 CB 執行了 FSSC 22000 審核， 這些也被允許包括在內。如果出現上述第 2 點或第 3 點，CB 應 在門戶中上傳審計證據

3.5.4.2 ONGOING TRAINING 持續培訓

1 ) Auditors shall attend any relevant annual training, including those specified by the Foundation e.g. training, conference, seminars and/or network meetings in order to keep up-to-date with Scheme requirements, industry sector best practices, food safety and technological developments. 審核員應參加任何相關的年度培訓，包括由 基金會，例如培訓、會議、研討會和/或網絡會議，以保持 了解最新的計劃要求、行業最佳實踐、食品安全和 技術發展。

2) Auditors shall have access to and be able to apply relevant laws and regulation. The CB
shall maintain written records of all relevant training undertaken. 審計師應接觸並能夠應用相關法律法規。中央銀行 應保存所進行的所有相關培訓的書面記錄

3.5.4.3 WITNESSED AUDIT 見證審核
1 ) At least one (1 ) FSSC 22000 witnessed audit shall be conducted every three (3) years to confirm acceptable auditor performance. The witness audit shall be conducted at a full FSSC certification audit. Stand-alone Stage 1 , Follow-Up and Special Audits cannot be used as witness audits1) 至少應每三 (3) 年進行一 (1) 次 FSSC 22000 見證審核，以 確認可接受的審核員績效。見證審核應在完整的情況下進行 FSSC 認證審核。不能使用獨立的第 1 階段、跟進和特殊審核 作為見證審計。

2) A witness audit assessment report shall be completed by the witnessor to confirm performance of – as a minimum- the elements described for auditing activities in ISO/TS 22003:201 3 Table C1 . 見證審核評估報告應由見證人完成，以確認 至少執行 ISO/TS 中為審核活動描述的要素 22003:201 3 表 C1


3.5.4.4 AUDITOR REQUALIFICATION 審核員再認證

1 ) The overall auditor performance shall be evaluated every three (3) years in order to confirm the continued competence of the auditor. The following aspects shall be evaluated by the appointed supervisor of the CB prior to requalification:
應每三 (3) 年評估一次整體審核員績效，以便 確認審核員的持續能力。應從以下幾個方面進行評估 由 CB 指定的主管在重新獲得資格之前：
a) the auditor audit log; 審核員審核日誌；

b) the auditor training log; 審核員培訓日誌；

c) result of the witness audit. 見證審核的結果。
2) The evaluation shall consider the auditor’s overall performance, including complaints from clients.
評估應考慮審核員的整體表現，包括來自 客戶。

3) Documented sign-off of the satisfactory completion of the entire requalification process shall be uploaded in the Portal.
圓滿完成整個再認證過程的書面簽字 應上傳到門戶網站。
Note: Only one witnessed audit is required, irrespective of the number of categories/subcategories that the auditor is qualified in.注：只需要一次見證審核，無論有多少次 審核員有資格的類別/子類別。