PART 3
REQUIREMENTS
FOR THE
CERTIFICATION
PROCESS
CONTENTS PART 3 REQUIREMENTS FOR THE
CERTIFICATION PROCESS
1
Purpose
2
General
3
Resources
4
Contract process .
4.1
Application
4.2
Scope 5
4.3
Audit Duration
4.4
Contract
5
Planning and Managing Audits
5.1
General
5.2
Multiple functions across more than one site .
5.3
Multi-site certification .
5.4
Unannounced audits
5.5
Use of Information and Communication Technology
5.6
Transfer of certification .
5.7
Upgrade audits
5.8
Transition audits
5.9
Allocation of audit team
5.1 0
Management of serious events
6
Audit report
6.1
Written report
6.2
Nonconformities
7
Certification decision process
7.1
General
7.2
Certificate design and content
7.3
Certificate suspension, withdrawal or scope reduction .
8
Portal data and documentation .
1 PURPOSE 目的
This Part states the requirements for the execution of the certification process to be conducted by
licensed Certification Bodies (CBs).
Where reference to FSSC 22000 requirements is made, this is also applicable for FSSC 22000-
Quality unless stated otherwise.
本部分規定了執行認證過程的要求 許可的認證機構 (CB)。 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
2 GENERAL 一般
The CB shall manage its certification management system according to the requirements of
ISO/IEC 1 7021 -1 :201 5, ISO/TS 22003:201 3, and the FSSC 22000 requirements including any FSSC
Board of Stakeholder decisions.CB應根據以下要求管理其認證管理體系: ISO/IEC 1 7021 -1 :201 5、ISO/TS 22003:201 3 和 FSSC 22000 要求,包括任何 FSSC 利益相關者委員會的決定。
The CB shall control all Scheme related documentation and records according to its own
procedures.CB 應根據其自身控制所有方案相關文件和記錄 程序
The CB shall have procedures of certification that confirm the compliance of the certified
organizations.CB 應具有確認被認證產品符合性的認證程序 組織
3 RESOURCES 資源
The CB shall provide sufficient resources to enable the reliable supply of its FSSC 22000
certification service.CB 應提供足夠的資源以確保其 FSSC 22000 的可靠供應 認證服務
4 CONTRACT PROCESS 合同流程
4.1 APPLICATION 申請
The CB shall collect and document the information from the applicant organization in an
application form which details the minimum information as required in the ISO/IEC 1 7021 -1 and
ISO/TS 22003, and additional Scheme requirements.
CB 應收集並記錄來自申請組織的信息 申請表,其中詳細說明了 ISO/IEC 1 7021 -1 和 ISO/TS 22003 和其他方案要求。
4.2 SCOPE 範圍
The CB shall assess the scope proposed by the organization on the application form and review it
against the requirements in Annex 1 .
CB應對組織在申請表上提出的範圍進行評估,並進行審核 違背附件 1 的要求
4.3 AUDIT DURATION 審核時間
The CB shall calculate the audit duration based on the information gathered from the
organization’s application and following the requirements of ISO/IEC 1 7021 -1 , ISO/TS 22003 and
FSSC 22000 as follows:
CB 應根據從 組織的應用並遵循 ISO/IEC 1 7021 -1、ISO/TS 22003 和 FSSC 22000 如下
a) The duration of an audit day normally is eight (8) hours; the effective audit duration does
not include a lunch break (unless in contradiction with local legislation);
a) 審核日的持續時間通常為八 (8) 小時;有效審計持續時間 不包括午休時間(除非與當地立法相抵觸)
b) The audit duration calculation for FSSC 22000 shall be documented by the CB, including
justifications for reduction or addition of time based on the minimum audit duration;
FSSC 22000 的審核持續時間計算應由 CB 記錄,包括 根據最短審核持續時間減少或增加時間的理由
c) The audit duration shall be stated in auditor working hours indicating the effective audit
time based on the audit plan. Deviations to the audit durations and audit plan shall be
recorded (including motivations);
審核持續時間應以審核員工作時間表示,表明審核有效時間以審核計劃為準。審核持續時間和審核計劃的偏差應記錄(包括動機)
d) The audit duration does not include planning, reporting or travel activities, only actual
auditing time;
審核持續時間不包括計劃、報告或旅行活動,僅包括實際 審核時間
e) The audit time shall only apply to auditors that are fully qualified, registered FSSC 22000
auditors;
審核時間應僅適用於完全合格、已註冊 FSSC 22000 的審核員 核數師
f) Where the FSSC 22000 audit is undertaken in combination or integration with other food
safety audits as a combined audit, the audit duration stated in the report shall be of the
total combined audit and be aligned with the audit plan. Total audit duration is then longer
than for FSSC 22000 alone. This is considered as an increase in audit duration and the
reason for this shall be justified.
如果 FSSC 22000 審核是與其他食品結合或整合進行的 安全審核作為合併審核,報告中註明的審核時間應為 合計審計並與審計計劃保持一致。總審計持續時間更長 比單獨的 FSSC 22000。這被認為是審計持續時間的增加和 這樣做的理由應該是正當的。
4.3.1 BASIC AUDIT TIME CALCULATION (SINGLE SITE)基本審核時間計算(單個站點)
The total audit duration/site audit time (for a single site) is defined as T s + T FSSC where:
總審核持續時間/站點審核時間(針對單個站點)定義為 T s + T FSSC,其中
a) T s = (T D + T H + T MS + T FTE ) calculated according to ISO/TS 22003:201 3; and
b) T FSSC shall be calculated as follows: 計算如下
i) 0.5 auditor day (4 working hours) when the company has less than 250 FTE and 1 or 2
HACCP studies. 當公司少於 250 FTE 和 1 或 2 HACCP研究
ii) 1 .0 auditor day (8 working hours) when the organization has 250 FTE or more; or 3
HACCP studies or more. 當組織擁有 250 FTE 或更多時,1 .0 個審核員日(8 個工作小時);或 3 HACCP 研究或更多。
When properly documented and justified, a reduction of the T s audit time can be made in
accordance with ISO/TS 22003:201 3, Annex B. The reduction in T s audit time can never be more
than 0.25 auditor day (2 working hours) and the T s cannot be reduced below 1 day. The reduction
cannot be applied on T FSSC 如果有適當的記錄和證明,可以減少 T 的審核時間 符合 ISO/TS 22003:201 3, Annex B. T 審核時間的減少再多不過了 超過 0.25 個審核員日(2 個工作小時)並且 T 不能減少到 1 天以下。減少 不能應用於 T FSSC
.
Preparation and reporting time shall be in addition to the audit time:審核時間之外的準備和報告時間
a) At least 0.25 auditor day (2 working hours) shall be added to the FSSC 22000
site audit time for audit preparation.FSSC 22000 應至少增加 0.25 個審核員日(2 個工作小時) 審核准備現場審核時間
b) At least 0.5 auditor day (4 working hours) additional shall be added to the FSSC 22000 site
audit time for audit reporting.FSSC 22000 現場應額外增加至少 0.5 個審核員日(4 個工作小時) 審計報告的審計時間。
If after the calculation the result is a decimal number, the exact hours may be used or where
rounding is applied to the number of days, this shall be rounded upwards to the nearest half day
(e.g. 5.3 audit days becomes 5.5).
如果計算後的結果是十進制數,則可以使用確切的小時數或 四捨五入適用於天數,這應向上舍入到最接近的半天 (例如 5.3 個審計日變為 5.5 個)
4.3.2 SURVEILLANCE AND RECERTIFICATION AUDITS 監督和再認證審核
a) Surveillance audits: audit duration shall be (one-third of T s ) + (T FSSC ), plus any other
additional audit time (as per §4.3.4 below).
監督審核:審核持續時間應為(T s 的三分之一)+(T FSSC ),加上任何其他 額外的審核時間(根據下面的 §4.3.4)
b) Recertification audits: audit duration shall be (two-thirds of T s ) + (T FSSC ), plus any other
additional audit time (as per §4.3.4 below).
再認證審核:審核持續時間應為(T s 的三分之二)+(T FSSC ),加上任何其他 額外的審核時間(根據下面的 §4.3.4)
Additional (special) audits may be performed on top – but never as a replacement of the annual
surveillance/recertification audits. These special audits shall be documented and uploaded in the
Portal.
附加(特殊)審計可以在最重要的基礎上進行但絕不能取代年度審計監督/再認證審核。這些特殊審核應記錄在案並上傳到門戶網站
4.3.3 MINIMUM AUDIT DURATION 最短審核時間
For all audit types (initial, surveillance, recertification), the following minimum audit duration rules
apply:對於所有審核類型(初始、監督、再認證),以下最短審核持續時間規則 申請
a) The minimum T s is 1 day as per ISO/TS 22003, Annex B.根據 ISO/TS 22003 附錄 B,最小 T s 為 1 天
b) The minimum basic FSSC 22000 audit duration is then 1 .5 - 2 days depending on the FSSC
additional time (refer 4.3.1 b); however, for categories C, D, I and K the minimum audit
duration shall always be 2 days;FSSC 22000 的最短基本審核持續時間為 1 .5 - 2 天,具體取決於 FSSC 額外時間(參考 4.3.1 b);然而,對於類別 C、D、I 和 K,最低審計 持續時間應始終為 2 天
c) The minimum audit duration for the annual audits shall always be respected.
應始終遵守年度審核的最短審核時間。
The following exemptions apply to the minimum audit durations:以下豁免適用於最短審核持續時間
a) For organizations with simple processes, having 5 FTE or less and maximum 1 HACCP
study, further reductions are allowed, but the total time T s + T FSSC shall be minimum one
day for all audit types.對於流程簡單的組織,擁有 5 個或更少的 FTE 和最多 1 個 HACCP 研究,允許進一步減少,但總時間 T s + T FSSC 應至少為一 所有審計類型的一天
b) For organizations in category C, D, I or K that have simple processes, less than 20 FTE and
maximum 1 HACCP study, further reductions are allowed to a minimum audit duration of
1 .5 days for all audit types.對於流程簡單的 C、D、I 或 K 類組織,少於 20 FTE 和 最多 1 個 HACCP 研究,允許進一步減少到最短審核時間 所有審核類型為 1 .5 天
c) For subcategory A, ISO/TS 22003:201 3 states a minimum audit duration of 0.5 days, the
minimum FSSC 22000 audit duration for this category shall be 1 day.
對於子類別 A,ISO/TS 22003:201 3 規定最短審核時間為 0.5 天, 此類別的最短 FSSC 22000 審核時間應為 1 天。 如果應用
Where any of the exemptions above are applied, the CB shall ensure that the audit duration allows
for an effective audit, covering the full FSSC 22000 requirements.
上述任何豁免,CB 應確保審核持續時間允許 進行有效審核,涵蓋完整的 FSSC 22000 要求
4.3.4 ADDITIONAL AUDIT TIME 額外審核時間
Additional time shall be required for the following situations: 以下情況需要額外時間
a) Separate Head Office 獨立的總部
i. For organizations where some functions pertinent to the certification are
controlled by a Head Office separate to the manufacturing site(s), the minimum
time shall be 0.5 auditor day (4 working hours) to audit the functions pertinent
to the certification at the Head Office.對於一些與認證相關的職能是 由與製造地點分開的總部控制,最低限度 時間應為 0.5 個審核員日(4 個工作小時)來審核相關功能 去總部辦證
ii. When the responsible person from the Head Office attends the audit at
manufacturing site, no extra audit time is calculated. 總行負責人參加審計時 生產現場,不計算額外審核時間
iii. A maximum of 20% audit time reduction can be allowed for each of the single
manufacturing sites belonging to the group where the shared functions are
controlled by the (off-site) Head Office. The 20% audit time reduction is applied
to the minimum audit time (T s ) as per ISO/TS 22003:201 3, Annex B.每個單項最多可減少 20% 的審核時間 屬於共享功能的組的製造站點 由(異地)總部控制。減少 20% 的審核時間 符合 ISO/TS 22003:201 3,附錄 B 的最短審核時間 (T s )。
b) Off-site activities 場外活動
Where off site manufacturing or service activities take place (see §5.2.2), a 50% audit time
reduction of T s may be applied for each additional site OR the parameters of the off-site
activities shall be included in the audit calculation as under §4.3 and travel time between
locations shall be included in the audit plan.
在場外製造或服務活動發生的地方(參見§5.2.2),50% 的審核時間 減少 T s 可以應用於每個額外的站點或場外參數 活動應包括在 §4.3 下的審計計算中,並且之間的旅行時間 地點應包括在審核計劃中
For off-site storage: At least 0.25 auditor day (2 working hours) additional audit time shall
be added to the FSSC 22000 audit time for each off-site storage facility.
對於場外存儲:應至少增加 0.25 個審核員日(2 個工作小時)的額外審核時間 被添加到每個場外存儲設施的 FSSC 22000 審核時間中。
Cross docking is considered as an off-site activity which is covered by FSSC Part 3, section
交叉對接被視為 FSSC 第 3 部分第 1 節涵蓋的場外活動
5.2.2 with the exclusion of the last phrase of section 5.2.2, 1 , which is the requirement with
regard to the sole receiver/customer relationship. The requirements including audit
duration calculations related to off-site activities may be applied for cross docking.
Transshipment is not covered in this requirement.
排除第 5.2.2 節 1 的最後一句,這是要求 關於唯一接收者/客戶關係。審核要求 與場外活動相關的持續時間計算可適用於越庫配送。 此要求不包括轉運。
c) Additional time shall be considered in case an interpreter is required to support the
audit team.
如果需要口譯員支持,則應考慮額外時間 審核組
4.3.5 FSSC 22000-QUALITY 質量
a) The audit time for the ISO 9001 part of the audit shall be calculated using IAF MD 5.
ISO 9001 審核部分的審核時間應使用 IAF MD 5 計算
b) The audit duration for the integrated FSSC 22000 and ISO 9001 audit shall be based on IAF
MD 1 1 :201 9, section 2.2, to which T FSSC shall be added.
FSSC 22000 和 ISO 9001 綜合審核的審核持續時間應基於 IAF MD 1 1 :201 9,第 2.2 節,應向其中添加 T FSSC
4.3.6 TRANSITION TO FSSC 22000 過渡到 FSSC 22000
1 ) When transitioning from ISO 22000 or an equivalent GFSI recognized certification to FSSC
22000 certification, the minimum FSSC 22000 certification audit duration shall be two-
thirds of the initial certification audit time, with a minimum of 1 auditor day (8 working
hours plus T FSSC as defined in §4.3.1 .
從 ISO 22000 或同等 GFSI 認可的認證過渡到 FSSC 22000 認證,最短 FSSC 22000 認證審核持續時間應為兩次 - 初始認證審核時間的三分之一,至少 1 個審核員日(8 個工作 小時加上 §4.3.1 中定義的 T FSSC。
The transition audit shall result in an FSSC 22000 certificate with a validity of three (3) years.
轉換審核應產生有效期為三 (3) 年的 FSSC 22000 證書。
2) Transition to FSSC 22000-Quality is only possible when the organization has a valid ISO
22000 or FSSC 22000 certificate AND a valid ISO 9001 certificate. In this case, the audit
duration is two-thirds of the initial combined audit time (see 4.3.5.) plus T FSSC .
只有當組織擁有有效的 ISO 時,才有可能過渡到 FSSC 22000-質量 22000 或 FSSC 22000 證書和有效的 ISO 9001 證書。在這種情況下,審計 持續時間是初始聯合審核時間(見 4.3.5)的三分之二加上 T FSSC
4.4 CONTRACT 合同
A certification contract shall be in place between the CB and the organization applying for
certification, detailing the scope of the certificate, and referring to all relevant Scheme
requirements.CB 和申請認證的組織之間應簽訂認證合同 認證,詳細說明證書的範圍,並參考所有相關方案 要求
This contract shall detail or have reference to the agreements between the CB and the
organization which shall include but are not limited to:本合同應詳細說明或參考 CB 與 CB 之間的協議 組織包括但不限於
1 ) Ownership of the certificate and the audit report content shall be held by the CB;證書和審核報告內容的所有權歸CB所有
2) Conditions under which the certification contract can be terminated; 認證合同可以終止的條件
3) Conditions under which the certificate can be used by the certified organization;獲證組織可以使用證書的條件
4) Terms of confidentiality in relation to information gathered by the CB during the
certification process;
與 CB 在審核期間收集的信息相關的保密條款 認證過程
5) The certified organization allows the CB to share information relating to the certification
and auditing process with the Foundation, GFSI and governmental authorities when
required;
獲證組織允許CB共享與認證相關的信息 必要時與基金會、GFSI 和政府機構進行審計
6) Procedures for nonconformity management; 不合格管理程序
7) Procedures for complaints and appeals; 投訴和申訴程序
8) Inclusion of information on the certified status of the organization on the FSSC 22000
website and in the Portal;在 FSSC 22000 中包含有關組織認證狀態的信息 網站和門戶網站
9) Cooperation in allowing witness assessments by the AB and/or the Foundation when requested;
合作允許 AB 和/或基金會根據要求進行見證評估
1 0) Communication obligations of certified organizations to the CB within 3 working days
related to the following:獲證組織在3個工作日內與CB的溝通義務 與以下相關
a) Any significant changes that affect the compliance with the Scheme requirements
and obtain advice of the CB in cases where there is doubt over the significance of
a change;影響符合方案要求的任何重大變化 並在懷疑其重要性的情況下獲得 CB 的建議 改變
b) Serious events that impact the FSMS or FSQMS, legality and/or the integrity of the
certification which include legal proceedings, prosecutions, situations which pose
major threats to food safety, quality or certification integrity as a result of natural
or man-made disasters (e.g. war, strike, terrorism, crime, flood, earthquake,
malicious computer hacking, etc.);
影響 FSMS 或 FSQMS、合法性和/或完整性的嚴重事件 認證,包括法律訴訟、起訴、情況 由於天然因素對食品安全、質量或認證完整性構成重大威脅 或人為災難(例如戰爭、罷工、恐怖主義、犯罪、洪水、地震、 惡意電腦入侵等)
c) Public food safety events (such as e.g. public recalls, calamities, food safety
outbreaks, etc.); 公共食品安全事件(例如公共召回、災難、食品安全 爆發等)
d) Changes to organization name, contact address and site details;公共食品安全事件(例如公共召回、災難、食品安全爆發等)
e) Changes to organization (e.g. legal, commercial, organizational status or
ownership) and management (e.g. key managerial, decision-making, or technical
staff);組織的變化(例如法律、商業、組織地位或 所有權)和管理(例如關鍵管理、決策或技術 職員);
f) Changes to the management system, scope of operations and product categories
covered by the certified management system;
管理體系、經營範圍和產品類別的變更 被認證的管理體系覆蓋
g) Any other change that renders the information on the certificate inaccurate.
任何其他導致證書信息不准確的變更
5 PLANNING AND MANAGING AUDITS 計劃和管理審核
5.1 GENERAL 總則
1 ) Annual audits shall take place to ensure certificate validity or that recertification is granted
before the expiry date of the certificate.應進行年度審核以確保證書有效性或重新認證被授予 在證書到期日之前
2) The annual audit shall be carried out at the premises of the organization and is a full audit
against all Scheme requirements. Surveillance audits shall be conducted within the
calendar year as per the requirements of ISO/IEC 1 7021 -1 .
年度審核應在組織場所進行,是一次全面審核 反對所有方案要求。監督審核應在 符合 ISO/IEC 1 7021 -1 要求的日曆年
3) The audit shall be conducted over a continuous number of days in accordance with the
audit duration calculated. Where the ICT Audit Approach is utilized, the requirements of
Annex 9 apply.審核應根據 審計持續時間計算。在使用 ICT 審計方法的情況下,要求 附件9 適用
4) The audit shall be carried out in a mutually agreed language. An interpreter may be added
to the team by the CB to support members of the audit team.
審核應以雙方同意的語言進行。可以增加一名口譯員 由 CB 向審核組成員提供支持
5) The CB is expected to operate discretely in case of emergencies (e.g. fire, major
catastrophic event, another audit on-going).CB 預計在緊急情況下獨立運作(例如火災、重大 災難性事件,另一項審計正在進行中)
6) The CB shall perform the stage 1 and stage 2 audits for initial certification according to the
requirements of ISO/IEC 1 7021 -1 CB 應根據 ISO/IEC 1 7021 -1 的要求.
7) The interval between stage 1 and stage 2 audits shall not be longer than 6 months. The
Stage 1 shall be repeated if a longer interval is needed.第一階段審核與第二階段審核的間隔時間不得超過 6 個月。這 如果需要更長的間隔,應重複第 1 階段
8) The 3-year certification cycle (ISO/IEC 1 7021 -1 §9.1 .3) shall be respected.
應遵守 3 年認證週期 (ISO/IEC 1 7021 -1 §9.1 .3)
5.2 MULTIPLE FUNCTIONS ACROSS MORE THAN ONE
SITE 跨多個站點的多種功能
5.2.1 HEAD OFFICE FUNCTIONS 總部職能
1 ) In all cases where functions pertinent to the certification are controlled by a Head Office
(such as procurement, supplier approval, quality assurance etc.), the Scheme requires that
those functions are audited, interviewing the personnel described in the food safety
management system as having the (delegated) authority and responsibility for these
functions. This Head Office audit shall be documented.
在與認證相關的職能由總部控制的所有情況下 (如採購、供應商批准、質量保證等),該計劃要求 審核這些職能,與食品安全中描述的人員面談 管理系統對這些具有(委派的)權力和責任 功能。該總部審核應記錄在案
2) The functions at the Head Office shall be audited separately where they are not part of a
site being assessed. 總部的職能如果不屬於某個部門的一部分,則應單獨進行審計 正在評估的站點
3) Every site belonging to the group shall have a:屬於該組的每個站點應具有
a. Separate audit,單獨審計
b. Separate report and 單獨報告和
c. Separate certificate 單獨的證書
4) The Head Office audit shall be carried out prior to the site audit(s).總部審核應在現場審核之前進行
5) The subsequent audit at the site(s) shall include a confirmation that the requirements set
out by Head Office are appropriately incorporated into site specific documents and
implemented in practice. 現場的後續審核應包括對要求設定的確認 由總部出局適當地納入現場特定文件和 落實到實踐中
6) The site audit reports and certificates shall show which FSMS functions and/or processes
have been audited at the Head Office.現場審核報告和證書應顯示哪些 FSMS 功能和/或過程 已在總部審核
7) All individual sites shall be audited within a time frame of 1 2 months from the audit of the
Head Office.應在審計後的 1 2 個月內對所有單個場所進行審計 總公司
8) The Head Office cannot receive a separate certificate.總公司無法獲得單獨的證書
9) The Head Office is mentioned on the site certificate by use of wording such as
“ This audit included the following central FSMS processes managed by (name and location of Head
Office): (describe FSMS processes audited at the Head Office) ”
總公司在現場證書上使用諸如以下的措辭提及 “ 該審核包括以下由(負責人的姓名和位置)管理的中央 FSMS 流程 辦公室):(描述在總部審核的 FSMS 流程)
5.2.2 OFF-SITE ACTIVITIES 場外活動
1 ) Where one manufacturing or service process is split across more than one physical
address, all locations may be covered in one audit provided that the different addresses
are part of the same legal entity, under the same FSMS and that they are the sole
receiver/customer of each other.一個製造或服務過程被拆分為多個物理過程 地址,所有位置都可以包含在一次審計中,前提是不同的地址 是同一法人實體的一部分,在同一 FSMS 下,並且它們是唯一的 彼此的接收者/客戶
2) Storage facilities at another location shall also be included in the same audit provided they
meet the requirements mentioned above.另一個地點的儲存設施也應包括在同一審核中,前提是它們 滿足上述要求
3) The scope statement shall show the audited locations with activities per location (on the
certificate or as an Annex to the certificate).範圍說明書應顯示每個地點的活動(在 證書或作為證書的附件)
4) The audit report shall include all relevant requirements at all locations and allow audit
findings to be identified as site specific.審核報告應包括所有地點的所有相關要求,並允許審核 結果被確定為特定站點
5.3 MULTI-SITE CERTIFICATION 多站點認證
5.3.1 GENERAL 總則
a) Multi-site certification (including sampling) is only allowed for the following food chain (sub)categories:
多站點認證(包括抽樣)僅允許用於以下食物鏈(子)類別:
• A – Animal Farming 動物養殖
• E – Catering 餐飲
• FI – Retail/wholesale 零售/批發
• G – Storage and distribution. 儲存和分配
b) When applying multi-site certification all requirements of IAF MD 1 shall be met, except:
當申請多地點認證時,應滿足 IAF MD 1 的所有要求,除了
• Paragraph 6.1 .3 (size of sample). This IAF MD 1 paragraph shall be replaced by the ISO/TS
22003:201 3 sampling regime paragraph 9.1 .5.4.第 6.1 .3 段段(樣本大小)。 IAF MD 1 段應由 ISO/TS 取代 22003:201 3 抽樣制度第 9.1 .5.4 段
• Paragraph 7.3: For audit time calculation see 4.3.3 where the same principles for a Head
Office can be used for the central function.
第 7.3 段:對於審計時間的計算,請參見 4.3.3,其中與主管的原則相同 辦公室可用於中央功能。
c) A multi-site organization need not be a unique legal entity, but all sites shall have a legal or
contractual link with the central function of the organization and be subject to a single
management system, which is laid down, established and subject to continuous surveillance
and internal audits by the central function. 多站點組織不必是唯一的法人實體,但所有站點都應具有合法或 與組織的核心職能的合同聯繫,並受制於單一的 制定、建立並接受持續監督的管理體系 中央職能部門的內部審計
d) The central function shall be audited at least annually and before the CB audits of the
(sampled) sites. If necessary, a small number of the sample sites may be audited prior to the
audit of the central function.
中央職能應至少每年審核一次,並在 CB 審核之前 (抽樣)網站。如有必要,可在審核之前審核少量樣本站點 審計中央職能
e) One audit report may be produced for the multi-site organization, including the central
function information, specific information about each site audited and complying with the
content of Annex 2 or Annex 3 (FSSC 22000-Quality). The summary sections of the audit report
shall clearly reflect what was audited at each site with supporting objective evidence.
Alternatively, separate reports may be produced for the Central function and each of the sites,
respectively.可以為多站點組織生成一份審計報告,包括中央 功能信息,每個站點的特定信息被審核並遵守 附件 2 或附件 3(FSSC 22000-質量)的內容。審計報告的摘要部分 應清楚地反映在每個站點審核的內容,並提供客觀證據支持。 或者,可以為中央功能和每個站點生成單獨的報告, 分別
f) The certificate shall be a group certificate.證書應為團體證書
5.3.2 SAMPLING METHODOLOGY 抽樣方法
a) The sampling requirements as set out in ISO/TS22003: 201 3, paragraph 9.1 .5.4 shall form
the basis for determining the sample size. In addition, the risk categories and performance
of the sites shall be considered and might result in an increase in the sample size. ISO/TS22003:201 3, paragraph 9.1 .5.4 中規定的抽樣要求應形成 確定樣本量的依據。此外,風險類別和績效 應考慮站點的數量,並可能導致樣本量增加。
b) Where sites are added to the group, an audit is required before adding them to the
certificate – either as a special audit or as part of the annual audit.
如果站點被添加到組中,則在將它們添加到組之前需要進行審核 證書——作為特殊審計或作為年度審計的一部分
c) Once every 3 years, the annual audit shall be conducted fully unannounced as set out in
Part 3, section 5.4.1 , including the central function and the site audits.
每 3 年一次,年度審計應按照 第 3 部分,第 5.4.1 節,包括中央職能和現場審核
5.3.3 REQUIREMENTS FOR THE CENTRAL FUNCTION
對中心功能的要求
a) The central function shall hold the contract with the CB and request to include multi-site
sampling as part of the application process should they wish to include it.
中央職能應持有與 CB 的合同,並要求包括多站點 如果他們希望將抽樣作為申請過程的一部分。
b) It is the responsibility of the central function to ensure management commitment to the
FSMS and have sufficient resources and technical capacity in place to support the system
and the internal audit program. The central function shall be impartial from the sites (e.g.
have different/ dedicated employees, governance, management etc.). 中央職能部門有責任確保管理層對 FSMS 並擁有足夠的資源和技術能力來支持該系統 和內部審計程序。中心功能應與站點保持中立(例如 有不同/敬業的員工、治理、管理等)
c) The central function shall take responsibility for coordinating, addressing, and closing out
of nonconformities raised at site level in conjunction with the relevant sites. Failure of the
central function or any of the sites to meet the Scheme requirements, shall result in the
whole organization, including the central function and all sites, not gaining certification.
Where certification has previously been in place, this shall initiate the CB process to
suspend or withdraw the certification.中央職能應負責協調、解決和收尾 與相關站點一起在站點級別提出的不符合項。失敗的 滿足方案要求的中央功能或任何站點,應導致 整個組織,包括中央職能部門和所有站點,都沒有獲得認證。 如果先前已進行認證,則應啟動 CB 流程以 暫停或撤銷認證
5.3.4 NONCONFORMITY MANAGEMENT 不合格管理
Nonconformities raised at multi-site organizations (refer section 5.3) shall follow the requirements
of the Scheme as well as those in IAF MD1 , section 7.7 with the following specific requirements in
addition:
在多站點組織(參見第 5.3節)提出的不符合項應遵循要求該計劃以及IAF MD1中的那些,第 7.7節具有以下具體要求添加
a) Where a critical nonconformity is identified, the certificate of the multi-site organization
shall be suspended within 3 working days of issuing the critical nonconformity, regardless
of whether or not all the site audits have been completed.
如果發現嚴重不合格,多站點組織的證書 應在發布嚴重不符合項後 3 個工作日內暫停,無論 是否已完成所有現場審核
b) Where a major nonconformity is identified and the audit takes more than 30 calendar days
to complete (central function and site audits), the organization shall provide a corrective
action plan including any temporary measures or controls necessary to mitigate the risk
until the nonconformity can be closed.
當發現嚴重不符合且審核時間超過 30 個日曆日時 為完成(中心職能和現場審核),組織應提供糾正措施 行動計劃,包括減輕風險所需的任何臨時措施或控制措施 直到可以關閉不合格。
c) The timeline for closure of nonconformities start at the end of the audit – after completion
of the central function audit and all the site audits.
關閉不符合項的時間表從審核結束時開始——完成後 中央職能審核和所有現場審核
5.4 UNANNOUNCED AUDITS 突擊審核
5.4.1 FREQUENCY 頻率
1 ) The CB shall ensure that for each certified organization at least one surveillance audit is
undertaken unannounced after the initial certification audit and within each three (3) year
period thereafter.CB 應確保每個獲證組織至少進行一次監督審核 在初始認證審核後和每三 (3) 年內不通知地進行 此後的時期
2) The certified organization can voluntarily choose to replace all surveillance audits by
unannounced annual surveillance audits. Recertification audits may be conducted
unannounced at the request of the certified organization.
獲證組織可以自願選擇通過以下方式代替所有監督審核 突擊年度監督審計。可以進行再認證審核 應獲證組織的要求不予通知
3) The initial certification audit (stage 1 and stage 2) cannot be performed unannounced.
初始認證審核(第 1 階段和第 2 階段)不能未經通知進行
5.4.2 EXECUTION 執行
1 ) The CB determines the date of the unannounced audit as part of the audit program.
CB 將突擊審核的日期確定為審核計劃的一部分
2) The site shall not be notified in advance of the date of the unannounced audit and the
audit plan shall not be shared until the opening meeting. In exceptional cases where
specific visa restrictions apply, contact with the certified organization may be needed as
part of the visa application process. However, the exact dates of the unannounced audit
shall not be confirmed, only a time window.
不得提前通知現場不通知的飛行審核日期和 審計計劃在開幕會議之前不得共享。在特殊情況下 適用特定簽證限制,可能需要與認證組織聯繫 簽證申請流程的一部分。但是,突擊審計的確切日期 不得確認,只是一個時間窗口
3) The unannounced audit takes place during normal operational working hours including
night shifts when required.突擊審核發生在正常工作時間,包括 需要時上夜班
4) Blackout days may be agreed in advance between the CB and the certified organization.CB 和獲證組織可以提前商定停電日
5) The audit will start with an inspection of the production facilities commencing within 1
hour after the auditor has arrived on site. In case of multiple buildings at the site the
auditor shall, based on the risks, decide which buildings/facilities shall be inspected in
which order.審核將從 1 天內開始的生產設施檢查開始 審核員到達現場後一小時。如果現場有多個建築物, 審核員應根據風險決定應檢查哪些建築物/設施 哪個訂單。
6) All Scheme requirements shall be assessed including production or service processes in
operation. Where parts of the audit plan cannot be audited, an (announced) follow-up
audit shall be scheduled within 4 weeks.
應評估所有計劃要求,包括生產或服務流程 手術。如果審核計劃的某些部分無法審核,則(宣布的)跟進 審計應安排在 4 週內。
7) The CB decides which of the surveillance audits shall be chosen for the unannounced audit
taking into consideration the requirement that unannounced audits shall be conducted at
least once every 3 years and adhering to the calendar year requirement.
CB 決定選擇哪些監督審核進行不通知審核 考慮到突擊審核應在以下時間進行的要求 至少每 3 年一次,並遵守日曆年的要求
8)If the certified organization refuses to participate in the unannounced audit, the certificate
shall be suspended immediately, and the CB shall withdraw the certificate if the
unannounced audit is not conducted within a six-month timeframe from the date refusal.
如果獲證組織拒絕參加飛行審核,證書 應立即暫停,CB 應撤銷證書,如果 自拒絕之日起六個月內未進行突擊審計
9) The audit of separate Head offices controlling certain FSMS processes pertinent to
certification separate to the site(s) (see 5.2.1 ) shall be announced. Where Head Office
activities are part of a site audit, they shall be unannounced.對控制與以下產品相關的某些 FSMS 流程的獨立總部進行審計 與現場分開的認證(見 5.2.1)應公佈。總部所在地 活動是現場審核的一部分,應不通知
1 0) Secondary sites (off-site activities) and off-site storage, warehouses and distribution
facilities shall also be audited during the unannounced audit.
二級站點(場外活動)和場外儲存、倉庫和配送 還應在突擊審核期間對設施進行審核
5.5 USE OF INFORMATION AND COMMUNICATION
TECHNOLOGY 信息和通信技術的使用
Information and Communication Technology (ICT) may be used as a remote auditing tool during
FSSC 22000 audits with the following applications and meeting the applicable requirements of IAF
MD4:信息和通信技術 (ICT) 可用作遠程審計工具 FSSC 22000 審核以下應用並滿足 IAF 的適用要求 MD4:
1 ) For conducting interviews with people and review of policies, procedures, or records as
part of the on-site audit;與人面談和審查政策、程序或記錄 現場審核的一部分
2) When utilizing the ICT Audit Approach as set out in Annex 9.當使用附件 9 中規定的 ICT 審計方法時
5.6 TRANSFER OF CERTIFICATION 認證轉移
The CB shall follow the requirements of IAF MD2 for the transfer of certified organizations from
another CB. CB 應遵循 IAF MD2 的要求,將獲證組織從 另一個CB
5.7 UPGRADE AUDITS 升級審核
The Foundation will issue instructions when upgrade audits are required. This typically occurs
when there is a significant change to the Scheme requirements.
The CB shall: 當需要進行升級審計時,基金會將發出指示。這通常發生 當計劃要求發生重大變化時。 認證機構應
1 ) Follow the upgrade requirements as issued by the Foundation;遵循基金會發布的升級要求;
2) Ensure all staff and auditors are familiar with the upgrade process; 確保所有員工和審核員熟悉升級過程
3) Additional audit time shall be recalculated and advised to the clients where applicable;
額外的審核時間應重新計算並在適用時通知客戶
4) Following the successful upgrade audit (including closure of nonconformities) the
certificate will be re-issued when required as part of the upgrade requirements.
升級審核成功後(包括關閉不合格項) 作為升級要求的一部分,證書將在需要時重新頒發
5.8 TRANSITION AUDITS
1 ) Transition audits are allowed from ISO 22000 and GFSI recognized certification programs
with equivalent scopes. For FSSC 22000-Quality, transition audits are allowed for
organizations holding a valid ISO 22000, FSSC 22000 and a valid ISO 9001 certificate (see
section 4.3.5 for audit duration).ISO 22000 和 GFSI 認可的認證項目允許進行轉換審核 具有等效範圍。對於 FSSC 22000-質量,允許進行轉換審核 持有有效 ISO 22000、FSSC 22000 和有效 ISO 9001 證書的組織(參見 4.3.5 節審計持續時間)
2) Transition audits are the start of a new certification cycle and shall therefore be a stage 2
audit (a stage 1 may be performed at the discretion of the CB).
轉換審核是新認證週期的開始,因此應為第 2 階段 審核(第 1 階段可由 CB 自行決定執行)
3) The FSSC 22000 certificate/FSSC 22000-Quality certificate issued shall have a validity of 3 years.
頒發的FSSC 22000證書/FSSC 22000-Quality證書有效期為3年
5.9 ALLOCATION OF AUDIT TEAM 審核組的分配
1 ) All audit team members shall meet the competence requirements set out by the
Foundation in Part 4 chapter 3.所有審核組成員應滿足審核組規定的能力要求 第 4 部分第 3 章中的基礎。
2) The audit team shall have the combined competence for the food chain sub-categories
supporting the scope of the audit and following the requirements of ISO/IEC 1 7021 -1 .
審核組應具備食品鍊子類別的綜合能力 支持審核範圍並遵循 ISO/IEC 1 7021 -1 的要求。
3) The FSSC 22000-Quality audit is a fully integrated audit and the audit team shall meet the
competence requirements set out by the Foundation in Part 4 of the Scheme.
FSSC 22000-質量審核是完全整合的審核,審核組應滿足 基金會在計劃第 4 部分中規定的能力要求。
4) The lead auditor shall always be a FSSC 22000 qualified auditor.首席審核員應始終是 FSSC 22000 合格審核員。
5) An auditor is not allowed to perform more than two 3-year certification cycles at the same
certified site either as lead auditor or co-auditor. If an auditor starts auditing within a
certification cycle, he/she will be rotated out after six (6) years for a minimum of one year.
審核員不得同時執行兩個以上的 3 年認證週期 經認證的場所作為主任審核員或聯合審核員。如果審核員在一個範圍內開始審核 認證週期,他/她將在六(6) 年後輪換至少一年
5.10 MANAGEMENT OF SERIOUS EVENTS 嚴重事件的處理
1 ) The CB shall have a process to review planned audits when a serious event affects a
certified organization, and the audit cannot be performed as planned.
CB 應有流程在嚴重事件影響 獲證組織,審核不能按計劃進行。
2) The CB shall assess the risks of continuing certification and establish a documented policy
and process, outlining the steps it will take in the event a certified organization is affected
by a serious event to ensure the integrity of certification is maintained. The minimum
content of the risk assessment shall cover the aspects listed in IAF ID3, section 3.
CB 應評估持續認證的風險並建立書面政策 和過程,概述在認證組織受到影響時它將採取的步驟 通過一個嚴重的事件來確保認證的完整性得到維護。最低 風險評估的內容應涵蓋 IAF ID3 第 3 節中列出的方面。
3) The outcome of the Risk Assessment and planned actions shall be recorded. Deviations
from the audit program and their justification for changes shall be recorded. CBs shall
establish in consultation with certified organizations a reasonable planned course of
action.應記錄風險評估的結果和計劃的行動。偏差 應記錄來自審核計劃的更改及其更改的理由。認證機構應 與認證組織協商建立一個合理的計劃過程 行動
4) In cases where the annual surveillance audit cannot take place within the calendar year as
a result of a serious event, an exemption shall be requested from the Foundation or the
certificate shall be suspended.年度監督審核無法在日曆年內進行的情況 嚴重事件的結果,應向基金會或 證書將被暫停。
6 AUDIT REPORT 審計報告
6.1 WRITTEN REPORT
The CB shall provide a written report for each audit.書面報告 CB 應為每次審核提供書面報告。
a) The audit report is to be treated confidentially by the CB but shall be made available to
Food Safety Authorities after approval of the organization.審核報告將由CB保密處理,但應提供給經食品安全部門批准後組織。
b) The audit report shall confirm that all Scheme requirements are assessed, reported and a
statement of (non) conformity given. Furthermore, it shall comply with all relevant
requirements of ISO/IEC 1 7021 -1 . The content shall comply with the requirements of
Annex 2 or Annex 3 in the case of FSSC 22000-Quality.審核報告應確認所有方案要求均已評估、報告,並且給出的(不)符合性聲明。此外,它應符合所有相關ISO/IEC 1 7021-1 的要求。內容應符合要求如果是 FSSC22000-質量,則為附件 2 或附件 3。
c) Both the procedural and operational conditions of the food safety management system
shall be verified to assess the effectiveness of the food safety management system
meeting the Scheme requirements and reported.
食品安全管理體系的程序和操作條件應驗證以評估食品安全管理體系的有效性符合方案要求並上報。
d) In exceptional cases, a requirement can be deemed not applicable. Where a requirement
is deemed to be N/A then suitable justification shall be recorded in the relevant section of
the audit report.在特殊情況下,可以認為某項要求不適用。哪裡有要求 被視為 N/A,則應在相關部分記錄適當的理由審計報告。
e) Exclusions from scope shall be assessed and justified in the audit report.應在審核報告中評估並論證排除在範圍之外的情況
f) Deviations from the audit plan shall be motivated in the report 審計計劃的偏差應在報告中加以說明
g) Auditors shall report all nonconformities (NCs) at all audits. For each nonconformity (NC),
a clear concise statement of the requirement, the NC, grade of the NC and the objective evidence shall be written.
審核員應在所有審核中報告所有不符合項(NC)。對於每個不合格項(NC),對要求、NC、NC等級和目標的清晰簡明陳述證據應該寫下來
h) Corrections, corrective action plans and their approval shall be included as per Annex 2 or
Annex 3 in the case of FSSC 22000-Quality.糾正、糾正措施計劃及其批准應按照附件 2 或 FSSC 22000-質量的附件 3
i) A Head Office report shall contain as a minimum the NCs found at the HO. This report shall
be uploaded. At each site audit the implementation of the corrective actions shall be
verified and reported.總部報告應至少包含在HO發現的NC。本報告應 被上傳。在每次現場審核中,糾正措施的實施應核實並報告
j) The full audit report meeting the minimum requirements as set out by the Scheme, shall
be sent to the (certified) organization within 2 weeks of the certification decision for all
audits conducted.滿足計劃規定的最低要求的完整審計報告應 在做出所有認證決定後的 2 週內發送給(認證的)組織 進行的審計
k) It is the Foundation’s requirement that audit reports are written in English. Where an
organization requests the report to be written in the language the audit was conducted in
(if other than English), this is allowed based on mutual agreement between the CB and the
organization. However, the mandatory fields in the portal shall always be completed in
English. In all instances where CBs are translating audit reports, the CB shall have
verification procedures in place to ensure the translations are accurate.
基金會要求審計報告以英文撰寫。在哪裡 組織要求以審計進行時使用的語言編寫報告 (如果不是英語),這是允許的,基於 CB 和供應商之間的相互協議 組織。但是,門戶中的必填字段應始終填寫 英語。在 CB 翻譯審核報告的所有情況下,CB 應具有 驗證程序已到位,以確保翻譯準確無誤
6.2 NONCONFORMITIES 不符合項
In accordance with the definitions in the Scheme and as defined below, the CB is required to apply
these criteria as a reference against which to determine the level of nonconformities for findings.
There are three nonconformity grading levels:
根據方案中的定義和如下定義,CB 需要申請 這些標準作為確定不符合項級別的參考。 不合格等級分為三個等級
a) Minor nonconformity; 輕微不合格;
b) Major nonconformity; 嚴重不符合;
c) Critical nonconformity. 嚴重不合格
Nonconformities shall always be written to the most relevant Scheme requirement linked to the
specific audit criteria in ISO 22000:201 8; the specified PRP standard or the FSSC Additional
Requirement. 不符合項應始終寫入與鏈接的最相關的計劃要求ISO 22000:2018中的特定審核標準;指定的 PRP標准或FSSC附加要求
Nonconformities raised at a Head Office audit, are assumed to have an impact on the equivalent
procedures applicable to all sites. Corrective actions shall therefore address issues of
communication across the certified sites and appropriate actions for impacted sites. Such
nonconformities and corrective actions shall be clearly identified in the relevant section of the site
audit report and shall be cleared in accordance with the CB procedures before issuing the site
certificate.在總部審計中提出的不符合項,假定對等同的影響 適用於所有網站的程序。因此,糾正措施應解決以下問題 認證站點之間的通信以及受影響站點的適當行動。這樣的 應在現場的相關部分清楚地標識不符合項和糾正措施 審核報告,並應在現場發布前按照CB程序清除 證書。 ”
The Scheme does not allow “Opportunities for Improvement”.該計劃不允許“改進機會
6.2.1 MINOR NONCONFORMITY 輕微不合格
A minor nonconformity shall be issued when the finding does not affect the capability of the
management system to achieve the intended results:當發現不影響供應商的能力時,應發布輕微不符合項達到預期結果的管理體系
1 ) The organization shall provide the CB with objective evidence of the correction, evidence
of an investigation into causative factors, exposed risks, and the proposed corrective組織應向CB提供糾正的客觀證據,證據 調查致病因素、暴露的風險和建議的糾正措施
action plan (CAP);行動計劃(CAP)
2) The CB shall review the corrective action plan and the evidence of correction and approve
it when acceptable. The CB approval shall be completed within 28 calendar days after the
last day of the audit. Exceeding this timeframe shall result in a suspension of the certificate;
CB應審查糾正措施計劃和糾正證據並批准 它什麼時候可以接受。 CB 批准應在 28 個日曆日內完成 審計的最後一天。超過此期限將導致證書被吊銷;
3) Corrective action(s) (CA) shall be implemented by the organization within the timeframe
agreed with the CB;組織應在時限內實施糾正措施 (CA) 同意 CB;
4) Effectiveness of implementation of the corrective action plan shall be reviewed, at the
latest, at the next scheduled audit. Failure to address a minor nonconformity from the
previous audit could lead to a major nonconformity being raised at the next scheduled
audit糾正措施計劃實施的有效性應在 最晚,在下一次預定的審核中。未能解決來自供應商的輕微不合格 之前的審核可能導致在下一次計劃中提出重大不符合項 審計。
.
6.2.2 MAJOR NONCONFORMITY 重大不合格
A major nonconformity shall be issued when the finding affects the capability of the management
system to achieve the intended results:當發現影響管理能力時,應發布嚴重不符合項 系統達到預期效果:
1 ) The organization shall provide the CB with objective evidence of an investigation into
causative factors, exposed risks, and evidence of effective implementation;
組織應向 CB 提供調查的客觀證據 致病因素、暴露的風險和有效實施的證據
2) The CB shall review the corrective action plan and conduct an on-site follow-up audit to
verify the implementation of the CA to close the major nonconformity. In cases where
documentary evidence is sufficient to close out the major nonconformity, the CB may
decide to perform a desk review. This follow-up shall be done within 28 calendar days from
the last day of the audit;CB 應審查糾正措施計劃並進行現場跟踪審核,以 驗證 CA 的實施以關閉主要不符合項。在這種情況下 書面證據足以關閉主要不符合項,CB 可以 決定進行案頭審查。此跟進應在 28 個日曆日內完成 審核的最後一天;
3) The major nonconformity shall be closed by the CB within 28 calendar days from the last
day of the audit. When the major cannot be closed in this timeframe, the certificate shall
be suspended;
重大不符合項應在最後一次檢查後的28個日曆日內由CB關閉審計日。當專業不能在這個時間段內關閉時,證書應被停職;
4) Where completion of corrective actions might take more time, the CAP shall include any
temporary measures or controls necessary to mitigate the risk until the permanent
corrective action is implemented.
如果完成糾正措施可能需要更多時間,CAP 應包括任何 減輕風險所必需的臨時措施或控制措施,直到永久性的 實施糾正措施。
6.2.3 CRITICAL NONCONFORMITY 嚴重不合格
A critical nonconformity is issued when a direct food safety impact without appropriate action by
the organization is observed during the audit or when legality and/or certification integrity are at
stake:當食品安全受到直接影響而未採取適當措施時,將發布嚴重不合格 在審核期間或當合法性和/或認證完整性處於 賭注:
1 ) When a critical nonconformity is raised at a certified organization the certificate shall be
suspended within 3 working days of being issued, for a maximum period of six (6) months;
當認證組織提出嚴重不符合時,證書應 在簽發後 3 個工作日內暫停,最長暫停時間為六 (6) 個月;
2) When a critical nonconformity is issued during an audit, the organization shall provide the
CB with objective evidence of an investigation into causative factors, exposed risks, and
the proposed CAP. This shall be provided to the CB within 1 4 calendar days after the audit;
當在審核期間發出嚴重不符合時,組織應提供 CB 對致病因素、暴露的風險和風險進行調查的客觀證據 擬議的 CAP。這應在審核後的 1-4 個日曆日內提供給 CB;
3) A separate audit shall be conducted by the CB between six (6) weeks to six (6) months after
the regular audit to verify the effective implementation of the corrective actions. This audit
shall be a full on-site audit (with
a minimum on-site
duration of one day). After a successful
follow-up audit, the certificate and the current audit cycle will be restored, and the next
audit shall take place as originally planned (the follow-up audit is additional and does not
replace an annual audit). This audit shall be documented, and the report uploaded;
CB 應在審核後六 (6) 周至六 (6) 個月內進行單獨審核 定期審核以驗證糾正措施的有效實施。本次審核 應是一個完整的現場審核(與 最少現場 持續一天)。成功後 後續審核,證書和當前審核週期將恢復,下一次 審核應按原計劃進行(後續審核是額外的,不 取代年度審計)。該審核應記錄在案,並上傳報告;
4) The certificate shall be withdrawn when the critical nonconformity is not effectively
resolved within the six (6) month timeframe;關鍵不符合項不能有效消除時,撤銷證書 在六 (6) 個月的時間內解決;
5) In case of a certification audit (initial), the full certification audit shall be repeated.
如果是認證審核(初始),則應重複完整的認證審核。
7 CERTIFICATION DECISION PROCESS 認證決策過程
7.1 GENERAL 總則
1 ) CBs shall conduct a technical review for all audits to agree with the audit reports content
and outcome, NC's (objective evidence and grading) and effectiveness of corrections and
corrective action plans. Following each technical review, CB’s shall make a decision on the
certification status of the organization (e.g. certify, continue certification, suspend,
withdraw).CB應對所有審核進行技術審核,以同意審核報告內容 和結果、NC(客觀證據和分級)和更正的有效性和 糾正行動計劃。在每次技術審查之後,CB 應就 組織的認證狀態(例如認證、繼續認證、暫停、 提取)。
2) The CB shall keep documented information of decisions on certification status that have
been considered and by whom. This information shall include: the names of those making
each decision, and the date the decision was made
.CB 應保存關於認證狀態決定的文件化信息 被誰考慮過。該信息應包括: 每個決定,以及做出決定的日期。
Note: not all decisions may lead to issuing a new certificate.
注意:並非所有決定都可能導致頒發新證書。
3) The maximum certificate validity period is 3 years from the date of initial certification
decision, with subsequent 3-year cycles.CB 應保存關於認證狀態決定的文件化信息 被誰考慮過。該信息應包括: 每個決定,以及做出決定的日期。 注意:並非所有決定都可能導致頒發新證書。
7.2 CERTIFICATE DESIGN AND CONTENT 證書設計和內容
1 ) The CB shall issue FSSC 22000 and FSSC 22000-Quality certificates in accordance with the
scope rules and certificate templates set out by the Foundation (see Annex 1 and Annex
4).
CB 應根據 FSSC 22000 和 FSSC 22000-質量證書頒發 基金會制定的範圍規則和證書模板(見附件1和附件 4).
2) The certificate shall be in English and correspond with the certificate in the portal and the
details on the public register. It is possible to include a translation of the scope statement
following the English statement on the certificate.證書應為英文,並與門戶網站和網站上的證書一一對應 公共登記冊上的詳細信息。可以包括範圍聲明的翻譯 按照證書上的英文聲明。
3) The FSSC 22000 logo shall be used by the CB on its certificates. CB 應在其證書上使用 FSSC 22000 標識
4) Head Office details shall be included, where applicable.如適用,應包括總部詳細信息
5) Where applicable Off site and Multi-site locations shall be listed, (including name, address,
and activities); details may be provided in an Annex to the certificate.
在適用的情況下,應列出非現場和多現場位置,(包括名稱、地址、 和活動);詳情可在證書的附件中提供。
6) Dates on the certificates shall be as follows:證書上的日期如下
a) Certificate decision date: date at which a new decision is made after a certification or recertification audit (excluding regular surveillance audits).證書決定日期:在認證後做出新決定的日期或 再認證審核(不包括定期監督審核)。
New certificate decision dates are also required in situations such as version changes
of the Scheme and/or scope extensions/reductions. In these cases, the valid until
date remains unchanged;
在版本更改等情況下也需要新的證書決定日期 方案和/或範圍擴展/縮減。在這些情況下,有效期至日期保持不變;
b) Initial certification date (i.e. the certification decision date after the initial audit). This is
a fixed date that is maintained as long as the organization is linked to the CB and holds
a valid FSSC 22000 certificates;
初始認證日期(即初次審核後的認證決定日期)。這是 只要組織鏈接到 CB 並持有固定日期 有效的 FSSC 22000 證書;
c) Issue date: date certificate is issued to the client; or re-issue date when a new
certificate is issued (e.g. because of version change, scope extension etc.);
簽發日期:證書籤發給客戶的日期;或重發日期當一個新的 頒發證書(例如,由於版本更改、範圍擴展等)
d) Valid until date: certificate expiry date (e.g. original certification decision date + 3 years
for the initial cycle).Valid until date:證書失效日期(例如原始認證決定日期+3年 為初始週期)
7.3 CERTIFICATE SUSPENSION, WITHDRAWAL OR
SCOPE REDUCTION 證書暫停、撤銷或 範圍縮小
1 ) Suspension : the CB shall immediately suspend certification when a critical nonconformity
is issued and/or there is evidence that their client is either unable or unwilling to establish
and maintain conformity with Scheme requirements.
暫停:當出現嚴重不符合時,CB 應立即暫停認證 已發布和/或有證據表明他們的客戶無法或不願建立 並保持符合方案要求
2) Withdrawal : the CB shall withdraw a certificate when:撤銷:CB 應在以下情況下撤銷證書
a) The status of suspension cannot be lifted within six (6) months; 暫停狀態在六(6)個月內不能解除
b) The organization ceases its FSSC 22000 certification activities; 組織停止其 FSSC 22000 認證活動
c) Any other situation where the integrity of the certificate or audit process is severely
compromised.
證書或審核過程的完整性嚴重受損的任何其他情況 妥協
3) Scope reduction : When the CB has evidence that their client holds a certificate whose
scope exceeds their capability or capacity to meet Scheme requirements, the CB shall
reduce the certification scope accordingly. The CB shall not exclude activities, processes,
products or services from the scope of certification when those activities, processes,
products or services can have an influence on the food safety of the end products as
defined in the scope of certification.
縮小範圍:當 CB 有證據表明他們的客戶持有其證書時 範圍超出其滿足方案要求的能力或容量,CB 應 相應縮小認證範圍。 CB 不得排除活動、流程、 當那些活動、過程、 產品或服務可能會對最終產品的食品安全產生影響,因為 在認證範圍內定義
7.3.1 ACTION UPON SUSPENSION, WITHDRAWAL AND SCOPE
REDUCTION 暫停、撤銷和範圍後的行動 減少
1 ) In case of suspension or withdrawal, the organizations’ management system certification
is invalid. The CB shall complete the following actions within 3 working days after the
certification decision has been made:
在暫停或撤銷的情況下,組織的管理體系認證 是無效的。 CB 應在 3 個工作日內完成以下操作 已做出認證決定:
a) Change the status of the certified organization in the Portal and its own Register
of certified organizations and shall take any other measures it deems appropriate;
更改認證組織在門戶網站及其註冊簿中的狀態 獲得認證的組織,並應採取其認為適當的任何其他措施;
b) Inform the organization in writing of the suspension or withdrawal decision;將暫停或退出決定書面通知組織
c) Instruct the organization to take appropriate steps in order to inform its interested
parties.
指示組織採取適當的步驟以通知其感興趣的人 派對
2) In case of scope reduction, the organizations’ management system certification is invalid
beyond the revised certification scope statement. The CB shall complete the following
actions within 3 working days after the certification decision has been made:
縮小範圍時,組織的管理體系認證無效超出修訂後的認證範圍說明書。CB應完成以下工作作出認證決定後3個工作日內採取的行動:
a) Change the scope of the certified organization in the FSSC 22000 database and its
own Register of certified organizations and shall take any other measures it deems
appropriate;
更改 FSSC 22000 數據庫中獲證組織的範圍及其 自己的獲證組織登記冊,並應採取其認為的任何其他措施 合適的
b) Inform the organization in writing of the scope change;將範圍變更書面通知組織
c) Instruct the organization to take appropriate steps in order to inform its interested
parties.
指示組織採取適當的步驟以通知其感興趣的人 派對
8 PORTAL DATA AND DOCUMENTATION 門戶數據和文檔
8.1 DATA OWNERSHIP 數據所有權
a) A (certified) organization is the owner of an audit report, whilst the CB is responsible
for the report data.
(認證)組織是審核報告的所有者,而 CB 負責 為報表數據。
b) A (certified) organization is the certificate holder, not the owner. The CB is the data
owner of the certificate data.
(獲證)組織是證書持有者,而不是所有者。 CB就是數據 證書數據的所有者。
8.2 DATA UPLOAD REQUIREMENTS 數據上傳要求
For all audit types, the required data and documentation shall be entered in the Portal at
the latest 28 calendar days after the certification decision with a maximum of 2 months
after the last day of the audit. The mandatory data in the Portal shall be entered in English.
對於所有審計類型,所需的數據和文件應輸入門戶網站 認證決定後的最近 28 個日曆日,最多 2 個月 在審計的最後一天之後。門戶中的強制性數據應以英文輸入
8.3 DATA QUALITY CONTROL 數據質量控制
The CB shall have a data quality control process in place that provides assurance for CB
Portal Data Quality. The quality parameters include the following as a minimum:
CB 應制定數據質量控制流程,為 CB 提供保證 門戶數據質量。質量參數至少包括以下內容:
a) Completeness: All the mandatory data has been registered in the Portal;完整性:所有必填數據均已在門戶中註冊
b) Timeliness: All the data has been registered in the Portal within the required
timelines;
及時性:所有數據均已在要求的時間內在門戶網站上註冊 時間線;
c) Validity: The registered data values meet the Scheme requirements;有效性:註冊數據值符合方案要求
d) Accuracy: The data is a true representation of the actual facts relating to the
complete audit and the certification process;準確性:數據真實地反映了與 完成審計和認證過程;
e) Consistency: The registered data in the Portal is a true representation of the data
stored in the CBs internal system(s). 一致性:門戶中的註冊數據是數據的真實表示 存儲在 CB 的內部系統中。
8.4 CB PORTAL 門戶
a) When requested by the certified organization, CBs shall actively provide the
Certified Organization access to the associated Organization Profile, Audit and
Certification data registered in the CB Portal using the available functionality.
當獲證組織提出要求時,認證機構應主動提供獲得認證的組織訪問相關的組織簡介、審計和使用可用功能在CB門戶中註冊的認證數據
b) CBs shall ensure that Certified Organization access is only granted to authorized
individual(s).
CB 應確保認證組織的訪問權限僅授予授權的 個人。
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