现场审核表 Onsite Audit Form
Supplier 供应商:  Address 地址:
Supplier Rep. 陪审人员:  City/State 省/县:  Title/Position 职位:
Zip 邮编:
Date of Completion 日期:
/            /
Quality Systems Third Party or Customer  Approval
第三方或客户 批准的质量体系
Personnel  Contacted
相关人员
Number of Personnel 人员数量
Production
Quality
Inspection
Engineering
Other
Total Plant Area
Lead Auditor 审核组长  Department 部门  Auditor 审核员  Department 部门  Auditor 审核员  Department 部门
Survey/ Audit Disposition 调查/审核描述: Re-surveyed and Approved : Yes    Date:____________ Auditor Name:__________________ Reason for Conditional Approval:
______________________________________________________________________________________ Reason for Disapproval:
______________________________________________________________________________________ Approved to Manufacture or Service Only:
______________________________________________________________________________________
ISO 9001 ISO 13485 cGMP (QSR)
Other(s)
Yes
No
Yes No Yes No Yes
No
Approved 批准 Conditional Approved Disapproved Yes 是 No 否 Yes No
Date Expires____________
Date Expires____________
Audit Categories
CATEGORY I QUALITY ASSURANCE ORGANIZATION AND PLANNING (2)
CATEGORY II INITIAL QUALITY PLANNING (3)
CATEGORY III INSPECTION AND TEST DOCUMENTATION (3)
CATEGORY IV RECORD RETENTION (3)
CATEGORY V CORRECTIVE AND PREVENTIVE ACTION (4)
CATEGORY VI DRAWING, DOCUMENTATION AND CHANGES (4)
CATEGORY VII MEASURING AND TEST EQUIPMENT (4)
CATEGORY VIII PURCHASE RESPONSIBILITY (5)
CATEGORY IX MATERIALS CONTROL (5)
CATEGORY X PRODUCTION PROCESS CONTROL (6)
CATEGORY XI FINAL INSPECTION (6)
CATEGORY XII STOCKROOM CONTROL (6)
CATEGORY XIII PACKAGING, MARKING AND SHIPPING (6)
CATEGORY XIV NONCONFORMING MATERIAL (7)
CATEGORY XV STATISTICAL SAMPLING (7)
CATEGORY XVI FACILITIES/HOUSEKEEPING (8)
CATEGORY XVII STERILIZATION/LABORATORY CONTROL (6)
Audit Notes:
a)Items noted in the “P” column, on the following pages, indicates a deficient area identified during the
performance of the audit.
b)  A certificate showing third party approval / compliance to either ISO 9001 or ISO 13485 or CMDCAS will
satisfy the quality systems portion of the survey/ audit.
c)Self-Declare compliance to cGMP (QSR),  at a minimum document control,  material control,
manufacturing control, and quality control shall be verified.
d)Sterilization subcontractor should have ISO 11137 (Radiation) or ISO 11135 (EtO) certified.
Category I Quality Assurance Organization and Planning
Yes No P Other
A Is the supplier’s system of the Quality Assurance adequately described in approved written
procedures/instructions/policies?
供應商的質量认证系統是否在經核准的程序/手册/方针里面说明？
B Are procedures/instructions/policies maintained current and made available to all concerned
personnel?是否所有相关人员使用的是最新的程序/手册/方针。
C Has the responsibility for Quality Assurance/Inspection been formally established? (Organization
Chart)
是否建立質量保證/檢驗的职责？（組織結構圖）
D Does the Quality Assurance/Inspection Department have the freedom to satisfactory perform the
quality functions and meet customer requirements?
質量保證/檢驗部門是否符合質量職能并滿足客戶的要求？
E Is a periodic review of the quality program performed by management?
管理層是否制定定期质量審核改进計劃？
Comments:
Category II Initial Quality Planning质量控制计划
Yes No P Other
A Does the Quality Assurance/Inspection Department prepare quality plans to implement identified
quality requirements.
品质部是否有制定质量计划来满足质量要求。
B Does the Quality Assurance/Inspection review manufacturing processes, contract reviews,
packaging, inspection / test instructions to assure customer requirements.
为了保证客户要求是否进行制程评审，合同评审，包装评审，并建立检查/测试的指
引。
Comments:
Category III Inspection and Test Documentation检验和测试文件
Yes No P Other
A Are inspection instructions available current and used?
当前使用的检验指引/文件是否是最新的。
B Do the inspection instructions contain accept/reject criteria?
检验指引是否包含接受或拒收的标准？
C Is completed product subject to inspection and test in accordance with the applicable drawings,
specification, inspection instructions, etc.
是否根據合适的圖紙，規範，檢查指引等，完成產品檢驗和試驗？
Comments:
Category IV Record Retention文件保存期
Yes No P Other
A Are records maintained for a minimum of 2 years or required by customer contract?
记录是否保存最少2年或依据客户合同要求？
B Do inspection records and test records reflect number of observations made, as well number of
defects and types?
检查记录和测试报告是否与检查类型和数量相符？
C Are records used by management to evaluate manufacturing processes and/or quality programs?
记录是否可以用於評估制程/或質量計劃
Comments:
Category V Corrective Action and Preventive Action纠正预防措施
Yes No P Other
A Does the supplier have a system that assures prompt and appropriate corrective action when
required?
是否有系统确保在必要时采取适当的纠正行动？
B Are all corrective and preventive actions documented?
是否有记录所有的纠正和预防措施？
C Is the system applicable to all elements of the quality programs (i.e. design, purchasing,
manufacturing, etc)?
纠正预防措施系統適用於所有的质量问题（即設計，採購，製造等）？
D Does the corrective/ preventive action system extend to the supplier’s vendors?
是否纠正预防措施延伸到自己的供应商
E Are trend analysis used to prevent recurrence of the discrepancy?
是否有进行趋势分析用于防止异常的再次发生？
F When corrective/ preventive actions are instituted, is their effectiveness monitored?
當糾正/預防措施确立，是否有按照纠正预防措施进行执行/监控？（供应商及公司内
部）
Comments:
Category VI Drawing, Documentation and Changes图纸、文件的变更
Yes No P Other
A Does the supplier’s documented system assure that all manufacturing processes are performed
in accordance with the latest applicable revision of the drawings or specifications?
供應商的文件系統是否可確保用于製造過程的圖紙或文件是最新版本？
B Is there a system in place to control the use of old revision drawings, marked up or illegible
drawings?
是否有系统控制标识舊的版本的或難以辨認的圖紙/文件？
C Is there a system in place to prohibit the deviation of a purchase order requirement? (i.e. verbal
instructions) Explain.
体系是否有防止采购出现误差的程序，（例如：口头指令）
D Who notifies the customers of changes to the manufacturing procedures or materials?
由谁通知客戶关于製造過程或材料變化？
E What process is used to transfer the customers’ specification to the suppliers’ specifications?
使用什么程序/方法将客户规范转换到供应商的规格
Comments:
Category VII Measuring and Test Equipment测量和试验仪器
Yes No P Other
A Does the supplier’s quality system assure that inspection measuring and test equipment, process
control devices and tooling used for media of acceptance are inspected and calibrated at required
intervals in accordance with the requirements of a calibration specification. Please indicate
calibration specification.
Calibration Specification:_________________________________
供應商的質量體系是否能保證用于檢驗，測量和試驗的設備在規定的時間間隔里按照
校验规格要求进行校準。校准规格：_________________________________
B Is all such equipment identified and traceable to individual records attesting to the last
position职位calibration, calibration due date, the requirement for calibration?.
所有的設備是否有識別，并可追溯到上次校準期，校準到期日期期，校準要求？
C Are the reference standards which are employed in the inspection and calibration of equipment,
currently certified and traceable to International Standard(s)?
設備的檢查和校準是否可以溯源到相关的国际标准？（行业标准、检定规程、
国家标准，國際標準）
D Are un-calibrated or outdated items identified and stored in a manner as to prevent their use
pending calibration?
未经校準的或过校准期的仪器/设备是否有标识和隔离，以防止非预期的使用？
E Does the supplier maintain written instructions/procedures providing detailed methods for
calibration?
供應商是否有書面文件/程序提供詳細的校準方法？
F Is the measuring and testing equipment used to control the products involved?
供应商是否有使用計量檢測設備来控制产品？
G Are personally owned tools calibrated and controlled when used for product acceptance?
用于产品的自制夹具或设备使用前是否有进行校准或确认
Comments:
Category VIII Purchase Responsibility采购职责
Yes No P Other
A Does the supplier have a system for selecting qualified vendors?
供应商是否有程序/系统说明其如何选择合格的供应商？
B Does the supplier re-audit those vendors not performing to a quality acceptance rate?
供應商是否对其不达标的供应商进行重新審核
C Does the supplier’s procurement system allow for information feedback and early correction of
vendor nonconformance?
供應商的採購系統是否允許供應商的不合格信息反饋和早期矯正。
D Does the supplier’s purchase order to sub-tier sources clearly state applicable specification
and/or approved secondary processes?
E Do purchase orders reflect the revision number and effective dates?
採購訂單是否可以反映版本號和生效日期
Comments:
Category IX Materials Control原料控制
Yes No P Other
A Are purchased supplies or products inspected upon receipt to assure conformance to drawings or
customer specification?
購買物料或产品是否在收到时进行檢驗，以確保符合圖紙或客戶的要求？
B Is incoming raw materials adequately identified and certified?
采购的原料是否有充分識別和确认？
C Are certified raw materials stored in a controlled area, separated from uncertified material and
protected from damage and corrosion?
未經检验的原材料是否分開儲存在控制，防止損壞或腐蝕？（是否有区域标示）
D Is raw material issued and remnant controlled?
是否有对发料及余料进行控制？
E Are all remnant material properly identified and controlled?
是否所有餘剩材料都有进行适当的識別和控制？
F Is customer furnished material controlled by identification and segregated?
客供材料是否有进行标识及隔离控制？

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