PHILIPS驗廠輔導---PHILIPS質量介紹（一）
1.Introduction.
The purpose of this Self-Assessment Questionnaire is to collect relevant information as part of the preparation for a planned audit.
The responsible Supplier Quality Engineer of Philips will evaluate the submitted results and decide on how to perform necessary audit activities.
Your Philips’ contact for questions or support is:<Name of SQE>, <job title><E mail adress><Post adress><City>, <Country><ZIP code><tel number>
2.How to use?
-Please read carefully each requirement.
-Fill in how your organization performs against this requirement.
-Mention applicable written procedures that are being used to effectuate your approaches.Provide document numbers of these procedures.
-Where possible, provide results of the approaches. ( “SMART”)
-Attach where appropriate copies of procedures.
-Fill your response in the column “Response”. You can also add remarks here if our requirement is not clear or not applicable.
-Enter in the last column “Yes” or “No” as your estimation on your organization’s compliance.
-Count the number of “Yes” in the last column as ‘number of requirements met’
-Calculate your score: = <Nr of requirements with 'Yes'> / 56 * 100% = <your score> %
-If your score is lower than 80% you should contact your Philips’ contact person before submitting.
-Send your Word file to the above mentioned SQE. (Please note that we cannot process other formats like PDF, etc.)
3.Questionnaire:17. Commercial Supplier
4.Sign off by Philips:
Name: …………………………………………………… job title: ……………………………… Date/Location: …………. /…... Signature:
5.Sign off by Supplier:
Name: …………………………………………………… job title: ………………………………Date/Location: …………. /…... Signature:
M02.02 Human Resources
Is sufficient personnel available with the necessary education, background, training and experience to assure that activities can be performed adequately? 是否為足夠的人員提供必要的教育、 背景、培訓和經驗，以確保能充分執行活動嗎?
M05.01 QMS: General requirements. ISO9001/13485
In order to continually improve its effectiveness in accordance with the requirements of this International Standard, an organization shall為了持續改進其有效性按照本國際標準的要求，組織應：
a) Determine the processes needed for the quality management system and their application throughout the organization, a)確定所需的質量管理體系和整個組織，其應用過程
b) Determine the sequence and interaction of these processes, b) 確定的順序和這些過程之間的相互作用
c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective, c) 確定的標準和方法的需要以確保操作和對這些過程的控制是有效的
d) Ensure the availability of resources and information necessary to support the operation and monitoring ofthese processes, d) 確保提供的資源和支持的運行和監控這些過程所需的信息
e) Monitor, measure where applicable, and analyze these processes, and e) 監視、測量適用時和分析這些過程，和
f) Implement actions necessary to achieve planned results and continual improvement of these processes. f)實施必要行動，實現策劃的結果和對這些過程的持續改進。
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system, 針對組織所選擇外包的任何影響產品符合要求，過程，組織應確保對這些過程的控制。用于對此類外包過程的類型和控制程度應在質量管理體系內定義
