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? 是否为足够的人员提供必要的教育、 背景、培训和经验，以确保能充分执行活动吗?
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为了持续改进其有效性按照本国际标准的要求，组织应：
a) Determine the processes needed for the quality management system and their application throughout the organization, a)确定所需的质量管理体系和整个组织，其应用过程
b) Determine the sequence and interaction of these processes, b) 确定的顺序和这些过程之间的相互作用
c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective, c) 确定的标准和方法的需要以确保操作和对这些过程的控制是有效的
d) Ensure the availability of resources and information necessary to support the operation and monitoring ofthese processes, d) 确保提供的资源和支持的运行和监控这些过程所需的信息
e) Monitor, measure where applicable, and analyze these processes, and e) 监视、测量适用时和分析这些过程，和
f) Implement actions necessary to achieve planned results and continual improvement of these processes. f)实施必要行动，实现策划的结果和对这些过程的持续改进。
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, 针对组织所选择外包的任何影响产品符合要求，过程，组织应确保对这些过程的控制。用于对此类外包过程的类型和控制程度应在质量管理体系内定义