0.  INTRODUCTION  0. 개요 
0.1  General  0.1 일반사항 
This International Standard specifies requireme  이 국제규격은 의료기기의 설계및개발, 생 
nts for a quality management system that can  산, 설치 및서비스를제공하는 조직 및 관련 
be used by an organization for the design and  서비스를 제공하는 조직이 사용할 수있는 
development,  production,  installation  and  품질경영시스템에  대한 특정  요구사항을  규 
servicing of medical devices, and the design,  정한다.  
development, and provision of related services.   
It can also be used by internal and external p  이 규격은인증기관을 포함하여, 내외부관계 
arties, including certification bodies, to assess  자가  고객 및법규  요구사항을 충족시키는 
the   organization’s ability to meet customer  조직의능력을평가하는데 사용할수있다.  
and regulatory requirements.   
Information marked “NOTE” is for guidance in  “  주”는관련요구사항을이해 또는 명확하 
understanding  or  clarifying  the  associated  게 하는지침이다.  
requirement.   
It is emphazid that the quality management  이 국제규격에  명시된  품질경영시스템  요구 
system  requirements  specified  in  this  사항은제품에대한 기술적요구사항을보완 
International  Stnadard are complementary  to  한다는것이강조된다.  
technical requirements for products.   
The adoption of a quality management system  품질경영시스템의  채택은 조직의 전략적  결 
should be a strategic decision of an organizati  정이어야할것이다. 조직의 품질경영시스템 
on. The design and implementation of an org  설계 및실행은 조직의다양한필요성, 특정 
anization's quality management system is influ  한 목표,  제공되는 제품,  사용  프로세스 및 
enced by varying needs, particular objectives,  규모 및구조에 의해영향을 받는다. 품질경 
the products provided, the processes employe  영시스템구조의획일화또는문서화의획일 
d and the size and structure of the organizati  화는 이 국제규격의의도가아니다.  
on. It is not the intent of this International Sta   
ndard to imply uniformity in the structure of q   
uality management systems or uniformity of d   
ocumentation.   
There is a wide variety of medical devices and  다양한의료기기가있으며이국제규격의 특 
some  of the particular requirements of this  정 요구사항의일부는특정 의료기기에만적 
International  Standard  only apply  to named  용된다. 이러한의료기기그룹은3 항에 규정 
groups of medical devices. These groups are  되어 있다.  
defined in Clause 3.   
0.2  Process approach  0.2  프로세스접근법 
This International Standard is based on a proc  이국제규격은품질경영에대한 프로세스 접 
ess approach to quality management.  근방법에근거한다.  
Any activity that receives input and converts  입력을받아출력으로변환시키는모든 활동 
them to outputs can be considered as a process.  은 프로세스로 간주될수있다.  
For an organization to function effectively, it h  조직이 기능을 효과적으로 발휘하기위해서,  
as to identify and manage numerous linked  조직은수많은연결된활동을파악하고관리 
processes.  하여야한다. 
Often the output from one process directly for  흔히, 하나의프로세스로부터나온출력은바 
ms the input to the next.  로다음프로세스의입력이될수있다.  
The application of a system of processes with  프로세스의파악과상호작용, 그리고그에대 
in an organisation, together with the identificati  한관리를포함하여, 조직내에서프로세스로 
on and interactions of these processes, and t  구성된시스템을적용하는것을  “프로세스접 
heir management, can be referred to  as  the  근방법”이라할수있다.   
“process approach”.    
0.3  Relationship with other standards  0.3  다른규격과의관계 
0.3.1  Relationship with ISO 9001  0.3.1  ISO 9001 과의관계 
While this is a stand-alone standard, it is based  이것은독립적인 규격이지만 ISO 9001 에기 
on ISO 9001.  반을 두고있다.  
Those clauses or subclauses that are quoted  ISO  9001 에서 직접적으로 인용되고  변경이 
directly and unchanged from ISO 9001 are in  되지않은 조항이나  세부조항은  정상적인  글 
normal font. The fact that these subclauses are  씨체를 사용하였다. 이러한조항들은부속서 
presented unchanged is noted in Annex B.  B에 명시되었다.  
Where the text of this International Standard is  이 국제규격의 본문이ISO 900 1의내용과 일 
not identical to the text of ISO 9001, the sentence  치하지 않는경우, 내용을포함한 문장은 전체 
or indent containing that text as a whole is shown  적으로 이탤릭체로 씌여진다(전자번역본은 
in italics (in blue italics for electronic versions).  푸른색의  이탤릭체).  변경된  내용의 특성과 
The nature and reasons for the text changes are  이유는부속서B 에 명시되어 있다.  
noted in Annex B.   
0.3.2  Relationship with ISO/TR 14969  0.3.2  ISO/TR 14969 와의관계 
ISO/TR 14969 will be a technical Report intended  ISO/TR 14969 는ISO 13485 적용 지침을 제 
to provide guidance in the implementation of ISO  공하도록의도된 기술보고서이다.  
<ICMC Business Item for Global Approvals>

(ISO13485인증.국제의료기기.화장품.의약품.의약외품 인허가.인증 컨설팅) 
한국KOREA-  KFDA(KGMP/제조.수입인허가)
유럽EU-       CE(MDD.IVD.ISO13485;2003)
일본JAPAN-  MHLW(cosmetic.food.drug.medical device.qms)
미국U.S.A-   FDA (cGMP.QSR)
중국CHINA-  SFDA(GMP)
캐나다CANADA-CMDCAS(ISO13485)
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1. KFDA 의료기기 제조품목 인,허가.KGMP.제조기술문서작성.제품시험등

2. KFDA 의료기기 수입품목 인,허가.KGIP.수입기술문서작성.시료확인서.
   표준통관예정보고.문서번역(영.일문) 

3. ISO9001.ISO14001.ISO13485.ISO22000.HACCP.TS16949 

4. U.S.A-FDA(Listing).FDA(510K):Medical Devices.Cosmetic.Food.Drug.   
    Approvals

5. JAPAN-MHLW(Medical Devices. Cosmetic. Food. Drug.etc...Approvals)

6. EU-CE(MDD).CE(IVD).CE(PED).CE(MD).CE(PPE).CE(COC) etc......

7. CHINA-SFDA(Medical Devices.Cosmetic.Food.Drug.etc....Approval)
 

8. ICMC TRADE(IMPORT.EXPORT BUSINESS)
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