CONTENTS  목 차 
Foreword  머리말  ---------  3  
0  Introduction  0  개요  --------- 5  
0.1  General  0.1  일반사항 --------- 5  
0.2 Process approach  0.2  프로세스접근법  --------- 5  
0.3 Relationship with other standards  0.3  다른규격과의관계  --------- 6  
0.4 Compatability  with  other  management  0.4  다른경영시스템과의부합성  ---- 7  
systems     
1.  Scope  1.  적용범위  --------- 8  
1.1  General  1.1  일반사항  --------- 8  
1.2 Application  1.2  적용 --------- 8  
2.  Normative reference  2.  인용규격  --------- 9  
3.  Terms and definitions  3.  용어의정의  --------- 10  
4.  Quality management system  4.  품질경영시스템  --------- 13  
4.1 General requirements  4.1  일반요구사항  --------- 13  
4.2 Documentation requirements  4.2  문서화요구사항  --------- 14  
5.  Management responsibility  5.  경영책임  --------- 17  
5.1 Management commitment  5.1  경영의지  --------- 17  
5.2  Customer focus  5.2  고객중심  --------- 17  
5.3 Quality policy  5.3  품질방침  --------- 17  
5.4 Planning  5.4  기획  --------- 18  
5.5 Responsibility, authority & communication  5.5 책임, 권한및의사소통  --------- 18  
5.6 Management review  5.6 경영검토  ---------19  
6.  Resource management  6.  자원관리  --------- 20  
6.1  Provision of resources  6.1  자원확보  --------- 20  
6.2  Human resources  6.2  인적자원  --------- 20  
6.3  Infrastructure  6.3  기반구조  --------- 21  
6.4  Work environment  6.4  업무환경  --------- 21  
7.  Product realization  7.  제품실현  --------- 22  
7.1 Planning of product realization  7.1  제품실현의기획  --------- 22  
7.2 Customer-related processes  7.2  고객관련프로세스  --------- 23  
7.3 Design and development  7.3  설계및개발  --------- 25  
7.4 Purchasing  7.4  구매  --------- 28  
7.5 Production and service provision  7.5  생산및서비스제공  --------- 30  
7.6 Control of monitoring and measuring  7.6  모니터링및측정장치의관리  ---  35  
Devices     
8.  Measurement, analysis and improvement  8.  측정, 분석및개선  --------- 36  
8.1  General  8.1  일반사항  --------- 36  
8.2 Monitoring and measurement  8.2  모니터링및측정  --------- 37  
8.3 Control of nonconforming product  8.3  부적합제품의관리  --------- 39  
8.4 Analysis of data  8.4  데이터의분석  --------- 40  
8.5 Improvement  8.5  개선  --------- 41  
Annex A  부속서 A  --------- 44  
Annex B  부속서 B  --------- 48  
Bibliography  관련규격  --------- 80  

Foreword  머리말 
ISO (the International Organization for  ISO (국제표준화기구)는국가표준기관(ISO  
Standardization) is a worldwide federation of  회원기관)들의세계적인연합체이다. 국제규 
national standards bodies (ISO member bodies).  격의준비작업은 ISO 기술위원회에서수행한 
The work of preparing International Standards is  다. 기술위원회가다루는주제에대하여관심 
normally carried out through ISO technical  을가진각회원기관은당해위원회에참여 
committees. Each member body interested in a  할권리를갖는다.  
subject for which a technical committee has been   
established has the right to be represented on   
that committee. International organizations,  ISO 와연관되어있는정부및비정부국제 
governmental and non-governmental, in liaison  기구도그작업에참여한다. ISO 는전기기술 
with ISO, also take part in the work. ISO  표준화에관한모든문제에관하여국제전기 
collaborates closely with the International  기술위원회 (IEC) 와밀접하게협력한다.  
Electrotechnical Commission (IEC) on all matters   
of electrotechnical standardization.   
International Standards are drafted in accorda  국제규격은 ISO/IEC 지침, 파트 2에서정한 
nce with the rules given in the ISO/IEC Direct  규정에의거하여작성된다.  
ives, Part 2.   
The main task of technical committees is to prep  기술위원회의주요업무는국제규격을작성 
are International Standards. Draft International S  하는것이다. 기술위원회에의해채택된국제 
tandards adopted by the technical committees  규격의초안은투표를위하여회원국에회람 
are circulated to the member bodies for votin  된다. 국제규격으로서공표되기위하여는적 
g. Publication as an International Standard req  어도투표하는회원기관의 75% 이상의찬성 
uires approval by at least 75 % of the memb  을필요로한다.  
er bodies casting a vote.   
Attention is drawn to the possibility that some  이규격의일부요소는특허권에관련될가 
of the elements of this document may be the  능성이있음에유의하여야한다. ISO 는그러 
subject of patent rights. ISO shall not be held  한특허권에관한사항을파악할책임을지 
responsible for identifying any or all such pate  지않은다.  
nt rights.   
ISO 13485 was prepared by Technical  국제규격 ISO 13485 는 ISO/TC 210 기술위 
Committee ISO/TC 210, Quality management  원회 (품질경영및의료기기에대한일반사 
and corresponding general aspects for medical  항)에의하여작성되었다.  
devices.   
This second edition cancels and replaces the first  이제2판은제1판 (ISO 13485:1996) 을취소 
edition (ISO 13485:1996), which has been techni  및대체한다. 제 1판은기술적으로개정되었 
cally revised. It also cancels and replaces ISO 13  으며 ISO 13488:1996 를취소및대체한다.  
488:1996. Those organizations which have used  과거에 ISO 13488 을사용했던조직은 1.2항 
ISO 13488 in the past may use this Internationall  에따라일부요구사항을제외함으로써이 
Standards by excluding certain requirements in a  규격을사용할수있다.  
ccordance with 1.2.   
This edition of ISO 13485 carries a revised title  ISO 13485 제2판(개정판)은규격명이개정되 
and addresses quality assurance of product,  었고제품의품질보증, 고객요구사항및품질 
customer requirements, and other elements of  경영시스템의다른요소를다룬다.  
quality system management.   

<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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