《《ISO13485-中英-F-andy》.pdf

M edical devices Quality managementsystems Requirements for regulatorypurposes Dispositifs médicaux Systèmes de management de la qualité Exigences à des fins réglementaires ISO 13485:2003(E) Contents Foreword . iv 0 Introduction v 0.1 0.1 General v 0.2 0.2 Process approach v 0.3 0.3 Relationship with other standards vi 0.4 0.4 Compatibility with other management systems vi 1 1 Scope 1 1.1 1.1 General 1 1.2 1.2 Application 1 2 2 Normative references 2 3 3 Terms and definitions 2 4 4 Quality management system 4 4.1 4.1 General requirements 4 4.2 4.2 Documentation requirements 4 5 5 M anagement responsibility 6 5.1 5.1 M anagement commitment 6 5.2 5.2 Customer focus 6 5.3 5.3 Quality policy 6 5.4 5.4 Planning 7 5.5 5.5 Responsibility, authority and communication... 7 5.6 5.6 M anagement