Correspondence between ISO 9001:2000, ISO 13485:2003, US FDA and AS9100-B

ISO US FDA
Requirements
Clause No 9001:2000 13485:2003 21 CFR, Part 820 AS 9100-B Document Ref
Scope 1 F F F
General 1.1 F F F
Application 1.2 F F F
Normative Reference 2 F F F
Terms and Definitions 3 F F F
Quality Management Systems 4 F F F
General requirements 4.1 F F 820.50 F
Documentation Requirements 4.2 F F F
820.50
General F F F
4.2.1 820.20(e)
Quality Manual 4.2.2 F F 820.50 F
Control of Documents 4.2.3 F F 820.40(a)(b) F
Control of Records 4.2.4 F F 820.180 F
Configuration Management Q 4.3 Q
Management Responsibility 5 F F F
820.20 (a)(b)(2)
Management Commitment F F F
5.1 820.50
Customer Focus 5.2 F F 820.160(a) F
Quality Poilcy 5.3 F F 820.20 (a) F
Planning 5.4 F F F
Quality Objectives 5.4.1 F F 820.20 (a) F
QMS Planning 5.4.2 F F 820.20(d) F
Responsibility, Authority and Communication 5.5 F F F
Responsibility, Authority 5.5.1 F F 820.20(b)(1) F
Management Responsibility 5.5.2 F F 820.20(b)(3) F
Internal Communication 5.5.3 F F F
Management Review 5.6 F F F
General 5.6.1 F F 820.20 (c) F
Review Input 5.6.2 F F 820.20 (c) F
Review Output 5.6.3 F F 820.20 (c) F
Resource Management 6 F F F
Provision of Resources 6.1 F F 820.20(b)(2) F
Human Resources 6.2 F F F
820.20(b)(2) (d)
General F F F
6.2.1 820.25
Competence, Training and Awareness 6.2.2 F F 820.25 F
820.20(b)(2)
Infrastructure F F F
6.3 820.70-820.75
Work Environment 6.4 F F 820.70-820.75 F
Product Realisation 7 F F F
820.20(d)
820.70
Planning of product realization 820.75
820.80(a)
7.1 F F 820.200 F
Customer-related processes 7.2 F F F
820.160(a)
Determination of requirements related to the product F F F
7.2.1 820.30 (c)
Review of requirements related to the product 7.2.2 F F 820.160(a) F
Customer Communication 7.2.3 F F 820.160(a) F
Design and development 7.3 F F F
820.30(b)
820.20(e)
Design and development planning
820.20(f)
7.3.1 F F 820.20(g) F
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Design and development inputs 7.3.2 F F 820.30(c) F
Design and development outputs 7.3.3 F F 820.30(d) F
Design and development review 7.3.4 F F 820.20(e) F
Design and development verification 7.3.5 F F 820.20(f) F
Design and development validation 7.3.6 F F 820.20(g) F
Documentation of Design and/or Development verification
and validation Q 7.3.6.1 Q
Design and/or Development verification and validation
testing Q 7.3.6.2 Q
Control of design and development changes 7.3.7 F F 820.20(i) F
Purchasing 7.4 F F F
Purchasing process 7.4.1 F F 820.50(a)(1)(2)(3) F
Purchasing information 7.4.2 F F 820.50(b) F
820.80(b)(c)(d)
Verification of purchased product F F F
7.4.3 820.50(a)(2)
Production and service provision 7.5 F F F
820.70
820.75
Control of production and service provision 820.80 (c)
820.120
7.5.1 F F 820.200 F
General requirements €/ Production Documentation Q 7.5.1.1 € Q
Control of production and service provision — Specific
requirements € / Change Q 7.5.1.2 € Q
Control of production equipment, tools and numerical
control machine programs 7.5.1.3 Q
Control of work transferred, on a temporary basis, outside
the organisation facilities 7.5.1.4 Q
Control of service operations 7.5.1.5 Q
Cleanliness of product and contamination control € 7.5.1.2.1 €
Installation activity € 7.5.1.2.2 €
Servicing activities € 7.5.1.2.3 €
Particular requirements for sterile medical devices € 7.5.1.3 €
Validation of processes for production and service
F F 820.70-820.75 F
provision 7.5.2
General requirements € 7.5.2.1 €
Particular requirements for sterile medical devices € 7.5.2.2. €
Identification and traceability 7.5.3 F F F
820.60
820.65
Identification €
820.80(e)
7.5.3.1 € 820.86
820.60-820.65
Traceability € €
7.5.3.2 820.86
General € 7.5.3.2.1 €
Particular requirements for active implantable medical
devices and implantable medical devices € 7.5.3.2.2 €
Status identification 7.5.3.3 € 820.86
Customer property 7.5.4 F F F
820.120
820.130
Preservation of product
820.140
7.5.5 F F 820.150 (a) F
Control of monitoring and measuring devices 7.6 F F 820.72 (a)(b) F
Measurement, analysis and improvement 8 F F F
820.80(a)
General F F F
8.1 820.250(a)
Monitoring and measurement 8.2 F F F
Customer satisfaction F Q / Feedback € 8.2.1 F € F
Internal audit 8.2.2 F F 820.22 F
820.22
820.70
Monitoring and measurement of processes
820.75
8.2.3 F F 820.250(a) F
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 820.80(b)(c)(d)(e)
Monitoring and measurement of product F F F
8.2.4 820.250(a)(b)
General requirements €/Inspection Documentations Q 8.2.4.1 € Q
Particular requirement for active implantable medical
devices and implantable medical devices €/ First Articla
Inspection Q 8.2.4.2 € Q
Control of nonconforming product 8.3 F F 820.90 (a)(b) F
Analysis of data 8.4 F F 820.100(a)(1-4,7) F
Improvement 8.5 F F F
Continual improvement F Q / General € 8.5.1 F € Q
820.100(a)
Corrective action F F F
8.5.2 820.100(a)(1-4)
Preventive action 8.5.3 F F 820.100 (a)(1,3,4,7) F
F - ISO 9001:2000 €- ISO 13485:2003 Q-AS 9100 B:2004

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Compeny Name Knowledge Sharing Page 5 of 10
 QEHS
EMS
EHS
IR
AR
QSP
QSM

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 LOGO
Process and Clause Mapping

ISO
Requirements
Clause No 9001:2000 13485:2003 AS 9100-B Responsibility Interacting Process
Scope 1 F F F
General 1.1 F F F
Application 1.2 F F F
Normative Reference 2 F F F
Terms and Definitions 3 F F F
Quality Management Systems 4 F F F
General requirements 4.1 F F F
Documentation Requirements 4.2 F F F
General 4.2.1 F F F
Quality Manual 4.2.2 F F F
Control of Documents 4.2.3 F F F
Control of Records 4.2.4 F F F
Configuration Management Q 4.3 Q
Management Responsibility 5 F F F
Management Commitment 5.1 F F F
Customer Focus 5.2 F F F
Quality Poilcy 5.3 F F F
Planning 5.4 F F F
Quality Objectives 5.4.1 F F F
QMS Planning 5.4.2 F F F
Responsibility, Authority and Communication 5.5 F F F
Responsibility, Authority 5.5.1 F F F
Management Responsibility 5.5.2 F F F
Internal Communication 5.5.3 F F F
Management Review 5.6 F F F
General 5.6.1 F F F
Review Input 5.6.2 F F F
Review Output 5.6.3 F F F
Resource Management 6 F F F
Provision of Resources 6.1 F F F
Human Resources 6.2 F F F
General 6.2.1 F F F
Competence, Training and Awareness 6.2.2 F F F
Infrastructure 6.3 F F F
Work Environment 6.4 F F F
Product Realisation 7 F F F
Planning of product realization 7.1 F F F
Customer-related processes 7.2 F F F
Determination of requirements related to the product 7.2.1 F F F
Review of requirements related to the product 7.2.2 F F F
Customer Communication 7.2.3 F F F
Purchasing 7.4 F F F
Purchasing process 7.4.1 F F F
Purchasing information 7.4.2 F F F
Verification of purchased product 7.4.3 F F F
Production and service provision 7.5 F F F
Control of production and service provision 7.5.1 F F F
General requirements €/ Production Documentation Q 7.5.1.1 €x Q
Control of production and service provision — Specific
requirements € / Change Q 7.5.1.2 €x Q
Control of production equipment, tools and numerical
control machine programs Q 7.5.1.3 Q
Control of work transferred, on a temporary basis, outside
the organisation facilities Q 7.5.1.4 Q
Cleanliness of product and contamination control € 7.5.1.2.1 €
Validation of processes for production and service
provision 7.5.2 F F F
Identification and traceability 7.5.3 F F F
Identification € 7.5.3.1 €
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 Traceability € 7.5.3.2 €
General € 7.5.3.2.1 €
Status identification 7.5.3.3 €
Customer property 7.5.4 F F F
Preservation of product 7.5.5 F F F
Control of monitoring and measuring devices 7.6 F F F
Measurement, analysis and improvement 8 F F F
General 8.1 F F F
Monitoring and measurement 8.2 F F F
Customer satisfaction F Q / Feedback € 8.2.1 F € F
Internal audit 8.2.2 F F F
Monitoring and measurement of processes 8.2.3 F F F
Monitoring and measurement of product 8.2.4 F F F
General requirements €/Inspection Documentations Q 8.2.4.1 € Q
Particular requirement for active implantable medical
devices and implantable medical devices €/ First Articla
Inspection Q 8.2.4.2 €x Q
Control of nonconforming product 8.3 F F F
Analysis of data 8.4 F F F
Improvement 8.5 F F F
Continual improvement F Q / General € 8.5.1 F € Q
Corrective action 8.5.2 F F F
Preventive action 8.5.3 F F F
F - ISO 9001:2000 €- ISO 13485:2003 Q-AS 9100 B:2004 x- Not Applicable / Excluded

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Process and Clause Mapping

Documents

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3485:2003 Q-AS 9100 B:2004 x- Not Applicable / Excluded

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