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Compeny NameKnowledge SharingPage 1 of 10
Correspondence between ISO 9001:2000, ISO 13485:2003, US FDA and AS9100-BRequirementsClause NoISO US FDAAS 9100-BDocument Ref 9001:200013485:200321 CFR, Part 820Scope1
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General 
1.1
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 Application
1.2
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Normative Reference2
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Terms and Definitions3
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Quality Management Systems4
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General requirements
4.1
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820.50
F
Documentation Requirements
4.2
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General 
4.2.1
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Quality Manual 
4.2.2
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820.50
F
Control of Documents
4.2.3
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820.40(a)(b)
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Control of Records
4.2.4
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820.180
F
4.3
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Management Responsibility5
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Management Commitment 
5.1
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Customer Focus
5.2
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820.160(a)
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Quality Poilcy 
5.3
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820.20 (a)
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Planning 
5.4
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Quality Objectives
5.4.1
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820.20 (a)
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QMS Planning 
5.4.2
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820.20(d)
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Responsibility, Authority and Communication
5.5
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Responsibility, Authority 
5.5.1
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820.20(b)(1)
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Management Responsibility 
5.5.2
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820.20(b)(3)
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Internal Communication
5.5.3
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Management Review 
5.6
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General 
5.6.1
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820.20 (c)
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Review Input 
5.6.2
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820.20 (c)
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Review Output 
5.6.3
FF
820.20 (c)
F
Resource Management6
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Provision of Resources
6.1
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820.20(b)(2)
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Human Resources
6.2
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General 
6.2.1
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Competence, Training and Awareness
6.2.2
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820.25
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Infrastructure
6.3
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Work Environment 
6.4
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820.70-820.75
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Product Realisation7
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Planning of product realization
7.1
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Customer-related processes
7.2
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Determination of requirements related to the product 
7.2.1
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Review of requirements related to the product 
7.2.2
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820.160(a)
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Customer Communication
7.2.3
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820.160(a)
F
Design and development 
7.3
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Design and development planning 
7.3.1
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820.50820.20(e)
Configuration Management 
Q
820.20 (a)(b)(2)820.50820.20(b)(2) (d)820.25820.20(b)(2)820.70-820.75820.20(d)820.70820.75820.80(a)820.200820.160(a)820.30 (c)820.30(b)820.20(e)820.20(f)820.20(g)
 
Compeny NameKnowledge SharingPage 2 of 10
Design and development inputs
7.3.2
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820.30(c)
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Design and development outputs
7.3.3
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820.30(d)
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Design and development review 
7.3.4
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820.20(e)
F
Design and development verification
7.3.5
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820.20(f)
F
Design and development validation
7.3.6
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820.20(g)
F
7.3.6.1
Q
7.3.6.2
Q
Control of design and development changes
7.3.7
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820.20(i)
F
Purchasing 
7.4
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Purchasing process
7.4.1
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820.50(a)(1)(2)(3)
F
Purchasing information
7.4.2
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820.50(b)
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Verification of purchased product 
7.4.3
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Production and service provision
7.5
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Control of production and service provision
7.5.1
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7.5.1.1
Q
7.5.1.2
Q
7.5.1.3
Q
7.5.1.4
Q
Control of service operations
7.5.1.5
Q
7.5.1.2.1
7.5.1.2.2
7.5.1.2.3
7.5.1.3
7.5.2
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820.70-820.75
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7.5.2.1
7.5.2.2.
Identification and traceability 
7.5.3
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7.5.3.1
7.5.3.2
7.5.3.2.1
7.5.3.2.2
Status identification
7.5.3.3
820.86
Customer property 
7.5.4
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Preservation of product 
7.5.5
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Control of monitoring and measuring devices
7.6
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820.72 (a)(b)
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Measurement, analysis and improvement8
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General 
8.1
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Monitoring and measurement 
8.2
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8.2.1
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Internal audit 
8.2.2
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820.22
F
Monitoring and measurement of processes
8.2.3
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Documentation of Design and/or Development verificationand validation
Q
Design and/or Development verification and validationtesting 
Q
820.80(b)(c)(d)820.50(a)(2)820.70820.75820.80 (c)820.120820.200
General requirements
 / Production Documentation
Q
Control of production and service provision — Specific requirements
/ Change
Q
Control of production equipment, tools and numerical control machine programsControl of work transferred, on a temporary basis, outsidethe organisation facilitiesCleanliness of product and contamination control 
Installation activity 
Servicing activities
Particular requirements for sterile medical devices
Validation of processes for production and service provisionGeneral requirements
Particular requirements for sterile medical devices
Identification
820.60820.65820.80(e)820.86
Traceability 
820.60-820.65820.86
General 
Particular requirements for active implantable medical devices and implantable medical devices
820.120820.130820.140820.150 (a)820.80(a)820.250(a)
Customer satisfaction
F
Q
 
 / Feedback 
820.22820.70820.75820.250(a)
 
Compeny NameKnowledge SharingPage 3 of 10
Monitoring and measurement of product 
8.2.4
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8.2.4.1
Q
8.2.4.2
Q
Control of nonconforming product 
8.3
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820.90 (a)(b)
F
 Analysis of data
8.4
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820.100(a)(1-4,7)
F
Improvement 
8.5
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8.5.1
F
Q
Corrective action
8.5.2
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Preventive action
8.5.3
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820.100 (a)(1,3,4,7)
F
820.80(b)(c)(d)(e)820.250(a)(b)
General requirements
 /Inspection Documentations
Q
Particular requirement for active implantable medical devices and implantable medical devices
 / First ArticlaInspection
Q
Continual improvement 
F
Q
 / General 
820.100(a)820.100(a)(1-4)
F
- ISO 9001:2000
- ISO 13485:2003
 
Q
-AS 9100 B:2004
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