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Alpha Quality Assurance can help you set up, monitor and conform to an ISO 13845 quality system

   

Alpha Quality Assurance Associates
111 Nataqua Avenue
Pacifica, CA 94044
Phone 650.359.4297
Fax 650.359.6171
kenmiles@alphaqa.biz
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FDA Regulations and ISO 13485:2003 implementation matrix

 

ISO 13485 is a medical device quality systems standard that supplements ISO 9001. The following chart shows the correlation between FDA regulations and ISO13485:2003.

 

 

Key Quality System Areas and Functions Processes and Procedures FDA Regulations, including QSRs ISO 13485 (2003)

Executive Management Quality Policy and Objectives 820.20 5.3
Quality Planning 820.20 5.4
Quality System 820.5  
Quality Manual, Quality System Records, SOPs & Work Instructions 820.20   4.2.2  
Organization 820.20 5.5.1
Internal communication   5.5.3
Resource Management 820.20 6.1 - 6.2 -6.3
Training 820.25
820.70
6.2

Management Representative Management Review  (QMS) 820.20 (c) 5.6
Risk Management (ISO 14971)   7.1-7.2.1-7.3.2 8.3.4
Management Review 820.20(c) 5.6
Quality System Records 820.186 4.2.4
Quality Audits 820.22 8.2.2

Regulatory Affairs MDR (vigilance reporting) 803 8.2.1
Recall, corrections and removals 7.3, 806, 810 8.3 8.5

Quality Assurance Document control 820.40 4.2.3
Quality Audits 820.22 8.2.2
Training 820.25 820.70 6.2
CAPA 820.100 8.5.2 - 8.5.3
Quality  System Records 820.180 4.2.4

HR Resource Management 820.20 6.1 - 6.2 -6.3
Training   820.25

820.70
6.2

Development and Design Controls Design Control   820.30(a-j) 7.3
Design History Files (DHF) 820.30 (j) 4.2.3.2
Design Transfer 820.30 (h) 7.3.8
Document control 820.40 4.2.3
Risk Management (ISO 14971)   7.1-7.2.1-7.3.2 8.3.4
Quality System Records 810.180 4.2.4

Procurement Purchasing control 820.50 7.4
Document control 820.40 4.2.3

Production Planning Identification Traceability

820.60

820.65

7.5.3.1

7.5.3.2


Manufacturing Document control 820.40 4.2.3
Device History Record (DHR) 820.184 4.2.4.1
Identification Traceability 820.60 820.65 7.5.3.1 7.5.3.2
Training 820.25 820.708(d) 6.2
Device Labeling Packing 820.120 820.130 7.5.5.1 7.5.5.3
Handling 820.140 7.5.5.2
Storage 820.150 7.5.5.4
Environmental Control 820.70 (c) 7.5.1.2.1.1
Contamination Control 820.70 (f) 7.5.1.2.1.6
Buildings 820.70(f) 6.4

Production Process Validation Process Validation 820.75   7.5.2
Document control 820.40 4.2.3
Automated process validation 820.70(i) 7.5.2

Complaint Handling Document control 820.40 4.2.3
Complaint Handling 820.198 4.2.4.2
Medical Device Reporting  (vigilance reporting) 803 8.2.1
Recall, corrections and removals 7.3, 806, 810 8.3 8.5
Risk Management (ISO 14971)   7.1-7.2.1-7.3.2 8.3.4

Supplier Quality Control Purchasing control 820.50 7.4
Acceptance activities (QC) 820.80 7.4.3 8.2.4

Customer Support Recall, corrections and removals

7.3,

806,

810

8.3 8.5

Production Process Control Production and Process Control 820.70 7.5
Acceptance activities 820.80 7.4.3 8.2.4
Document control 820.40 4.2.3
Traceability and identification 820.60 - 65  
Calibration 820.72(b) 7.6
Inspection 820.72(a) 7.6
Nonconforming product 820.90 8.3
Device Labeling Packing 820.120 820.130 7.5.5.1 7.5.5.3
Risk Management (ISO 14971)   7.1-7.2.1-7.3.2 8.3.4

Document Control Document control 820.40 4.2.3
Device Master Record (DMR) 820.181 4.2.3.1
Identification Traceability 820.60 820.65 7.5.3.1 7.5.3.2

Environmental Health Safety Environmental Control 820.70 (c) 7.5.1.2.1.1
Contamination Control 820.70 (f) 7.5.1.2.1.6
Buildings 820.70(f) 6.4

IT Document control   820.40 4.2.3
Electronic record & signatures 21 CFR Part 11  
Automated process validation 820.70(i) 7.5.2

Marketing

Design Control   820.30(a-j) 7.3
Device Labeling Packing 820.120 820.130 7.5.5.1 7.5.5.3
Device Master Record 820.181 4.2.3.1

Sales Device Labeling Packing 820.120 

820.130

7.5.5.1 7.5.5.3
Complaint handling   820.198 4.2.4.2
Identification Traceability 820.60

820.65

7.5.3.1 7.5.3.2

Servicing Identification Traceability 820.60

820.65

7.5.3.1 7.5.3.2
Installation 820.170 7.5.1.2.2
Complaint handling 820.198 4.2.4.2
Recalls, corrections and removals 7.3,

806,

810

8.3, 8.5

Distribution Identification Traceability 820.60

820.65

7.5.3.1 7.5.3.2
Device Labeling Packing 820.120

820.130

7.5.5.1 7.5.5.3
Handling 820.140 7.5.5.2
Storage 820.150 7.5.5.4

 

Alpha Quality Assurance  111 Nataqua Ave   Pacifica, CA 94044  650.359.4297 info@alphaqa.biz

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