FDA requirement: 21 CFR 820 and ISO 9001:2008

Compliance ISO 9001:2008 to requirement FDA: 21 CFR 820

21 CFR 820: Brief Description: ISO 9001:2008 clauses:
§ 820.1 – Scope.
§ 820.3 – Definitions.
§ 820.5 – Quality system.
General Provisions Scope: 1, 2, 3                                               4.1-General Requirement
§ 820.20 – Management responsibility.
§ 820.22 – Quality audit.
§ 820.25 – Personnel.
Quality System Requirements clause 5: Management Responsibilityclause 8.2.2: Internal Audit

clause 6.2 Human Resources

§ 820.30 – Design controls Design Controls clause  7.3 Design and Development
§ 820.40 – Document controls Document controls clause 4.2 Documentation Requirements
§ 820.50 – Purchasing controls. Purchasing controls. clause 7.4 Purchasing
§ 820.60 Identification.
§ 820.65 – Traceability.
Identification and Traceability clause 7.5.3 Identification and Traceability
§ 820.70 – Production and process controls.
§ 820.72 – Inspection, measuring, and test equipment.
§ 820.75 – Process validation.
Production and Process Controls clause 7.5 Production and service provision                                                  clause 7.6 Control of monitoring and measuring equipment
 § 820.80 – Receiving, in-process, and finished device acceptance.
§ 820.86 – Acceptance status.
Acceptance Activities clause 7.4.3 Verification of purchased product  clause 7.1 Product realization
§ 820.90 – Nonconforming product. Nonconforming product. clause 8.3 Control of noncoforming product
§ 820.100 – Corrective and preventive action. Corrective and preventive action. cluase 8.5.2 Corrective Actionclause 8.5.3 Preventive action
§ 820.120 – Device labeling.
§ 820.130 – Device packaging.
Labeling and Packaging Control

§ 820.140 – Handling.
§ 820.150 Storage.           § 820.160-Distribution

Handling, Storage, Distribution, and Installation 7.5.5 Preservation of product
§ 820.180 – General requirements.
§ 820.186 – Quality system record.
§ 820.198 – Complaint files.
Records clause 4.3 Control of records
§ 820.250 – Statistical techniques. Statistical Techniques clause 8.4 Analysis of data
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