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