Comparison between FDA QSR and ISO 13485

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1 Comparison between FDA QSR and ISO Most countries in the world including the Europe, for the conformity assessment of medical devices to be used by their countrymen, assess not only whether the product itself is designed safely with technical files but also whether a quality system that can continuously manufacture and supply safe products is established and maintained In addition, after the product is approved through the conformity assessment procedure, in order to evaluate the effectiveness of the conformity, the quality system of the manufacturer is regularly audited. The standard that is applied during the audit is ISO FDA, like any other countries, requires a quality system for medical devices administered by the FDA and that quality system is called Current Good Manufacturing Practice (CGMP). The requirements of CGMP are defined in Part 820 of the Code of Federal Regulation Title 21, and these are the Quality System Regulation (QSR) of the FDA. FDA, when it amended the CGMP in 1990, made sure that it harmonized with international standards as much as possible. As the result, the current QSR of the FDA harmonizes with ISO 13485:2003 in many sections. This can be clearly seen from the table below comparing the clauses of the QSR of the FDA and ISO Table 1: Comparison of the clauses of FDA QSR and ISO FDA Quality System Regulation (QSR) ISO 13485:2003 Subpart A General Provisions Sec Scope 1 Scope Sec Definitions 3 Terms and definitions Sec Quality system 4. Quality management system 4.1 General requirements Subpart B Quality System Requirements Sec Management responsibility (a) Quality policy 5.3 Quality policy (b) Organization (1) Responsibility and authority Responsibility and authority (2) Resources 6.1 Provision of resources (3) Management representative Management representative (c) Management review 5.6 Management review General (d) Quality planning Quality management system planning (e) Quality system procedures 4.2 Documentation requirements General Sec Quality audit Internal audit Sec Personnel 6.2 Human resources

2 Subpart C Design Controls Sec Design controls (a) General Design and development planning (b) Design and development planning Design and development planning (c) Design input Design and development inputs (d) Design output Design and development outputs (e) Design review Design and development review (f) Design verification Design and development verification (g) Design validation Design and development validation (h) Design transfer Design and development planning (i) Design changes Control of design and development changes (j) Design history file Subpart D Document Controls Sec Document controls Control of documents Subpart E Purchasing Controls Sec Purchasing controls Purchasing process Purchasing information Subpart F Identification and Traceability Sec Identification Identification Sec Traceability Traceability Subpart G Production and Process Controls Sec Production and process controls (a) General control of production and service provision General requirements (b) Production and process changes (c) Environmental control 6.4 Work environment (d) Personnel 6.4 Work environment (e) Contamination control 6.4 Work environment (f) Buildings 6.3 Infrastructure (g) Equipment 6.3 Infrastructure (h) Manufacturing material (i) Automated processes Validation of processes for production and service provision General requirements Sec Inspection, measuring and test equipment 7.6 Control of monitoring and measuring devices Sec Process validation Validation of processes for production and service provision

3 Subpart H Acceptance activities Sec Receiving, in-process and finished device acceptance (a) General (b) Receiving acceptance activities Verification of purchased product (c) In-process acceptance activities (d) Final acceptance activities (e) Acceptance records Sec Acceptance status Status identification Subpart I Nonconforming Product Sec Nonconforming product 8.3 Control of nonconforming product Subpart J Corrective and Preventive Action Sec Corrective and preventive action Corrective action Preventive action Subpart K Labeling and Packaging Control Sec Device labeling Sec Device packaging Preservation of product Subpart L Handling, Storage, Distribution, and Installation Sec Handling Preservation of product Sec Storage Preservation of product Sec Distribution General requirements Sec Installation Installation activities Subpart M Records Sec General requirements Control of records Sec Device master record Sec Device history record Sec Quality system record Sec Complaint files Feedback 8.5 Improvement General Subpart N Servicing Sec Servicing Servicing activities Subpart O Statistical Techniques Sec Statistical techniques 8.4 Analysis of data As you can see from the above table, most of the clauses of FDA QSR and ISO are identical.

4 Then, let us take a look at major differences of FDA QSR from ISO Differences between FDA QSR and ISO Permissible exclusions Both QSR and ISO allow exclusion of inapplicable clauses of the quality requirements. However, ISO limits the exclusions to Chapter 7. Therefore, for ISO 13485, exclusions must be specified. 2. Design control For ISO 13485, all products can be subjects of design control. But for FDA QSR, design control is applied only to Class 2 and Class 3 products, and of Class 1 products, to tracheobronchial suction catheter, surgeon s glove, protective restraint, manual radionuclide applicator system and radionuclide teletherapy source. 3. Design validation FDA QSR requires the validation of design to be conducted on initial products and products to pass the tests during actual operation. In addition, QSR includes software validation and risk analysis in design validation. 4. Design history file This is a document not particularly required by ISO 13485, and this is a document, which include all design-related documents and records or references to those documents and records. 5. Change of document FDA QSR requires changes to a document to be communicated to related personnel. 6. Control of purchasing FDA QSR requires, if possible, the purchasing documentation to include an agreement that requires the supplier to inform the changes to the manufacturer if a change is made to purchased products. 7. Changes to production and processes FDA QSR requires the control of changes to product manufacturing procedures. There is no specific requirement regarding the changes in ISO Equipment FDA QSR includes detailed requirements on the schedule of maintenance, inspection and calibration of equipments.

5 9. Raw material FDA QSR requires, if raw material affects the quality of product negatively, a procedure for the use and removal of raw material to be established 10. Incoming inspection, in-process inspection and approval of finished product Overall both are the same but FDA QSR specifies in more details about incoming inspection, inprocess inspection and finished product inspection. 11. Nonconforming product They are overall the same but QSR requires in more details about procedures to be established and documentation. 12. Corrective and preventive action FDA QSR specifies in more details about the contents of the documented procedure. 13. Labeling of device This is a requirement not found in ISO and it defines the status, inspection, storage and use of labels to be attached to medical devices. 14. Handling, storage and release FDA QSR requires in more details about the handling, storage and release of products. 15. Device master record Device master record is a collection of specifications and procedures regarding a specific device from design to production to release of the device. 16. Device history record Device history record includes documents and production records that prove each batch, lot or device is manufactured according to the device master record. 17. Quality system record It is a collection of procedures and documents not belonging to specific devices. There is no requirement for such record in ISO but each of the documents in quality system record is required throughout ISO Complaint files FDA QSR describes in details the handling and documentation of customer complaints.

6 As described so far, FDA QSR is not that different from ISO In particular, quality managers having had experience with the establishment of a quality system in accordance with ISO will feel familiar with the contents of FDA QSR. If the differences between FDA QSR and ISO are understood and applied to the existing quality system, it will help preparing for the quality system audit of FDA.

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