Aligning the requirements of ISO 13485:2003 to ISO 9001:2008 (A 5 Part Series)

By: Mona Elkhatib


Company certifications to ISO 13485:2003 grew by approximately 14% during last year in comparison to other standards, such as ISO 9001, AS 9100, and ISO 14001, in which certifications grew by approximately 3% – 4%. This is attributed to regulatory bodies for the medical devices industry and the growth of that sector.


Typically organizations seeking ISO 13485 certifications are within the supply chain of the licensed medical device manufacturer, and are already certified to ISO 9001:2008.


This is a 5 part series that identifies key requirements of ISO 13485 that are not requirements of the ISO 9001:2008 standard. This series does not include regulatory requirements set by regulators such as FDA, Health Canada (CMDCAS), Brazil (ANVISA), or Australia (TGA). This will hopefully be presented in the near future.


The following is a breakdown of what will be included in this series:

Part 1: Documentation requirements

Part 2: Management commitment

Part 3: Resources

Part 4: Product realization

Part 5: Measurement, analysis and improvement



Part 1 of 5: Documentation Requirements


Documentation requirements and established procedures per ISO 9001:2008 are limited to the quality manual (4.2.2), control of documents (4.2.3), control of records (4.2.4), internal audit (8.2.2), control of nonconforming product (8.3), corrective action (8.5.2), and preventive action (8.5.3). In short, a quality manual and six required procedures.


Documentation requirements for ISO 13485:2003 are much more extensive. In addition to the six required procedures listed above, there are 16 other required procedures, 7 documentation requirements and 1 requirement for establishing a device master record (DMR).


Below is a listing of the documentation requirements per ISO 13485:2003.


Clause No. Procedure Requirement
4.2.1 Documentation requirements DMR
4.2.3 Control of documents X
4.2.4 Control of records X
6.3 Infrastructure X
6.4 Work environment X X
7.1 Planning for product realization (risk management) X
7.3 Design and development X
7.4.1 Purchasing process X Control of production and service provision X X Cleanliness of product and contamination control X Installation activities X Servicing X Validation of processes X Particular requirements for sterile medical devices X Identification X Traceability X
7.5.5 Preservation of product X
7.6 Control of monitoring and measuring devices X
8.2.1 Feedback X
8.2.2 Internal audit X
8.3 Control of nonconforming product X
8.4 Analysis of data X
8.5.1 Improvement (Advisory Notices/ Mandatory Reporting) X
8.5.2 Corrective action X
8.5.3 Preventive action X




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