Using ISO 13485 Together with ISO 9001

Using ISO 13485 together with ISO 9001 delivers meaningful value for firms. As is well known, ISO 13485 is a standard built specifically for medical devices, while ISO 9001 is the quality management system designed to apply across virtually every sector.

Running the two together, which means building ISO 9001 requirements alongside the additional requirements below, gives the medical-device firm a single, integrated management system:

• Product hygiene and sanitation requirements and rules must be defined and documented. Actions required for product hygiene include:

Sterilisation of the medical device, where applicable. For products that do not require sterilisation, hygiene conditions must be met during manufacture.

• Requirements related to the production area:

The manufacturer must document the facility requirements in writing, define the minimum facility conditions, establish the verification criteria for those conditions, and retain the associated facility records.

• Requirements related to distribution:

If distribution is a material requirement for the product, the firm must document procedures and work instructions for distribution. Distribution records must be retained.

• Requirements for medical devices that must be sterile:

The firm must retain sterilisation conditions and the associated documents for every production batch, linking them to the lot number used during manufacture. Because ISO 9001 is the quality management system, supplier evaluation must be carried out so that raw-material requirements are met, and suppliers must be recorded. Nonconforming products must be segregated, and the retention-sample records required for certain medical devices must be held along with the related records. The other ISO 9001 requirements continue to apply as written. The combined system is then recognised alongside the ISO 13485 medical-devices standard.