Medical devices – Quality management systems requirements
Many companies are in the process of upgrading their management systems to include Aerospace and Medical certifications. Registration to these Standards is the key to diversifying your client base.Management Solutions Group, Inc. has been in the forefront of this effort to provide our clients with assistance in training and implementation. We hope that the following information will be useful as you explore new opportunities in the medical device industry.
This standard is based on ISO 9001: 2000 as are IATF 16949: 2002 and AS 9100 B. Therefore companies that have a strong ISO 9001 or TS 16949 system will find that they have many of the required processes in place. They will still, however, need to address the requirements specific to the medical device industry as required in ISO 13485. We will highlight some of the additional and specific requirements here.
Many of the new requirements relate to design, manufacturing environmental control, regulatory requirements, traceability and records required. This new management system also includes additional procedures. Specific details are outlined below:
Requiring that Management ensures awareness of regulatory requirements
- There are several references in the standard that explicitly call out management’s responsibility.
- Product files with specific required documentation
- A FMEA including actions and records may be able to be used to implement this requirement.
- This is slightly different but parallel to many of the requirements in TS 16949 and the associated APQP process. An effective & documented product launch process will address many of the requirements. This is also an appropriate place to ensure all requirements are covered.
- For many medical products there are cleanliness, contamination control, and environmental condition requirements (e.g. clean room and sterilization). This also applies to installation and services where applicable.
- There are traceability requirements for implantable devices, and where required by the standard and/or regulatory or customer, that must be addressed in the procedures and the process.
In the measurement, analysis, and improvement section of the standard there are additional, slightly more prescriptive requirements within ISO 13485 that include:
- Procedures for feedback of quality problems
- Monitoring of product requirements
- Inspection Personnel records
- Recording of customer complaints
- Verification of the effectiveness of corrective and preventive actions.
Following formal registration / certification, the ongoing effort and cost will be largely based on the type of manufacturing and products. For companies further down the supply chain (Tier 2 & 3), these requirements are typically minimal. However having a good process to ensure understanding of customer requirements is essential. Many customers will also assist with specific regulatory requirements for the specific products.