Medical Devices – Management Systems Requirements

Many companies are in the process of upgrading their management systems to include Medical Device 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 9001:2008.  Therefore companies that have a strong ISO 9001 or IATF 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 documentation requirements (Records)

• Product files with specific required documentation

Requires risk analysis and management during design and product development / realization with associated records.

• A FMEA including actions and records may be able to be used to implement this requirement.

For companies responsible for design; documented procedures, reviews, verification, validations and design transfer activities must be more formally addressed.

• 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.

Companies must establish procedures in the manufacturing and work environment to ensure product safety

• 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.

Sterilization records (Traceability and process validation) are required when 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.

Validation of processes is required for sterile medical devices

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.

While there are specific requirements that a company must address to become registered to ISO 13485, if the company has a strong and effective ISO 9001 quality system, the additional implementation work is not tremendous.

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.

One important decision an organization needs to make regarding ISO 13485: 2016 implementation is whether they still have products and customers that desire or require ISO 9001 registration. Since ISO 13485: 2016 is based on ISO 9001: 2008, there are a small number of ISO 9001: 2015 requirements that would need to be addressed by the organization’s quality management system.