ISO 13485 is a Management Systems Standard developed solely for the manufacture of Medical Devices published by International Organization for Standardization in 2003. This standard provides a framework for a comprehensive management system for the design and manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485 stipulates essential requirements for any organization in the medical device and pharmaceutical supply chain.

OVERVIEW OF ISO 13485:2016 & QMS

How do you manage your Quality Management System? If you are following a traditional management system, you are running a up ‘high risk’ business.

Some medical device companies have progressed from eQMS software tools that are highly customizable and configurable, but this approach is very risky. Our team of medical device industry experts has designed and built an eQMS software platform specifically for the medical device industry. Our industry specific platform is architected to support the requirements of ISO 13485:2016 (and other regulatory requirements), where they are addressed automatically with no configuration required.


A QMS is often times seen as the set of procedures that define the rules and restrictions that must be followed in the quest for designing, developing, and manufacturing medical devices. Few only embrace the notion that a QMS is beneficial. Most companies implement a QMS that is largely rule-based, restrictive, cumbersome, and largely ineffective. QMS should be a set of processes that help me to run a better, more efficient business that focuses on true quality and what is best for the patients who will be recipients of my medical devices.

Companies implemented a QMS because they were forced to comply with applicable regulations governing medical device companies. As times changed, the QMS processes and procedures were edited, often times to satisfy the request of an auditor. The company would add new people, sometimes growing, sometimes outsourcing. As a result, existing procedures would be edited and/or more new procedures defined.

Insistence on quality by the Quality Control Department was seen as a restriction to slow down the progress of the company. So the notion of quality became viewed as a function of compliance and an impediment.


Establishment of ISO 13485:2016 standard is an important milestone for the medical device industry. It describes and defines current QMS expectations for medical device companies. Prior to these refinements being formally defined and documented in the standard, many of the best practices being advised and adopted were very often seemed to be based on auditor opinions.


A Quality Management System is “A formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management.” A QMS is comprised of the core set of business policies, procedures, forms, and work instructions, along with their sequence, interactions, and resources required to conduct business within a medical device company. Quality records are documentation that demonstrate the QMS is being executed and followed.

If you choose to outsource any process(es) that impacts requirements of the standard (for example, contract manufacturing), it is your responsibility to monitor and ensure controls over the outsourced processes. This includes defining roles and responsibilities in documented quality agreements with any outsourcing resources.

In the event you use an eQMS software tool, software validation procedures must be defined and the system must be validated before use. It is worth noting that validating most eQMS tools available to you will be time consuming and frustrating. Why? Most eQMS tools are general purpose and not specifically aligned to ISO 13485:2016 and medical device QMS requirements.

This means the first step you have to do to even use these types of tools is to customize and configure to align with ISO 13485. And this easily takes several months. Then, once configured, you have to define protocols and execute testing in order to validate the tool–again taking weeks and months to complete.
At Exsolutiongroup it is our goal to alleviate those efforts and streamline your processes through our multi-tenant, cloud-based SaaS platform. According to a LNS Research ‘State of the Market’ piece on Software Validation in the Life Sciences industry, they assert,

Cloud-based technologies create new opportunities to streamline validation [and] industry leading vendors are providing pre-validated platforms, pre-validated functions, and pre-validated pre-configurations.


Adage goes as “…if it is not documented, then it did not happen.” Yes, documentation of QMS processes, quality events, and workflows is critically important. Sometimes the notion of documentation can create dread within a company. Sometimes the idea of documentation is viewed as overly burdensome and often times unnecessary with little value added.

Documentation should be about defining processes and maintaining the records required to demonstrate these processes are being followed. Documentation is key for objective evidence. Objective evidence to support your employees through design, development, manufacturing, and support of medical devices. Objective evidence to demonstrate that requirements are being addressed.


A key part of your QMS is your quality manual. Sections of ISO 13485 and describes from a high-level how the medical device company addresses the clauses. This approach is fine. Your quality manual must meet the following criteria:

  •  Describe the scope of your QMS. Include any clauses that are excluded or   non-applications supported with justification.
  •  List or reference the procedures comprising the QMS.
  •  Describe interactions of QMS processes.
  •  Outline the structure of QMS documentation.


Every medical device type or device family must have a medical device file.
The contents of a medical device file shall include:

  • Description of the product, including intended use and indications for use.
  • Product labeling and instructions for use.
  • Specifications for the product.
  • Specifications and procedures for manufacturing, inspection, labeling, packaging, storage, handling, and distribution.
  • Specifications for measuring and monitoring.
  • Specifications and procedures for product installation (if applicable).
  • Procedures for product servicing (if applicable).


Documentation is a necessary aspect of a QMS.
A document control procedure shall define your company’s criteria for document control. This includes ensuring documents are reviewed and approved prior to implementation, means to revise documents and identify changes, and ensure current versions are available at point of use.


Records require similar controls as documents. And sometimes the distinction between a document and record can be a bit confusing. Records are evidence that certain processes have been followed.