This is still a big question mark for most people. We are often focused at building a good product and/or service, managing project timeline, keeping investors excited or engaging potential customers. Many items down the checklist. Of course, these are important milestones for the survival of all businesses. However, setting up a set of internal procedures or system is never less important. This structure must be put in place at some point of time – with the objective to ensure your eventual product/service consistently meet expectations of customers and regulators (in regulated industry like medical devices). This is known as the Quality Management System (QMS) of a company.
"QMS is a set of policies and procedures required for the company to identify, measure, control and improve core activities to meet customer and regulatory requirements applicable to the product and related services”.
Most industries have also adopted international standards that are published by committees such as the International Organisation of Standardisation (ISO) as the basic requirement for compliance. For medical devices, we commonly hear about the widely adopted standard - ISO 13485.
ISO 13485 defines the QMS specifically for the medical devices industry. It is usually adopted by companies involved in the design and development, production, distribution, installation, servicing and other peripheral roles.
ISO 13485 is the preferred method of meeting QMS requirements in most countries such as Europe, Japan, Canada, Singapore and other Asia markets. Many countries may also impose additional requirements on top of those outlined in the ISO 13485. Your appointed third-party assessor will be conducting the yearly on-site audit to ensure compliance. However, in the U.S., FDA 21 CFR 820 is used instead. Therefore, it is important to know your target markets and build your QMS accordingly.
Who Are Involved In QMS
QMS is not an activity solely for the quality department. It is a company wide implementation and involves the management and employees from sales, business development, marketing, procurement, research and development, quality, regulatory and etc. Basically, it involves everyone who plays a role in maintaining the quality of the medical device, directly and indirectly.
When Should YOU Establish QMS
Many companies have the wrong perception that a QMS should only be setup when they are approaching the commercialisation phase. This is incorrect.
It is always recommended to establish a QMS as early as possible and building it up as the company progresses. You may only have product development activities initially but you should have a set of documents to already start documenting these actions. As you have no plans for manufacturing activities, there is no requirement for you to established manufacturing procedures until you have decided to do so one day.
Why You Should Establish QMS
There are numerous benefits for implementing a QMS:
- Align with regulations
- Expand market access
- Establish framework on business leading to competitive advantage
- Define expectations and delivery for key processes
- Procedures for design control and ensuring no critical design issues are overlooked
- Procedures for risk management and demonstrate that products are safe and effective
- Meet customer expectation
- Enhance efficiency and marketability
- Establish organisational credibility & reputation
- Robust framework on product consistency
How to establish QMS
We have set up and implement ISO13485 for several organisations, including the National University of Singapore, Medical Engineering Research & Commercialization Initiative (MERCI). To find out more about the process, please refer to our previous post here!
The new ISO 13485:2016 was published in March 2016, with several changes from the previous ISO 13485:2003. Some of the changes include items such as additional details for design stages, QMS software validation, updated requirements for risk management, verification and validation, and more robust supplier controls. This has definitely provided more structure and clarity to what a company needs to comply with.
Companies with the 2003 version have three years to transit to the newly published ISO13485:2016. ISO 13485:2003 and ISO 13485:2016 will coexist over the next three years. After the 2nd year of implementation, new or re-certification will be given for ISO 13485:2016. After the 3rd year, any ISO 13485:2003 will no longer be valid.
So, start working on your QMS today!
Interested to setup and implement a QMS for your company? Contact us now for more information, including a 30-minute complementary gap analysis to understand what's needed for you to get or stay compliant!