ISO 13485:2016: 6 tips to optimise your medical device quality management system

During Quality Context's Annual Training Conference, Victoria Cavendish, medical device quality consultant at Orca Solutions, shared six tips for optimising your medical device quality management system to meet the new requirements of ISO 13485:2016.  

We've shared Victoria's tips here so you can get started today.



#1 – Integrate process management

Process diagram

Victoria says:

"One of the common issues I come across is that processes are managed by each department. This causes a number of issues, such as a lack of communication between departments when a change is made, feedback is not always provided where it needs to be and it is very difficult to identify and measure risk." 

EQMS helps to overcome this issue. The powerful quality management software is ideal for medical device manufacturers, where there are often complex, multi-faceted processes which require the expertise of employees from across different departments or which need to be communicated to stakeholders across the organisation.

Whether there is an issue or an opportunity, EQMS will log this, then create a pre-configured workflow and send notifications to the relevant personnel. EQMS assigns responsibility for tasks, so employees know what they are accountable for. Furthermore, users can view a full audit trail at any stage to demonstrate compliance. 

Read more on the process approach

#2 – Consider automating processes, where possible

EQMS Modules.png

Victoria says:

"Printing, sending emails, and manually compiling reports is not only tedious, it is prone to error. Reducing reliance on paper-based or hybrid solutions is key for an effective medical device quality management system. This reduces compliance burden, improves information integrity and accountability." 

EQMS helps to automate time-heavy, manual processes by:

  • sending out emails and push notifications when actions need to be completed (for example, when documents need reviewing, issues need resolving, new suppliers need adding, risk needs managing etc.)
  • assigning responsibility for resolving issues to pre-configured groups or individuals rather than spending hours searching for the person responsible, and 
  • instantly producing KPI Dashboards with all of your ISO 13485 metrics.

Read more on automating processes with EQMS 

#3 – Analyse data from quality processes

Victoria says:

"Many organisations are really good at documenting processes. But you need to also review the process itself. Are your processes effective? Are they delivering the intended results? Are the key performance indicators correct? Do key performance indicators translate into business effectiveness?"

For example, ISO 13485 follows a plan-do-check-act approach, by which organisations must:

  • plan how to evaluate the quality management system
  • establish procedures for evaluating it, and
  • use analytical results to improve the quality management system. 

Plan do check act

Collaboration is key here, and having a system such as EQMS where you can plan and continually review processes is essential for an effective medical device quality management system. 

Read more on KPI reporting

#4 – Make sure your system is scalable 

Victoria says:

"Your quality management system must be available to all of your employees, anywhere, at any time. This means ensuring your quality management system is scalable. How can you ensure employees can access your medical device management system anywhere, at any time, on any device, whilst all the information is controlled?" 


EQMS is intended to work across entire organisations. Although it has lots of advanced functionality, many of our customers love the system because of its user-friendly interface and scalable pricing module.

Read more reviews and about EQMS pricing

Read more on scalable quality management systems

#5 – Provide ongoing training

Victoria says:

"For an effective management system, employee training is key. You need to be systematically planning training, reviewing the training and testing employees on their knowledge." 

Having established processes to manage competence is a key requirement of ISO 13485:2016. Too many organisations still manage training ad-hoc, rather than through an ongoing process. 

EQMS Training Records Manager

With EQMS Training Records Manager, you can log training requirements, provide feedback and associate any standards and regulations with each training requirement. 

Time to get rid of the spreadsheets? Read more on EQMS Training Record Manager 

#6 – Carry out regular internal audits

Victoria says:

"You just cannot trust that your employees and suppliers are doing what they say they are doing. You need to go down and check for yourself. The only way to do this is through regular auditing." 

You should carry out regular internal audits to ensure that processes are being followed as planned.

Auditing software solutions such as EQMS Audit and Inspection Manager and iEQMS Auditor provide a configurable, off-the-shelf solution for managing the audit process from beginning to end. You can create, schedule and report on any type of audit and associate any relevant standards, directives and regulations with each checklist. 

Read more on driving supplier quality assurance through regular auditing

Read more on iEQMS Auditor 

iEQMS Auditor


What you should do now

Download our ISO 13485:2016 Toolkit to learn more about the standard and how it applies to your organisation. 

Free ISO 13485 Toolkit


Topics: ISO 13485

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