ISO 13485 2016 is here… what now?

ISO 13485 2016 is here… what now?

This very practical question seems to be on everyone’s lips, ‘ISO 13485 2016 is here, what do we do now?’

With a three year transition period proposed (N233 Draft White Paper – ISO Transition Planning Guidance for ISO13485:2016) and ISO ISO 13485 2016 templates14971 Software, Quality and Risk Management of Medical Devices also now mandated, the Australian medical device industry is rightly discussing what is a reasonable approach to the transition and PharmOut have already rolled out training courses in most major cities in Australia and New Zealand.

Case study – QRM

The medical device industry may benefit from looking back at how the Australian pharmaceutical manufacturer’s responded to integrated risk management with the implementation on PIC/S Guide to Good Manufacturing Practice V8 back in 2010.

The pharmaceutical manufacturing industry typically responded with a stand-alone Quality Risk Management (QRM) SOP. This stand-alone approach was not acceptable to regulators and subsequently QRM has been integrated within all processes which affect product quality, safety and efficacy.

The methodical integration of QMR across existing QMS’ has been progressively implemented via various routes including audit finding responses and pro-active periodic review. New QMS’s should be developed with QRM integrated.

With the wisdom of hindsight what is a good approach for the medical device industry to address the 2016 changes?

What is in scope?

Key changes to assess include:

  1. Inclusion of risk management and risk based decision making throughout the quality management system
  2. Additional requirements and clarity with regard to validation, verification, and design activities
  3. Strengthening of supplier control processes
  4. Increased focus regarding feedback mechanisms
  5. More explicit requirements for software validation for different applications


Validation, integrated risk management, supplier control processes, software validation are not quick changes.
These processes take time to develop and implement and should not be left to the last 12 months of the ISO 13485 transition period to start.

Option 1: Big bang

Assessing each ISO 13485 change, scoping the impact on your existing QMS documents and updating affected bundles as groups is my preferred approach. It allows your organisation to methodically assess, implement, train and close each change in a controlled manner (that sounds like GMP to me).

This assessment needs to start sooner rather than later to ensure sure your company has sufficient time to implement the change.

Option 2: Periodic review

Using your company’s periodic document review process ensures your organisation methodically updates each document affected by the change. The risk with this approach is inconsistent processes across your QMS, depending on what is being changed and when. This approach also requires careful upfront assessment for viability.

Where to start?

  • Purchase and review ISO 13485:2016.
  • Bring together your process owners and key stakeholders to form small teams to perform a gap assessment of ISO:13486 2016 on your QMS.
  • Output of the gap assessment is a risk assessment, project plan including scope of change, the documents, processes and people affected. Create a Plan-Do-Check-Act strategy.
  • Resource the work, raise a CC and get it done!
  • Confirm effectivity of the changes through inspection.
  • Tick the ‘been there done that box’ for a successful implementation of ISO 13485 2016.


Need help? PharmOut has a team of experienced ISO 13485 QMS and change specialists to support your journey. We can assist you with a range of ISO:13485 2016 transition activities ranging from gap assessments, technical writing, validation, supplier management and templates.

Read more blogs on Medical Devices here and here.