In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach. This doesn’t mean that the traditional process approach has gone away, it means that risk management and risk analysis are going to play a greater role in how companies manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system. Read The New ISO 13485:2016 – Procrastination Can Cost You to learn more about the differences between the versions.
What’s the Time Line?
Ultimately, ISO 13485:2016 will replace ISO 13485:2003; however, over the course of the next three years (March 2016-2019), the standards will coexist. This will give manufacturers, notified bodies and regulators time to transition to the new standard. According to a transition planning guidance by ISO, organizations will be accredited for either edition for the first two years of the transition period. After the second year, new accreditation will only be given for ISO 13485:2016. After year three, any existing certification for ISO 13485:2003 will no longer be valid. In reality, this does not give you time to procrastinate. When you see the level of requirements you will have to account for, you will realize that taking necessary action should be a top concern.
Preparing for the ISO 13485:2016 Transition Process
Step 1: identify resources necessary to help implement the new standard
- Identify what will be needed (e.g. document review, gap analysis, etc.)
- Determine who will be responsible for providing what is needed (e.g. quality manager or a third party subject matter expert, such as MethodSense, etc.)
- Reach out to your Notified Body early on to discuss timing and transition requirements
Step 2: planning
- Assess how the standard reconciles with the regulations you follow to ensure conformity and compliance to both this standard and your regulation
- Identify organizational changes that will be necessary (e.g. new roles) and their impact
- Create a quality plan that includes all of the activities that must be completed during the transition
- Create a schedule in the quality plan for when major milestones must be completed
Step 3: implementation
- Implement the quality plan
Step 4: training, awareness and competence
- Determine when training on ISO 13485:2016 should be conducted
- Identify when training be conducted on the revised quality management system
- Complete training according to the implementation and training plan
Step 5: certification
- Conduct an internal audit to ensure you’ve met all requirements (MethodSense can help with this, too)
- Host your Notified Body scheduled audit
What Support is Available to Help Us?
Switching gears to comply with ISO 13485:2016 may be a major undertaking for some organizations. It will require an in depth document review, process review, changes to your operation and many additional requirements. Keep in mind that Notified Bodies are going to be extremely busy over the course of the next few years, which could result in delays in technical file reviews and certification audits. Don’t delay in implementing your transition process, or you may find your organization facing a lapse in certification – and you know the risks associated with that!
To help you make it through the transition smoothly, MethodSense can provide you with the quality resources your organization needs, including:
- QMS Documents and Records reviews
- Process reviews
- Quality planning
- Standard Operating Procedures (SOP) creation
- Internal audits
- Regulatory compliance strategies
You won’t have to face this challenge alone … we’ll be right by your side throughout the entire process.