The new version of ISO 13485 was published in March 2016 in response to several globally reported medical device product failures (for example, the PIP breast implant failures). Consequently, there are significant changes in the new version to tighten quality requirements, particularly:
- transparency of product design and development
- risk management and applying ISO 14971 throughout the product life-cycle and within the QMS
- software validation
- sterile device manufacture
- post market surveillance
The new version of ISO 13485 also moves away from the structure of the latest ISO 9001 standard, to align more closely with the international medical device regulations and some requirements seen in Good Manufacturing Practice (GMP) in the pharmaceutical industry. This will allow a harmonised approach for medical device quality requirements across all the major regional regulators.
As Australian medical device manufacturers and critical suppliers prepare to transition across to the new ISO 13485 from 2016 onwards up to the deadline of March 2019, small to medium sized businesses will be looking to consultants for support and advice with these more challenging new requirements. Integrated Compliance Solutions has expert ISO 13485 consultants ready to support businesses to develop iso 13485 2016 quality management systems Australia-wide.
Whether you are a business needing to develop an ISO 13485 system from scratch or you have existing systems, we can provide support and guidance to whatever level you require to understand the iso 13485 2016 requirements and build an effective system which suits your business.
Continue reading or contact us today for more information.
What is ISO 13485 2016 transition and how will your business be affected?
ISO 13485 2016 is the new revision of the Medical Devices Quality standard published in 2016 to replace ISO 13485 2003. All manufacturers wanting ISO 13485 2016 certification will need to be audited against the new standard by the deadline of March 2019.
What are the main changes between ISO 13485 2003 and 2016 versions?
The main changes can be categorised as follows:
- Greater requirements to manage medical device patient safety and product performance
- Emphasis on regulatory requirements (e.g. TGA, FDA, EU)
- Applying risk management according to ISO 14971 to all processes including those that are outsourced – supply chain, critical suppliers, contract manufacturing, service providers
- Specific requirements for software validation, including software using during development, manufacture and in the Quality Management System (e.g. your business management systems)
- Specific requirements for validation of processes for sterilization, sterile barrier systems and contamination controls
- Stronger alignment of complaints and post-market surveillance requirements with regulatory requirements
- Significantly more detail requirements in Design and Development
- A higher focus on product quality and manufacturer’s understanding their processes
Most businesses we have helped thus far find they have little in place in these areas and need to dedicate some time to meeting the iso 13485 2016 requirements.
What are the benefits of transitioning to the new ISO 13485 2016 version of the standard?
The ISO 13485 2016 version of the standard has several benefits over the previous version:
- The new version brings greater alignment and regional consistency with regulator’s expectations for a therapeutic product – meeting ISO 13485 2016 requirements means your product should meet US FDA requirements as well
- It puts greater emphasis on design and development, bringing much more rigor and transparency to the process – this increases product safety
- The new revision helps manufacturers understand product, process and quality risks
- Software and high-risk processes are now addressed to ensure high assurance of product quality
How to transition to the new ISO 13485 2016 standard- start with an ISO 13485 gap analysis
If you already have systems in place, (whether these are ISO 9001 or ISO 13485 related) one of the most effective ways to transition to the new standard is to first implement an ISO 13485 2016 gap analysis to identify the gaps in your QMS and product files.
Out of an ICS gap analysis, you will receive a detailed action plan describing exactly what to do to fill any gaps. Using the action steps report, develop a project plan with a timeline to keep track of:
- How much time and resources can you allocate to complete the work required? Be aware that much of the responsibility for this sits with the management team.
- Time should be set aside for training of your staff in the new system and to develop/ tweak the management system.
- You will also require more frequent internal audits during and immediately after the transition period to help you identify and fix any non-conforming areas.
Getting ISO 13485 2016 certification?
Finding and booking in with a suitable certification body who are accredited for ISO 13485 (not all are) can take a while so it’s best to do this 3-6 months ahead if possible.
Need some help?
Especially with the more complex iso 13485 2016 requirements, it’s important not to leave development/ transition to the last minute. You should expect that DIY development of an iso 13485 2016 quality management system will take several months even if your systems are already in good order. Allow extra time for operational priorities during this period.
If you don’t have time or resources to DIY, we can help.
We can do a gap analysis for you or we can also manage the entire process of developing your ISO 13485 system, so you can get certified as quickly as possible and move on.
We have a team of professional medical devices consultants across Australia, ready to help you. If you would like some assistance to transition to ISO 13485 2016 or to book a gap analysis, call us on 1300 132 745 for a chat.