ISO 13485 is the international standard setting out requirements for a quality management system, specific to the medical devices industry. It sets out the requirements and standards expected of any organisation involved in medical devices, worldwide. Medical devices can be defined as:
“any instrument, apparatus, implement, machine implant, in vitro reagent, or another similar article, that is intended for use in the diagnosis, prevention and treatment of disease or other medical conditions”.
These organisations can include those involved in:
- Initial conception
- Production and post-production
- Storage
- Distribution
- Installation
- Certification and auditing
- Servicing and associated services
- Final decommission and disposal
The standard is being updated to become ISO 13485:2016 – more than a decade after the last change to international standards for the medical devices industry when ISO13485:2003 was first introduced.
The ISO13485 standard is being updated, in part to bring it more in line with other international standards, like the US FDA QSR. Additionally, the new standard is more in line with the global auditing process, the Medical Device Single Audit Programme which, administered and guided by the International Medical Device Regulators Forum, is working towards a standard whereby medical device manufacturing audits are rolled into a single, annual auditing process.
ISO 13485 is similar to (and has origins in) ISO 9001, the standard on implementing quality management systems more generally. ISO 9001’s latest version is ISO 9001:2015, which differs significantly to the new ISO 13485:2016 in a number of ways. One of the key challenges thrown up by the introduction of ISO 13485:2016 is for medical device manufacturers attempting to maintain both ISO 9001 and ISO 13485. The new guidelines for ISO 13485:2016 do include a section specifically laying out the discrepancies between the systems, but there will inevitably be some contradiction For manufacturers producing only medical devices, ISO 13485:2016 must be adhered to over ISO 9001:2015 but the two standards will be more of a challenge for manufacturers where ISO13485 must be maintained for medical device manufacturing, but ISO9001 is required for customers outside the medical device sector.
Even besides any challenge presented by the discrepancy between ISO 9001 and ISO 3485, implementing the changes between ISO 13485:2003 and ISO 13485:2016 will be a challenge for many medical device manufacturers. There will be a three-year grace period, to allow for certified organisations to comply with the updated standard, and to re-certify.
What are the key changes to legislation that will affect manufacturers of medical devices?
- Clearer definitions now need to be made about the roles and responsibilities of each organisation in the supply chain, whether they are a manufacturer, authorised representative, or distributor, that role must be properly documented to ensure that the proper, legal manufacturer is clearly identified.
- Any processes that are outsourced must now be clearly identified, with records kept of the sequences, interactions, and roles taken by each party in the outsourcing process.
- The standard makes it clear that the organisation identified as the legal manufacturer, cannot be absolved of responsibility for quality system requirements, and that they must retain responsibility for conformity. This means that written records may be required between parties, especially in the case of outsourcing.
- Where computer software is used in a quality management system, validation must be assessed and performed. This could include Enterprise Resource Planning (ERP) systems, electronic Quality Management Systems (eQMS), complaint management systems or corrective action systems.
- The standards have been brought more in line with the FDA’s Device Master Record legislation, to include a requirement for establishing and maintaining a Medical Device File, which details information (intended use, specifications, manufacturing, labelling, packaging, monitoring, traceability, installation and/or servicing) required for every device.
- Further clarification has been given for the retention of quality records: They must be maintained for, at minimum, the organisation’s defined lifetime of the medical device.
- In line with a significant shift in the electronic management of documents since the standards was last released in 2003, the new standard sets out the controls required for identification, storage, security and integrity of records, as they pertain to electronic data.
- More emphasis is placed on the responsibility of senior and executive management within medical device organisations, for the promotion and awareness of a strong quality management system.
- There were two key areas of change in relation to resource management:
- First, the updated standards included much more emphasis on ensuring that employees are competent to perform the job functions assigned to them.
- Additionally, there is a greater emphasis on systems within a facility – specifically on the need for systems to be inspected periodically, and for any special arrangements to be clearly defined.
- The bulk of the standard related to product realisation. As such, there were a number of changes and modifications to the standard in this area. In addition to changes that further clarified the existing standard, some new sections were added, including the requirements for design controls in line with FDA regulations, and the inclusion of sterile device packaging, which must be validated for use.
- In terms of measurement, analysis and improvement, changes to the previous standard have been minimal, and simply bring the standard into better alignment with other, existing regulatory requirements that govern the medical devices industry.
What are the potential impacts of the update to ISO 13485, and how can manufacturers prepare for the transition to ISO 13485
Planning for changes in advance is essential for any medical device manufacturer to stay compliant with international standards and best practice.
As a brief guideline for planning and preparation for the new standard, your organisation should, at a minimum:
- Identify and understand how the timeline of the transition fits with the timing of your current certification, and discuss that timing with your registrar or notified body.
- Perform a gap analysis, to understand the disparity between your current QMS procedures and the requirements of the new standard.
- Develop and establish a documented quality plan, that will engage your organisation to make the necessary changes and meet ISO 13485:2016 in the allotted timeframe.
- Ensure that any resources your organisation will require to make the transition are in place, from staff training to updated procedures.
- Communicate and monitor progress with internal audits, and adjust the plan to ensure that you are on target to meet the requirements.
- At the end of the transition period, complete a thorough internal audit and prepare for an external assessment and re-certification to the new ISO 13485:2016 standards.
By planning a structured approach to updating your quality management system, you can make the best use of your resources, and be ready to make the change and re-certify for the standard as soon as it is implemented.
In order to demonstrate adherence to international standards, like ISO 13485:2016, and to provide safe and effective medical devices, organisations rely on a Quality Management System (QMS). A QMS is a “set of policies, processes and procedures that help an organisation meet the requirements set by stakeholders”. In fact, for medical device manufacturers in most countries, a QMS is required by regulators in order to operate
Importantly, the change in standards and legislature marks an opportunity for medical device manufacturers to appraise their current QMS, and understand whether it is serving them and whether it will continue to serve them as the new standard takes place. By investing in a sector-specific QMS, like IQMS (now DELMIAWORKS) for medical device manufacturing, manufacturers are able to be confident that their QMS is truly fit for purpose, and enabling them to consistently deliver safe devices to the highest standards.
Contact us to schedule a discovery call and learn more about IQMS’ (DELMIAWORKS)’ sector-specific quality management sstem for medical device manufacturers
Posted by Paul on 18th September 2017.