Achieving Compliance to ISO 13485 – Barriers to Success & Overcoming them
‘ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices’. Source: Wikipedia
As a medical device manufacturer, you are no doubt aware that the primary objective of ISO 13485 is to standardise medical device regulatory requirements for quality management systems. ISO 13485 has become the global standard for those who manufacture medical devices because it provides a proven guideline for maintaining assurance and managing risk.
The standard is based on eight quality management principles – customer focus, leadership, involvement of people, process approach, system-approach to management, continual improvement, fact-based decision-making, and mutually beneficial supplier relationships. Ironically, some of these principles can be barriers to success in an organisation achieving compliance.
Consider the involvement of people as an example. Where employees within an organisation are not fully involved from the outset with the compliance processes or culture, they are not fully aware of how they should be involved any why – as a result, a lack of interest may occur in helping the company achieve their compliance goals.
With regard to leadership, inefficient leadership could also be a barrier to successfully achieving compliance to ISO 13485 – if the standard is not effectively embedded in a company’s culture or processes, or if senior management views the implementation of ISO 13485 as just another regulatory hurdle, this lack of leadership and involvement may be damaging.
Another barrier to success could be the approach taken to managing a company’s quality processes or compliance activities – if compliance is seen as an ‘add on’ to a company’s original purpose, e.g. manufacturing, or as time consuming or resource intensive, staff may be reluctant to embrace the principles of helping to achieve compliance to ISO 13485.
How do you overcome these barriers?
- Senior Management Commitment
Companies who achieve certification quickly have the complete support of senior management who recognise ISO 13485 is a tool for meeting customer requirements, reducing risk, and maintaining effective processes. Management support is key in pushing through the changes often demanded by ISO 13485 implementation – changes happen more quickly if there is support from all levels of senior management.
- Dedicated Internal Resource(s)
The moral support of senior management is not enough to make ISO implementation happen. The company must allocate sufficient in-house resource(s) – without a dedicated ISO 13485 representative who has the full support of senior management, change will happen slowly. For instance, if ‘time to market’ is important to your organisation and every month your product is not on the market means thousands in lost sales, dedicating a representative to oversee compliance across the organisation makes sense as if not, it will not be considered a priority by staff.
- Effective Quality Management System (QMS)
An effective QMS is vital for helping an organisation to manage its compliance activities, such as Document Control, Audits, Corrective/Preventive Actions, Incidents, Suppliers and Equipment. First and foremost, any QMS must meet the business needs of the organisation. Not only will such a system increase efficiency and productivity, but it could also reduce costs and help a business gain valuable insight into how the compliance processes that take place across their organisation could be improved.
Have a look at how medical device manufacturer, Orthoplastics achieves and maintains compliance to ISO 13485.
- Implement Staff Training Programme
It is vital that any employee receives comprehensive training in their job requirements and their role to ensure the quality of a company’s goods and services and to reinforce the importance of achieving compliance to ISO 13485. Training not only helps to minimise the occurrence of human error, but also helps to guarantee the delivery of safe, effective products. Incorporating ISO 13485 training into your programme will clarify the company’s goals, encourage a learning culture, and ensures that employees know their specific purpose and how they connect to larger company goals on a day to day basis.
This article has only touched upon a few barriers to success in achieving compliance to ISO 13485 and no doubt there will be many more that require to be addressed and overcome. We hope it has given you food for thought – let us know how your organisation manages and maintains compliance to ISO 13485? How do you engage your staff in the process?