ISO 13485 is an internationally recognised standard designed specifically for organisations operating within the medical device industry. A medical device is any machine, instrument, apparatus or software that is used within medicine for diagnosis, prevention or treatment of medical conditions or diseases.
Businesses and organisations operating within the medical device manufacturing sector must demonstrate that its quality management process complies with statutory and regulatory requirements of relevant legislation.
The ISO 13485 standard outlines the requirements that businesses and organisations need to meet within their medical device quality management system. Although there are many specifications required of the quality management system, this system should primarily be in place to ensure that the organisation can demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
John Jeffery can offer consultancy and impartial support to a range of organisations who operate within the medical device management system sector and are preparing for ISO 13485 certification and accreditation.
ISO 13485 is an internationally recognised stand-alone Quality Management System that offers an effective solution for meeting the comprehensive requirements surrounding consistent design, development, production, installation and delivery processes of medical devices.
The primary purpose of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. It focuses on establishing and maintaining effective processes that ensure organisations are operating safely, whilst consistently producing safe medical products to a high quality.
ISO 13458 is specifically designed to meet the needs of those working within the medical device sectors who are required to establish and maintain effectiveness across their processes.
This includes those who are involved in outputting the design, development, production, installation, delivery and disposal of medical devices. Examples of organisations that could benefit from ISO 13485 standard include:
ISO 13485:2016, published in March 2016, is the current version of the QMS that now overrides the previously published ISO 13458:2003.
Although ISO 13485 remains a stand-alone document, there are distinctive crossovers with ISO 9001:2008. Both focus on risk mitigation and management, are customer-focused and follow a ‘Plan-Do-Check-Act’.
There are some notable differences between the two management systems. Firstly ISO 13485’s documents are far more extensive than those of ISO 9001. Whilst ISO 9001 focuses on proactively monitoring customer satisfaction, ISO 13485 has a more refined focus on meeting customer requirements in terms of safety and efficiency of medical devices. ISO 9001 also requires manufacturers to demonstrate continuous improvement whilst ISO 13485 requires manufacturers to implement and maintain their quality system.
ISO 13485 contains additional requirements for preventing contamination, with multiple documentation requirements at all stages of product development, additional regulatory reporting, advisory notices and recalls, as well as a focus on risk management during design and production.
Because of this, organisations whose quality management systems conform to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system also conforms to all the requirements of ISO 9001.
The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. It helps to ensure that those organisations within the medical device management industry maintain quality, whilst enhancing process efficiency. The standard includes:
As well as ensuring that you comply with legislation surrounding the management of medical device design, development, production, distribution and disposal, there are a number of benefits of gaining ISO 13485 certification.
One of the core quality management principles for ISO 13485 standard is assessing customer requirements and expectations to ensure the delivery of customer satisfaction. By following and actioning upon the principles outlined, you can better understand your product requirements and ensure that your customer’s needs and expectations are delivered, thus maintaining a high level of customer service.
Ability to contract with larger companies and wider markets
As an internationally recognisable commitment to quality, ISO 13485 can aid organisations in reassuring current and potential stakeholders of credibility and reputation for quality. Being recognised as a reputable organisation within the medical device sector can also open the door to opportunities for entering into new international markets and building stakeholder relationships with larger or global organisations. Many larger businesses minimise their risk when taking on a new subcontractor by seeking those who are ISO 13485 certified.
The standard assists organisations to plan and carry out revision of processes and recognise opportunities for improvement and development. ISO 13585 can help you to ensure process efficiency. In the long term, this can reduce operating costs, errors and speed up processes whilst producing high-quality products.
Expand business knowledge
ISO 13485 enables you to improve processes and identify new business opportunities based on performance data and statistics, rather than opinion or speculation. Because you are keeping track of the data, you can gain a better understanding of your business and how much you are aligned with your overall goals.