Medical devices Quality management systems
The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for
a quality management system (QMS). Adopting ISO 13485 provides a practical foundation
for manufacturers to address the regulations and responsibilities as well as demonstrating a
commitment to the safety and quality of medical devices.
The medical device manufacturing sector is one of the most
regulated sectors in which significant quality systems and
product requirements must be satisfied. The regulatory
requirements are intended to ensure that manufacturers
consistently design, produce, and place onto the market,
medical devices that are safe and fit for their intended
purpose.
What is ISO 13485?
ISO 13485 is a stand-alone QMS standard, derived from the
internationally recognized and accepted ISO 9000 quality
management standard series. ISO 13485 adapts the ISO 9000
process-based model for a regulated medical device manufacturing
environment. While ISO 13485 is based on the ISO 9001 process
model concepts of Plan, Do, Check, Act, it is designed for regulatory
compliance. Thus it is more prescriptive in nature and requires a
more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in
designing quality management systems that establish and maintain
the effectiveness of their processes. It ensures the consistent design,
development, production, installation, and delivery of medical
devices that are safe for their intended purpose.
QMS’s approach to excellence
QMS selects and recruits professionals to conduct ISO 13485
audits. Candidates must have design or manufacturing or process
knowledge and general knowledge on use of medical devices.
Our assessment staff come to QMS with exceptional real industry
experience and then go through rigorous internal training and QMS
qualification processes including best practice quality systems
auditing techniques, understanding critical manufacturing processes,
interpretation of regulatory compliance expectations.
QMS auditors are experts in current state-of-the-art requirements and
are constantly trained on new requirements and future changes, QMS
is always looking forward and ensuring our customers are prepared
and well placed for future regulatory and compliance concerns.