MEDICAL DEVICES: ISO 13485

Medical Devices Quality Management: ISO 13485

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What is Medical Device quality management and ISO 13485?

ISO 13485: 2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.  It can be used by manufacturers to address the Medical Device Directives, regulations and responsibilities, as well as demonstrating a commitment to the safety and quality of medical devices. It will help you to:

  • Identify medical device processes and map out the most efficient methods
  • Understand the needs and expectations of your customers
  • Set responsibilities and authorities for the activities and personnel involved
  • Identify customer requirements and how you comply with them
  • Set measurable objectives to improve your quality performance
  • Communicate your quality policy and plan to your employees and gain their input
  • Assess how you deal with nonconformances
  • Document how you deal with nonconformances and put plans in place to stop them happening again

Using ISO 13485 can provide assurance to company management and employees as well as external stakeholders that medical device safety and quality is being measured and improved upon.

 

What are the benefits of ISO 13485?

  • Improve image and credibility
  • Improve customer satisfaction
  • Achieve full integration of processes
  • Use evidence-based decision making
  • Create a culture of continuous improvement
  • Savings in time, money and resources
  • Engage employees

 

What does Provenza offer?

We will work with you to:

  • Fully document your medical device quality management system
  • Help write your quality policy
  • Communicate the medical device quality system to your employees
  • Identify your areas of weakness
  • Assess the risks associated with your processes
  • Put plans in place to reduce your risks
  • Identify customer requirements
  • Measure customer feedback
  • Carry out independent quality checks on-site
  • Assess the quality performance of your suppliers and subcontractors to strengthen your supply chain
  • Carry out investigations for nonconformance or customer complaint
  • Map out training required to demonstrate competency of employees
  • Create an Annual Planner showing what actions are required and when
HEALTH AND SAFETY
ISO 18001
QUALITY
ISO 9001
ENVIRONMENT
ISO 14001
ISO STANDARDS
SUPPLIERS PRE- QUALIFICATION
NATIONAL HIGHWAYS SECTOR
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EMAIL – stuart@provenza.co.uk

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