What is ISO 13485?
ISO 13485 specifics the requirements for a quality management system where an organisation may need to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements and establishes and maintains the effectiveness of their organisational processes. There organisations may be involved in one or more stages of the life cycle which may include design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities e.g. technical support.
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Why should it be considered?
Patient safety is one of the necessities of medical device manufacturing, this depends massively on the quality and ensure the medical is consistently effective. Ensuring your organisation has an efficiently quality management system in place is crucial. Implementing ISO 13485 will give your customers, stakeholders, patients, and regulatory agencies peace of mind that your processes are controlled and maintained regularly.
What impact will it have?
Improve credibility and image:
ISO 13485 is an internationally recognised standard for Quality Management specifically for medical devices. Certification shows customers that quality is taken seriously and has become a requirement for many countries for suppliers to show compliance and can be an opportunity to set yourself apart from competitors.
Information and analysis
Information is essential to any business decision making. Implementing ISO 13485 will enable the identification of suitable metrics for your business processes, which will enable you obtain a true picture of operational and business performance. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their purpose.
Implementing ISO 13485 gives your organisation the opportunity to discover improvements due to the process approach outlined within the standard. This will help to identify waste within your current process, reduce the likelihood of errors which will lead to more efficient processes, less waste and cost savings.
How can Quadra help?
With over three decades of experience, Quadra have developed a tried and tested approach to implementing ISO systems, which has been applied with a wide range of clients in many countries.
When implementing ISO 13485, the process is simple.
Gap Analysis: Quadra will measure your organisations current systems and controls against the ISO 13485 requirements.
Action Plan: Planning will then take place for the key steps and milestones in the ISO 13485 implementation and certification process.
Implementation Support: Quadra will provide your organisation with support to help build evidence of compliance with ISO 13485.
Preparation for External Audit: We can also assist with preparation for external audit by conducting internal audits and management reviews. As well as attending the certification audit.
We Can Help to Add Value to Your Organisation
Our simple no-nonsense approach is focused on delivering value and adding benefit.
Highly Experienced Consultants
Our consultants are both highly skilled and experienced in their field.
Proven Track Record
Quadra has a proven track developed over 30 years in both national and international markets.
Making ISO Work For You
Our approach ensures that you don't have to reinvent your organisation.
Our clients are our most important assets and our aim is to become your trusted partner of choice.
We have developed a strong reputation in all industry sectors and with a varied client base. From small, local, indigenous companies to large multinationals.
Big Enough to Cope, Small Enough to Care
Our aim is to provide our clients with a solution which addresses their need. Our aim will always be to deliver a solution that works.
We have over 30 years’ experience assisting businesses in the provisions of ISO Standards, Compliance and Training.
Ensuring our customers are satisfied is our number one commitment.
With over 3000 projects completed to date on a local, national and international basis we have developed an approach which is focused on delivering a solution which will add value.
Need ISO Training?
Quadra can offer both awareness and internal auditor training for the ISO 13485 standard. This training is available through public in-house and online training throughout Northern Ireland and Ireland.
IMS Internal Auditor – Northern Ireland
ISO 9001 Internal Auditor – Northern Ireland
With over 30 years’ experience and having assisted over 3000 organisations to achieve ISO certification, there is no provider better placed to assist your organisation on its journey to implement ISO 13485.
Our tried and tested approach will enable your organisation to achieve certification to the medical device management standard in a realistic timescale with minimal disruption and cost while adding maximum value.
If you feel implementing a medical device management system to your organisation will bring benefit to your business, contact us.