ISO 13485
Medical Devices
Quality Management
Continuously improve the quality of your organisation, your processes, your products and services
to ensure you consistently meet your customers’ and the medical industry's expectations.
to ensure you consistently meet your customers’ and the medical industry's expectations.
ISO 13485
Medical Devices
Quality Management
Continuously improve the quality of your organisation, your processes, your products and services to ensure you consistently meet your customers’ and the medical industry's expectations.
ISO9001 Services
Expert ISO13485 Support
With Practical Application
ISO13485
Achieve ISO Certification Simply, Quickly and Cost Effectively
Achieving your ISO13485:2016 Medical Devices Quality Management System certification may seem like a daunting task. Trying to understand what each of the clauses mean and what the requirements are can sometimes seem harder than it should be. Knowing how to integrate additional standards, such as ISO14971 for Medical Device Risk Management, into the system can be even harder. That is where our expertise in ISO Management Systems can help.
While ISO13485 has more mandatory document requirements than an ISO9001 system those documents are largely about helping you meet regulatory requirements of people like the FDA in the US or the European Medical Devices Directives. This new version of the standard lets you use your compliance to the ISO standard as evidence you meet those regulatory requirements
Many Caps Consulting specialise in helping Kiwi businesses not just achieve their ISO Certifications but maintain it and ensure it adds value to their businesses rather than being one more thing to do.
We focus on taking a practical approach to implementation and keeping things simple. Success for us is that when we step back you know your systems and how to run them, that is why our expert ISO13485 consultants focus on coaching your team rather than implementing a cookie cutter solution.
Our ISO consultants will help you understand what the requirements of the ISO standards are in plain English, help you develop the required documents, processes and systems that will give you with the tools to run an ISO13485:2016 Medical Devices Quality Management System that genuinely adds value to your business.
The Benefits of an ISO13485 Certification
International Standard 
Improved Performance 
Employee Engagement 
Customer Satisfaction 
Independent Certification
The International Standards Organisation’s ISO13485:2016 standard is the International Standard for creating and maintaining your organisation's Medical Device Quality Management System. That means it is going to be recognised by Government Bodies, your customers, suppliers and your competitors world wide. It reflects your organisations desire to set and maintain great quality management systems that everyone can count on.
An ISO13485 Medical Devices Quality Management System ensures that you have the systems in place that you need to effectively run the organisation and that everyone knows about them. That you have one way of doing things which ultimate cuts wasted costs and rework. It means you have traceability of your products and controls around yoru designs. It also means that you are committed to continuously improving your systems driving improved performance across your organisation.
Your ISO13485 Medical Devices Quality Management System is created and owned by its users, your employees. That means they get input into your business processes, setting and improving your systems. They are actively engaged in the system to help continuously improve the systems that they use in order to make it better for everyone.
ISO13485 has a requirement to seek feedback from your customers on how you are doing and via post market surveillance to look for wider trends and issues. These feedback loops allow you to look at how you can improve your business from the point of view of the customer. It helps you identify the areas you need to continuously improve if you are going to keep your customers satisfied.
ISO13485:2016 is an independantly assessed and certified international standard. That means that your employees, suppliers and customers can take comfort in knowing that an external auditor has assessed what you do and confirmed it meets the high standards of the ISO13485 certification. They know with an ISO13485 certification you have the systems and processes in place to ensure great products and services.
The Benefits of an ISO13485 Certification
- International Standard
- Improved Performance
- Employee Engagement
- Customer Satisfaction
- Independent Certification
The International Standards Organisation’s ISO13485:2016 standard is the International Standard for creating and maintaining your organisation's Medical Device Quality Management System. That means it is going to be recognised by Government Bodies, your customers, suppliers and your competitors world wide. It reflects your organisations desire to set and maintain great quality management systems that everyone can count on.
An ISO13485 Medical Devices Quality Management System ensures that you have the systems in place that you need to effectively run the organisation and that everyone knows about them. That you have one way of doing things which ultimate cuts wasted costs and rework. It means you have traceability of your products and controls around yoru designs. It also means that you are committed to continuously improving your systems driving improved performance across your organisation.
Your ISO13485 Medical Devices Quality Management System is created and owned by its users, your employees. That means they get input into your business processes, setting and improving your systems. They are actively engaged in the system to help continuously improve the systems that they use in order to make it better for everyone.
ISO13485 has a requirement to seek feedback from your customers on how you are doing and via post market surveillance to look for wider trends and issues. These feedback loops allow you to look at how you can improve your business from the point of view of the customer. It helps you identify the areas you need to continuously improve if you are going to keep your customers satisfied.
ISO13485:2016 is an independantly assessed and certified international standard. That means that your employees, suppliers and customers can take comfort in knowing that an external auditor has assessed what you do and confirmed it meets the high standards of the ISO13485 certification. They know with an ISO13485 certification you have the systems and processes in place to ensure great products and services.
Support Options
Support in a way that keeps it Simple
options
Implement Only
Our consultants work through the implementation process with you to help you achieve certification in around 14-16 weeks.
Manage Only
We run your system for you acting as your Virtual Quality Systems Manager, so you only pay for what you need rather than a full time employee.
Full Service
We implement your ISO13485 system with your team and manage your system for you, acting as your Virtual Quality Systems Manager.
ISO13485 Implementation Only
Our consultants work through the implementaiton process with you to help you achieve certification in around 14-16 weeks. We ensure that when we step back your key team members are able to fully manage your systems.
Management of your System
We run your system for you acting as your Virtual Quality Systems Manager, so you only pay for what you need rather than a full time employee.
Implement & Manage Your System
We implement your ISO13485 System with your team and also manage your system for you, acting as your Virtual Quality Systems Manager.
Our approach
Simplify the complex and make things Practical
Simplify the complex & make things Practical
approach
Plan
Understand the Direction
Understand the Gap
Understand the Challenges
Map the Steps
Communicate the Steps
Understand the Gap
Understand the Challenges
Map the Steps
Communicate the Steps
Do
Carry out the Coaching
Agree Ownership
Agree time frames
Implement Actions
Agree Ownership
Agree time frames
Implement Actions
Check
Check the outcomes
Check new gaps
Assess the success
Identify the improvements
Check new gaps
Assess the success
Identify the improvements
Adjust
Review the changes
Implement any improvements
Document the processes
Implement any improvements
Document the processes
Ready To Start Your ISO Journey?
Make a booking now and find out how we can help you make it faster and simpler to achieve certification
Ready To Start Your ISO Journey?
Make a booking now and find out how we can help you make it faster and simpler to achieve certification
We Recommend
Integrated cloud based compliance made Simple
Mango
Mango QHSE is a fully integrated SAAS cloud-based compliance system which dramatically simplifies, integrates and accelerates the creation and use of your ISO Management System.
With dedicated modules for Document Control, Customer & Supplier Management, Improvement & Non-conformances, Risk Management, Auditing and Plant & Equipment Maintenance this is a single solution that can be used across all ISO Management System requirements.
Mango QHSE is a fully integrated SAAS cloud-based compliance system which dramatically simplifies, integrates and accelerates the creation and use of your ISO Management System.
With dedicated modules for Document Control, Customer & Supplier Management, Improvement & Non-conformances, Risk Management, Auditing and Plant & Equipment Maintenance this is a single solution that can be used across all ISO Management System requirements.
