Is your Quality, Health & Safety or Environmental Compliance system working for you? How much time are you wasting trying to chase people to get things done, trying to remember to follow up on tasks, getting your Audits up to date, controlling documentation, dealing with customer complaints and capturing your Health & Safety Risks or incidents?
Let MANGO help you with a simpler way that makes the system not only work for you but, gets everyone involved in the system simply so you never have to remember again.
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The International Standards Organisation’s ISO13485 standard is the International Standard for creating and maintaining your organsiaitons Quality Management System for medical Devices, it’s built on top of the widely used ISO9001 standard which means you can integrate them together and save a lot of rework and duplication! It is a standard that can add huge benefits to Medical Device organisations of size and can help you drive real business improvement and change throughout your organisation and your products. Think about it as a tool to improve the Quality of the Management of your organisation.
ISO13485 helps you to make sure that risk of your product, processes and service are well understood and managed. I help you manage things to provide a consistent methodology to deliver the design, development, production, installation, and delivery of your medical devices to guarantee that are safe for their intended purpose.
When people think about implementing ISO13485 into their organisation they think about lots of paperwork, while it’s true this standard has far more mandatory document requirements than an ISO9001 system they 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.
However, do not think it stifles creativity and individualism, in fact it does the exact opposite if you do it right. A good Quality Management System should be about adding value to your company and your clients, it should support you in improving quality, meeting client and market requirements, help you make good decisions based on facts & data. It should not suck the life out of your business or be a road block to change or getting things done meaning that you have more time to focus on what is vital, growing your business and setting it up to support local & export markets and their quality management or compliance requirements.
Planning exactly what needs to be done to create your ISO 13485 QMS for Medical Devices is our first step. This starts with a Gap Analysis of your organisation as it works today vs the requirements of the standard. This generates the work content we need to tackle together and a realistic timeframe for implementation.
Working together, we will support you in generating the required processes, procedures, risk assessments and records to meet the requirements of both the business and the standard. Linked with this we will also work with you to roll out the training required to help run the systems.
We will help run several internal audits, management meetings and process reviews with your team to help ensure that things are happening, and actions are being followed through. We will then support you through your 1st External ISO Audit, the Stage 1 Audit by your accreditation body which verifies you have all your systems in place.
Based on the outputs from our internal audits and the external Stage 1 ISO Audit we may well have a few things to tweak in advance of the full Stage 2 Certification Audit. This is our chance to carry out any updates, fix the remaining issues and update the training of your teams before the big day(s)
We will support you during the certification audits to ensure that everything is covered off and that we can help with any answers that are missing. Our aim is to make it a stress-free non-event for you and your team!
Of course, that is not the end of the journey, there’s always more to do to keep improving and we’d love to be part of that ongoing journey.
If you are ready or even just thinking about starting your ISO13485 journey, we would love to have a chat.
Just fill in the form below and we'll be in touch to sort out a time that works for you.