Medical Devices Quality Management
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ISO13485 Quality Management Systems for Medical Devices
What's it all about?
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.
It does more than you think:
- An ISO13485 Quality Management System for Medical Devices ensures that you have the systems in place that you need to effectively run the organisation and that everyone knows about them, that way you have one way of doing things which ultimate cuts wasted costs, rework and risk.
- An ISO13485 Quality Management System for Medical Devices is not locked in stone, in fact you need to keep evolving your system to meet the changing needs to your business, products and the industry. That means your team need to be involved in crafting your systems which drives up employee engagement.
- An ISO13485 Quality Management System for Medical Devices provides detailed requirements for mandatory documents and records that your organisation needs to have both at system level and product level meaning you don't have to guess what is required, everyone is on the same page.
- While the ISO13485 Quality Management System for Medical Devices doesn't follow the new ISO Annex SL structure it is simple to map it to the ISO9001 structure and requirements or any of the other Annex SL standards such as ISO14001, ISO27001 or ISO45001 allowing you integrate these into one single manual.
- ISO13485 encodes your business strategy, you write it into the system, ISO13485 does not mandated what it should be, they do however insist that you communicate it and review it on a regular basis, now that sounds like a really good practice and your team will really appreciate it!
- An ISO13485 certification provides international authorities, clients, prospective clients, and suppliers alike with confidence that you operate in a systematic and repeatable way.
- An ISO13485 certification for your Quality Management System is a requirement when tendering for work in the medical device industry, so it is going to open doors for you.
- An ISO13485 Quality Management System for Medical Devices helps you understand what your compliance requirements are, not just to meet the standard but also within your industry, internationally, at your location and the market in general.
- An ISO13485 Quality Management System for Medical Devices ensures that everyone is on the same page about what the various compliance requirements are, from Legal to industry and international standards and everything in between, these all need to be considered in your system.
- An ISO13485 Quality Management System for Medical Devices ensures that you consistently review and evaluate how your organisation is meeting its compliance requirements and ensures that someone is responsible for the controls that should be in place.
- ISO13485 Quality Management System for Medical Devices aligns with both European and United Stated Medical Device Requirements allowing you to sell products into those markets.
- An ISO13485 Quality Management System for Medical Devices helps you understand the business risks associated with your organisation. What risks are linked to the marketplace, your clients, your suppliers, your internal skills and many more. It also asks you what your plan is to deal with them!
- An ISO13485 Quality Management System for Medical Devices asks you to ensure that everyone is aware of the risks in your organisation and working to minimise them, so everyone is aligned and working together for the good or the organisation.
- An ISO13485 Quality Management System for Medical Devices gives you a structure and routine to work around, this helps to be a more resilient organisation.
- ISO13485 Quality Management System for Medical Devices requires you to use ISO14971 to evaluate the Risks linked to your Medical Device or service. You must understand and document the acceptable and unacceptable risks at each of the life cycle stages from initial conception into the design, development, production, installation, delivery and even removal and disposal of medical devices.
- ISO13485 Quality Management System for Medical Devices helps you understand the risks of each product, product family and helps you make better decisions on those risks.
- ISO 13485 for Medical Devices Quality Management Systems is designed to provide alignment to European Medical Devices Directives: MDD, AIMDD and IVDD. Add to this the decision by the US FDA to make ISO13485 it is mandatory Quality management System and you understand why it is important.
- Being certified to ISO13485 now means that you can use your Quality Management System as the evidence of compliance to these other requirements around the world saving time and duplication of evidence and paperwork.
Our approach is to provide you with an expert consultant who can work alongside you both on site and remotely to help you step through the process of creating an ISO13485 Quality Management System for Medical Devices that fits your organisation’s needs.
We start with a comprehensive Gap Analysis of your organisation to let us identify what you already have in place and what things need to be focused on, this generates a full clause by clause GAP Analysis Report highlighting where we need to focus attention to achieve the standard.
We will then work with you to develop an implementation plan around the 5 phases process that will work to meet the timeframes you need to achieve and ensure that your organisation keeps working at the same time. The plan covers every clause in the standard that is applicable to your organisation and provides a summary of the actions required to meet the requirements of the standard in a way that works for you as an organisation.
Our focus is about making the implementation as simple as it can be and a key part of that is to help you make the right decisions that help your organisation and meet the standard, our focus is firmly on delivering the right balance for you.
The 5 Phases of Your ISO13485 Journey
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.
Make an Appointment
If you are ready or even just thinking about starting your ISO13485 journey, we would love to have a chat.
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