You might be asking yourself: 'What is a Quality Management System?’ (QMS). Well, you're in the right place as we can define it for you. A QMS is a structured set of policies, processes, procedures, and measures used to ensure that an organisation can achieve its policies and objectives. A QMS helps coordinate and focus an organisation’s activities to meet customer and regulatory requirements, creating consistency in daily business operations. The QMS is a tool used to improve the effectiveness and efficiency of a company’s output and allows for ease of evaluation and monitoring on a continuous basis.
You can apply a QMS to a range of industries in addition to quality, including but not limited to;
- Information Security
- Food Safety
- Occupational Health
- Aerospace Engineering
In the medical device industry, and here at QMS Regs and Patient Guard we use ISO:13485 2016 +A11:2021 which is a QMS focused standard.
There are different types of documents used within the QMS mainly in the form of Word, PDF, or Excel Files, including:
- Quality Policy
- Quality Manual
- Quality Procedures
- Work Instructions
- Live Quality Records, Forms and Templates
For larger organisations, E-QMS systems are implemented to manage document and change control more efficiently via a digital software application, or multiple platforms combined. It is important to consider how your QMS will be stored, some common platforms include Google Drive, SharePoint and, OneHub and Microsoft OneDrive.
Once you have selected appropriate platform that best suits your business needs, considerations around data storage and back up/security should also be assessed against user requirements. Cyber Essentials is a government backed scheme can help certify and approve your systems security and protect it against cyber-attacks.
Top QMS Benefits
- Being able to define who is responsible for what
- To set out and achieve quality policies/objectives and to work against continual improvement initiatives
- To clearly outline the what, why, how, where and when for activities within the business and ensure effective employee communication
- To keep things organised, accessible, safe and in a centralised location
- Ensuring continual compliance with any applicable standards/ regulations
- Creates consistency within daily business operations
- Assists with evidence-based decision making and effective investigation processes
QMS Do’s and Don’ts
A QMS should
A QMS should not
Establishing and implementing a QMS
The main steps involved in establishing and implementing a QMS are:
Establishing what ISO standards and regulations your company is looking to comply with, for example for medical device companies the QMS will be structured around ISO 13485, environmentally focused businesses may be working towards ISO 14001 certification, or for production/ manufacturing environments the popular ISO 9001 QMS standard me be best suited.
Depending on the above, a specific set of templated documents will need to be written and customised to reflect the daily activities within the business
QMSRegs currently offer a full set and individual templates for ISO 13485 compliance.
Once an accurate set of procedures have been written, there will also be a need for additional documents such as quality records, record logs, form templates and work instructions.
The QMS procedures are then followed and adapted by various departments within the company depending on its scope.
The effectiveness of the QMS is monitored and measured over time via processes such as frequent Management Review Meetings and CAPAs.
The most common challenges a QMS presents and how to overcome them
If you implement too many procedures and documents, it will become harder and more time consuming to manage the system.
My advice, keep things condensed, get creative and combine similar procedures together into one.
Use folders effectively, we have simple and easy to use folder structures available for purchase on our site that you may find useful.
Invest in your document control process, even if it takes a while to master, this is the most important part of the QMS to focus on ways of reducing admin time. Perhaps create some rules so that not all your documents are subject to the same change control processes, consider having some live records on the go too.
Oh, and archive, archive, archive!
Successful companies can undergo rapid expansion and growth, for the QMS it can sometime feel hard to keep up. As the daily business operations grow so do the QMS inputs and outputs, ensuring enough resources are available to maintain the system should be monitored closely.
Think outside the box, if you are an expanding organisation with a small quality department consider bridging the gap whilst recruiting. Perhaps outsourcing specialist areas to other departments for example software and hardware management could be maintained by the IT department, document and change control carried out by an administrative officer etc.
If you do fall behind on your QMS maintenance, we have a team who are happy to help you get back on track. We offer a range of quality services.
Adapting to and implementing change
If you have recently created a new QMS within your organisation, depending on the size of your company, it can take up to 12 months to successfully implement the new procedures. It is always worth investing time into implementation planning and taking your time to work directly with those who are going to be adapting the new procedures and processes on a daily basis. This will ease in the changes over time rather than overwhelming individuals who work across multiple departments with multiple changes at once.
This will also allow for some breathing space to step back and see if the changes are effective. Asking employees for feedback on new processes and procedure is vital, as is allowing the change process to be double sided. Ensuring everyone within the organisation has a means to request for a change to be made.
A QMS is a lot more than just a set of documents and records. If successfully implemented, well maintained, and used effectively, the benefits are huge for businesses of any size.
The top overall benefit here being an increase in profits for your company. Making it easier for you to access new marketplaces, increasing sales, having your certifications in place to show your current and future customers that you take quality seriously. The marketplace is forever competitive in nature having an approved QMS can help your company stand out from the crowd.
It may also be worth mentioning that in some industries, such as the medical device realm, ISO 13485 certification is slowly being seen as a mandatory requirement across some parts of the globe. This is also being seen via specific organisations, due to companies having high quality standards they may only choose to select 13485 certified suppliers/ manufacturers.
An example of this could be seen in manufacturing environments. A QMS allows for processes to be in place to prevent and detect production issues before they even result in re-work in non-conforming products can save a lot of money in the longer term.
Quality is worth the investment.
Written by Laura Mcvittie (Quality Assurance Manager)
About the author
‘Laura is qualified to degree level in Forensic and Applied Science, with additional higher-level studies in microbiology and biotechnology. Since graduation she has worked across a wide range of industries with scientific based roles in clinical healthcare, administrative, manufacturing, and educational settings and had experience working in project management and coordination roles. Laura has over 10 years’ experience working within, BRC, FSA, GMP/ GLP, ISO 9001 and UKAS accredited laboratories in multidisciplinary, research support, technical support, QC and QA roles. She now works for Patient Guard Ltd as a Quality Manager and offers consultancy services for ISO 13485 QMS implementation/ accreditation and management. Laura also provides internal and supplier evaluation auditing services for the medical device industry and is here to help you with your companies QMS and Quality needs.’