ISO 13485 is a universally acknowledged standard that delivers an effective way to implement quality management and provides a useful structure for business management. ISO 13485 medical device management defines the prerequisites for organisations that manufacture, design and or distribute medical devices, ensuring quality in a device’s lifecycle and the business processes. Implementing an organised system will enhance your business, providing you with the following benefits:
As the most recognized standard for quality management systems in the medical device industry worldwide, organisations that have achieved ISO 13485 certification can demonstrate to potential customers that they follow best practices and ensure quality. Furthermore, after certification an organisation will generally be considered competent under their scope. These benefits and more should quickly recoup the outlay needed to obtain and maintain certification.
The advantages of ISO 13485 are not exaggerated. Organisations of all sizes have acknowledged how beneficial certification has been, in addition to different advantages that a productive quality management system normally includes. We will further explain six benefits that ISO 13485 can bring for your organisation:
Certification to the ISO 13485 standard establishes you as a quality organization in the medical device industry. Certification proves to customers that your organisation ensures quality, and you will have an implemented system and certification to prove it. A Quality Management System or QMS can be an incredibly effective marketing tool, and it has become a prerequisite for many countries, as it promises quality. Therefore, ISO 13485 certification provides a greater chance for more business opportunities.
The ISO 13485 standard is based on the quality management principles, one of which is customer focus. This can be accomplished by observing customer needs and planning and ensuring their needs are met. Customers expect quality and will not as easily engage with a provider that isn't certified. Additionally, satisfying your customer’s needs ensures there is a greater likelihood for retention, and it allows you to offer other products or services to new clients. This will translate to greater income.
By utilising the procedural approach recommended in the ISO 13485 standard, quality is made easier and more consistent. You'll benefit from fewer mistakes, efficiency improvements, and perhaps encourage investment interest in your organisation.
Another quality principle of ISO 13485 is the utilisation of evidence-based decision making. When you implement evidence-based decision making, your choices will be better aligned with the objectives of your organisation. Another benefit is a better understanding of the effectiveness or deficiencies of your systems and the effectiveness of improvements made to your systems.
An additional benefit that comes from ISO 13485 certification is the idea of continuous improvement. When you are certified, senior management and employees will be required to look out for opportunities to improve your systems, product and services. By establishing effective procedures, you reduce issues and avoid extra stress on your organization. There will be less energy and time invested in resolving mistakes, giving you increased time to provide quality products or services.
When employees are asked to search for ways to improve procedures, they frequently give the best advice, as they have more personal experience with the procedures. Because of this, they will experience more job satisfaction and increase their commitment to the organisation. The more your employees experience quality in their job capacities and business processes, the more connected they are, which prompts increased efficiency and profitability.
If you want these benefits, you should endeavour to meet the ISO 13485 requirements. Compliancehelp, one of the best ISO 13485 consultancies, can help you meet these requirements.
ISO 13485:2016 establishes prerequisites for a quality framework. By complyting with this standard you will show that you can reliably provide medical devices that meet customer expectations through better quality management. Organisations can be engaged with one or more phases of the medical device cycle including planning designing, purchasing, manufacturing, stockpiling, delivery, and servicing.
At Compliancehelp, our team can help your business implement the ISO 13485 medical devices standard utilising the following steps:
As part of our commitment to provide a turnkey solution so you do not need constant assistance from your consultant, we will provide training to help you understand the standard and the intent of them. Training is performed at the beginning and throughout the interviewing process, then as needed thereafter during the remainder of your consulting engagement.
We will interview key personnel regarding each of the processes and their interactions. With the training from step 1, you will have better context for answering questions during the interviewing engagement and the certification stages. Every organisation is different and therefore there is no required way an organisation meets ISO 13485:2016, as long as the standard is met. We will work with you to retain existing good practices that meet the standard, and where needed, help you identify newer practices better aligned to the standard.
We will prepare your management system documentation, including Quality Manual, policies, procedures, forms, etc. as agreed during the interviewing process from step 2. All documentation will be checked for compliance with ISO 13485:2016, our interviews, and for grammatical accuracy.
We will review the management system and documentation with you and your team to ensure accuracy to your business and that your needs are met. Any changes to documentation during this stage will be made by the consultant.
We will also provide a list of items / actions that need to be addressed prior to the upcoming certification audit. These actions could include for instance implementing new practices, communicating policy and objectives, internal audit, management review, and implementing a corrective/preventive action program. Typically, we find that the list of items to implement is fairly brief but comprehensive because of the time we took in the early stages of the consulting engagement to provide a solution specific to your business.
With the completed management system in your possession and an action list of items to implement before the certification audit, you will be ready to start the implementation stage.
When you have implemented the relatively short list of actions from step 5, you will be ready for your certification audit. The certification audit is performed in two stages. For stage 1, the auditor checks your management system (policy, procedures, forms, etc.) for compliance against ISO 13485:2016. Another phrase that might better describe a Stage 1 audit is a "Desktop audit". Another part of the stage 1 audit is where the auditor checks your readiness for the final, or Stage 2 audit. You should receive a Report after the Stage 1 audit including any items that need to be completed before you are ready for the next stage. Sometimes however, the Stage 2 audit is scheduled immediately after the Stage 1 audit in cases where the auditor is confident that the Stage 1 audit will be successful.
For Stage 2, the certification auditor will be questioning and viewing objective evidence to determine whether ISO 13485:2016 has been implemented in your organization, according to your management system. If all items from the action list have been implemented, there should be no reason that the Stage 2 audit would not be successful first time.
You’re certified now. Kick back and enjoy the moment for a very short while. Most of the hard work has been done, all that is needed is upkeep of the management system and continually following it in preparation for your next audit in a year’s time.
You might want to take the time to write a press release and also inform your customers that you are now certified to ISO 13485:2016. Feel free to put the certification body’s standards logo on your website and advertising materials, you've earned it.
Let us help you implement effective management practices in your medical devices business by helping you implement the standard ISO 13485 medical devices? Get in touch with us!
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