“Expert Certifier is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification with Expert Certifier in Kenya“
Up your business, talk to our Expert Certifier masters who are available for you to coach and on how to get your business and process certified with ISO 13485, ISO 14001, ISO 45001,ISO 22000,ISO 27001,ISO 20000-1 and HACCP.
WHAT IS ISO 13485?
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the implementation and maintenance of a top quality management system intended to be used by medical device manufacturers and suppliers. Originally developed within the 1990s, the quality details requirements for a top quality management system that meets both customer requirements and regulations round the world. ISO 13485 certification in Kenya is analogous in scope and intent to ISO 9001, but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions. Therefore, in most jurisdictions, ISO 9001 certification isn’t a substitute for certification to the wants of ISO 13485.
ISO 13485 – QMS for Medical devices
ISO 13485 is the International standard for QMS for Medical devices. It provides your company with a group of principles that ensure a standard sense approach to the management of your business activities to consistently achieve customer satisfaction while standardizing your processes and continually improving effectiveness of the business processes.
By getting ISO 13485 Certified there’s the potential for increased business in both current and new markets. Additionally, there’s an overall improvement within the service/product quality being offered to the client. Having a certification will provide a definite advantage over other competitors and helps your ability in client acquisitions.
GET CERTIFIED IN 5 STEPS
- CALL/EMAIL US AND SHARE YOUR REQUIREMENTS
We will do a FREE GAP analysis of your organization with reference to ISO 13485 Standard and provides you a quote.
- TRAINING AND DOCUMENTATION
Once you’ve got agreed to our quotation, our team will provide the specified trainings to you and can complete the documentation work required for ISO 13485 certification.
- IMPLEMENTATION AND REVIEW
We will then conduct a pre assessment audit to make sure that you simply organization meets the specified certification requirements.
- FINAL AUDIT BY CERTIFICATION BODY
We will provide assistance during final certification audit to make sure that your organization achieves certification successfully.
- RECEIVE CERTIFICATE
We are a top quality conscious organization and believe Total Customer Satisfaction. So if you’re 100% satisfied and proud of our service, make payment to us.
How ISO 13485 certification benefits your company?
Certification also can expand your market access and improve your company’s profitability. Here are a number of the long-term benefits of ISO 13485:
- It is the de facto standard for global medical device QMS compliance for medical devices, and may be a prerequisite for access to most major markets worldwide.
- ISO 13485 certification requires commitment and energy to achieve, so it gives you extra credibility with potential customers.
- A refined QMS system will increase efficiency, enhance product quality, and improve customer service within your company.
We’ll assist you implement ISO 13485 or upgrade from ISO 9001
We focus solely on medical device, so we understand the unique needs and manufacturing scenarios of the industry. With local offices round the world, our team of experienced QA consultants has helped many medical device manufacturers achieve ISO 13485 certification. Here’s how we will help you:
- We will fully customize your ISO 13485 quality system to satisfy your specific needs and confirm you’re ready for a certification audit.
- Our ISO 13485 consulting and project management teams work closely with you to implement your QMS on time and on budget.
- We can recommend qualified third-party testing and certification firms that concentrate on your device category.
- Expert Certifier will perform on-site ISO 13485 training for your key employees as a part of the implementation project.
ISO 13485:2016 is meant to help with the following:
- Meet customer and applicable regulatory requirements
- Safety and performance
- Identify and manage risks
- Enhance marketing
- Promote international trade
How does the certification process work?
The certification process consists of two phases:
Phase 1 includes of a visit to the business to review the status of the organization, system documentation, infrastructure, etc. This assesses the maturity of the standard management system.
Phase 2 is that the certification audit getting to verify that the system documentation meets the wants of ISO 13485 standard. The certification audit will give feedback to the organization on issues that aren’t in conformance with the quality, which got to be corrected before a certificate is issued.
The certificate is going to be valid for 3 years after being granted. During this era, annual surveillance audits are going to be conducted.
Significance of ISO 13485:
The medical device industry is suffering from a posh array of regulatory systems, national and international standards and other requirements. We offer ISO 13485 certification in Kenya which is globally recognized standard & helps a product in meeting compliance (national & worldwide). ISO 13485:2003 is that the latest version of ISO 13485 which was published in July 2003. This standard is analogous to ISO 9001:2008 and is predicated on process model approach. Our certificate is formally recognized worldwide. Being a medical device manufacturer, it’s your responsibility to deliver a tool which is effective & safe for everybody. By implementing ISO 13485 in your organization you’ll achieve this goal.
Why choose Expert Certifier certification for your audit?
Expert Certifier is an accredited certification body. We offer certification against a spread of management systems including ISO 13485 certification medical devices. While quality has been our first priority and now we’ve accompany the more systematic approach to assist your business keep ahead within the competition.
How to get ISO 13485:2016 certification in Kenya – Consultants in Kenya?
Our masters have more than 15 plus years of global experience, with hands-on experience in the field of ISO certification, assessment and training.
With Expert Certifier your Business and process excellence is well guaranteed.
Reach us at: contact@ExpertCertifier.com