ISO 13485 certification in Kenya 

ISO 13485 Certification in Kenya: Elevating Medical Device Quality The ISO 13485 accreditation stands as a symbol of excellence in medical device quality management in Kenya’s healthcare system, where the safety and efficacy of medical devices are of the utmost importance. This certification demonstrates a company’s dedication to following strict standards and guaranteeing that medical equipment adhere to the strictest quality and safety guidelines.

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Certvalue is professional ISO 13485 Consultant in Kenya, providing ISO 13485 Certification in Kenya, Nairobi, Kisumu, Eldoret, Thika, Malindi, Garissa, Mombasa, Naivasha, Embu, Lamu  with the assurance of training, Audit, Documentation, Certify, Templates, Gap Analysis, Implementation, Registration, Consulting services at affordable cost to all organizations to get certified under Quality Medical Certification in Kenya. ISO 13485 Certification in Kenya is one of the medical device industry’s most widely used international standards for quality management, ISO 13485 in Kenya, is evolving with the publication of an advanced version of the standard by the International Organization for Standardization (ISO). The ISO 13485:2016 Certification in Kenya standard is an advantageous answer to meet the comprehensive requirements for a QMS. Adopting ISO 13485  in Kisumu presents a realistic basis for manufacturers to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485 Certification in Kenya can also be used by means of suppliers or external parties that provide products, together with quality management system-related services to such companies.

Why is ISO 13485 certification in Kisumu a good idea for your organization?

The benefits of ISO 13485 in Kenya cannot be overstated. Organization has realized significant savings in cost and time, plus other improvements that an efficient Quality Management System naturally brings about. Reasons to ISO 13485 implementation in Kenya organization:

Improve your image and credibility – When customers see that you are certified by an identified certification body, they will recognize that you have implemented a system that is focused on meeting customer requirements and improvement. This ISO 13485 Consultants in Kenya improves them to believe that you will supply what you have promised.

Improve customer satisfaction – One of the key principles of the ISO 13485 Certification in Kisumu QMS is the focus on enhancing customer satisfaction by identifying and meeting customer necessities and needs. By enhancing satisfaction, you improve repeat customer business.

Fully integrated processes – By using the process approach of ISO 13485 Certification in Thika, you not only look at the individual processes in your company, but also at the interactions of those processes. By doing this, you can extra easily find areas for improvement and resource savings inside your company.

Use evidence-based decision making – Ensuring that you are making decisions based on correct evidence is a key to the success of an QMS of ISO 13485 Certification  in Thika. By making sure that your decisions are based on good evidence, you can better target assets to the best effect to correct problems and improve your organizational efficiency and effectiveness.

Create a culture of continual enhancementISO 13485 Implementation in Kisumu With continual improvement as the enhanced output of the Quality Management System; you can gain ever-increasing gains in savings of time, money, and different resources. Through making this the culture of your company, you can focus your workforce on improving the processes they are directly responsible for.

Which Industries are eligible to get ISO 13485:2016 Certification in Kenya?

Many organizations of varying types of Medical Manufacturing Companies are using ISO 13485:2016 Certification in Kenya as a most recognized method of delivering customer pride and controlling quality of product and Service within their chosen sector. ISO 13485:2016 not only can be used to supply enhancements and help assurance quality, however the accreditation is often viewed as an assurance of uniformity of product and offerings throughout borders, languages, and cultural boundaries. Therefore, having ISO 13485:2016 accreditation can be considered as fine on a reputational basis, as well as a practical one. Implementation of ISO 13485:2016 Certification in Kenya is different in nature of business. So that the Implementation can be done by ISO 13485 Consultants for all the industries in Kenya, which improves the customer satisfaction

How to get ISO 13485 Certification in Kenya?

If you are thinking about how to get ISO 13485 Certification in Kenya I would gladly prefer Certvalue with no apprehension. You can easily achieve Certvalue by just visiting www.certvalue.com where you can chat with a specialist or you can also compose an inquiry to [email protected], so that one of our experts will get in touch with you at the earliest to gives best possible solution available in the market.

Checklist for ISO 13485 certification in Kenya

The ISO 13485  Certification Audit Checklist covers the seven main areas of the ISO 13485  Standard:

  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement

Certvalue – YOUR ISO 13485  CERTIFICATION CONSULTANT

Certvalue is a reputable and widely recognized global leader in the provision of certification, advice, audit services, and ISO 13485  Consulting Services anywhere in the world. It operates ethically and has an unmarked track record of achievement in the certification process. Certvalue ISO 13485 consultants have a wide range of knowledge and expertise in many fields and industrial sectors. Organizations pick Certvalue to handle complex solutions because of the service’s superiority. With Certvalue, registering for ISO 13485 certification in Kenya is simple and fast.

The cost of obtaining ISO 13485 certification in Kenya can vary widely based on several factors. The easiest way to get the cost is using our Free cost calculator and get the cost for your ISO 13485  Certification instantly in your email.

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Faq

Asked Any Questions

An international standard called ISO 13485 was created especially for the medical device sector. It provides specifications for a quality management system (QMS) targeted at the creation, distribution, and design of medical devices.

The ISO 13485 accreditation is advantageous for businesses in Kenya engaged in the design, development, production, and marketing of medical equipment. This covers producers, providers, and distributors of medical devices.

Initiating the certification project, carrying out a gap analysis, putting in place an approved quality management system, conducting internal audits, applying for certification from an accredited authority, and maintaining compliance are the typical procedures.

Although it is not normally required by law in Kenya, regulatory agencies, clients, and business partners frequently need or prefer ISO 13485 certification to guarantee adherence to international quality standards.

PLAN

Conduct Gap Analysis to find any Shortcomings from the standard requirements.
 

DO

Policies, procedures, Work Instructions, Evidences, Records, Training

CHECK

Conduct frequent internal audit and management review meeting.

ACT

Apply corrective actions on the identified root cause or shortcomings

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Process for ISO Certification in Kenya

Certvalue make the ISO certification process in a simple way for every organization in Kenya to get their certification sitting at their place in lesser time and at an affordable cost.

Get Consultation

Seek guidance from Certvalue to determine the relevant ISO standards.

Submit Your Documents

Collect and prepare the required documents and records.

Get Audited

Undergo a thorough audit by Certvalue’s auditors to assess compliance.

Get ISO Certificate

Upon successful audit, receive your ISO certification from Certvalue.

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WHY CERTVALUE?

CERTVALUE – CREATING VALUE FOR YOUR CERTIFICATION

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Client/Compliance

Bottom-line of any business organization is profit and Customers are the only source of Profit. Certvalue will help balancing both customer and compliance requirement at the same time with the help of ISO certification

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Enhancement of Performance

ISO certification is a tool to streamline and enhance the process performed internal to the organization. Certvalue indulges in inculcating best industry practices.

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Recognition and Brand Value

It is always about the Brand value of your organization in the market and ISO certification from Certvalue can make your organization to be an excel and stand out in the market globally

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Tender Eligibility

ISO certification is a basic requirement to bid or participate in any tenders floated by government or private sector. And ISO certification from Certvalue is an assurance win over the tenders.

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Testimonials

Our Client Reviews

Sobiya Rajesh
Sobiya Rajesh
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We are happy on Certvalue services. The team guided through applicable SOPs, forms and policies to implement QMS and manage it effectively so as to comply with ISO requirements. It included training part as well. Hence we are satisfied and recommend anyone who seek professional service.
Dhruv Parekh
Dhruv Parekh
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Certvalue team was very professional in their approach from the time we engaged them. Special mention to Ms. Jeevika Uchil who consulted and worked extensively with our team.
Anita Okonigene
Anita Okonigene
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CyberDome Nigeria Limited. CertValue made the acquisition of our ISO 27100 certification seamless. The person assigned to us Jeevika Uchil was very helpful.
Neeladri Bose
Neeladri Bose
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Amazing organisation to work with! Certvalue is definitely the best of the best. Thank you Certvalue Team!
Shehan Athukorala
Shehan Athukorala
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Certvalue is a very professional and responsive consultation firm. It did show us the right direction towards the ISO and GMP certifications for the PPE devices we are manufacturing. Hoping to work with them for ISO 13485 /CE and FDA as well. Well recommended for all.
Aditya vakoda
Aditya vakoda
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We got good service from certvalue and its team I was satisfied,thank you Certvalue for making my work easy
Mounika Kona
Mounika Kona
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Thank you certvalue, we have built information security management system in our organization with the help of certvalue. They were really help to get certified under iso 27001. Thank you.
somraj daroji
somraj daroji
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Very professional in consultation, documentation etc right from the first point of meeting with them. . .thank you certvalue for all the support !
Pushkar Patwardhan
Pushkar Patwardhan
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Certvalue team was very responsive right from the time we contacted them for the first time. Consultants who worked with us were very professional and demonstrated a lot of patience to get us through required documentation / requirments for the certification. Thank you Certvalue!
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