Everything you need to know about ISO 13485 Certification in Kenya

ISO 13485 Certification in Kenya

ISO 13485 Certification in Kenya Device manufacturers must adhere to ISO 13485 Certification in Kenya quality management standards. Your route to market will be sped up by certification, which assures the trust of your regulators, stakeholders, and future customers.

There’s no denying that it’s a complex process that must be done right.

Using the right toolset and expert guidance, your company can fully comply with ISO 13485 Certification in Kenya. 

With this guide’s help, you can introduce your medical device to the market before your competitors. Let’s get started. 

ISO 13485 Certification in Kenya: What does it mean?

Regulatory compliance with ISO 13485 Certification in Kenya is a requirement for companies that design, manufacture, install, service, or manufacture medical devices.

1996 ISO 13485 Certification in Kenya was first published, and in 2003 and 2016, it was revised.

ISO 13485:2016 became effective in March 2016. By meeting these requirements, medical devices and services meet customer expectations and regulatory requirements.

ISO 13485 Certification in Kenya is important for what reasons?

Standardization is a non-governmental organization comprising industry leaders collaborating to solve global problems.

A few additional requirements in ISO 13485 Certification in Kenya make it an effective replacement for ISO 9001. It is common for consumers and the life science supply chain to refuse to purchase medical device products from companies that do not have ISO 13485 Certification in Kenya. 

For medical devices to obtain CE markings, which indicate conformity with safety standards, manufacturers must be certified by notified bodies or have quality systems.

There are five components of ISO 13485 Certification in Kenya.

A medical device company must meet design, development, risk management, production, and post-production requirements to comply with ISO 13485. To qualify for ISO 13485 certification, companies must meet these five key requirements.

• An integrated quality management system (IQMS)

ISO 13485 Certification in Kenya requires a company to comply with the quality management system standards. This section discusses the general quality management system requirements and the documentation necessary for implementation and maintenance.

1. ISO recommends that organizations:
2. Determine how the quality management system should be implemented throughout the organization, considering the different roles involved.
3. Ensure quality management systems are controlled according to risk-based guidelines.
4. Identify how these processes interact and how they are sequenced.

•  Management responsibility

 This section outlines management’s unique roles and responsibilities concerning implementing and maintaining a quality management system.

In short, management should provide evidence of its commitment to developing and maintaining the quality management system and its effectiveness. To do that:

1. Communicate the importance of meeting regulatory requirements
2. Establish a high-value quality policy
3. Ensure that quality objectives are established
4. Conduct management reviews
5. Resource availability for quality management systems must be ensured

• Managing resources

Life sciences organizations should implement and maintain quality management systems using the resources described in this phase. The document outlines the provisions necessary to comply with major regulatory and customer requirements.

Resources outlined in this section include:

1. The provision of resources
2. Human resources
3. Infrastructure
4. Work environment
5. Contamination control

•  Product realization

 Many organizations often overlook the planning phase in a rush to get products into development as soon as possible. In Section 7.1, it is required that your realization efforts be appropriately planned.

In more detail, it states that you should:

• Make sure your product(s) meet the quality requirements
• Identify the processes that are required and the supporting documentation that will be required.
• Provide a description of the infrastructure and work environment to be created
• Determine the training and qualification requirements for employees.
• Verify, validate, measure, monitor, handle, inspect, store, distribute, and track your processes.

Finally, it would help if you organized all that information to be easily accessed and understood.

• Analyzing, measuring, and improving

 ” Monitoring, measurement, analysis, and improvement shall be planned and implemented by the organization” related to quality management systems and products, according to ISO.

Organizations need to:

• Demonstrate conformity of product
• Maintain quality management system compliance
• Enhance the efficiency of the quality management system

Why Factocert for ISO 13485 Certification in Kenya

We provide the best ISO consultants in Kenya , Who are very knowledgeable and provide the best solutions. And to know how to get ISO certification in Kenya . Kindly reach us at contact@factocert.com. ISO Certification consultants work according to ISO standards and help organizations implement ISO certification with proper documentation.

For More Information, Visit ISO 13485 Certification in Kenya.