ISO 15189 Certification in Kenya

ISO 15189 Certification in Kenya: Elevating Medical Laboratory Excellence The precision and dependability of medical laboratory services are essential for patient care and treatment in Kenya’s evolving healthcare system. The ISO 15189 certification, which guarantees the greatest degree of accuracy and precision in diagnostic testing, is a symbol of the medical laboratories’ dedication to upholding strict quality standards in Kenya.

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Certvalue is one of the best ISO 15189 Consultant in Kenya for providing ISO 15189 Certification in Kenya, Nairobi, Kisumu, Thika  and other major cities in Kenya, with the services of implementation, training, documentation, gap analysis, registration, Audit and templates services at affordable cost to all organizations to get certified under quality of medical laboratory in Kenya. ISO 15189 Certification in Kenya  specifies requirements for quality of medical labs. ISO 15189 Standard helps labs develop quality management systems and assess their own competence. ISO 15189:2012 Standard used for recognizing the competence of medical labs by laboratory customers, accreditation bodies and regulating authorities. It was developed with the participation of the medical, scientific, clinical community, accurate, reliable results and requirements for diagnostic labs to demonstrate competence to deliver timely.

Requirements for ISO 15189 in Kenya:

ISO 15189 standard includes five additional criteria for medical labs.

  • ISO 15189 Services in Kenya providing advice on the type of sample and testing that may be required.
  • ISO 15186 Certification is interacting with clinical staff with the laboratory responsible for the quality of service to clinicians referring patient samples for testing.
  • ISO 15189 Consultants in Kenya providing opinions on results of testing relative to diagnosis and patient care.
  • ISO 15189 is providing information on collection procedures, sample volumes and sample containers.
  • Ethical practice.

ISO 15189:2012 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, quality assurance, and analytical, pre-analytical, and supplies, equipment, reagents, and post-analytical factors. ISO 15189 Certification is qualified assessors conduct a thorough evaluation of all factors affecting the production of test data and to ensure continued compliance, accredited medical laboratories are regularly re-assessed to ensure they maintain their technical expertise. 

Benefits of ISO 15189 Certification in Kenya:

  • ISO 15189 Certification Services in Kenya is quality control checks will be carries out periodically by which system is always maintained.
  • Assurance to clients of good laboratory practice.
  • Meets purchaser or regulatory specifications.
  • Improves staff motivation and esteem.
  • ISO 15189 Implementation in Kenya improves national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • It saves money by getting it right the first time.
  • It ensures better support in the event of legal challenge.
  • ISO 15189 Standard is customer satisfaction is achieved through the introduction of a quality management system.
  • MRA amongst various countries’ test reports is acceptable without repetition of analysis.
  • It is National and international recognition.

How to get ISO 15189 Certification in Kenya:

Certvalue is one of the leading ISO 15189 Implementation in Kenya providing quality of medical laboratory standards to all organizations. We are one of the well recognized firms with experts in every sector to implement the standard with a 100% track record of success.

How to get ISO 15189 Consultants in Kenya:

If you’re looking for How to get ISO 15189 Services in Kenya. You can write to us at [email protected] or visit our official website as we are ISO Certification Consultant Companies in Kenya. Certvalue and provide your contact details so that one of our certification experts shall contact you at the earliest to understand your requirements better and provide best available service at market.

Checklist for ISO 15189 certification in Kenya

 The ISO 15189 Certification Audit Checklist covers the seven main areas of the ISO 15189    Standard:

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

Certvalue – YOUR ISO 15189 CERTIFICATION CONSULTANT

Certvalue is a reputable and widely recognized global leader in the provision of certification, advice, audit services, and ISO 15189 Consulting Services anywhere in the world. It operates ethically and has an unmarked track record of achievement in the certification process. Certvalue ISO 15189 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 15189 certification in Kenya is simple and fast.

The cost of obtaining ISO 15189 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 15189  Certification instantly in your email.

 

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Faq

Asked Any Questions

Medical testing facilities and laboratories can obtain ISO 15189 Certification, an internationally recognized quality management system standard. It guarantees that the diagnostic and testing services provided by these businesses adhere to strict criteria of accuracy, dependability, and expertise.

Kenya needs ISO 15189 certification to guarantee the high standard and security of healthcare services. It improves patient confidence, adherence to international standards, and industry competition.

They can apply for ISO 15189 Certification at any medical testing center in Kenya, whether it is public or private. 

The length of time it takes to achieve ISO 15189 certification can change depending on how ready the healthcare organization is and how readily available the certification .

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.

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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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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