What is the difference between ISO 9001 certification in Nigeria and ISO 13485 certification in Nigeria | no 1 best ISO 9001 Certification in Nigeria

What is the difference between ISO 9001 certification in Nigeria and ISO 13485 certification in Nigeria?

An ISO 9001 Certification in Nigeria is proof that your supplier has established a systematic approach to quality control and runs its company to ensure that your needs are understood, acknowledged, and satisfied. ISO 9001 Certification in Nigeria, in particular, is a requirement for a quality management system that contributes to meeting the laws and regulations associated with products or services that are required to meet the needs of customers and other relevant parties.

What are the benefits of ISO 9001 certification in Nigeria?

  • ISO 9001 can help organizations structure their work processes and gain a competitive edge.
  • Incorporating ISO 9001 into your business can bofost your chances of obtaining government or commercial contracts.
  • Higher profit margins are possible since it makes a company more likely to become well-known worldwide.
  • Upon reviewing the fundamentals and benefits of ISO 9001 Certification in Nigeria, you’re undoubtedly curious about the certification process.

What is the difference between ISO 9001 certification in Nigeria and ISO 13485 certification in Nigeria? 

9001 ISO Certification ISO 13485 Certification  in Nigeria is a national standard in Nigeria, while it is a global standard for quality management systems. When the ISO 9001 standard is applied, customers are guaranteed to receive the highest calibre goods and services.

In Nigeria, however, ISO 13485 Certification is associated with a quality management system for medical devices. It stood out as the lone outdated ISO 9001 system among all of them. Numerous individuals believe that ISO 13485 will eventually be built upon  ISO 9001 Consultant in Nigeria.

Nigerian ISO 9001 certification documentation contains the following data:

ISO 9001 and ISO 13845 share many commonalities, including an emphasis on product quality. Additionally, the two sets of systems differ in five key ways:

  • Details about the merchandise.
  • Rules have to be observed.
  • Recordkeeping is necessary.
  • Customer satisfaction.
  • Ongoing improvement.
  • The ISO 13485 quality management system requires measuring and monitoring of products. The personal health information of a consumer should not be accessible to third parties.
  • Concessions must follow the ISO 13485 requirements, authorized personnel must be identified, and any rework must be documented. Compared to ISO 9001, ISO 13845 has many higher documentation requirements. Medical device approval companies are required to incorporate a risk-assessment approach within their product development process.

The following details are included in medical device documentation:

  • Thorough justification.
  • Requirements.
  • Making a finished good.
  • Installing an application is happening.
  • Processes for providing services.

Traceability is also required for records and paperwork related to purchases. A foundation’s qualification, along with the procedures and methods used, needs to be documented. The product’s clean or contamination-free status needs to be documented.

Recordkeeping is necessary for projects during installation, verification, and maintenance. Maintain documentation for every sterilization batch.

The traceability of returned goods and the validation procedures for computer software, sterilization, and product identification ought to be recorded. Documentation of a traceability process is required.

Charts that show the parts, materials, and operating conditions of medical devices that need implants must be kept on file, together with the names and identification numbers of the personnel who inspect them.

How can one receive certificates for ISO 9001 and ISO 13485 In Nigeria?

  • In order to obtain ISO certification, a company needs to fulfil the requirements of the ISO 9001 management system, prioritize customer satisfaction, and enhance the management system.
  • Getting certified as an ISO 9001 practitioner could take three to six months in Nigeria.
  • Regarding size, there is no differentiation between industries or businesses. Many companies use the ISO 9001 standard; the only ones that need to be certified are, 
  • An organization’s credibility can be increased by ISO certification, which attests to the fact that its offerings will live up to customer expectations. Most of the time, certification is required by law or may be required by decree.
  • Standards for ISO 9001 Certification in Nigeria are applied as a part of the certification process. The organization must complete the registrar’s audit to attest to its compliance with those conditions before achieving certification.
  • In addition to ISO 13845 certification in Nigeria, a third-party certification from a third-party body would be quite beneficial. A corporation can obtain certification by meeting certain requirements.

Why did Nigeria decide to certify its ISO 9001 compliance with Factocert?

Our experts in  ISO 9001 consultant in Nigeria routinely produce top-notch outcomes. Each system head’s automated name representations enable the company to function without them. Method layout techniques are still unfinished in this way.

Major Nigerian cities such as Lagos, Abuja, Kano, Ibadan, Benin City, Port Harcourt, and others offer environmentally friendly ISO 9001 consulting services. The ISO 9001 criteria cover ISO requirements, ISO 22000, 17025, 45001, audit registration, and energy training. All ISO standards, including ISO 14001 and ISO 27001, are met by these products.

Visit to find out more: ISO 9001 Certification in Nigeria.

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