ISO 13485 Certification In Nigeria | Best ISO 13485 Consultants In Nigeria

ISO 13485 Certification In Nigeria

ISO 13485 Certification In Nigeria

ISO 13485 Certification in Nigeria, Factocert is a company with expertise in Nigeria that offers ISO 13485 Certification and Consultation. With the services of advice, implementation, documentation, training, auditing, and registration, we offer the best ISO Consultant service in Abuja, Ibadan, Lagos, Kano, and Port Harcourt. We do offer both HALAL and CE mark certification. 

The ISO 13485 certification in Nigeria confirms the effectiveness and efficiency of the medical device quality management system built on the ISO 13485 standard. It oversees the procedures surrounding the safe production and distribution of medical equipment. The goal of ISO 13485 certification is to make your organization’s management system comply with the relevant regulatory standards. Exporting nations can benefit if companies producing and distributing medical equipment have ISO 13485 certificates. For businesses manufacturing or exporting medical products, ISO 13485 certification in Nigeria becomes crucial.

What are the steps to get ISO 13485 Certification in Nigeria?

ISO 13485 Certification in Nigeria

What advantages does ISO 13485 Certification in Nigeria offer?

  • consumer contentment.
  • lower operating expenses.
  • increased interaction with your stakeholders.
  • the legality of your procedures.
  • enhances your reputation in the market.
  • positions you favorably as a supplier.
  • enhanced risk-taking.

The ISO, or International Organisation for Standardisation, published the first edition of ISO 13485 in 1996. These guidelines undergo a comprehensive examination every 6 to 8 years to keep them current. The ISO 13485 standard underwent its first upgrade in 2003, and its most recent revision was released in 2016. As a result, it is written as ISO 13485:2016. According to ISO, this standard must be updated” to adapt to the most current standards for quality management systems, including technological advancements and statutory requirements.” The producers can use various tools to ensure that medical devices are consistently high quality. Apply for ISO 13485 for medical equipment, given after the certification organization’s careful management system assessment.

Why Do I Need an ISO 13485 Certification In Nigeria?

Implementing ISO 13485 certification enhances the quality management system in the medical industry, and QMS enables a company to show its clients that it provides high-quality products.

  • a certification that is respected globally
  • Increase output and reduce waste with an official seal
  • Trade between countries may be more consistent

What specifications does ISO 13485 have?

Producing high-quality IVD and implantable medical devices is possible by adhering to the Nigerian ISO 13485 Certification criteria. Additionally, it guarantees that customer expectations are consistently met. As far as producers are concerned, it ensures that they can comply with national regulatory standards. The ISO 13485:2016 standard offers a framework for developing and implementing quality management systems for medical device manufacturers. This standard applies to all small and large enterprises engaged in creating, selling, or distributing medical equipment, regardless of the size of their respective industries. It is one of the favored choices for medical device sellers or suppliers.

The ISO 13485 standard is divided into eight sections, the first three primarily introductions. The final five contain the criteria for a quality management system for medical devices. Let’s quickly review the last five paragraphs of this standard:

The control of records, the quality manual, and the power of documents are covered in Section 4 of the quality management system, which satisfies the documentation requirements for quality management systems for medical devices.

Part 5: Management Responsibility – This part states that senior management is in charge of successfully implementing a QMS for medical devices. It calls for the senior management to review ongoing procedures regularly to assess the management system’s effectiveness.

Part 6: The methods to mobilize resources for putting quality management systems for medical devices into place are described in Section 6: Resource Management. It consists of financial, human, and physical resources, among others.

Section 7: Product Realisation – This section discusses all the product creation steps. This area can be skipped when establishing the management system for organizations that do not produce medical devices. They include design, purchasing, and equipment control for monitoring and measuring the products and processes.

Section 8: Analysis, Measurement, and Improvement This comprises the specifications for your QMS’s efficiency and effectiveness monitoring and measurement. Customer satisfaction is evaluated, internal audits are conducted, products and processes are regularly monitored, non-conformities are examined, and remedial and preventive measures are taken.

Who is eligible for ISO 13485 Certification in Nigeria?

The ISO 13485 accreditation applies to all businesses in Nigeria engaged in the production, sale, or retail of medical devices. It is the preferable option when selecting vendors to provide medical devices. As a result, any organization, regardless of size, can apply for ISO 13485 Certification and demonstrate its dedication to quality. It includes the specifications for businesses participating in any or all stages of the production of medical devices and those in the pharmaceutical supply chain.

Organizations with ISO 13485 certification comply with the nation’s strict regulatory standards. As a result, it becomes crucial for the makers.

How can one get ISO 13485 Certification in Nigeria?

The quality management system must be implemented in your company to demonstrate its efficacy before you can begin the certification process. This needs to be thoroughly recorded for review during the certification audit. Once you are confident in your management system’s functionality, you should apply for ISO 13485 certification in Nigeria. You must first fill out the application form and review the certification’s prerequisites. You must conduct an internal audit if the documentation of your procedures complies with the standards of the ISO 13485 standard. 

The specific steps for obtaining ISO 13485 certification are as follows:

  • Internal Control: An internal party does this to ensure that papers meet the standard’s requirements.
  • Management audit: At this level, management evaluates the weaknesses found in internal audits and decides whether parts of the ISO 13485 standard apply to your company.
  • Corrective actions: You must take several remedial measures to address the gaps found during the previous two stages. You must keep track of your disciplinary actions for this.

The following steps make up the ISO 13485 certification process:

  • Stage one (documentation survey):

To determine your readiness for the certification audit, auditors from the certification organization of your choice analyze your documentation.

  • The auditors analyze your procedures in Stage 2(primary audit):

 for compliance and nonconformities with ISO 13485 regulations and your documentation. Examining reports, documents, and your company’s procedures helps with this.

Contact Factocerts’ staff if you’re seeking ISO 13485 certification in Nigeria. Factocerts, an ISO Certification Body in Nigeria, provides hassle-free certification experience thanks to its extensive experience in certification audits and its success stories with 16,000+ delighted clients from more than 55 nations. For more assistance contact the best ISO 13485 Consultant in Nigeria at or visit our website at so that our Consultant can assist you with this ISO 13485 Certification in Nigeria

Who wants ISO 13485 Certification in Nigeria?

  • ISO 13485 Auditor in Nigeria is an international standard that is applicable for any company that is completely or partly involved in the entire life cycle of medical devices and those demands of the standard applied to the organization irrespective of their size or type.
  • It’s an international standard that can be used by external parties (such as distributors for contract makers) or by suppliers by offering the service or merchandise to the medical device market. Implementing the necessity of an ISO 13485 Certification in Nigeria’s quality management system for medical devices is a voluntary choice by an outside party or a provider or sometimes it might be among the mandatory requirements provided by the nation.
  • In meeting the regulatory requirement in some countries ISO 13485 Certification body in Nigeria standard plays a very prominent part, or it may be a prerequisite for several industries to set up particular regulatory approvals in the subject of the medical device supply chain. So, overall ISO 13485 certification in Nigeria is expected in most of the countries that take part in the manufacturing of medical devices.

Merits of ISO 13485 Certification in Nigeria

ISO 13485 Certification cost in Nigeria standard acts as a Standard for businesses that are involved in medical manufacturing. The organizations which have undergone or attained ISO 13485 Certification in Nigeria standard have enhanced their products’ quality, regulatory compliance, and reliability and are in relation to the business best practices. Organizations of any type or dimensions which are involved in implementing and developing ISO 13485 Certification in Nigeria match the quality management system. Therefore, the future of this quality management system and your business depends upon your current decision

Now We’ll see a few other benefits

  • ISO 13485 Certification in Nigeria enables the organization to have a continuous advancement in its culture.
  • ISO 13485 Certification in Nigeria helps the organization to have a better quality of devices which will Lead to Equity
  • Among the best way to have client satisfaction at a greater level
  • ISO 13485 Certification in Nigeria helps to reduce the cost and increase efficiency by with better quality factors
  • Decisions are based on the info’s and details that are coordinated with the organizational strategic goals

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ISO 9001: ISO 9001 sets out the standards for a quality Management system and is the only standard in the household that may be licensed to (although this isn’t a requirement). It can be used by almost any organization, big or small, regardless of its field of activity. In reality, there are over one million businesses and organizations in over 170 nations certified to ISO 9001.

This standard is based on several Quality management fundamentals including a solid customer focus, the motivation, and implication of best management, the process strategy, and consistent improvement. These principles are explained in much greater detail in ISO’s quality management principles. Using ISO 9001 helps make sure that customers get constant, good-quality merchandise and services, which consequently brings several business benefits.

ISO 14001: ISO 14001 sets out the standards for an Environmental management system and can be certified. It maps a frame that a company or organization can follow to establish an effective environmental management system.

Designed for any type of organization, Irrespective of its activity or business, it could assure the business management and employees as well as external stakeholders that environmental effect is being measured and improved.

What do the standards in the ISO 14000 family cover?

The ISO 14000 family of standards Are manufactured by ISO Technical Committee ISO/TC 207 and its various subcommittees. For a full list of published standards in the series view their standards catalog.

ISO 14001 provides demands With advice for use that relates to environmental systems. Other standards in the family focus on specific approaches such as reports, communications, labeling, and life span analysis, as well as environmental issues like climate change.

ISO 45001: Based On the International Labour Organization, over 7 600 people die from work-related injuries or diseases every moment. That is the reason an ISO committee of occupational health & safety specialists places to work to develop an International Standard using the capability to save almost three million lives every year. Structured in a similar way to other ISO management systems, the approach will be familiar to customers of standards like ISO 14001 or ISO 9001.

ISO 45001 builds on the achievement of previously international standards in this area including OHSAS 18001, the International Labour Organization’s ILO-OSH Regulations, different federal standards, and the ILO’s international labor standards and conventions

ISO 22000: The effects of harmful food could be severe. ISO’s food safety management standards help organizations identify and control food safety hazards, at the same time as working together with other ISO management standards, such as ISO 9001. Applicable to all types of producers, ISO 22000 provides a layer of reassurance inside the worldwide food distribution chain, helping goods cross borders and bringing folks food that they can trust.

ISO 20000-1: It demands an organization to establish, implement, maintain and continually enhance a service management system (SMS). The requirements specified in this document include the planning, design, transition, shipping, and enhancement of services to fulfill the service demands and deliver value. This record can be used by:

ISO 31000: ISO 31000, Risk management — Strategies, Supplies principles, a framework, and a process for managing risk. It can be used by any organization no matter its size, activity, or business.

Utilizing ISO 31000 can help Organizations increase the probability of achieving objectives, improve the identification of opportunities and risks and effectively allocate and utilize resources for risk therapy.

But, ISO 31000 Can’t be used For certification purposes but can guide external or internal audit programs. Organizations utilizing it may evaluate their risk management practices using an internationally recognized benchmark, supplying sound fundamentals for successful management and corporate governance.

ISO 10002: This standard gives guidelines for the process of Complaints handling related to products and services inside an organization, including planning, design, creation, operation, maintenance, and improvement. The complaints-handling process described is suitable for use as one of the procedures of an overall quality management system.

ISO 27001: ISO/IEC 27001 is broadly known, supplying requirements for an information security management system (ISMS), though there are more than a dozen standards in the ISO/IEC 27000 household. Applying them empowers organizations of any sort to manage the security of assets like financial information, intellectual property, employee details, or information secured by third parties.

ISO 17025: ISO/IEC 17025 enables laboratories to demo That they function competently and create valid outcomes, thereby promoting confidence in their work both nationally and around the globe.

Additionally, it helps facilitate collaboration Between laboratories and other figures by generating broader acceptance of results between nations. Evaluation reports and certificates could be accepted from one country to another without the need for further testing, which, in turn, enriches international trade.

ISO 22301: This standard specifies requirements to implement, maintain and improve a management system to protect against, reduce the likelihood of the incidence of, prepare for, respond to and recover from disruptions when they appear.

The requirements specified in this document are generic and intended to be relevant to most organizations, or components thereof, regardless of the size, type, and temperament of their organization. The level of application of these requirements depends on the organization’s operating environment and sophistication.

ISO 50001: For organizations committed to addressing their effect, conserving resources, and improving the bottom line by effective energy management, we developed ISO 50001. Designed to support organizations in all industries, this ISO standard provides a practical way to improve energy use, through the development of an energy management system (EnMS).

CE mark: The Conformity Europeans (CE) Mark is defined as The European Union’s (EU) mandatory conformity indicating for controlling the goods marketed within the European Economic Area (EEA) as of 1985. 

The CE marking and ISO 13485 Certification in Kenya represents a manufacturer’s statement that products comply with the EU’s New Approach Directives. 

All these directives not just apply to goods within the EU but also for products that are made in or intended to be sold at the EEA. This makes the CE marking familiar worldwide even to people unfamiliar with the EEA.

HACCP: Is a Quality organization of the Government of Kerala Providing cost-effective & professional assessment, analysis, and certification of Hazard Analysis Critical Control Point (HACCP) System for the food business and other food-related vendors.

What’s HACCP?

HACCP (Hazard Analysis Critical Control Point) is an internationally accepted method for preventing microbiological, chemical, and physical contamination along the food supply chain.

The HACCP method does this by identifying the risks, establishing critical control points, setting critical limits, and ensuring control steps are verified, confirmed, and monitored before execution.

The effective implementation of HACCP Will enhances the capability of businesses to protect and enhance brands and private labels, encourage customer confidence, and conform to regulatory and market requirements.

GLP: Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled by quality standards. It’s designed to minimize the risks involved with any pharmaceutical production that may not be eliminated through testing the final product.

The main risks are sudden contamination of goods, causing harm to health or even death; wrong labels on containers, which could indicate that patients receive the wrong medicine; inadequate or too much active ingredient, leading to ineffective therapy or adverse effects. 

GMP covers all facets of production; in the beginning materials, premises, and equipment to this training and personal hygiene of staff. Detailed, written processes are critical for each procedure that could influence the quality of the completed product. 

There must be systems to present documented proof that correct procedures are followed at each step of the manufacturing process – every moment a product is created. WHO has established detailed guidelines for good manufacturing practices. 

Most countries have formulated their particular requirements for GMP according to WHO GMP. Others have harmonized their needs, for example in the Association of South-East Asian Nations (ASEAN), in the European Union, and through the Pharmaceutical Inspection Convention.

VAPT: Vulnerability assessment and penetration testing Are the 2 types of evaluations comprising different strength and complete vulnerability assessment. Any cybersecurity exposures could be identified with the support of both of these security testing procedures.

HALAL: Halal signifies “permissible” In Arabic and describes food items that are permissible to consume under Sharia law, whereas haram (lit. “criminal”) refers to any material not permitted to consume. As stated by the Australian Food and Grocery Council, halal foods ought to be “free of any the substance is taken or extracted by a haram animal or ingredient, eg. pigs, dogs, carnivorous animals, animals not slaughtered according to Islamic rites). 

[be] produced, processed, manufactured, and/or stored by using utensils, gear, and/or machinery that’s been cleaned by Islamic law, eg. not cleaned with alcohol); and [be] free from contact with, or being close to, a haram material during preparation, manufacture, processing, and storage (e.g. alcohol, blood, poisonous and intoxicating plants and insects such as worms and cockroaches).”

GMP: GMP certification & ISO 13485 Certification in Kenya is vital. Good Manufacturing Practice isn’t anything but steps that are taken to be able to have a controlled practice based on quality standards.

SA 8000: The SA8000 and ISO 13485 Certification in Kenya standard is your World’s leading social certification application. Even the SA8000 Standard and Certification System provides a platform for organizations of all kinds, in virtually any market, and in almost any state to conduct business in a means that is fair and adequate for workers and also to show their adherence to the greatest social standards. 

Made by SAI in 1997 as the first credible societal certification, it has caused the business for more than 20 years.

CMMI: is a process-level improvement training and Evaluation program. Administered by the CMMI Institute, a subsidiary of ISACA, it was developed at Carnegie Mellon University (CMU). 

It’s demanded by several U.S. Government Contracts, particularly in software development. CMU asserts CMMI could be used to direct process Improvement across a project, division, or a whole organization. 

CMMI & ISO 13485 Certification in Kenya defines The next maturity levels for procedures: Initial, Managed, Defined, Quantitatively Managed, and Optimizing. Version 2.0 was published in 2018 (Version 1.3 was published in 2010, 

and it that is still the reference model for its Remaining information within this wiki essay). CMMI is registered in the U.S. Patent and Trademark Office from CMU.

Why Choose Factocert For ISO 13485 Certification in Nigeria?

To be able to implement this ISO 13485 Certification in Nigeria standard complete International standards required to go With the expertise that has subject Knowledge on these worldwide standards. Thus, Factocert is just one of those Dominant leading Consulting companies that consist of those types of Expertise and provide associations with the best answer.

Back to particular Not only does the implementing and consulting part but also, it also provides the Certification and third-party audit services of International standards and we Constantly guarantee that the customers are satisfied by our solutions provided during the Consulting methodology. And also to learn more about our consulting and services Methodology please do visit our site we would be Very Happy to help you

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To accumulate ISO 13485 Certification in Nigeria, interact with Factocert ISO professionals. The manual groups enforce high-quality control systems for medical gadgets, ensuring compliance with ISO 13485 requirements. Factocert streamlines the certification system, promoting excellence within the healthcare enterprise.


The fee for ISO 13485 certification in Lagos varies primarily based on elements like corporation period, complexity, and the selected certification frame. Factocert ISO 13485 Consultants in Lagos can provide tailor-made costs, ensuring charge and effectiveness on sesame and providing seamless certification for corporations.

ISO 13485 certification in Nigeria, is critical for groups concerned with scientific device manufacturing corporations. It ensures compliance with global necessities, enhancing product quality and safety and demonstrating a determination to meet regulatory necessities within healthcare.

ISO 13485 audit services in Nigeria are essential because if you’re facing the ISO 13485 auditor in Nigeria you have to be very careful about every parameter in your organization but when you join hands with Factocert. We as an ISO 13485 Consultancy Service in Nigeria, are tagged up with so many different ISO 13485 certification bodies in Nigeria.

Benefits of ISO 13485 Certification in Nigeria

You will have the edge over your list of ISO certified companies in Nigeria.

Marketing becomes very easy when you have ISO 13485 certification in Nigeria tagged on to your name and which will help you to get into a global market and be a global player.

Employee satisfaction rates increases which are directly proportional to your employee retention and by retaining your critical employees you will have higher stability as a company​

A government will recognize you for having such ISO 13485 certification in Nigeria

You will be automatically qualifying for any tenders because most of the companies require you to certify for ISO 13485 certification in Nigeria for participating in tender

Customer satisfaction rates will go high, and you will not have to face any more consequences from your customers or your vendors​

Are you looking for

ISO 13485 Certification Consultants in Nigeria

What else are you waiting for the only step you have to take care of is getting in touch with us, and we would take the best care, and in no time you would be certified for relevant ISO 13485 certification inNigeria you prefer. Most thing companies worry about is ISO 13485 service cost in Nigeria but let us just tell you that ISO 13485 Consultant in Nigeria is not what you should be thinking of because when this certification can give a boost to your organizations’ process. We will make sure that the cost of ISO 13485  Certification in Nigeria is as minimal as possible.

To get you ISO 13485 Certification Services in Nigeria than we assure you 100% guarantee results and we ensure that you will definitely be certified because have 100% success rates to date in getting our customers certified. So get in touch with us as early as possible and get your ISO 13485 certification in Nigeria at the earliest.

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