ISO 13485 certification in Nigeria is an important certification standard to improve the quality standards followed by the industries and organizations. Nigeria belongs to the west Africa. It is often referred to as the Giant of Africa, owing it its large population and economy. It is the seventh most populous country in the world and 20th largest economy in the world. It is classified as mixed economy emerging market. From only exporting it’s natural resources and raw materials growth of industrial sectors and organizations have made some remarkable changes by manufacturing and exporting the ready goods. Nation in abundant in natural resources. Oil, overseas remittances, Service based organizations, mining, manufacturing are the major source of GDP. ISO 13485 in Nigeria is a must and should standard certification to gain potential stability in the emerging medical device marketplace.
What standard is all about?
Any part of the world, major importance are given to two factors. One is education and another is Medicine. And also these two domains are the big business sectors in the market today. But then medicines and related services are very critical as it directly related to welfare of human society. ISO 13485 certification consultant in Nigeria is the best possible solution for an organisation involved in complete cycle of medical devices manufacturing and related service. Its requirements are quite simple that quality management system and other technical requirements related to the medical equipment and medical devices manufacturing and other related services. ISO 13485 consultant in Lagos can implement the standard at its best. Establishes a Framework for an organisation to effectively manage the quality and the safety of the Medical components weather related Medical Services. ISO 13485 consultant service in Ibadan could show path for successful implementation. Consequences of non compliant with the medical related directives and other regulatory and statutory requirements will lead organisation into a penalization and the penalty will be huge.
Quality and technical documentation requirements:
- Classify the devices: The first job of Technical filing is classifying the devices or equipment that are manufactured by the organisation. A medical device manufacturing industry will not have single equipment manufacturing which is produced in massive quantity.ISO 13485 consulting service in Kano van help in classification. There will be many class of products produced and every products should be classified to the belonging category and filed.
- Conformity document: each and every product again classified and filed in a document should the given with reference regulatory directives related to medical directives. The conformity document should comply with the ISO 13485 audit in Nigeria and other applicable medical directive regulatory standard.
- Description of the product: Each category of the product should contain technical documentation of describing the product specification and the class it is been categorized ISO 13485 certification audit in Benin city can help you with the entire process. The descriptions of file should contain the data such as manual on how to use a product or equipment its name, its number, its code and everything has to be disclosed in the document.
- Defining the procedure for each product category: Defining the procedure not only defines on how to the product has been manufactured but also streamlines the process performed internal to the organisation. Deep briefing about test product in the form of a procedure helps in many ways. ISO 17025 certification bodies in Nigeria can help your organization certified. It also helps in curing the awareness about the product to the newly appointed employee which helps in training them and also briefing about the product to the customers, interested parties and stakeholders.
- Specification of the product: This is a requirement which rather goes deep into the dimensions of the Medical product being manufactured.ISO 13485 audit service in Nigeria is an helping hand. This document should contain the critical dimensions of the product comma material specifications, manufacturing specifications.
- Service and installation procedure: this specification is very specific and exclusive only two few of the product categories. This file should be maintained only for the weak wire requirement for the peculiar product or service. It should contain the technical documentation and procedure of installation and service being delivered by the manufacturer or service provider.Cost of ISO 13485 in Nigeria is a pretty good investment for long term benefits. It should contain the steps for installation and it has to be recorded in the form of a document and also the time frame for maintenance, repairs and servicing the product on a regular basis.
Of course the advantages of the standard are enormous for the organisation involved in manufacturing and other related activities of medical devices.One should be wise enough to extract all the benefits out of it. ISO 13485 certification cost in Nigeria is worth investment walking your organization towards success.
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