Introduction to ISO 13485
An international standard ISO 13485 is specifically developed to establish, monitor, maintain, manage, and continually improve the quality of medical devices and equipment. This standard specifies requirements for quality management systems particular to medical devices. It ensures the organization to meet applicable legal requirements. However, the requirements of the ISO 13485 are applicable to all organizations that manufacture and deliver medical equipment. Also, this standard applies equally to the organizations that provide associated services.
About IAS – An accredited ISO 13485 certification body in Nigeria
Integrated Assessment Services (IAS), one of the recognized ISO 13485 certification bodies in Nigeria! We deliver ISO 13485 certification service not only in Nigeria but also in various African countries such as Ghana, South Africa, and so on. IAS also has numerous branches and representatives across the world including India, Malaysia, Singapore, Bangladesh, Gulf, USA, etc.
We have an excellent team of auditors who have years of professional experience in real-time auditing to support the organization in the effective implementation of the desired standard’s requirements and specifications.
Other than auditing and issuing the ISO 13485 certification, we also perform as a consultant to help our clients to design a well-developed management system.
Why ISO 13485 Certification?
By implementing the requirements of the ISO 13485:2016 certification standard, an organization can obtain the following benefits.
- Guarantees the high-level performance of the medical laboratories
- Improves customer satisfaction
- Enhances clients’ confidence
- Develops organization’s reputation
- Also, promotes the corporate image of the organization
Steps to contact IAS in Nigeria
- Make an enquiry through our website
- Drop us a mail to firstname.lastname@example.org
- Fill out the application form in our website and send us
- You can also contact us directly and have free discussion about ISO 13485 certification and auditing process
Highlights of our ISO 13485 certification process:
- Certification audit
After receiving the application, our team will review and initiate the audit procedure. Normally, the ISO 13485 Certification audit includes 2 stages such as readiness audit and effectiveness audit. Our auditors will give you the audit report with effective implementation and also we support you to improve the non-conformities. Finally, IAS will issue the ISO 13485 Certificate.
- Surveillance audit
IAS also conducts a surveillance audit every 12 months to maintain the high-level performance of the management system.
- Re-certification audit
We also conduct a re-certification audit, if the validity of the initial certification is over. This helps the organization to continually improve the management system and its techniques.
Want to know more details about ISO 13485 Certification and its specific auditing process? Feel free to call us!