The purpose of this service is to assist in ISO 13485 certification process. ISO 13485 Certificate is an important Certification required by the manufacturers, designers, suppliers, distributors, and service providers of all medical devices including in vitro devices (IVDs).
The regulatory body involved in the process is the Accredited Notified Body. The following procedure needs to be followed to avail the ISO 13485 certificate:
The Designers, manufacturers, suppliers, service providers, and distributors of IVDs can apply for the ISO 13485 certification.
|Applicant must define the scope of the ISO 13485 Certificate, which will mention the objectives and scope of the certificate.|
|Applicant must select the notified body|
|Applicant must establish a quality management system|
|Applicant must work according to the established quality management system|
|Prepare for the audit|
|Get audited by the Accredited Notified Body. The notified body will audit the company for two to ten days, depending on the size of the organisation. The organisation will obtain the certificate(s) if it passes the audit.|
The validity of the ISO certificate depends upon the notified body.
6 to 9 months
The following tips will be beneficial during the application process:
Applicant must establish Quality Management System before the certification audit
Applicant should ensure every stakeholder is trained
Preliminary internal audit must be performed before the external audit to ensure the training efficacy. The following problems can be faced during the process, and must be avoided by good mock audit and thorough training:
Lack of adequate resources
Lack of qualified resources
A compliant culture of laxity
Experts at CliniExperts provide the following advice: Management team and seniors should thoroughly review the quality management system for any loopholes and try to overcome them before the actual audit.
The team should work according to Standard Operating Procedures and WIs
Applicant must ensure external suppliers should be audited
All computerized systems should be validated
No. ISO 13485:2016 does not demonstrate compliance with GMP. They are separate requirements.
The ISO 13485 certificate is essential to implement a Quality Management Systemto achieve a high level of control, focus on safety, and tough requirements and standards that can benefit the manufacture of IVDs or its components.
No. The ISO 9001 certificate is not enough to establish a certified QM System an ISO 13485 certification is required to prove compliance with regulatory requirements of medical devices
The latest revision of ISO 13485 for QMS in IVDs companies is available from March 2016.
Yes. The ISO 13485 isestablished explicitly for companies working in the IVDs field.
There are no special requirement of testing , but standards must be met.