ISO 13485 Implementation and certificate of the quality management system
for manufacturers of medical devices
How to get ISO 13485 certificate
Nothing simpler! To enjoy having this certificate, you have to fulfill requirements of ISO 13485 standard. How to achieve that? Do you have questions? – Contact us and we will advise you for sure.
Our Institute help organisations to implement ISO 13485 through: free pre-audit, free quotation of implementation and certification, system implementation, training for representative and auditors, audits which will prepare organisation to certification.
After finishing of our activities we will give you the guarantee for positive certification of ISO system. Due to the specific language of the standard, we can also assist during certification.
ISO 13485 and ISO 9001 standard
The quality management system according to ISO 13485, in the main assumptions is identical to the quality management system according to ISO 9001. It can be concluded that ISO 13485 is a development of the requirements of ISO 9001 in the field of design, production, confectioning and import of medical devices. Originally, the ISO 13485 standard was a supplement to the ISO 9000: 1994 series, and not an independent standard.
Having a quality management system compliant with ISO 13485 is identical to having the ISO 9001 quality management system. Unfortunately, it does not work the other way.
However, if you have ISO 9001 certification, which works correctly in terms of quality assurance, then its development in order to meet the requirements of ISO 13485 will be an easy and pleasant task.
ISO 13485 Certificate
Certification to ISO 13485 is exactly the same as in the case of ISO 9001, but auditors are trying to be more thorough. The audit time and the cost of the audit is usually twice as high as in the case of ISO 9001. It is important to properly select the certification body depending on whether it must be accredited or not.
ISO 13485 ma nam przynieść określone korzyści, a nakłady jakie ponosimy mają się nam co najmniej zwrócić!
ISO 13485 is supposed to bring us certain benefits and the expenses we incur are expected to be returned at least!
Requirements of ISO 13485 standard should be adopted to conditions of your organisation!!! And not the company to requirements of ISO 13485 system!!