NoBoMed Zrt. is a certification body accredited according to standard MSZ EN ISO 17021-1:2016 and its scope is the management system certification of manufacturers of medical devices according to standards MSZ EN ISO 9001:2015 and MSZ EN ISO 13485:2016. Certification activity is performed by highly trained, competent auditor personnel.
What is the task of a certification body?
The certification body is an independent, accredited body by an authority and that performs certification activity, and it issues a certification at the end of such successful procedure based on the conformity according to the requirements of different standards. Task of the certification body is to inspect the compliance according to the given standards. If the company and the quality management system that is to be certified conforms the standard requirements by the results of documentation evaluation and audits, the certification body issues a certification that validates the compliance.
The certification bodies of quality management systems relating to medical devices are under regular inspection, surveillance themselves. This ensures the continuous reliability and competence, because during their activity they perform a task delegated by an authority which aim is that only the medical devices conforming all the relevant aspects can reach the users. Therefore, they must conform the ethical norms of independency and impartiality on the highest level.
For maintaining the independency and objectivity, certification bodies must not take part in any way in the operation or decision-making process of the companies that take the services of a certification body.
Process of certification
The certification body receives, processes and evaluates the clients’ requests for certification. This includes the preparation of a price offer based on the data given on the downloadable request form. If necessary data for the price offer is missing, the certification body will ask it from the inquiring company.
After the acceptation of the price offer from the client’s side, a contract is signed from both the client’s and the certification body’s side according to the data presented in the price offer.
The certification body performs the audit in two phases: phase 1 and phase 2, this is also knowns as on-site audit. During phase 1, the certification body performs a preliminary documentation evaluation in order to decide whether the quality management system of the client has been designed and operated accordingly and it is matured enough for the performance of the on-site audit.
Performance of the on-site audit is based on an audit plan according to the determined parameters (place, time, position etc.). The audit team makes notes about the on-site audit, they are searching for and documenting the objective evidences of conformity. If a nonconformity is detected, they inform the client about it on-site and prepares a report about it. The audit closes with a closing meeting and audit closing report.
After phase 1 of the audit, an evaluation documentation form is prepared by the certification body in which the results of the evaluation of the documentation and possible gaps are summarized and they are fixed in a list form with the qualification “conforms” or “does not conform”. Phase 2 of the certification process can be initiated according to this document.
If the clint’s quality management system conforms the requirements of the relating standard, the certification body issues the certificate after a final consultation with the client. This is a written evidence that the quality management system of the client conforms the requirements of the standard of certification.
The certification body regularly inspects its clients in the framework of surveillance audits in order of the continuous and conforming maintenance of the quality management system and the completion of standard requirements.
What does ISO 17021-1 standard mean?
MSZ EN ISO 17021-1 is a standard relating to certification bodies. This standard determines the requirements and policies for the accredited certification bodes to perform a certification process. Standard describes in details the certification processes, the decision-making processes and the content of the reports. This standard essentially manages and regulates the certification bodies in order of ensuring independency, objectivity, impartiality and professional competence during the certification processes. Standard MSZ EN ISO 17021-1 ensures that certification bodies to be reliable and professionally competent in the performance of certification processes. This contributes to the reliable qualification of the clients and to gain the clients’ and market members’ trust.
What does ISO 9001 standard mean?
ISO 9001 is an international standard developed by the International Organization for Standardization (ISO) and which relates to quality management systems. Aim of ISO 9001 is to determine the relating requirements of quality management for a company and to help them gain their clients’ trust. ISO 9001 is a standard that can be certified independently and that has three main pillars: continuous development, customer focus and documented processes. Establishing a quality management system according to ISO 9001 helps the companies to make their business processes more effective, to decrease their mistakes, to continuously improve the quality and to increase customer satisfaction. Certification according to ISO 9001 is issued by an accredited certification body after the company has successfully completed a certification audit relating to this standard and verified that they conform the requirements of standard ISO 9001. ISO 9001 is an international standard and it is applied in many industries all over the world.
What does ISO 13485 mean?
ISO 13485 is an international standard relating to the quality management systems of medical devices. This standard guides the manufacturers and service providers to design and maintain their quality management systems on the field of medical devices. ISO 13485 emphasizes the insurance of quality in every phase of product development, design, manufacturing, setup, sales and service activities during every phase of the lifecycle of medical devices. Application of ISO 13485 promotes the completion of legal requirements, increase of product safety and effectiveness and continuous development of the processes and quality for manufacturers and service providers. Certification according to ISO 13485 can be issued by accredited certification bodies as a result of a certification audit performed according to the requirements.