ISO 13485 Certification - QMS Consultant For Medical Device ppt
                     ISO 13485 
CERTIFICATION - 
QMS CONSULTANT 
FOR• Inpat ienMt Suites• Diagnostic EDICAL 
Centers
DE•VSurgiIcaCl Theaters• Emergency CaEre Unit
• Specialized 
Treatment Areas
OPERON 
STRATEGIST
What is ISO 
13485 
ISO 13485 is a certification that sets forth the standard 
Cof emedricatl dievfiicesc. Saafetyt animportant, especially in the casid quality assurance is e of mnedic?al equipment. 
To that end, prove that your medical devices fall to the 
right standards with ISO 13485 certification. 
The international standard EN ISO 13485 forms the 
basis for the certification of quality management 
systems in companies that manufacture, distribute, and 
are involved in any life cycle activities of medical 
devices.
6 Steps To Obtaining ISO 13485 
C1.Uendretrsitafindc thae Sttainodanrd  
2.Conduct a Gap Analysis 
3.Develop a Quality Manual 
4.Implement the Medical Device Quality Management System 
5.Conduct ISO 13485 Internal Audits 
6.Obtain Certification
What Is the Difference Between ISO 13485 and EN ISO 13485?
ISO 13485 is the internationally recognized basic version of the 
standard, it has been harmonized/recognized for its consideration in 
the implementation of the regional regulatory approval procedures 
like EN ISO 13485, ANSI ISO 13485, and IS/ISO 13485 for India. 
By complying with a harmonized standard, a manufacturer can 
prove that its products or services comply with the technical 
requirements of the regional legislation. 
Also, read the difference between 21 CFR 820 and ISO 13485:2016
Benefits of ISO 13485:2016 Certification
• Improves the company’s credibility and identity 
• Evidence-based decision making 
• Continual improvement in product process and quality 
• Increased employee involvement. 
• Enhanced customer satisfaction. 
ISO 13485 is a Non-personal Standard 
ISO is a non-personal standard. An individual cannot get certified to ISO 
13485 standards. Only an organization or a company can become ISO-
certified. However, there is a provision for an individual to gain the ISO 13485 
certification. He can obtain an ISO 13485 Certification as a Lead Auditor after 
a 5-day training course. With such a certificate, he or she can audit other 
companies. 
To become ISO certified, your organization must conduct the following 
operations: 
• Implement an ISO 13485 standard’s QMS 
• Further, the Certification Body or a Registrar audits the performance of 
the organization as per the latest version of ISO 13485. 
• If the applicant passes the audit, the Registrar issues the ISO 13485 
Certificate. This certificate demonstrates the organization has been 
registered to ISO 13485 for the next three financial years. 
• The ISO-certified organization must re-certify every three years to 
maintain the ISO certification. 
Eligibility Criteria for ISO 
13485 Certification in 
IBenfore applying for ISO 13485 Certification, you must adhere to the pointds sipaecified in ISO 13485 standards. For that purpose, you need 
to train your organization as per this standard. 
ISO 13485 Certification Requirements
• Identify and adopt a risk management approach to product 
development and product realization. 
• Creation of QMS Manual, Processes, Procedures, Formats/Records. 
• Creation of Medical Device Master File. 
• Analysis of the validation of processes and procedures.
Operon 
FoSr morte inrformaationt aboeut Megdical Device Regulationsplease feiels free to contact: [email protected]
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