ISO 13485 Certification

What is ISO 13485 Certification?

ISO 13485 is a set of standards that provides a framework for the quality management systems (QMS) for medical devices.

The ISO 13485 certification makes it easier for the designers, manufacturers, and suppliers of the medical devices to demonstrate compliance with the regulatory requirements and build confidence among the stakeholders about averting any risks. ISO 13485 emphasizes on risk-based thinking as well as stronger involvement at all levels.

What is the purpose of ISO 13485?

There are certain regulations of the land that are needed to be adhered to for the demonstration of commitment to the safety and quality of medical devices. Hence, with the adoption of ISO 13485, the manufacturers can become compliant to regulations such as, the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations.
By identifying the customer’s requirements for QMS, and with the management support, you will need to begin the documentation of quality policies, quality objectives, and quality manual. These define the overall scope of your quality management system you will also need to create additional processes along with mandatory procedures for your organization to realize the desired outcomes.

Is ISO 13485 Certification mandatory?

Although none of the ISO certifications are mandatory, but ISO 13485 certification id usually demanded by the customers because of its ability to provide assurance of safety. By implementation of this standard, the process of manufacturing can meet the international criteria. This not only helps in implementation of the quality management system for medical devices, but also enables compliance to various legal and statutory requirements. By applying ISO 13485 standard in your organization, you also become compliant to the EU MDR regulation. It is also helpful if your organization goes for the CE mark for the products. For all such compliances, getting ISO 13485- Quality Management System for Medical Devices becomes very important.

Requirements of ISO 13485:2016

ISO 13485:2016 is the only standard that proves compliance with the regulatory requirements for quality management systems.

Following are the ways through which you can establish quality management system for your medical devices.

  1. Distinctly define quality policies, goals, and hierarch in your organization.
  2. Detailed description of the processes in your organization, which should cover the following requirements:
    • Development
    • Production
    • Service delivery
    • Risk management
    • Document control
    • Internal audits
    • Management reviews
    • Corrective and preventive actions
    • Handling of resources (human resources, infrastructure, equipment, locations)
    • Communication with customers
  1. Appropriate allocation of financial and human resources, including a quality management deputy.
  2. Follow the processes in order to achieve your objectives and maintain proper documentation.

Benefits of ISO 13485 Certification:

  1. Global Recognition & Financial Benefits
  2. Improved satisfaction of the customer
  3. Increased effectiveness through improved processes.
  4. Better decision making by involving the top management.
  5. Better involvement of the workforce.

Enroll yourself on our training courses and gain the confidence to assess your knowledge and competency against the quality management systems (QMS) for medical devices – ISO 13485 international standard. This will enable you to plan an audit and conduct it in accordance with ISO 19011 (and ISO 17021, where required). This training is relevant for medical devices quality professionals, who are interested in conducting first-party, second-party or third-party audits. It is also relevant for management representatives, quality directors, engineers, consultants, and so on.

What are the prerequisites for the training?

It is very important for the interested candidates to have a basic idea of the following management principles before enrolling themselves in ISO 13485 management training courses:

  • The Plan-Do-Check-Act (PDCA) cycle.
  • The relationship between quality management an customer’s satisfaction.
  • Common jargons of the quality management.
  • Model of the process-based Quality Management system and structure of ISO 13485.

1. Internal Auditor Training

Internal auditor course is designed to train the candidate on the required standard.

The training includes a class room session, which normally of two days, and includes:

  1. A group exercise, and
  2. Some practical illustrations

How is the training helpful?

  1. It helps the candidate to understand the need of the standard and perform the audits in a systematic manner.
  2. It helps the candidate to perform the internal audits and manage the audit plan in accordance with the relevant certification.

The structure of the course:

  • Introduction to the relevant standard.
  • Introduction to audits, definition and types of audits.
  • The planning and preparation for internal audit
  • Individual and group exercises
  • Taking the internal auditor test.

What will you gain?

At the end of the training the candidate shall get the training certificate which will be internationally acceptable.

2. Lead Auditor Training

What is the training about?

  • This training includes in-depth knowledge of the relevant standards.
  • Lead auditing can be performed on the concerned organization as well as the certification body.

How is the training helpful?

  • Lead auditor training helps the candidate to gain knowledge and skills to perform the audits as per the relevant standard.
  • It also helps the candidate to enhance their practical knowledge of auditing skills and become internationally recognized auditor.

Structure of the training:

  • Lead auditor registration scheme
  • Structure & Overview of the ISO Standard
  • Audit definition/types/principles
  • Audit Planning & preparation
  • Audit Tools & Techniques
  • Audit Performance
  • Recording & Reporting Non Conformities
  • Audit report preparation
  • Corrective Action & audit follow-up
  • Surveillance audits
  • Continuous Assessment exercises & feedback,
  • Syndicate & role play exercises & feedback
  • Written Examination

At the end of the training the candidate shall get the training certificate which will be internationally traceable.

2. Awareness Training

What is it about?

  • Awareness training on any ISO Standard helps the candidate to understand the basic requirements of the standard.
  • It helps the candidate to choose the right direction to implement the standard in his organization.
  • It also helps him to choose the right certification body or industry to move in his career or get his organization certified.

WHY CHOOSE US?

  • Kingsmen Consulting Services helps the candidate to understand more than what is there in the standard.
  • We also help the candidate to choose the right path for his career and for his organization.

The candidate gets to know the importance of the standard in day-to-day life during his period of employment in the organization or while deciding to choose his career. It helps in remaining competitive in several areas, including the process improvements and operational efficiency.

The course consists of:

  • The basic knowledge of the requirements of the standard.
  • Interactive exercises to enhance instructional delivery

At the end of the training, the candidate shall get the training certificate which will be internationally acceptable.

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