A Detailed Insight into ISO 13485 Certification & R2 Standard

This article discusses ISO 13485 and R2 Standards that can help medical device and electronics industry in many ways.

Do you really need to maintain a set of quality assurance standards? Yes, you do! If you want to achieve all of your business goals, you should achieve high levels of quality first. Quality leads you to the valuable ISO certification. This certification acts as a hallmark of your products and services. Gone are those days when quality assurance was considered as an added value; these days, it is a mandate for every industry. Perhaps, this is the reason why every company is running after ISO certification. This certification does not solely relate to the services or products offered by your organization, it also investigates the way your employees process the services or products. In this article, we are going to delve into the details of two generic standards- ISO 13485 certification and R2 standard.

ISO 13485

ISO 13485 is a set of requirements suggested for maintaining a quality management system. This standard helps an organization demonstrate its competence to provide medical devices and similar services related to medical equipment so that the organization can let their customers know about their consistency and efficiency. The prime aim of 13485 standards is to facilitate the medical device related regulatory requirements for the quality management system. In turn, it includes certain requirements for medical devices and discards some of the requirements of ISO 9001 that do not fit well into this particular industry.

Due to these exclusions, businesses whose quality assurance systems adhere to the ISO 13485 standard cannot claim compliance with ISO 9001. They will be able to claim the conformity only when they will meet all the requirements of ISO 9001. In this context, it is important to note that all the requirements of ISO 13845 have been designed only for the organizations that provide medical devices or offer services related to medical devices. No matter what is the type or size of the organization, it must obtain the ISO 13845 certification when it deals with medical devices.

A Checklist of documents required by ISO 13845

• Roles initiated by the organization under applicable regulatory requirements
• Procedure and records essential to validation of the software applications
• Quality Manual
• Quality Objectives
• Quality Policy
• Medical Device File
• Procedure for document control
• Authorities
• Training Procedures
• Responsibilities
• Management Procedures
• Management Records
• Infrastructure Requirements
• Maintenance Activities
• Work Environment Requirements
• Arrangement for Controlled Contaminated
• Risk Management Process
• Product Realization plan and Outputs
• Customer requirements and Reviews
• Design and Development Process
• Design and Development Output
• Design and Development Review
• Design Verification Plan, Results, and Conclusions
• Purchasing Process

There are many other documents that an organization should submit for ISO 13485 certification. It is important to keep all of these documents ready before the auditors during the final assessment.

R2 Standard

As per a number of surveys, 20 to 50 million tons of electronic wastes were produced in the year 2007. You would be surprised to note that the United States alone was responsible for generating three million tons of electrical wastage in the same year. This shocking revelation has made both the corporations and the consumers more conscious of the idea of recycling that can protect the environment. The Responsible Recycling Standard or R2 certification has been introduced to address this particular concern. A group of recycling stakeholders developed this set of standards. EPA facilitates this particular standard. This set contains certain voluntary principles and guidelines that can assess and promote responsible exercises and activities for electronics recyclers.

R2 demands the implementation of a management system that can be accountable for those practices, which can affect the health of the workers and their safety and security. This certification examines the domestically and internationally downstream management, quality, and durability of electronic equipment etc. Instead of replacing the legal obligations of electronic recycling, the standard covers all the existing legal obligations related to recycling of electronic materials and equipment.

Some of the key benefits of R2 standard

• Promotes safety
• Encourages effective recovery
• Emphasizes reuse or electronic equipment
• Protects downstream control of the recycling chain
• Reduces environmental risks
• Minimizes public health risks
• Establishes compliance with national and international laws
• Minimizes the recycler’s liability and insurance costs
• Helps the original equipment manufacturers regarding their end-of-life electronics
• Instils public confidence through certified third-party review

Implementation of the R2 standard is beneficial for both the humankind and the environment. It can serve as an effective business strategy as it is able to attract the modern consumers who are concerned about the surrounding environment.

Though ISO 13845 and R2 are two entirely different standards that serve two different sets of purposes, one thing is common between the two. Both of these two standards help the organization win their clients’ trust. By implementing these standards, the companies can build their brand image and establish credibility in their respective industries. Moreover, these quality assurance standards attract potential customers and stakeholders.