3 Things to Know When Transitioning to the ISO 13485 Standard



While quality assurance is a non-negotiable concept for medical device manufacturers, the ISO 13485 standard is the specific standard for medical device quality management systems.  The standard helps medical device organizations to manage the design, development, manufacturing, installation, repairing, maintenance, and sales of the medical devices. The standard specifies the requirements for establishing the QMS (Quality Management System) which encompasses the processes of medical device manufacturing and ensures that customer expectations and product regulations are met. Regulatory requirements for medical devices are also increasing often to enhance product safety because of growing public scrutiny. ISO 13485 also has gone through several changes throughout the years with the latest update completed in 2016. 

If you have a medical device manufacturing organization, then you should learn about the necessary changes introduced in the latest version, which are intended to strengthen the regulatory quality requirements, as well as how to go about updating to ISO 13485:2016, and the benefits that will follow. 

 

3 Points to Know when Transitioning Your Medical Device QMS to ISO 13485: 2016

Changes Made in the Standard

The new version of the standard promotes greater safety and quality assurance in the products by incorporating the following changes:

• More requirements emphasizing medical device patient safety, usability, and performance

• Higher emphasis on regulatory requirements 

• Applying risk management to all key processes including design, development, manufacturing, and supply chain activities

• Special emphasis on specific requirements for validating processes such as sterilization, contamination, and other controls

• Stronger management of customer complaints and surveillance of post-marketing activities aligning with regulatory requirements

• Significant focus on understanding the product quality attributes and the manufacturer’s understanding of them

Procedure of Transitioning to ISO 13485: 2016

Most medical device manufacturing organizations already have a QMS in place or have it implemented according to the earlier version of the ISO 13485 standard.  To transition it to the new version, you need to conduct a gap analysis. It helps in identifying the procedures of your QMS which fail to meet the current version’s requirements.  The gap analysis is useful to find out inefficiencies in your existing procedures and decide actions to improve them.  Using the findings of the gap analysis, you need to prepare a plan of action specifying what changes are to be made in the QMS for mending the gaps.   Some of the key details to include in your action plan are:

• Required time and necessary resources to allocate for carrying out the changes 

• Responsibilities or tasks of the employees the transition process

• Time needed for training the staff about the changes and how to adjust their QMS with them

  

Benefits of ISO 13485: 2016 Standard to Medical Device Organizations

Medical device organizations need to consider the ISO 13485 standard to deliver best quality products, ensure higher customer satisfaction, and meet regulatory requirements.  However, there are more benefits beyond that including:

• Improved ability to win supply contracts with larger companies and health services providers

• Improved efficiency of internal processes that saves costs by preventing errors 

• Greater control on product design and development processes of medical devices, which ensures transparency and results in product safety

• The revision of the standard helps manufacturers to better realize the risks to the medical devices, their quality, and processes of manufacturing

 

Key Takeaway!

The ISO 13485 standard lays down the practical foundation for manufacturers to address the medical device specific regulations and demonstrate their commitment to providing safe and quality devices. If your organization already has a QMS or has an earlier version implemented, then transitioning to the ISO 13485: 2016 version is necessary to strengthen your quality compliance. You just need to review your existing QMS and update it to support the new requirements. 

Contact Details:

Business Name: Compliancehelp Consulting, LLC

Email Id: info@quality-assurance.com

Phone No: 877 238 5855

Also Read: Learn the Purpose of Quality Management in Healthcare


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