Benefits of ISO 13485

Implementing ISO 13485 will have many benefits for your organization. Although changes in your QMS will take immediate additional energy, the results of having an ISO 13485 quality management system will provide you with many benefits in operations, sales, and customer satisfaction.

Why Achieve ISO 13485 Registration?

Global Recognition & Financial Benefits

ISO 13485 is recognized by the Global Harmonization Task Force (GHTF) and has become the model QMS standard for the medical industry, and in major markets around the world.  

A well-run operation with processes under control leads to financial rewards for your hard work and investment in the Quality Management System.  It has been observed that QMS certified companies have shown improvements in financial performance as compared to uncertified ones.  An ISO 13485 QMS can help an organization:

• Meet legal, regulatory, contractual and marketing requirements
• Improved product safety
• Although not fully harmonized, an ISO 13485 Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards
  (Read More – Harmonizing ISO 13485 and FDA QSR 21 CFR 820)

Increased Customer Satisfaction

Many organizations decide to implement ISO 13485 and obtain registration because it assures customers that the company has a good Quality Management System (QMS). An organization with an effective QMS will typically meet customer expectations better than an organization that does not have one.  This is because the Goals and Objectives of the QMS take the customer needs into account.  As goals focus on the customer, the organization spends less time focusing on individual goals of departments and more time working together to meet customer needs.

Internal Effectiveness through Process Improvement

ISO 13485 emphasizes audit processes, management review and improved processes based on collected data. Using facts and a system of documentation and analysis, improvements are carefully planned and implemented. This ensures that the best decisions are made for your company, which leads to better operations, improved performance, and improved profitability.

Improved Decision Making & Involvement of Top Management

With the QMS in place and working for you, the organization is focused towards the Quality Goals. Management is provided with data on a continual basis and able to see progress or lack of progress towards goals and take appropriate action. The organized, scheduled process of conducting Management Reviews (Clause 5.6) ensures that this evaluation takes place. It provides the mechanism of reviewing performance against goals on a scheduled basis, and for taking action based on the evaluation.

Because of the requirements addressed in the Standard, organizations often see an increased involvement of top management with regards to the Quality Management System. This starts with the setting of the Quality Policy (Clause 5.3) and Quality Goals and Objectives. It continues with Management Review looking at data from the QMS, and taking actions to make sure that Quality Goals are met, new Goals are set, and continual improvement is achieved. The quality policy also ensures that corrective action is taken whenever defects occur.  

Increased Employee Involvement

Section 6.2 of ISO 13485 requires that employees understand their role in the QMS.  With improved training and qualification of employees, productivity and involvement increase. Better documentation or control of processes leads to consistency in performance, and less scrap and rework. Managers experience fewer late-night troubleshooting calls; employees have more information for troubleshooting problems on their own, and new employees are able to find information they need to follow processes. ISO 13485 creates a work atmosphere that is open to feedback and idea sharing, allowing employees the chance to provide their thoughts on current processes.

Make your QMS beneficial for your business

While it is easy to see the benefits when implementing ISO 13485, it is important to remember that your Quality Management System will only return what you put into it. The standard tells organizations what needs to be implemented, but not how to implement it. As an organization, you must define your scope and tailor your QMS to suit your needs. So work with enthusiasm and optimism knowing you are contributing to the future success and profitability of your company.