Step-by-Step Guide to ISO 13485 Certification

This article sums up the process of achieving ISO 13485 certification step by step for medical device manufacturers. Read on if this applies to you in order to understand where your manufacturing unit stands and how to start getting certified.

Medical devices are perhaps the most crucial category of products that serve humanity and contribute to improving quality of life! Hence, any medical device manufacturer must make the quality and safety of their products their first priority. They should have a quality management system (QMS) that will consistently regulate their products and help meet customers’ needs. With an ISO 13485 certification, most medical supplies providers are able to comply with essential quality and safety regulations. It is also a way to demonstrate their ability to provide high standard products that assure quality care and treatment.

ISO 13485 is also used by external parties or services providers of medical devices who follow a QMS to ensure their supplied services or products and reliable. In short, the certification demands development of a QMS that will regulate every aspect of medical device manufacturing, including all stages of the product life cycle. How do you make your medical device manufacturing eligible for and achieve the certification? Learn here about the mandatory steps for certification and make your medical manufacturing firm ready as quickly as possible.

Step 1: Planning for QMS

A section of ISO 13485 standard outlines the requirements of QMS which is a way to thoroughly manage the production processes of medical devices or equipment. Writing or documenting the QMS is the first step to planning for it. By analyzing all basic gaps or irregularities in your existing quality system, you can prepare a modified and more comprehensive QMS that will address everything from designing, development, manufacturing, packaging, storage, and distribution. It should be able to assess and take care of associated infrastructure, materials, and technical support equipment that will be used in production.

Step 2: Meeting ISO Requirements

Just after completing the planning, the next step is meeting all regulatory requirements of ISO 13485 standard in QMS for compliance. Any medical device company also may also want to comply with general quality requirements specified ISO 9001 standard. At this step, you should consider chatting with some expert ISO consultants who will interpret all requirements/regulations with you and will guide you in incorporating them into your QMS.

Step 3: Implement Design Control

Most medical device producers already have design controls to ensure that every aspect or attribute of products is designed with utmost authenticity and with limited risks of failing the end product. Implementation of design controls means regulating the pathway of a device to ensure it gets approved and meets user needs. From design planning to design inputs and outputs, design verification to design reviews, controls are included in all aspects for clinical safety of devices or products. Implementing design controls also includes risk analysis, initial hazard identification, risk classification, and clinical evaluation for regulatory approval of final products.

Step 4: Implementation and Training

Once documentation of your QMS is done, it is time to implement and execute it, ensuring that all your processes align with it. While the quality system manual has clearly defined every process’s interaction with QMS, employees or staff should also know about them. They should be trained about QMS interactions at every process or department, design controls, documentation and record-keeping, and other quality management restrictions. Letting employees know about the 19 different sections of ISO 13485 regarding medical device quality management along with 5 to 6 general quality regulations is a huge task, and so your management should engage experts in educating them. It is only when every employee at each level understands their respective quality procedures, implementing the QMS is possible.

Step 5: Management Review

Once you have implemented the QMS, it is essential to review it to see that it is doing its job in improving or regulating your products for better quality satisfaction of customers. Your management officials should be deeply involved in consistently reviewing the processes, production performance indicators, quality parameters, and other necessary aspects like customer complaints or refund requests to evaluate the effectiveness of the implemented QMS.

Step 6: Certification Audit

Auditing is necessary to ensure that each and every clause of ISO 13485 is met by your QMS. While it can be conducted internally by designated assessment officers or auditors, appointing an external team of qualified auditors from a professional ISO compliance agency is more effective. They not only have an eye for detail but also have in-depth knowledge of each ISO standard’s clauses, so they can evaluate your compliance best. Besides, they will give you an unbiased review or statement after checking your QMS compliance and so you will able to know all shortcomings and decide corrective actions.

Once all these stages are completed, your QMS will become full-fledged ready for ISO 13485 certification. Getting a registrar or a certification body and applying for certification is the final and easiest step. The certification body must be an authorized one. They will just review and validate your documented system and implemented procedures of QMS and issue the certification.