Standard Operating Procedures to Follow for the ISO 13485 Medical Device Standard

Summary:

This article tries to point out the standard operating procedures that are included in the ISO 13485 standard for medical devices quality management.

Medical device businesses achieve the ISO 13485 certification to establish a strong Quality Management System (QMS) complying with the best practices and guidelines. ISO 13485 is the specially designed standard that provides medical device companies with the requirements of a turnkey QMS. It primarily includes the standard operating procedures that companies need to follow for designing and manufacturing products or devices. Standard Operating Procedures (SOPs) are formulated for every type of business and ensure that the procedures followed by a business adhere to certain regulations and requirements to deliver fine-quality products or services in time. Since SOPs are important for quality assurance of the finished products or services, they are included as a major requirement of the QMS in standards like ISO 9001 and ISO 13485. The SOPs underlines the uniform operating procedures and work instructions that should be followed by the companies to ensure consistency and reliability in the output. In this article we are going to elaborate on the key SOPs that are a part of the ISO 13485 standard for medical devices and form the foundation of their QMS.

Key Standard Operating Procedures (SOPs) Needed for Achieving the ISO 13485 Standard

While companies generally write their own SOPs and ensure that everything including work instructions is properly documented in their QMS, these are the specific SOPs that medical device companies must include for achieving compliance with ISO 13485.

Documentation Control

An important part of the SOPs is maintaining written records or manual of QMS requirements. Good documentation should include everything from quality objectives, policies, processes, to responsibilities of the employees, and training records. Proper arrangement and control of the documentation are required to ensure that the manufacturers can identify or trace any issue in production processes and act to correct them. It also leads to a sense of accountability in the employees as the roles/responsibilities are clearly defined in the document.

Design Controls

Design controls are a major part of the medical device QMS and determining them can be a big challenge for the companies as they include controls for every phase of the production process. The controls are required to review the applied design concepts and requirements of each phase before the final launching of the products. Some of the key phases for which the controls are implemented are product planning or conceptualization, designing of inputs, designing of outputs, product verification, product validation, and product reviews.

Risk Management

A key part of the SOPs is the risk management approach. It must include the procedures for identifying, assessing and controlling the risks that may emerge in designing or production processes. Risk management is an entire process that starts with risk assessment. It includes analysis and evaluation of the identified risks. It then moves forward to risk control under which the risks are managed (i.e. eliminated, alleviated, accepted or transferred) according to their acceptability criteria. Risk management also covers post-production processes which included packaging, distribution and installation.

Qualification of Suppliers

SOPs also include evaluating a supplier and their processes to ensure that they have best practices for quality management in place and are qualified to be a supplier of a medical manufacturing company. The SOP for supplier qualification involves checking on resources, inputs, and processes of the suppliers. There are no specific methods or regulations to evaluate the supplier; the only thing required is that there should be a systematic approach to evaluate and keep records. Evaluation of suppliers should also be risk-based to ensure that none of the inputs are defective and affect the reliability of the end products or devices.

Control of Nonconformance in Products

A critical part of the SOPs is controlling the nonconformance in the products with effective CAPA (Corrective and Preventive Actions). It means the manufacturers should have a specific procedure for auditing the QMS processes and checking the products to ensure that the requirements for the ISO 13485 standard are met. If nonconformance issues are discovered, the manufacturers should enquire deep into the issues and uproot their causes. Accordingly, they should implement appropriate CAPAs to rectify the issues by eliminating the root causes.

These are a few crucial SOPs that medical device manufacturers need to adopt to achieve the ISO 13485 certification and demonstrate their quality compliance. There are many more SOPs such as management review, process validation, complaint handling and creation of CAPA plan. SOPs mainly depend on the product nature, processes, quality, and regulatory requirements. However, every SOP must be formed including some basic elements which are purpose, scope, background, roles/responsibilities, procedure steps, reference documents, and revision history.

Author Bio:

Damon Anderson is the owner of a renowned ISO consultancy that provides certification assurance services to all types of businesses and helps them become ISO certified in a short time. He is a specialized consultant for the ISO13485 certification and likes to write blogs on medical device quality management and compliance.