ISO 13485 – Quality Management System for Medical Device Manufacturers

Guidance Consulting and Training provides qualification, training, and grant services for ISO 13485 the medical devices quality management in Saudi Arabia, as the requirements of this standard specify the quality management of medical device manufacturing. The system aims to demonstrate the institution’s ability to provide medical devices and related services that meet the high-quality requirements of the customer and relevant regulatory authorities. This standard supports and guides manufacturing institutions to ensure the application of international quality standards in the design, development, manufacture, and distribution of medical devices, and aims to ensure the safety and effectiveness of these devices, and maintain customer satisfaction. It also ensures that manufactured medical devices meet the specified quality and safety requirements and provide customer trust in the products and services they provide.

The Importance of Implementing ISO 13485 in Saudi Arabia

ISO 13485 improves the operational processes of companies specialized in manufacturing and supplying medical devices. The following is the importance of implementing this system in healthcare:

• ISO 13485 contributes to improving the reliability and safety of manufactured medical products. By complying with this system, organizations can ensure that quality and safety requirements are met, thus providing safe medical products to consumers.
• The system improves companies’ operational processes, allowing for increased efficiency and reduced errors in the manufacturing process. This means that medical products manufactured according to ISO 13485 will be more accurate and of higher quality.
• ISO 13485 is committed to matching globally recognized best practices in the medical device industry. Therefore, adherence to this system will help organizations comply with strict laws and regulations related to health, safety, and quality in healthcare.
• The system specifies the requirements of medical device manufacturers. Compliance with ISO 13485 is a prerequisite for accessing most global markets, so implementing this system allows companies to expand and grow in the medical devices market.
• Compliance with ISO 13485 indicates the commitment to quality, safety, and superior professional practices in the medical devices industry. Consequently, this system enhances the organization’s reputation and increases customer confidence in its products.

ISO 13485:2016 Medical Devices Quality Management System Requirements

Medical device manufacturers and suppliers need a quality management system corresponding to the international standard ISO 13485:2016.

Scope: This point defines the scope and application of the organization’s quality management system for medical devices.

Normative references: This point contains a list of normative references that must be participated by the implemented system.

Terms and definitions: This point explains the basic terms and definitions used in the system.

Quality management system: How to build and implement a quality management system based on ISO 13485. It also requires the availability of documents and records to prevent purposes that may negatively affect the quality of medical devices.

Management responsibilities: The responsibilities of the top leadership in the organization regarding the quality management system implementation and ensuring compliance with the standard.

Resource management: Includes requirements for allocating the resources necessary to implement and maintain the quality management system.

Product realization: Describes the procedures necessary for manufacturing and supplying medical devices to ensure compliance with the standard.

Measurement analysis and improvement: Addresses the measures that must be taken to measure the performance of the quality management system and analyzes the collected data to improve performance continuously.

Benefits of ISO 13485 Medical Device Quality Management System

• Enable access to international markets that require certification such as Canada and Europe.
• Reduce operational costs by highlighting deficiencies in processes and improving their efficiency and effectiveness.
• Enhance product safety and quality and provide greater confidence to consumers.
• Develop reliable and documented procedures that comply with industry standards.
• Demonstrate commitment to quality through an internationally recognized standard.
• Increase customer satisfaction by providing high-quality products regularly Complaint handling.
• Add handling transparency to the complaints, monitoring, or product recalls.
• Implementing a quality management system generally helps motivate employees and provides a better definition of key roles and responsibilities.

Improve operational efficiency and ensure compliance with global quality standards for any organization specialized in the medical device industry by implementing a quality management system compatible with ISO 13485:2016. Implementing a quality management system for medical devices in manufacturing organizations is crucial to maintaining high quality and safety in various medical device manufacturers. Therefore, implementing this system in an effective manner proceeds according to these steps:

Step 1: Identifying regulatory requirements

By understanding and identifying all relevant regulatory requirements for the medical device industry reviewing local and international laws and regulations related to this type of product and ensuring that they are applied correctly.

Step 2: Risk Management

Identify and evaluate all potential risks that may affect the quality of medical products and public safety, and then develop and implement strategies to deal with these risks and reduce them to a minimum.

Step 3: Supplier Controls

Develop accurate procedures and controls to identify and evaluate potential suppliers choose the best among them, and ensure that all contracts and agreements are documented and that suppliers comply with health standards and laws specific to the industry.

Step 4: Determine the design, manufacturing, and production processes

Define and document all medical device design, manufacturing, and production processes to ensure that all steps and procedures are clearly defined, detailed, and consistent with applicable regulatory requirements and quality standards.

Step 5: Implementing the Quality Management System

After completing the definition and documentation of all the previous steps, you must implement the quality management system fully and effectively. All employees in the organization must be familiar with this system and apply it in their daily work to ensure that the necessary training is provided to employees and that the implementation of the system is monitored continuously to ensure full compliance.

Recent updates to the ISO 13485 medical devices quality management system standards

The recent updates to these standards include many important aspects, such as improving evaluation and review procedures and identifying risks related to medical devices. They also focus on improving the safety and sustainable performance of medical devices, focus on supply chain management and accurate and continuous monitoring of manufacturing processes. These updates aim to ensure that medical device implementation complies with safety and quality requirements, thus ensuring the highest healthcare level for patients.

ISO 13485 vs ISO 9001

While both the standards focus on the quality management system, there are some key differences between them.

• ISO 9001 is more general and can be adopted by any organization while ISO 13485 is specific to medical devices and related services.
• The new 9001 version is more risk-based while the older versions were process-based. On the other hand, 13485 has always been risk-based.
• Some additional clauses in 13485 were not present in 9001 such as design, development, sterilization, medical devices software validation, etc.
• ISO 9001 certification is not mandatory in most countries but ISO 13483 certification is a must in European countries

Compatibility with ISO 9001:2008 and not ISO 9001 2015

ISO 13485 complies with the requirements of ISO 9001:2008 and does not comply with ISO 9001:2015. This incompatibility is because the amendments to both standards were completed in parallel and because ISO 9001:2015 was deemed unnecessary for medical devices. These changes were managed by the ISO 210 Technical Committee, whose task was to ensure that this standard remained a quality management system fit for purpose.

What are the main requirements for ISO 13485 certification?

To obtain ISO 13485 certification, medical device manufacturers must meet the following set of key requirements:

• Establish a medical device quality management system: Manufacturers must establish a documented quality management system following ISO 13485. This system aims to organize and manage all aspects of the medical device industry’s quality.
• Implement regulatory requirements: Companies must demonstrate the ability to meet regulatory requirements applicable to medical device services. These requirements include relevant local and international laws, regulations, and standards.
• Provide devices: Companies must demonstrate their ability to provide high-quality medical devices and follow approved health requirements and standards.
• Commitment to customer requirements: Companies must consistently meet their requirements following the specified standards and specifications.
• Provide technical documents: Companies must submit a set of technical documents required to ensure the quality of their products and compliance with health standards.
• Review the system: The system must be reviewed and evaluated periodically to ensure its continued compliance with ISO 13485 standards.
• Request for certification: After completing all necessary stages and implementing the system, the company must apply for ISO 13485 certification from an accredited certification body.

Guidance for Consulting and Training

We have the knowledge and experience to help institutions and individuals comply with the requirements of the Saudi Standards and Quality Organization, the Food and Drug Authority, and other entities that impose legal and mandatory requirements in the Saudi market.

To qualify your facility, train its personnel and fulfill the required documents to implement the quality and ISO systems.