What is ISO?

ISO, the International Organization for Standardization, is an independent, non-governmental international organization that develops and publishes standards. ISO standards are designed to provide guidance and establish best practices across different sectors, organizations of various sizes, and diverse geographic locations. ISO management system standards (MSS) are created by consensus among global experts and are applicable to all types of organizations, whether they are large or small.

Understanding Management Systems

A management system is a framework through which an organization manages its interconnected components to achieve its goals and objectives. These objectives may encompass different aspects, such as product or service quality, operational efficiency, environmental performance, workplace health and safety, and more. The complexity of the management system depends on the specific context of each organization. While smaller organizations might focus on strong leadership and clear expectations without extensive documentation, highly regulated sectors may require comprehensive documentation and controls to meet legal obligations and organizational objectives.

ISO Management System Standards

ISO management system standards (MSS) help organizations improve their performance by providing clear and repeatable steps to achieve their goals. Implementing these standards encourages organizations to develop a culture of continuous self-evaluation, correction, and improvement. By fostering employee awareness, management leadership, and commitment, an effective management system brings numerous benefits to an organization:

1. Enhanced risk management and protection of people and the environment.
2. Increased capability to deliver consistent and improved services and products, adding value to customers and stakeholders.
3. Efficient resource utilization and improved financial performance.

ISO 13485: Medical Devices Quality Management System

ISO 13485 is a specific ISO standard that focuses on the medical device industry. It sets forth the requirements for a quality management system to ensure organizations consistently meet customer and regulatory requirements. ISO 13485 applies to organizations involved in various medical device life cycle stages, including design, development, production, storage, distribution, installation, servicing, and associated activities.

Regulatory agencies such as Health Canada and the FDA have specific MSS requirements to ensure public safety and proper market controls. ISO-13485 offers the framework for companies to comply with these regulatory requirements.

Regardless of their size or type, organizations must comply with the requirements of ISO 13485, unless explicitly stated otherwise. The standard also applies to suppliers or external parties providing product-related services to organizations in the medical device industry. Additionally, organizations are responsible for managing and controlling any processes required by ISO 13485 that are applicable but not performed by them.

Certification to ISO 13485

While certification to ISO 13485 is not mandatory, organizations can benefit significantly from implementing the standard. Third-party certification provides independent verification of an organization’s compliance with ISO 13485 requirements. Technimount Medical is ISO-13485:2016 certified by SAI Global / Intertek, which is one of the most renowned certification bodies and offers international recognition. The affiliated companies such as Technimount EMS use the same MSS as Technimount Medical as best practices and business coherence. This means that Technimount’s affiliates companies are complying with Health Canada and the FDA regulatory requirements.

Importance of ISO 13485

ISO 13485 plays a crucial role in the medical device industry by helping organizations establish and maintain effective quality management systems.

Compliance with this standard brings several benefits:

1. Enhanced customer confidence: ISO 13485 certification demonstrates an organization’s commitment to delivering high-quality medical devices and related services, thereby instilling confidence in customers, proper communication, commitment to resolving issues, and providing consistent results.
2. Regulatory compliance: ISO 13485 aligns with regulatory requirements in the medical device industry. Certification to this standard helps organizations meet these obligations and simplifies regulatory audits.
3. Risk management: ISO 13485 emphasizes risk management and risk-based decision-making, enabling organizations to identify and mitigate potential risks throughout the entire product life cycle.
4. Supply chain management: ISO 13485 certification is often a prerequisite for collaboration with suppliers and external parties. It ensures that quality standards are consistently met throughout the supply chain and traceability of the product is ensured throughout its manufacturing and distribution process.