A Guide to ISO 13485 for Medical Device Manufacturers

What is ISO 13485?

Published by the International Standards Organization, ISO 13485 is the global standard for quality management system (QMS) requirements for companies involved in the design, production, installation and servicing of medical devices and related services. A quality management system (QMS) is a set of policies, processes and procedures that help an organization meet the requirements to achieve quality policies and objectives. It can also be used by internal and external parties, such as certifying bodies, to help them with their auditing processes. Many organizations in the medical device industry are expected to demonstrate their quality management processes and ensure best practice in everything they do; therefore, this internationally agreed upon standard sets out the requirements for a quality management system and guidance for common regulatory concepts to ensure those processes are properly maintained and regulated.

The Importance of ISO 13485

When it comes to medical devices, ISO 13485 is an important standard because patient safety greatly depends on the quality and consistency of medical equipment. Ensuring effectiveness, control, and maintenance of your QMS is critical to customers, stakeholders, patients, users, and regulatory agencies. It also ensures that the medical device is consistent when it comes to its design, development, and manufacturing, and that it operates safely and effectively. For instance, medical device labeling requirements are in place to ensure the safety of medical device users. In addition, ISO 13485 can be used as a tool for a thorough audits to test the effectiveness of the QMS and provide an organization with a higher confidence to achieve and maintain compliance with regulatory requirements.

ISO 13485 Requirements

The ISO 13485 standard is organized into 8 sections that a medical device company should follow and abide by.

Section 1: Scope
Describes the purpose and use of the standard.

Section 2: Normative Reference
Provides introductory information and confirms the common nomenclature.

Section 3: Terms and Definitions
Defines the terms and provides the definition of the terminology used throughout the standard.

Section 4: Quality Management System
Outlines the general and documentation of the organization’s QMS. This section talks about the general QMS requirements, and requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS. This section also specifies the requirements for controlling documents and records. Document control includes reviewing and approving of documents before use, controlling changes and ensuring that current versions of controlled documents are available where needed for use. Requirements for control of records include maintaining their integrity and establishing procedures for how long documents and records are maintained.

Section 5: Management Responsibility
This section requires management involvement at the level of the person who makes policy and financial decisions and covers the need for top management to be instrumental in the implementation and maintenance of the QMS. This section establishes that the quality policy and objectives, support, and oversight of the QMS and provision of resources are the direct responsibility of upper management.

Section 6: Resource Management
This section requires management to provide the assurance of the facilities such as the space, tools, and equipment used. Buildings, tools, and equipment must be sufficiently maintained to enable production of devices that meet all their requirements. Additionally, the QMS must include processes that ensure all required maintenance activities are performed.

Section 7: Product Realization
This section covers everything that is required to realize a product, from planning to creating (designing and manufacturing) to implementing and supporting a medical device. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service.

Section 8: Measurement, Analysis, and Improvement
This section provides instruction on how to incorporate feedback and other related information that will enable the management team to sustain the effectiveness of their QMS, such as customer reviews, complaints, internal audits, monitoring and measurement of processes and products, CAPA, non-conformances, and corrective and preventive actions.

Importance of ISO 13485 Certification

Obtaining an ISO 13485 certification is not a requirement for medical device companies, but many organizations find benefits in obtaining third party certification and demonstrating to regulators that they have met the requirements of the standard. “ISO 13485 Certified” means that an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485.

Certification is important because it allows for organizations to communicate a commitment to its customers and regulators, and many customers believe it gives the organization more credibility when it comes to the safety of medical devices. Getting ISO 13485 certified can also help a company make more positive and permanent quality and process improvements that strengthen the company when it comes to the products and services they provide.

Is Gilero ISO 13485 Certified?

Gilero is ISO 13485:2016 certified. We operate a Quality Management System which is compliant with the requirements of ISO 13485 for the design, development, manufacture, and packaging of medical devices. If you are looking for an ISO certified company to help with your next medical or drug delivery device project, contact Gilero today.

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