How Does ISO 13485 Certification Help Medical Device Manufacturers?

While some medical devices are complex - like heart-rate monitors - even simple devices like stethoscopes must meet stringent requirements. Both simple and complex medical equipment benefits from being designed and produced following the ISO 13485 standard.

ISO 13485 is recognized as the international standard for quality management systems (QMS) used in the medical industry. It was first issued by the International Organization for Standardization (ISO) in 1996, with the current version becoming active in 2016. This article will explain the origin and purpose of the ISO 13485 standard, its requirements, and the benefits it brings both to individual companies and to the medical industry as a whole.

What is the origin and purpose of ISO 13485?

Like the AS9100 standard for the aerospace industry and the IATF 16949 standard for the automotive industry, the ISO 13485 was first published in 1996 and is based on the older ISO 9001 standard. It was introduced to help medical device manufacturers implement quality management systems that establish and maintain all the processes within their facilities. This allows manufacturers to ensure not just consistent design and development processes, but also consistent production and delivery processes for each manufactured medical device that leaves their doors.

While it is a standalone document, ISO 13485 is identical to ISO 9001 except for the addition of amendments that discuss medical industry-specific topics. The main difference between the two is that ISO 13485 is designed for regulatory compliance related to medical device manufacturing, not generalized continuous improvement of processes, as with ISO 9001. Because of this, ISO 13485 is stricter and requires a more refined and documented QMS.

What are the requirements of ISO 13485?

Regardless of the scope of products produced by a company, if it manufactures medical devices, then the requirements of ISO 13485 apply across the entire company - even for non-medical device-related products and processes.

The structure of the ISO 13485 standard is divided into eight sections. The first three are introductory. They describe the scope of the standard and the nomenclature used throughout the document. The last five describe the actual requirements for a company’s QMS should they decide to adhere to the standard. Those five sections are explained below:

• Section 4: Quality Management System

This section states the general requirements for the QMS. It describes the required procedures, forms, and records needed to implement a QMS following the standard.

• Section 5: Management Responsibility

Here, the responsibilities and duties of management in an ISO 13485-certified environment are described, from establishing quality policies and objectives to ensuring customer satisfaction.

• Section 6: Resource Management

Section 6 describes the requirements for all the resources that must be controlled to operate a sound QMS. This includes everything from human resources, to raw material, to the facilities and infrastructure used to produce parts.

• Section 7: Product Realization

This section focuses on elements related to the development of a product or service. It sets requirements on planning, reviewing product requirements, product design, purchasing, and all of the equipment used to create a product. 

• Section 8: Measurement, Analysis, and Improvement

Section 8 states the requirements for monitoring a company’s QMS to ensure it continues to function as intended. Additionally, it touches on the need for internal audits, continuous improvement, risk minimization, quality defects, and methods for assessing customer satisfaction.

Once a company believes that its QMS meets these requirements, it must conduct operations with it in place. This gives companies time to collect the necessary records to move forward with certification. After completing all documentation, companies must then apply for certification and conduct a series of internal and external audits to verify compliance with the standard.

Three ways ISO 13485 Certification impacts medical manufacturers

The benefits that ISO 13485 certification can provide to medical manufacturers of all sizes cannot be overstated. With certification and implementation of its QMS, manufacturers can achieve significant cost and time savings. Three benefits of ISO 13485 certification are listed below:

1. Increased efficiency and lower costs

Through the establishment of reliable and well-documented process control systems, manufacturers can consistently and efficiently deliver high-quality parts. With the process approach emphasized in the standard - a method of thinking where companies methodically plan their processes and how they interact with these processes - manufacturers are mandated to improve and optimize manufacturing processes. Additionally, the process approach makes it easier for manufacturers to identify wasteful and inefficient processes. Given that continuous improvement is one of the cornerstones of ISO 13485, companies can benefit from continually identifying areas of improvement that eliminate manufacturing problems, leading to more efficient processes at lower costs.

2. Expanded customer base

ISO 13485 certification has the power to expand a company’s customer base. When potential customers from around the globe see that a potential supplier has ISO 13485 certification, they are assured that their goals and expectations for a medical product are aligned with those of the supplier, and will be easier to reach if that supplier is selected. At its core, the ISO 13485 standard works to create a QMS that prioritizes the goals and objectives of customers. For customers, this means consistently safer and more reliable medical devices. For manufacturers, this means a clear and concertedly executed framework that focuses on customer requirements and the delivery of high-quality parts.

3. Greater market competition

For the whole medical industry, ISO 13485 leads to greater market competition. The most recent version of the standard states that certified companies should insist on ISO 13485 certification from their subcontractors as well. This leads to across-the-board improvements to the industry in part quality, efficiency, and profits. For manufacturers looking to expand business operations, certification shows customers that quality is the focus of their processes. Moreover, certification allows companies to avoid burdensome and repetitive certification processes in different countries - making it easier to expand operations around the world. As more companies in the industry become certified and look to outperform each other, innovative and valuable new medical devices and products emerge. For the general population, this means access to innovative health care devices that lead to a higher quality of life.

Why ISO 13485?

ISO 13485 certification  can help a manufacturer improve its processes and expand business operations. Certification shows potential customers that a particular company will meet their requirements and deliver high-quality parts by using industry best practices in compliance with regulatory requirements. On a macro level, ISO 13485 pushes the boundaries of the medical industry, planting the seeds that foster innovative new products that dramatically improve patient outcomes and well-being. ACHB is an ISO 13485 certified manufacturer. Contact an ACHB representative today to discuss your medical device manufacturing needs.