Ensuring Safety and Quality in Medical Device Manufacturing: A Comprehensive Guide to ISO 13485 Standards and Certification

Safety and quality are non-negotiable considerations in various aspects of the medical industry, particularly medical devices. These devices are often used directly with patients and, as such, have a significant impact on health and quality. Therefore, it is imperative to manufacture them to stringent quality levels. ISO 13485 is a medical device manufacturing standard that ensures that devices used in the medical industry are produced to be of the highest quality possible through the implementation of quality management systems.

This article comprehensively explores the ISO 13485 standard, its requirements, and the benefits of ISO 13485 implementation and certification - particularly in medical device contract manufacturing.

What is ISO 13485?

ISO 13485 certification

ISO 13485 requirements

Medical devices contract manufacturing

Benefits of ISO 13485 in medical devices contract manufacturing for customers and manufacturers

What is ISO 13485?

ISO 13485 is an ISO (International Standards Organisation) standard that specifies quality management systems (QMS) for the design, manufacture, installation, and maintenance of medical devices. “Medical devices” in this standard refers to parts, components, instruments, machines, equipment implants, and other medical paraphernalia used to prevent, diagnose, and treat medical conditions.

ISO 13485 Medical devices

Primarily created for medical device manufacturers and related entities, this ISO medical device manufacturing standard stipulates the requirements of quality management structures these entities should implement to ensure that their products and services meet customer and regulatory quality requirements.

The standard does not directly address the actual design, manufacturing, installation, and maintenance processes behind medical devices. Instead, it defines the creation of comprehensive quality management systems (QMS) around these processes, ensuring that they are executed with quality and safety as the paramount considerations. This standard is one of many ISO standards for medical devices that ensure overall quality and safety.

ISO 13485 undergoes revision every five years to adapt to technological and regulatory changes. The latest version, ISO 13485:2016, places a greater emphasis on risk management and risk-based decision-making. It also incorporates changes related to the increased regulatory requirements for organisations in the supply chain.

ISO 13485 Certification

Similar to other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organisations can implement the standard without undergoing the certification process. However, an ISO 13485 certification officially proves an entity’s commitment to stringent quality and safety standards through the implementation of robust quality management systems. This elevates the entity's standing regarding quality and enables their customers to rest assured of quality products every time. Accredited third-party bodies of auditors give ISO 13485 certification after a thorough audit of the manufacturer's QMS.

ISO 13485 Certification

Particularly beneficial in the field of contract manufacturing, this certification demonstrates, to customers and regulators, the medical device contract manufacturer’s ability to provide safe, high-quality medical devices. For customers or businesses that deal in the procurement and supply of medical devices, dealing with ISO 13485-certified medical device manufacturers is highly recommended, as the certification not only guarantees the quality of the manufacturer’s product but also saves the business time, effort, and cost of carrying out an audit. This article comprehensively outlines the benefits of ISO 13485 later on.

ISO 13485 Requirements

To fully understand the benefits of ISO 13485 implementation and certification, it is necessary to first understand the standard's requirements. These requirements dictate how a medical device quality management system should be structured. A quality management system is an internal framework that comprises documented procedures, policies, and processes an organisation, in this case - a medical device manufacturer, follows to ensure it delivers high-quality products. It covers rules, responsibilities, and numerous checklists throughout the manufacturing process.

The ISO 13485 standard requires a comprehensive quality management system that addresses various aspects of production and management. Note that quality management systems vary by the organisation’s products, objectives, environment, and size. ISO 13485 is adaptable and applicable to all medical device manufacturers’ QMSs.

ISO 13485 Quality Management System

General requirements

The general requirements of the ISO medical device manufacturing standard stipulate that an organisation must create and maintain an effective medical device quality management system that meets the regulatory requirements of the specific medical device and those of the standard itself.

The organisation needs to establish processes that comprise the QMS, identifying the sequence and interactions of these processes and how they would be controlled using a risk-based approach. It also needs to establish methods that ensure that each process, whether handled internally or outsourced, is effective. These methods include monitoring, measurement, analysis, and providing any necessary resources.

Documentation requirements

A crucial aspect of the ISO 13485 standard as a whole is documentation. The documentation requirements require an organisation to clearly and comprehensively document every aspect of the QMS. The organisation has to create a quality manual that covers the QMS’s scope, procedures, rules, interactions between processes, and the documentation structure used in the QMS.

For each medical device type, the manufacturer must also create a comprehensive medical device file containing a general description of the device, its purpose, usage instructions, and labelling. The medical device file should also include specifications and procedures for the manufacturing, packaging, storage, handling, installation, monitoring, and servicing of the product, where applicable.

In addition to creating fixed documentation, the organisation must continually keep records of all aspects of the QMS in practice. Record keeping is done to provide evidence of effective QMS implementation and identify when the opposite is the case. Lastly, the organisation must establish documented procedures to control documents and records. These criteria cover review, approval, revision, updates, identification, and maintenance of all documents and records.

Management responsibility

ISO 13485 clearly outlines what is expected of the management of a medical devices manufacturing company. The effective implementation of a QMS significantly depends on the management. Management responsibilities include:

• Establishing quality policies and ensuring adherence to these policies, as well as their maintenance
• Creating a comprehensive QMS system along with quality objectives
• Provision of resources required to implement QMS procedures
• Outlining and communicating customer and regulatory requirements and ensuring that they are met
• Assigning, documenting, communicating, and enforcing responsibilities within the organisation, especially tasks affecting quality
• Ensuring seamless communications among different structures within the organisation

In addition, ISO 13485 stipulates that the management must assign a representative who, regardless of any other responsibilities, is responsible for documenting QMS processes, reporting back to the management on the effectiveness of the QMS, and promoting regulatory requirements. The management is also responsible for planning and executing thorough reviews of the QMS at scheduled intervals.

Resource management

The ISO 13485 standard addresses the management of physical, human, and infrastructural resources needed for effective QMS implementation. This medical devices standard stipulates that the organisation must determine and provide all necessary resources to meet customer and regulatory requirements and to implement and maintain the QMS. The medical device manufacturer must evaluate the level of competence needed by its personnel performing quality-related tasks and ensure that all personnel are trained to this level of competence. The manufacturer must keep all records of training.

Furthermore, ISO 13485 stipulates that the organisation must provide and maintain infrastructure, such as facilities, equipment (hardware and software), utilities, and support services, which are needed to achieve the utmost product quality. They must also create the necessary environment needed to achieve product conformity. This requirement addresses every interaction between the product and the environment, including personnel. Procedures must also be put in place to prevent and manage contamination.

Product realisation

The product realisation aspect of ISO 13485 is the broadest section of the standard, comprising numerous sets of requirements. From understanding the customers' needs to the actual production, product realisation comprises:

• Planning of product realisation
• Customer-related processes
• Design and Development
• Purchasing
• Production and Service Provision
• Control of Monitoring and Measuring Equipment

The first requirement in product realisation is planning. Under this requirement, ISO 13485 stipulates that the medical device manufacturer must plan for the processes required for product realisation. Planning involves determining quality objectives, providing resources and infrastructure, establishing processes and documents, ensuring well-trained personnel, establishing product-related tasks, etc.

After planning, the manufacturer establishes all the needs and requirements of the customer, from product specifications and regulatory requirements to user training. ISO 13485 requires the manufacturer to review all requirements before committing to production. It also requires clear and as-needed communication with the customer.

For development and design, the medical device manufacturing standard requires manufacturers to document procedures covering design and development planning, inputs, outputs, review, verification, and validation before transfer for manufacturing.

The next step in product realisation is purchasing and procurement. This requirement ensures that all purchased items used in medical device manufacturing are of the utmost quality. Under this requirement, the ISO 13485 manufacturing standard requires manufacturers to establish criteria for evaluating and documenting various aspects of purchased products, including product quality, supplier reputation, and impact on the medical device. The table below contains supplier control requirements of ISO 13485 and some implementation examples.

ISO 13485 Supplier Control Requirements

Product realisation requirements also stipulate that medical device manufacturers plan, monitor, and control the actual production and service provision to ensure product conformity to specifications. The manufacturer also has to document procedures to ensure the cleanliness of the product while preventing contamination. Furthermore, the manufacturer must document product installation and servicing procedures, validate production processes, and document product identification and traceability procedures.

Lastly, ISO 13485 requires medical device manufacturers to verify all equipment used to measure and monitor various aspects of the medical device throughout product realisation. The equipment must be calibrated or verified to meet the required standards to ensure accurate monitoring and measuring data. Medical device manufacturers must also maintain proper records of equipment details.

Measurement, analysis, and improvement

The final aspect of ISO 13485 requires medical device manufacturers to plan and implement monitoring, measurement, analysis, and improvement processes. These processes demonstrate product conformity, ensure QMS conformity to ISO 13485, and maintain the QMS’s conformity. Manufacturers must document procedures for the following.

• Monitoring and measurement of products and procedures
• Feedback management
• Control of nonconforming products
• Analysis of data
• Improvement

Contract Manufacturing for Medical Devices

Contract manufacturing is a system of manufacturing in which a business contracts an independent manufacturer to manufacture products on its behalf. In this system, which is commonly applied to medical device manufacturing, the manufacturer has the resources, such as facilities and personnel, to manufacture the product. The business owns no production facilities but has 100% ownership of the finished products and is thus responsible for its quality, distribution, and sales.

A broad subsystem of contract manufacturing that has become indispensable in the medical industry is custom manufacturing. In this system, a business or an individual customer approaches the contract manufacturer with a unique concept/design of the product or a statement of the problem according to the customer’s specifications. The key factors here are the production of unique custom products and the option to carry out one-off or bulk-volume production. Through CNC machining services, 3D printing, injection moulding, and other modern manufacturing processes, custom manufacturing has led to several advancements in the medical industry, especially in implants, prosthetics, orthotics, and similar devices. To learn more about custom manufacturing in the medical sector, see our articles on CNC machining in the medical industry.

CNC-machined hip replacement implant

In both contract and custom manufacturing, the production responsibility and, therefore, quality management lies with the manufacturer, with the customer having little to no input in the process. However, liabilities regarding quality fall on the contracting business and the customer. Considering these factors, how can businesses and customers ensure or be guaranteed quality without being directly involved in the manufacturing process? This is where the ISO 13485 manufacturing standard comes. By being ISO 13485 certified, the medical device contract manufacturer demonstrates a high level of dedication to quality that the customer can trust. An ISO 13485 contract manufacturer is one that not only implements the standard but has also been audited and verified by a third-party body of auditors.

Benefits of ISO 13485 for Medical Device Manufacturers and Customers 

ISO 13485 certification is immensely beneficial to manufacturers and customers alike. “Customers” in this context are medical device businesses, engineers, procurement officers, medical professionals, and individual customers. Because of the medical industry's high quality and safety demands, the requirements of ISO 13485 are as comprehensive and in-depth as they are many. This standard requires stringent attention to many minute details, accounting for every single aspect of manufacturing that can impact quality.

Therefore, ISO 13485 certification is not simply a badge of accomplishment but indicates a medical device manufacturer’s unwavering, ongoing commitment to quality. The certification empowers ISO 13485 contract manufacturers to take on medical device manufacturing projects, demonstrating to customers and regulators that they have the necessary infrastructure to deliver quality products.

The benefits of working with ISO 13485-certified medical device manufacturers are even more impactful for customers. To begin with, customers can rest assured that the devices they receive are of the highest quality. This eliminates concerns related to quality and the need for further quality assurance processes. In addition, businesses can save the cost, time, and effort involved in conducting an audit of the manufacturer.

Furthermore, regulators typically require proof of conformity to certain regulations before businesses can introduce products to the market. For example, in the EU, compliance with MDR (Medical Device Regulations) is required to sell medical devices in the European Economic Area. Similarly, the US requires compliance with FDA 21 CFR 820. Both regulations either directly require proof of compliance with ISO 13485 or contain replicated QMS requirements, which conformity to the ISO medical device manufacturing standard satisfies.

Conclusion

ISO standards for medical devices are crucial for ensuring safety and quality. ISO 13485, one of these standards, ensures quality through the implementation of thorough quality management systems, offering immense benefits to both medical device manufacturers and customers. Need a certified ISO 13485 contract manufacturer for your medical device manufacturing project? Geomiq is officially accredited as a leading medical manufacturer. Our certifications, including ISO 13485, officially underline our expertise in medical device development and manufacturing and our rigorous adherence to international quality best practices.

Contact us or upload your designs to our platform to get started, and our team of experts will handle your project with unrivalled dedication and professionalism, whether for one-off custom implants or batch medical device manufacturing.

How to request a quote with Geomiq for Medical devices requiring ISO13485

1. Visit the www.geomiq.com website and click on the “Get a quote now” button to open up the instant quoting app

2. Upload your CAD file(s)

3. On the right-hand side configurator, select the 'Inspection & Certificates' section, which will expand and allow you to check ISO13485:2016 as a requirement for these parts.

Your parts will be manufactured in line with the rigorous demands of the ISO 13485 standard.