A Closer Look at ISO 13485 for Medical Device & Equipment Manufacturing

The medical device manufacturing industry is full of regulations. Governments and regulatory bodies worldwide (such as the FDA) have input on the devices that save lives and assist doctors, and for good reason.

But there’s an important standard that helps companies do more than just demonstrate certification to medical industry requirements. ISO 13485 adoption helps companies enhance their product consistency and reliability and boost their professional reputation. This is because it places a special focus on not just ensuring excellent product quality and safety but also meeting all regulatory requirements, building robust supply chain interactions, and ensuring a high level of customer satisfaction.

In this blog, we’ll explain some key points that you need to know about this complex yet invaluable standard.

The Benefits of ISO 13485 Certification for Medical Device and Equipment Manufacturers

For medical device and equipment manufacturers, ISO 13485 does more than just specify important items for your QMS — it’s an easy way to signal to your customers that you’re willing to go above and beyond their basic expectations to ensure that you are producing high-quality, quality-conforming products. It also shows your partners and suppliers that you’re committed to monitoring and taking action to drive improvements through your supply chain.

Reduces the Risk of Product Defects

As a QMS Standard, ISO 13485 was designed to help medical device manufacturers and equipment suppliers develop strong quality management systems from the ground up. ISO 13485 drives the focus on meeting regulations, assessing and improving supply bases, and maintaining “best-in-class” management standards that have been adopted by the regulatory authorities in many countries.

The standard reduces the risk of product defects by ensuring that manufacturers monitor quality throughout the entire medical device manufacturing process, including:

• Design and Development
• Process Verification and Validation
• Manufacturing and Production
• Distribution
• Field Service and Post-Market Surveillance

Builds Customer Confidence

Companies that meet the ISO 13485 standard have a clear and compelling competitive advantage over those that don’t. By following this quality system, they have a complete roadmap that helps them produce better products that keep improving. Having an edge in quality, reliability, delivery, and service translates into an enhanced level of trust with their customers.

This increased trust and credibility should drive new customers and increase sales. It should open up market share that is reserved for companies that produce only the highest quality and most reliable products, including those specifically in the U.S., EU, Canada, Australia, Japan, Brazil, and South Korea. Implementing ISO 13485 facilitates access to these major international markets.

Improves the Supply Chain

The market benefits aren’t just limited to customers. Companies that comply with ISO 13485 have demonstrated an increased commitment to managing their supply chains. This helps potential partners in the industry identify top suppliers and signals that a company is open to collaboration and has the resources to ensure successful partnerships.

Most of all, by reducing the number of errors and accurately tracking customer complaints through proactive problem-solving, certified companies experience fewer recalls and product defects. This makes the entire supply chain more efficient and reliable, which helps to drive the greater good.

ISO 13485 and Other Medical Device Manufacturing Regulations and Standards

ISO 13485 provides a framework for companies to ensure that they meet all legislative and regulatory requirements, but it’s not a mandate. It’s a voluntary standard that helps companies identify and proactively manage their risks, consistent design and development processes, and the need for effective product traceability and surveillance systems. Most importantly, even though it is not a law, it is often imposed as a customer requirement to do business. Larger companies greatly prefer conducting business with quality-certified companies because they don’t have the time or willingness to work with their suppliers on quality, safety, or delivery problems. Quite often, they regard a quality certification as the minimum starting point to consider onboarding a potential supplier.

Here’s how ISO 13485 relates and differs to some other well-known industry regulations and standards…

ISO 9001

ISO 13485 and ISO 9001 both provide a framework for quality management systems that emphasize continual improvement and customer satisfaction. 

However, ISO 13485 is tailored specifically for medical device manufacturers and has a stronger focus on meeting regulatory requirements and managing product risks, whereas ISO 9001 is applicable generically to any organization across various industry sectors.

FDA 21 CFR 820

Both ISO 13485 and FDA 21 CFR 820 establish requirements to ensure product safety and efficacy, specifically for the medical device industry in the U.S. 

While ISO 13485 has a broader international scope, FDA 21 CFR 820 contains specific mandates including documentation requirements for Device Master Records, Device History Records, and Design History Files that align with U.S. regulations which are more detailed procedural requirements. 

MDSAP (Medical Device Single Audit Program)

ISO 13485 forms a foundational component of the MDSAP which allows for a single regulatory audit of a medical device manufacturer's quality management system that satisfies the requirements of multiple jurisdictions. 

Additionally, MDSAP specifically facilitates market entry into countries like Australia, Brazil, Canada, Japan, and the U.S.

cGMPs (current Good Manufacturing Practices)

Both ISO 13485 and cGMPs focus on ensuring that products are consistently produced and controlled according to strict quality standards. They are set by the FDA to ensure the quality of regulated products such as food, drugs, medical devices, and biotechnology products.

Note that ISO 13485 is structured more specifically for medical devices and their particular safety requirements, while cGMPs are broader, covering a wider range of products including pharmaceuticals. 

Details of ISO 13485 Standards for Medical Device Manufacturing

The main categories of compliance within ISO 13485 each address specific aspects of quality assurance and regulatory adherence in the medical device manufacturing industry.

Documentation Requirements

ISO 13485 mandates that organizations establish and maintain documented procedures for controlling all documents related to the quality management system's requirements. This includes the approval, review, updating, and retrieval of documents to ensure accessibility and prevent the unintended use of obsolete documents.

Management Responsibilities

Top management must demonstrate their commitment to developing, implementing, and maintaining the quality management system and continually improving its effectiveness. The standard specifies that management must also ensure customer requirements are met and maintain the integrity of the QMS when changes are implemented.

Resource Management

Organizations must ensure that adequate resources are available to maintain their QMS. This has implications for human resources, infrastructure, and work environments. The competence, awareness, and training of personnel are crucial components, particularly in roles that can impact product quality. Those resources do not have to be permanent positions of the company — they can be temporary professional help hired to perform important tasks, such as conducting the annual course of internal audits that are required to maintain certification. 

In addition, since ISO 13485 specifically deals with medical device manufacturing, there are industry-specific requirements concerning contamination control, such as:

• Clean work environments and the clothing & health of personnel
• Contaminated product controls
• Microorganism/particulate controls
• Sterility of medical devices

Product Realization / Manufacturing / Production

Product realization encompasses the design, development, purchasing, production, and service of the product. It's essential that each stage is properly planned, carried out, monitored, and measured as necessary for each organization’s individual needs.

These requirements include setting quality objectives and requirements for the actual production of the company’s products. It requires the consideration and planning of all of the stages of a product's life cycle — from R&D conception to final completion. It combines the market requirements, technological capabilities, and resources to define the product design and the various manufacturing processes needed to produce and support it. 

Measurement, Analysis, and Improvement

Finally, the standard stipulates the need to monitor the quality management system's results to verify their conformity to product requirements, that it works efficiently (i.e., is not too burdensome), and is effective (i.e., the company actually generates the results that they’ve planned). 

It emphasizes the necessity of reporting data, controlling nonconforming products, and identifying areas for improvement. This includes conducting audits and corrective/preventive actions to improve the system continually.

CMTC Can Help You Meet Quality Standards

ISO 13485 was designed to be more than a set of quality guidelines. Its focus is to help organizations embed a culture of process excellence and product safety in the manufacture of medical devices or equipment.

Companies that apply the ISO 13485 standard into their QMS ensure that every device they manufacture upholds the required standard of quality and safety. This secures them a competitive edge in the global market and helps them foster trust among consumers and stakeholders alike.

CMTC is committed to helping California’s medical device manufacturers meet quality standards, especially those that apply to regulated industries such as ISO 13485. CMTC’s team of quality consultants comprises diverse backgrounds and expert skill sets to provide the knowledge necessary to meet the constantly increasing quality demands in the medical device manufacturing industry. They consist of ASQ published authors and are part of national working groups on quality management, such as the Baldrige Performance Excellence Program and the MedAccred Supply Chain Accreditation Program for the medical device industry. 

To learn more about how CMTC can help your company meet quality standards like ISO 13485, contact CMTC today.