ISO 9001 vs ISO 13485: Understanding Main Differences

Posted in Healthcare Compliance

ISO 9001 and ISO 13485 are often mentioned together, but they have different purposes in quality management. ISO 9001 is a general standard that applies to all types of organizations. Whereas ISO 13485 is designed specifically for medical device manufacturers, emphasizing regulatory compliance, risk management, and patient safety. ISO 9001 vs ISO 13485 have a standard base in principles, but their scope and intent differ significantly. ISO 9001 focuses on achieving customer satisfaction across all industries, whereas ISO 13485 goes a step further by embedding regulatory and safety requirements specific to the medical device lifecycle.

ISO 9001 Compliance

ISO 9001 was first issued in 1987, with the latest version released in 2015. It is a series of international standards that define the requirements for quality management systems (QMS) across all types of organizations, regardless of industry, sector, or size.

Companies can become ISO 9001 certified to demonstrate that they have the systems in place to consistently deliver products and services that meet customer and regulatory requirements.

The main goal of ISO 9001 vs ISO 13485 is to establish clear processes for documenting, implementing, and evaluating all aspects of an effective quality management system. These include:

• General QMS requirements, such as documentation and quality planning.
  
• Management responsibilities and leadership engagement in maintaining and improving the QMS.
  
• Human resources, work environment, and resource management to ensure operational effectiveness.
  
• Product lifecycle management covers every stage from design and development to final delivery.
  
• Evaluation and improvement of the QMS through internal audits and implementation of corrective and preventive actions.
  

ISO 13485 Compliance

ISO 13485 vs Iso 9001 was first published in 1996 and last updated in 2016. While it was originally based on the quality management principles of ISO 9001, it has since evolved into a distinct and increasingly specialized standard.

ISO 13485 outlines the QMS requirements and procedures specifically for the medical device industry. It provides a framework for ensuring the consistent design, development, production, installation, and delivery of medical devices that meet both customer needs and regulatory obligations.

When comparing ISO 9001 vs ISO 13485, one distinction is the emphasis ISO 13485 places on patient safety. The standard requires organizations to implement and maintain processes that ensure medical devices are developed and manufactured consistently, in compliance with all applicable regulatory requirements.

Achieving ISO 13485 quality management system certification is one of the most reliable ways to demonstrate the quality and effectiveness of a medical device manufacturer’s QMS.

The Difference Between ISO 9001 and ISO 13485

Feature	ISO 9001	ISO 13485
Scope	Generic and applicable to any industry or service.	Specific to organizations involved in the medical device life cycle.
Primary Focus	Customer satisfaction and continual improvement.	Regulatory requirements and product safety.
Design & Development	General requirements.	Includes specific requirements for design, verification, and validation, and the creation of a medical device file.
Documentation	Allows flexibility in defining documentation.	More prescriptive, with specific requirements for the control of documented information, including a medical device file.
Risk Management	A key component, but less emphasized than in ISO 13485.	A much stronger emphasis on risk management is due to the high-risk nature of medical devices.
Unique Requirements	Does not include medical device-specific requirements.	Includes unique clauses for medical device cleanliness, sterilization, and post-market surveillance, as well as clinical and performance evaluations.
Regulatory Compliance	Not a primary focus.	Essential, as it’s often a prerequisite for market access and regulatory approval (e.g., FDA, CE Mark).

 

Risk Management

When comparing ISO 9001 vs ISO 13485, both include elements of risk management but with very different levels of focus. ISO 9001 encourages organizations to use risk-based thinking to minimize potential issues that could impact product quality or customer satisfaction. 

ISO 13485 instills risk management into every stage of the quality system, ensuring that patient safety is prioritized above all else. The emphasis is so strong that the term “risk” appears nearly 40 times in the 13485:2016 version. 

QMS Responsibilities

Under ISO 9001, a Quality Management System (QMS) is defined as the collection of policies, processes, and procedures that support the consistent operation of core business functions. Organizations seeking certification must meet all standard requirements, including documentation and continuous evaluation. 

ISO 13485, however, extends these expectations by reinforcing the manufacturer’s accountability for maintaining the QMS and demonstrating its ongoing effectiveness. It introduces stricter documentation and record-keeping controls, reflecting the heightened regulatory expectations in the medical device sector.

Document Control

Document control is another area where ISO 13485 imposes stricter standards. While ISO 9001 requires documentation to support process consistency and traceability, ISO 13485 goes further, requiring extensive regulatory documentation specific to medical devices.

This includes detailed procedures for document approval, version control, retention, and accessibility. In practice, medical device manufacturers only need to comply with ISO 13485:2016, not ISO 9001, when producing and distributing medical devices.

Management Roles

In ISO 9001, management is responsible for promoting quality objectives, but can delegate many of those responsibilities without assigning specific roles. ISO 13485, on the other hand, mandates clear accountability within the management team for each QMS element. 

It requires leadership to take direct responsibility for regulatory compliance, ensure adequate resources, and remain informed about current cGMP (Current Good Manufacturing Practice) updates. This structure ensures that compliance and quality oversight are actively led from the top.

Product Requirements

Both ISO 9001 and ISO 13485 emphasize product realization, the process of turning customer needs into finished products. ISO 9001 defines this through effective policies and procedures that measure quality based on customer satisfaction. 

ISO 13485 builds upon this by requiring detailed controls for safety, validation, and risk management across the entire product lifecycle. It adds greater focus on process validation, equipment calibration, cleanliness, and contamination control, ensuring that every step meets strict safety and performance standards.

Continuous Improvement

ISO 9001 promotes continuous improvement as a means to enhance overall efficiency and customer satisfaction. ISO 13485 also emphasizes improvement, but with a more defined purpose: maintaining the suitability and effectiveness of the QMS while ensuring medical device safety and performance. 

The distinction lies in intent; ISO 9001 focuses on broad business outcomes, while ISO 13485 narrows the focus to regulatory compliance and patient well-being.

Training Procedures

Both standards recognize the importance of employee competence, but their approaches differ. ISO 9001 requires that personnel be competent and that training be provided where necessary. 

ISO 13485:2016 goes further, requiring documented procedures for identifying training needs, conducting training, and evaluating its effectiveness. 

When to Comply with ISO 9001 vs. ISO 13485?

While ISO 9001 and ISO 13485 share similar roots, their intended applications are quite different. ISO 9001 is a generic quality management standard suitable for any industry, from manufacturing and engineering to logistics and services. 

Its purpose is to help organizations consistently meet customer and regulatory requirements while improving efficiency and customer satisfaction.

However, ISO 9001 cannot be used to demonstrate QMS compliance in the medical device industry. 

This is because it does not address the specific regulatory, documentation, and safety requirements that apply to medical device design, production, and distribution. 

Organizations should adopt:

• ISO 9001: If they operate outside the medical device sector and seek to improve quality, efficiency, and customer satisfaction.
• ISO 13485: If they are directly involved in medical device design, development, manufacturing, servicing, or distribution, or if they supply critical components or materials to medical device manufacturers.

When to Comply with Both ISO 9001 and ISO 13485?

Many larger companies choose to comply with both standards, especially if they operate in multiple industries or maintain corporate-level quality frameworks that extend beyond medical devices.

A multinational medical device manufacturer may apply ISO 9001 at the corporate level to manage administrative, R&D, or cross-sector operations. Meanwhile, ISO 13485 would be implemented at the manufacturing level to satisfy medical device-specific regulatory and safety requirements.

Complying with both standards offers several strategic advantages:

• It allows organizations to maintain a unified corporate QMS while addressing industry-specific compliance needs.
• It supports smoother integration with other management systems (such as ISO 14001 for environmental management or ISO 27001 for information security).
• It demonstrates to regulators, customers, and partners that the company’s quality culture is embedded at all organizational levels.
  

A well-established and audited QMS leads to greater operational transparency, reduced nonconformities, improved employee accountability, and stronger supplier relationships.

In the case of ISO 13485, compliance also directly supports patient safety and risk reduction, ensuring medical devices are designed, produced, and maintained in a way that meets global safety expectations. 

This alignment with international regulations facilitates global market access, as ISO 13485 certification is widely accepted by regulators in Europe, Canada, Japan, Australia, and other major medical device markets.

Who needs to certify to ISO 13485?

Organizations involved in any stage of the medical device lifecycle, such as manufacturers, developers, and service providers, should seek ISO 13485 certification to meet regulatory requirements and demonstrate quality. 

While voluntary, certification is often a practical necessity for international trade and compliance with regulations like the EU’s Medical Device Regulation.  

Who should certify:

• Medical device manufacturers: Companies that design, produce, and test medical devices. 
• Contract manufacturers: Organizations that manufacture medical devices on behalf of another company. 
• Service providers: Businesses that provide services related to medical devices, such as installation, servicing, maintenance, or repair. 
• Software providers: Companies that develop software intended to be used as a medical device. 
• Suppliers and external parties: Any organization that supplies raw materials, components, or other products that are used in the medical device lifecycle. 
• Distributors and importers: Companies that handle the import or distribution of medical devices.

Why is certification necessary?

• Regulatory compliance: Many countries and regions, such as the European Union, require or highly recommend ISO 13485 certification to demonstrate compliance with their regulations. 
• Market access: It helps companies gain a competitive advantage, meet customer requirements, and export products globally. 
• Quality assurance: It provides a framework to ensure the quality and safety of medical devices, reducing risks and building trust with customers. 

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ISO 9001 vs ISO 13485 plays a vital role in building trust, consistency, and operational excellence across healthcare and related industries. By promoting process efficiency, continuous improvement, and customer satisfaction, it serves as the foundation for quality-driven organizations. At Folio3 Digital Health, we uphold these same principles through our HIPAA-compliant software solutions, designed to streamline workflows, enhance patient care, and ensure the highest standards of security and regulatory compliance.

Closing Note 

ISO 9001 vs ISO 13485 share the same foundation in quality management but with different purposes. ISO 9001 supports organizations across all industries in improving efficiency and customer satisfaction, while ISO 13485 focuses specifically on the safety, consistency, and regulatory compliance of medical devices. 

Choosing the right standard, or combining both, depends on your business scope and compliance goals. Ultimately, certification to either standard strengthens trust, quality, and long-term operational excellence.

Frequently Asked Questions

What are the 7 basic principles of ISO 9001?

The seven principles of ISO 9001 provide guidance for establishing and maintaining a strong Quality Management System (QMS). These principles are:

• Customer Focus
• Leadership
• Engagement of People
• Process Approach
• Improvement
• Evidence-Based Decision Making
• Relationship Management

What does it mean to be ISO 9001 certified?

Being ISO 9001 certified signifies that an organization has implemented a robust QMS that meets the standard’s requirements. 

Does ISO 9001 apply to medical devices?

ISO 9001 vs ISO 13485 can be applied to medical devices, but it is not the primary standard. It has a broad scope across industries. ISO 13485, on the other hand, is tailored to the unique regulatory, safety, and quality needs of the medical device industry.

How much does it cost to get ISO 13485 certified, and how long does it take?

The cost of ISO 13485 certification varies, typically ranging from $15,000 to over $100,000. Factors influencing the cost include company size, scope of certification, use of external consultants, QMS infrastructure costs, audit expenses, and certification body fees. Implementation time can vary from 3 to 12 months, depending on the organization’s size and readiness.

How do you prepare for an ISO 13485 audit?

To prepare effectively for an ISO 13485 audit, you should:

• Develop a comprehensive QMS aligned with the standard.
• Maintain complete and traceable documentation.
• Train staff regularly.
• Conduct internal audits and risk assessments.
• Ensure all processes are clearly documented and consistently followed.
• Conduct a gap analysis to identify areas for improvement, and ensure everyone involved understands the standard’s requirements for full readiness.

Why was ISO 13485 revised, and what are the main improvements?

All ISO standards are reviewed every five years to establish if a revision is required to keep them current and relevant for the marketplace. ISO 13485:2016 was revised to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The main improvements include a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

What Do ISO 9001 vs ISO 13485 Have in Common?

Both ISO 9001 and ISO 13485 share several key commonalities:

• Both are intended to help companies plan, build, and maintain an effective Quality Management System.
• Both focus on the realization of products through meeting customer needs.
• Risk assessment and mitigation are a significant focus in both standards.
• Both use cycles of Plan-Do-Check-Act to proactively assure quality.
• Both emphasize employee competency and infrastructure to deliver quality outcomes.

Other than 13485, what are the medical device ISO standards?

While there are many, the most notable and fundamental ISO standards for the medical device industry include:

• ISO 13485: This is the primary standard for a Quality Management System (QMS) specifically tailored to the unique regulatory, safety, and quality needs of the medical device industry.
• ISO 14971: This standard specifies requirements for the application of risk management to medical devices.
• ISO 15223-1: This covers the use of standardized symbols for medical device labels, labeling, and information to be supplied.
• ISO 62366-1: This standard addresses the application of usability engineering to medical devices.

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