ISO 13485 Explained

By Scott Dawson
November 28, 2023

What is ISO 13485?

ISO 13485 is a Quality Management System created for organizations involved in the design, production, installation, and servicing of medical devices and related services.

The Impact of Covid on Medical Equipment Sales

A few things happened related to the pandemic and the production and sale of medical equipment. While there was an increased demand for medical equipment and supplies because of Covid, there was also, simultaneously, a decrease in demand because of the postponement of elective surgery.
In addition, people were more sedentary during the pandemic which led to people developing more health issues than normal. Furthermore, demand grew for in-home health care and portable medical equipment, and is still on the rise. All these pandemic-related factors have affected the demand for medical equipment over the past couple of years.
Home Medical Equipment

The Medical Device Industry is Growing

In 2021, the global medical devices market totaled approximately $485 billion. According to Fortune Business Insights, the medical devices market was valued at $512.29 billion in 2022 and is projected to grow from $536.12 billion in 2023 to $799.67 billion by 2030.

Demand is increasing for medical equipment and medical equipment manufacturers need to be certified. This article discusses how to get ISO 13485 certification and explains the specific requirements of the standard.

Who wrote ISO 13485?

The ISO 13485 standard was published by the International Standards Organization (ISO) to provide ISO 13485 medical device companies with a set of requirements for establishing and maintaining quality systems. The standard was first published in 1996 as a quality management standard for medical device companies based on the ISO 9001 standards.

How is ISO 13485:2016 Different from the Previous Version?

The newest version, ISO 13485:2016 has 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.

How are the 13485 Requirements Organized?

ISO 13485 requirements are organized into the following sections:

 

  • Quality Management System

  • Management Responsibility

  • Resource Management

  • Product Realization

  • Measurement, Analysis, & Improvement

Together, these requirements make up the Quality Management System (QMS) described in company documentation and include the quality manual, procedures, policies, records, and other information used for day-to-day operational excellence. An effective QMS is one where a company follows its processes and documentation consistently, achieves the desired results of its objectives and key performance indicators, and continually improves to perform better for its customers.

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What are the Benefits of ISO 13485 Certification?

There are Numerous Benefits to Achieving ISO 13483 Certification:

 

  • Improved Customer Satisfaction

  • Improved Medical Device Products

  • International Recognition of Your Certification

  • Improved Business Processes

  • Reduced Risk

  • Reduced Cost Due to Errors & Waste

  • Business Growth & Diversification Opportunities

  • Involvement of All Employees in Ensuring the Effectiveness of Your Quality Management System

  • Greater Management Visibility

Who Issues the 13485 Certificate?

ISO 13485 certificates are issued by a third-party registrar after an extensive audit of a company’s QMS. During the audit, they will evaluate compliance with the standard’s requirements. Surveillance audits must be repeated on an annual basis to maintain certification.

What are the Clauses of the ISO 13485 Standard?

Clauses one through three are technically not auditable and simply provide additional supporting information like the overall purpose of the standard, an explanation of the process approach methodology, other documents or standards that may be referenced, and some terms and definitions that are applicable.

These are the clauses of the ISO 13485 Standards the Auditor will Expect to See Addressed:

Clause 4 – Quality Management System (QMS)

The very first auditable clause of the standard is all about setting the foundation for your quality management system.  In this section, we will define the purpose of the company and define quality objectives.  We will identify the key processes contributing towards the quality of our products or services.  Required documents and records are identified as well as requirements for their management and control.  The Quality Manual requirements are defined. Medical Device Files, needed to demonstrate compliance with any legal and ISO 13485 requirements, are also addressed in this clause.

Medical Equipment advisors

Clause 5 – Management Responsibility

This section of the standard is all about Management Responsibility as it relates to the quality management system (QMS). Management commitment to the QMS is a key foundation of the standard and a variety of tools are used to ensure this. The organization is required to publish a quality policy that establishes management’s vision and its commitment to quality and customer satisfaction.

This section also establishes expectations regarding QMS planning, including the establishment of quality metrics, communicating QMS requirements throughout the organization, and assigning QMS responsibilities. A Management Review of the QMS is required at least once annually.

Clause 6 – Resource Management

This clause establishes the resource requirements (personnel, infrastructure, etc.) to ensure that the QMS is effective, continually improves, and is structured to achieve customer satisfaction. Requirements for documentation of competence and training records are defined. Infrastructure, including IT and data security, work environment, and contamination control are addressed.

Clause 7 – Product Realization 

This clause is focused on the manufacturing of products and/or delivery of services. It establishes the need to thoroughly plan and consider all risks that may affect the processes. Contract review, a clear understanding of customer needs, and open lines of communication with customers are defined. Design and development are described in detail to establish expectations regarding effective methodology.

Vendor/supply chain management, including vendor selection and evaluation, effective communication of requirements to vendors, and verification of purchased/outsourced products and services are covered. The conditions in which production and service are conducted must be controlled to ensure product conformity. Requirements for the cleanliness of the product, any installation or servicing activities, sterilization, and (when applicable) process validation are defined. Identification and traceability requirements are addressed.

Warehouse/storage activities must be controlled to ensure the preservation of product (packaging/handling) and a process to manage customer-owned property must be established.

Clause 8 – Measurement, Analysis, & Improvement

This section establishes requirements for objective evaluation of how well the medical device conforms to specifications and the resulting customer satisfaction with the product and/or service. Documented processes for proactively obtaining and evaluating customer feedback and complaints are required. A system to report any legally required information to regulatory agencies is required.

The QMS must be internally audited regularly (annually at a minimum) and process metrics tracked. Nonconforming products must be formally addressed, and causes/corrective actions documented.

ISO 13485 Consultants

Rework must be conducted under controlled conditions. The QMS should be in a state of continual improvement and documentation of corrective and preventive actions must be retained and analyzed. Written by the International Organization for Standardization, ISO 13485 is the medical device industry’s most widely used standard for quality management. 

Your Company’s Pursuit of ISO 13485 Certification will help you:

 

  • Rise to the Top of Your Competition

  • Deliver Better Service & Products

  • Grow Opportunities for Both Your Business and your Team

How Core Business Solutions Can Help

Our modular approach breaks down the ISO 13485 standard into simple and manageable parts. We assist you in a guided self-assessment, provide expert online or onsite consulting services to help you develop your QMS, and layout a roadmap and budget for successful implementation and remediation – all in preparation for your 3rd-party certification audit.  

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