In today's international marketplace, many organisations require ISO certification to demonstrate credibility, meet legal requirements and stay competitive.
ISO standards help businesses keep product and service quality consistent. They also reduce risks and build trust among consumers, clients and partners.
By aligning with global regulations, ISO facilitates international trade, enhances market access and strengthens supply chains. It also promotes operational efficiency, cost savings and continuous improvement, while driving innovation and sustainability.
What is ISO?
The International Organization for Standardization (ISO) is a global non-governmental entity that creates and issues proprietary, industrial, and commercial standards. Operating in accordance with ISO standards is crucial for businesses, industries and governments worldwide. It provides a structured framework to ensure quality, safety, efficiency and compliance across various sectors.
ISO standards for diagnostic audiology devices
Over 25,000 ISO standards exist, covering a wide range of industries. This includes technology, manufacturing, food safety, healthcare, and environmental management. The ISO continuously develops new standards and updates existing ones to meet industry and regulatory needs.
Several ISO standards apply to different aspects of audiological devices. This includes hearing aids, audiometers and cochlear implants. In the case of audiometric equipment, it's important for manufacturers to observe the following standards:
ISO 13485:2016 Quality Management System
ISO 13485:2016 is an internationally recognised standard for manufacturing medical devices. ISO 13485:2016 is critical for audiometer manufacturers because it provides a structured Quality Management System (QMS).
The standard guides organisations involved in the design, production, installation, and servicing of medical devices and related services.
Having ISO 13485:2016 certification is not a legal requirement in most countries. However, some regulatory authorities strongly encourage or indirectly require compliance to this standard.
Following this standard shows that a company can consistently provide medical devices and services. This meets customer needs and follows the necessary regulations.
ISO 8253 Series – Audiometric Test Methods
The ISO 8253 series is a set of international standards. They define procedures for conducting audiometric tests, ensuring consistency, accuracy, and reliability in hearing assessments. These standards are crucial for audiologists, hearing specialists, and medical professionals who conduct hearing tests. The standard is divided into multiple parts, each focusing on different aspects of audiometry:
- ISO 8253-1:2010 – Basic pure-tone air and bone conduction
- ISO 8253-2:2009 – Sound field audiometry with pure-tone and narrow-band test signals
- ISO 8253-3:2012 – Speech audiometry
ISO 389 Series - Reference Zero for Calibration of Audiometric Equipment
The ISO 389 series establish reference levels for audiometric calibration, ensuring that hearing tests are accurate and consistent across different audiometers and environments.
These standards define Reference Equivalent Threshold Sound Pressure Levels (RETSPLs). Along with Reference Equivalent Threshold Force Levels (RETFLS) for various transducers (headphones, insert earphones, bone vibrators, etc.).
Like ISO 8253, there are many sub-standards within the IEC 60645 series. The main sub-standards cover air conduction audiometers ISO 389-1:2017, short duration signals (ISO 389-5:2006), free-field audiometry (ISO 389-3:2016) to insert earphones (ISO 389-4:1994) and more.
Following the ISO 389 series allows technicians to calibrate audiometers correctly, ensuring accurate hearing tests for patients worldwide.
IEC 60645 series - Electroacoustics – Audiometric Equipment
The ISO 60645, also called IEC 60645, comprises several international standards. These standards specify performance requirements for various types of audiometric equipment.
- ISO 60645-1:2017 – Pure-Tone Audiometers
- ISO 60645-2:2021 – Equipment for Speech Audiometry
- ISO 60645-3:2007 – Auditory Steady-State Response Audiometers
- ISO 60645-5:2004 – Instruments for the Measurement of Auditory Brainstem Reponses
These define technical and performance requirements for audiometric equipment. This ensures standardisation, accuracy, and reliability in hearing assessment devices. These standards cover various types of audiometers used in clinical and research settings.
It also ensures that audiological medical devices meet international standards for accuracy and reliability. Facilitates consistent hearing assessment across different clinics and research settings and also improves patient safety by regulating output levels and calibration procedures.
What are the benefits of ISO 13485:2016?
ISO 13485:2016 provides a structured framework for a Quality Management System (QMS) specific to the medical industry. The key benefits of implementing ISO 13485 include:
| Regulatory compliance |
- Helps meet global regulatory requirements (e.g., FDA, EU MDR, Health Canada)
- Reduces legal risks by ensuring adherence to industry standards.
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| Improved product quality and safety |
- Ensures consistent design, production, and servicing of safe medical devices
- Implements a risk-based approach to prevent defects and failures.
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| Increased market access |
- Companies often require certification to sell medical devices in international markets
- Builds trust with regulators, customers, and business partners.
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| Enhance process efficiency |
- Streamlines quality management processes, reducing waste and errors
- Improves traceability and documentation, making audits easier.
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| Stronger supplier and risk management |
- Ensures better control over suppliers and outsourced processes
- Enhances risk management strategies throughout the product lifecycle.
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| Continuous improvement |
- Encourages ongoing monitoring, evaluation, and enhancement of the QMS
- Helps companies stay competitive by adopting best practices.
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Amplivox quality management system
At Amplivox we dedicate ourselves to patient safety, innovation, and meeting regulations. We are a certified Legal Manufacturer of medical devices, committed to delivering high-quality, safe, and effective healthcare solutions.
Our QMS is fully compliant with ISO 13485:2016, ensuring strict adherence to regulatory requirements and industry best practices. We undergo regular audits by a Notified Body, demonstrating our commitment to maintaining the highest standards of quality control and compliance.
All our devices are CE marked, confirming their conformity with European Medical Device Regulations (MDR 2017/745) and enabling their distribution within the European market.
As a result, healthcare providers around the world can trust our medical devices for great performance and compliance. For more information on our regulatory compliance please contact us on +44 (0)1865 880 846 or email.