What is ISO 13485:2016? 

ISO 13485

The International Organization for Standardization (ISO) has generated the worldwide accepted standard ISO 13485:2016, especially for Quality Management systems of companies engaged in medical devices.

It’s a collection of standards that helps ensure medical devices that manufacturers create, develop, manufacture and sell that have market-safe and efficient devices. It is applicable in all stages from the initial phase to disposal.

What is the Purpose Of ISO 13485:2016? 

The most widely used international standard for quality management in the medical device business is ISO: 13485:2016. The ISO 13845: 2016 standard, published by the International Organization for Standardization (ISO), is a useful way to meet the Quality Management System in the medical device sector. This is the leading industry for medical equipment.

By implementing ISO:13845:2016, manufacturers show their dedication to medical devices and the safety and quality of Medical Devices while also complying with other laws like  Medical Device Regulation (MDR).

Establishing the management support system and customer needs for the Qualtity Management Standards is the very first step for creating the Qualtity Policy, Quality Objectives and Quality Manual, among the other paperwork. These, if taken together, constitute the General Framework for Quality Management System (QMS) for the system’s execution.

In addition to this, you need to develop essential and supplementary processes and procedures that are needed to develop and deliver the products and services successfully.

The International Accreditation Forum (IAF)  members need to certify certification bodies, and ISO surveys and the number of certifications the body issues.

What are the Benefits of Implementing ISO:13845:2016? 

Medical device companies can get profit in numerous ways by implementing ISO: 13845:2016:

  1. Superior Product Quality: Risk management and strict quality control are stressed by ISO 13485:2016 throughout a medical device’s whole lifespan. For patients, it means more safer and more reliable products.
  2. Regulatory Compliance: The standard aligns with global regulatory requirements for medical devices. Applying ISO:13485:2016 provides more assurance and even clears obstacles.
  3. Improved Client Confidence: By obtaining certificates, they can gain the trust of medical professionals, hospitals, and eventually the patients who use your gadgets.
  4. Efficient Processes and Operations: ISO defines encourages clear, concise and streamlined documentation and well-defined processes. This means lower cost, higher efficiency and even cost savings.
  5. Access to Wider Markets: Many countries require compliance with ISO 13485:2016 for medical device sales. Certification opens new ways to new markets and potential customers globally.

Where Does ISO:13845:2016 Apply?  

ISO:13485:2016 applies to the following things:

  1. Design and Development: From idea and design to prototyping and validation, the standard covers every step in the product development process.
  2. Production and Servicing: This includes product distribution, quality assurance, production procedures, and service delivery.
  3. Supply Chain Management: Managing suppliers of parts, raw materials, and services utilized in the manufacturing/ producing of medical devices is included in the standard.
  4. Risk management: Proactive risk identification, scrutiny, and mitigation throughout the device lifespan is a fundamental tenet of ISO 13485:2016
  5. Regulatory Compliance: The standard aids to guarantee that the applicable medical device laws in your intended markets are governed.
  6. Quality Management System (QMS): ISO 13485:2016 provides guidelines for creating a strong QMS that controls all procedures associated with the creation, manufacturing, and distribution of medical devices.

 What are the Requirements in ISO:13845:2016?  

An internationally accepted standard is referred to as ISO:13845:2016 describes the set of requirements for the Quality Management Systems (QMS) that are unique to many companies that design, produce and sell medical devices. Obtaining certifications with respect to that standard suggests that a company is capable of producing high-quality medical devices that can satisfy both client and regulatory requirements.

Here are the requirements for ISO:13845:2016

  1. Establishing a Quality Management System: In order to meet the requirements of ISO:13485:2016, one must create, record implement to maintain a QMS.
  2. Regulatory Compliance: In your target markets, the QMS must guarantee compliance with pertinent regulations related to medical devices.
  3. Risk Management: The basis of ISO 13485:2016 is an effective risk management procedure. This entails determining any possible hazards connected to your medical machines and putting measures in place to lessen those risks.
  4. Process Management: The standard focuses high emphasis on having well-defined and regulated procedures in place for all phases of the lifespan of a medical device, including development, manufacture, distribution, and service.

What Basic Documents are Required for ISO:13485:2016? 

The following documents are required for ISO:13485:2016

  • Quality Manual,
  • Control of documents,
  • Control of records,
  • Quality Policy,
  • Management Review documents,
  • Training and awareness,
  • SOP for Infrastructure,
  • work environment and
  • internal audit and records
  • other SOPs


Lastly, ISO:13485:2016 is the methodology for creating an excellent Quality Management System (QMS) that can be modified for the medical device sector. Organizations show their commitment to constantly creating high-quality medical devices that meet regulatory criteria and put patient safety first by adhering to its regulations. The standards set out in the standard for documentation, process control, and risk management encourage a daily improvement culture inside the company. It helps to improve and maintain the quality of the devices and ensure efficacy and safety.   In the end, ISO 13485:2016 certification is an assurance of a manufacturer’s commitment to supplying dependable medical equipment that enhances patient outcomes.


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