ISO 13485

What is ISO 13485:2016? [Quality Management Systems]

Have you spent countless hours thinking about what ISO 13485:2016 or Quality Management Systems is?

Let us inform you that you are not ALONE.

ISO 13485:2016 – For the medical device manufacturer it is an internationally recognized quality management system benchmark. When you obtain this license then you guarantee the trust of your regulators, stakeholders and future customers when you enter in the market.

But when you try to obtain this license then there is no denying that the process is quite complicated to needs to be done right.

But with the help of Expert guidance, you can simply apply for the ISO 13485:2016 quality management certificate online.

Here you will get to know what is ISO 13485:2016 (Quality Management Systems), its process, documentation and further details that will help you to understand this. Let’s dive deep

What Does ISO 13485 Mean?

ISO 13485 is a set of international working standards for the quality management system (QMS). It is mandatory for any company who is indulged in the design, production, installation, servicing and manufacturing of medical devices.

ISO 13485 is the standard first published in the year 1996 and revised in 2003 and 2016. The current version of the ISO came into effect in March 2016. This ISO standard aims to ensure that medical devices and services consistently meet customer expectations and regulatory requirements.

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 applies in all stages from the initial phase to disposal.

What Does ISO 13485 Stand For?

The ISO in ISO 13485 stands for International Organization for Standardization. It published the international standards governing most modern industries.

If you are thinking why it is ISO rather than IOS as per the full form then let us inform you that as an internationally focused organization. Any business acronym in English wouldn’t neatly translate into other languages.’ ISO’ was therefore agreed upon as a snappy, short-form version of the Organization’s full name.

13485” stands for the numerical code that is given to the ISO medical device quality management standard.

Difference Between The ISO 13485 Certification and Accreditation

CertificationAccreditation
The ISO 13485 certification is granted to any medical device organization that meets the requirements of ISO 13485.The ISO accreditation is provided to a conformity assessment body as proof of its integrity, impartiality and operational ability.

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 first step for creating the Qualtity Policy, Quality Objectives and Quality Manual, among the other paperwork. If taken together, these 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 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? 

Implementing ISO 13485:2016 provides significant benefits for medical device companies. It is an internationally recognized standard that ensures regulatory compliance, enhances product quality, and boosts customer confidence.

  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 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.

Steps To Apply ISO:13845:2016 Certificate For Medical Devices

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 concerning 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 – 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

Conclusion

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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