ISO 13485 Standards | Process of ISO 13485 Certification

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ISO 13485 Certification

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ISO 13485:2016 Certification outlines a comprehensive quality management framework for Medical Devices to ensure quality, from design and development to decommissioning and disposal.

The International Organisation for Standardisation (ISO) has developed ISO 13485:2016 Certification specifically for the Medical Devices Industry. Moreover, the certification works on the same line as ISO 9001 Quality Management Systems (QMS) Certification. It further guarantees that the organisation upholds the highest quality standards, from developing a medical device to its disposal.

ISO 13485:2016 certification is widely known for Medical Devices – Quality Management Systems (MD-QMS). Furthermore, the standard applies to all the industries involved in the manufacturing and handling of medical devices in one or more stages of the life cycle of a medical device.

Evolution of ISO 13485 Certification

The International Organisation for Standardisation (ISO) released the first version of the standard in the year 2003. However, since then, it has been revised only once in 2016. Hence, the current version of the certification is ISO 13485:2016 Certification.

ISO 13485 demonstrates an organisation’s competency to deliver high-quality and safe medical devices. Moreover, it exhibits the organisation’s responsible behaviour towards the safety and well-being of clients, customers, and stakeholders.

Scope of ISO 13485:2016 Certification

ISO 13485 Certification divides the medical devices into two categories. These are:

  1. Active Medical Devices
  2. Non-Active Medical Devices

Non-Active Medical are further classified into five broad categories; these are as follows:

  • General Non-Active, Non-Implantable Medical Devices
  • Non-Active Implants
  • Devices for Wound Care
  • Non-Active Dental Devices and Accessories
  • Non-Active Medical Devices other than specified above

Seven Principles of ISO 13485 Certification

ISO 13485:2016 Certification for Medical Devices – Quality Management Systems (MD-QMS) works on the seven pillars to meet the intended quality objectives and goals. The seven principles of ISO 13485:2016 Certification are as follows:

  1. Customer focus –It aims to improve for the betterment of the interested parties and customers. Moreover, this will help the organisation sustain customers and increase its customer base by meeting their needs and requirements. The certification ensures to communicate its vision and mission by meeting the needs and requirements of clients and customers.
  2. Leadership – Leaders must establish unity of purpose by aligning their strategy, policies, procedures and resources to achieve quality objectives. Moreover, this will lead to better coordination of the organisation’s processes. The certification also establishes a culture of trust and integrity by providing people with the required resources, training, and authority to act with accountability.
  3. Engagement of people –Organisations must communicate the quality requirements and objectives with the employees to achieve the desired goals and objectives. Moreover, an organisation must share its knowledge and experience to enhance employees’ participation and people’s contribution to boost their morale.
  4. Process approach –The certification provides the organisation with a process-based approach to streamline various processes and operations to attain quality objectives.
  5. Improvement-The principle of continuous improvement is an integral part of Medical Devices – Quality Management Systems (MD-QMS). organisations must maintain the current level of performance and keep on setting new quality benchmarks by giving proper training, reviewing and audit planning.
  6. Evidence-based decision-making –Organisations can learn from mistakes and encourage the organisation to make decisions based on past evidence. Moreover, this will help one implement efficient solutions by adding more facts and information to support its actions.
  7. Relationship management –An organisation must manage relations with the stakeholders and interested parties such as providers. The organisation can achieve this by keeping a well-managed supply chain that provides a stable flow of products and services and determining the interested party’s relationship.

PDCA Cycle

  • Plan – to think that what do we need to achieve in our organization
  • Do – to execute a planned action which will help us achieve the required objective
  • Check – monitor against the standards) (policies, objectives, requirements)
  • Action – finally implementing what has been rechecked.

Benefits of ISO 13485:2016 Certification

ISO 13485 is helpful for organisations in all stages of the product life cycle- starting from its design development, manufacturing, storage, and distribution of the final product. The applicability of ISO 13485 does not stop at that. It can also be applied for relevant services of medical devices along with associated activities that are in the form of technical support- both remote and on-site.

Since ISO 13485 is an internationally recognised standard, building an MDQMS helps an organisation to reap the unfathomable benefits. It tremendously reduces your costs.

Some of the many benefits of ISO 13485 certification are listed below :-

  1. An improved process results in reduced costs.

 

  1. Better reliability of the management results in stronger relationships with the stakeholders.

 

  1. ISO 13485 certification boosts your image and makes you trustworthy in the eyes of customers.

 

  1. An effective QMS for medical devices will ensure the quality and consistency of products when strictly adhered to the ISO 13485 requirements.

 

  1. The global acceptability of ISO 13485 certification enables a wider market reach for your business.

 

  1. The Global Harmonization Task Force (GHTF) recognises the ISO 13485 certification as the standard for establishing model MDQMS for medical industries. In addition to that, ISO 13485 covers all legal and contractual requirements.

 

  1. ISO 13485 also covers the requirements of the Food and Drug Administration (FDA).

Requirements of ISO 13485:2016 Certification

ISO 13485 is helpful for organisations in all stages of the product life cycle- starting from its design development, manufacturing, storage, and distribution of the final product. The applicability of ISO 13485 does not stop at that. It can also be applied for relevant services of medical devices along with associated activities that are in the form of technical support- both remote and on-site.

Since ISO 13485 is an internationally recognised standard, building an MDQMS helps an organisation to reap the unfathomable benefits. It tremendously reduces your costs.

Some of the many benefits of ISO 13485 certification are listed below :-

  1. An improved process results in reduced costs.

 

  1. Better reliability of the management results in stronger relationships with the stakeholders.

 

  1. ISO 13485 certification boosts your image and makes you trustworthy in the eyes of customers.

 

  1. An effective QMS for medical devices will ensure the quality and consistency of products when strictly adhered to the ISO 13485 requirements.

 

  1. The global acceptability of ISO 13485 certification enables a wider market reach for your business.

 

  1. The Global Harmonization Task Force (GHTF) recognises the ISO 13485 certification as the standard for establishing model MDQMS for medical industries. In addition to that, ISO 13485 covers all legal and contractual requirements.

 

  1. ISO 13485 also covers the requirements of the Food and Drug Administration (FDA).

How many stages are involved in ISO 13485 Certification?

1. Stage One (Documentation review) – At this stage, the auditors from the certification body verify that your documentation meets the requirements of ISO 13485.

 

2. Stage Two (Main audit) –In this stage, the realities of your processes are matched with your statements in the documentation for their compliance with the requirements of ISO 13485 standard.

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Gap Analysis

  • Understand the prerequisites of ISO standards by analyzing each clause thoroughly.
  • Analyze your system for any shortcomings.
  • You may take help from any ISO consultant to get you through this stage.

Implementation

  • Prepare the required documents, records, and policies
  • Perform internal audits and management review to understand gaps and practical realties
  • Perform corrective actions to confirm conformities

Certification

  • Fill the application form provided by the certification body
  • Invite the auditors from certification body for audit and certification
  • Get your management system ISO certified.
ISO 13485 Process

Gap Analysis

  • Understand the prerequisites of ISO standards by analyzing each clause thoroughly.
  • Analyze your system for any shortcomings.
  • You may take help from any ISO consultant to get you through this stage.

Implementation

  • Prepare the required documents, records, and policies
  • Perform internal audits and management review to understand gaps and practical realties
  • Perform corrective actions to confirm conformities

Certification

  • Fill the application form provided by the certification body
  • Invite the auditors from certification body for audit and certification
  • Get your management system ISO certified.

ISO 13485 Frequently Asked Questions about Quality Management System for Medical Devices (MD-QMS)

Question: What is the aim of ISO 13485 Certification?

 

Answer: ISO 13485 certification is globally recognized for the efficiency and effectiveness of the quality management system for medical devices on the basis of ISO 13485 standard. It aims to provide superior medical devices that meet and fulfill the customer’s requirements establishing a better relationship with them.

 

Question : What is the latest version of ISO 13485 Certification?

 

Answer: ISO 13485:2016 is the latest version of ISO 13485 Certification which was published in March of 2016. It focuses on providing superior medical devices and other related devices that consistently fulfills customers expectations.

 

Question: How is the external audit of ISO 13485 done?

 

Answer: Your certification body follows certain procedures and checklists to make sure that you have implemented all the necessary requirements.

 

Question: How can I get an ISO 13485 certificate?

 

Answer: Achieving ISO 13485 Certification is not a big deal in today’s upgraded systems. The basic steps to become ISO 13485 Certified are listed below: Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.) Secondly, you need to document all the relevant information about your business. Thirdly, you have to implement all the documented information in your organization. Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after. Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.

 

Question: How much does it cost for ISO 13485 certification?

 

Answer: The cost of ISO 13485 certification varies from one organization to another. Basically, when you approach an internationally accredited certifying body for ISO Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving ISO certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.

 

Question: How long is an ISO 13485 certificate valid for?

 

Answer: Basically, an ISO Certificate is valid for three years. And during this time period of three years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.

 

Question: How do I maintain ISO 13485 certification?

 

Answer: Just because you received an ISO 13485 certification, your task is not complete. For proper functioning of the management system, you need to maintain the ISO 13485 certification. For that, your company has to continually undergo an annual surveillance audit for the period of three years. After completion of the validity period, you need to get recertified.

 

Question: Is ISO 13485 certification right for me? / Why become ISO 13485 certified?

 

Answer: Having an ISO 13485 certification is important for any organization because it helps you to lower your cost amount, maximize your profits ability in the organization. The benefit of a quality management system also helps you to earn new customers and retain those customers for a long period.

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