ISO 13485 Certification

ISO 13485 Certification(Quality Management System for Medical Devices) – let your medicine be secured with ISO 13485

The organizations that are involved in the manufacturing and handling of medical devices are required to adhere to the norms of ISO 13485 medical devices standard. ISO 13485 is a set of standards that helps in the implementation of the Quality Management System for Medical Devices (MD-QMS).

It demonstrates the competency of the organizations in delivering good quality and safe medical devices and relevant medical services that can fulfill the customer’s requirements as well as ensure compliance with the regulatory norms. The latest version of ISO 13485 Certification was published2016 and hence, it is termed ISO 13485:2016.

ISO 13485 certification involves building a quality management system for medical devices by identifying the potential risks and documenting them effectively. The threats may arise from contamination of equipment or errors during handling. ISO 13485 provides for analyzing those threats and planning appropriate actions to prevent those risks.

Our accreditation with IAS and IOAS, and our close links with the medical authorities enable us to meet your certification requirements effectively. In some countries, certain local certification is required ISO Certification for Medical Devices along with ISO 13485 medical devices in order to be eligible to manufacture and sell medical equipment’s. Our vast network of experienced auditors all over the world helps you achieve this certification in a time-bound and hassle-free manner.

Importance of ISO 9001 Certification

ISO 9001 Certification is a universal standard for Quality Management System and one of the most used ISO standards. Over 1.1 million certificates have been issued in 178 countries.

85% of the certified organizations report benefits, such as higher demand for products and services, increased market share and improved business operation. Organizations with ISO 9001 Certification are more competent and pay 7% more on average.

ISO 9001 certification is the only standard in the ISO 9000 family of standards that requires certification. An entire organization seeks Certification, but the scope of the QMS can be accommodated to improve performance at a particular facility or department.

ISO 13485 Certification Principles:

  1. Customer focus – aiming to improve for the betterment of the interested parties and customer, this will help one sustain customer, increase customer base, makes sure to communicate their needs and expectation by monitoring throughout the organization.
  2. Leadership – to achieve quality objectives leaders need to establish unity of purpose which is by aligning its strategy, policies, procedure and resource this will lead to better coordination of the organization’s processes one needs to establish a culture of trust and integrity, provide people with the required resource, training, authority to act with accountability.
  3. Engagement of people – for efficiency involve people of all levels, this can be done by communicating with the employees their needs in the organization, sharing knowledge, and experience, recognizing people’s contribution, learning, and improvement.
  4. Process approach – when activities are understood and then executed then the efficiency of the delivered output will increase, by understanding organizations’ capabilities and determining resource constraints prior to action.
  5. Improvement – improvement is important for an organization to maintain the current level of performance and to even keep on developing, this can be done by giving proper training and letting them understand that how does a work happens with that track, review and audit planning, implementation, recognize and acknowledgment, which will result into anticipation of internal and external risks and opportunity, improved process performance.
  6. Evidence-based decision making – learn from mistakes, it is simply that decisions should be driven from evaluation of data, this will help one take better efficient solutions adding more, intuitions should never be neglected.
  7. Relationship management – manage relations with relevant interested parties such as providers, one can achieve by keeping a well-managed supply chain that provides a stable flow of products and services, determining interested party’s relationship that needs to be managed.

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.

ISO 13485 Benefits

ISO 13485 is helpful for organizations in all stages in 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 recognized standard, building your MDQMS in accordance with it has unfathomable benefits for your organization. It tremendously reduces your costs. Some of the many benefits of ISO 13485 certification are listed below:

  • An improved process results in reduced costs.
  • Better reliability of the management results in stronger relationships with the stakeholders.
  • ISO 13485 certification boosts your image and makes you trustworthy in the eyes of customers.
  • Your QMS for medical devices will ensure the quality and consistency of products when strictly adhered to the ISO 13485 requirements.
  • The global acceptability of ISO 13485 certification enables a wider market reach for your business. 
  • ISO 13485 is recognized by Global Harmonization Task Force (GHTF) as the standard for establishing model MDQMS for medical industries. In addition to that, ISO 13485 covers all legal and contractual requirements.
  • ISO 13485 also covers the requirements of the Food and Drug Administration (FDA).

ISO 13485 Requirements

Define the scope – It is very important to understand the purpose and market of the medical device in order to define the scope. It is also important to consider the regional regulations related to the product.

Perform ISO 13485 Audit & analyze the gap – An audit validates the conformities of your management system against the requirements of the management system. Any gaps should be thoroughly examined.

Prepare a project plan – The gap analysis after the audit helps you in developing a corrective action plan that takes into consideration all the non-conformities and ensures that you are compliant with ISO 13485 requirements as well as with other regional regulations.

Maintain documentation – the mandatory documentation, i.e., Quality Manual, procedures, work instructions, and documentation with evidence of proof of implementation should be maintained for the ease of the audit.

Train your workforce – It is very important to educate your workforce involved in the production of medical devices, regarding the requirements of ISO 13485 medical devices certification. This includes both legal and procedural requirements.

Implementation – Once you have established your quality management system for medical devices, you must run it for a period of at least three months and document your processes.

Conduct an internal audit – This is necessary to check for any deviation from the ISO 13485 certification requirements. It can either be conducted by one of your qualified employees or by any third party. 

Conduct a management review – A management review is necessary to ensure that your quality management system is functioning as per the requirements.

Apply for ISO certification – This involves inviting a certification body to conduct an audit on your management system. After the successful completion of the audit, you may be awarded ISO 13485 certification.

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Why Choose ISO 13485 from SIS Certifications?

We provide global services in issuing the ISO 13485 medical devices certification that is IAS and IOAS accredited. Our presence in over 55 countries ensures that the audit of your organization will be carried out by your local-language auditors.

We can help you in:

  • Gaining IAS and IOAS accredited ISO 13485 certification. 
  • Fulfilling your commitment to meeting your customer’s expectations.
  • Complying with the government’s regulations and gaining additional local certifications in order to be eligible for manufacturing and selling the medical devices.
  • The manufacturers of medical devices or their components, the contractual service providers, or the distributors of medical devices are all eligible for ISO 13485:2016.

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

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.

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

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.

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.

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.

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.

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.

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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