ISO Certification for Medical Devices | ISO 9001, 14001, 45001, 50001, 27001 ,13485, GMP ,HACCP | Accredify Global
How ISO Certification helpful for medical devices
ISO certifications for medical devices guarantee that every organization or management system has all the requirements for standardization, quality assurance, and consistency. ISO certifications are helpful for almost every organization regardless of its size, type, or process. ISO standard for medical devices is helpful for medical devices because it helps in the improvement of your product quality, and efficiency, builds international credibility, and so on.
Why do medical devices need ISO Certification?
All organizations that manufacture or fabricate medical devices are required to prove their efficiency and safety to the customers. In that regard, ISO Certification for medical devices is very much essential for those organizations. ISO standards for medical devices will help your organization to maintain the overall quality of your products. It also helps your organization to identify all the risks related to your devices and also helps you to find measures to mitigate those risks.
Which ISO Standard Required for Medical devices?
The International Organization for Standardization (ISO) publishes certain standards that help in implementing management systems for delivering quality products and services as well as enabling compliance to the related legislations. The most required ISO standards that are appropriate for medical devices are listed below:
ISO 9001:2015 Standard
ISO 9001 certification is an internationally accredited standard for quality management systems (QMS). This standard helps in the accomplishment and maintenance of quality management systems (QMS) in your organization so that the quality of your products, as well as processes, are top-notch.
ISO 14001:2015 Standard
ISO 14001 Certification is the general standard for Environment Management Systems. ISO 14001 standard helps in the execution of Environmental Management Systems (EMS) in your organization to make sure that your products and services are not causing environmental damage. It also helps your organization to minimize the harmful impacts of your processes in the environment.
ISO 45001:2018 Standard
ISO 45001 Certification is an internationally required standard which is probably the most important one for your organization, as it ensures the safety and wellbeing of your manpower, contractors as well as the nearby population. This standard helps in the implementation of Occupational Health and Safety Management Systems (OHSMS) in your organization.
ISO 50001:2018 Standard
ISO 50001 Certification is an internationally accepted standard for energy management systems. This ISO standard for the industry helps to improve your overall energy management and can reduce costs and operating expenses.
ISO 27001:2022 Standard
ISO 27001 Certification is a globally recognized standard that helps in implementing Information Safety Management Systems (ISMS) in your organization that would protect the data stored within your premises from any breach or loss.
ISO 22301:2019 Standard
Ensures operations remain functional during crises. Reduces downtime by 60%, enhancing resilience. Minimizes downtime and financial losses.
ISO 10002:2014 Standard
Improves customer feedback management. Enhances brand reputation and consumer trust. Reduces customer complaints by up to 30%.
ISO 26000:2010 Standard
Encourages ethical sourcing and fair trade practices. Supports sustainable agriculture and food production. Builds consumer trust in ethical food brands.
ISO 28000:2022 Standard
Ensures operations remain functional during crises. Reduces downtime by 60%, enhancing resilience.Essential for critical operations.
ISO 20121:2012 Standard
Ensures sustainability in food-related events and catering services. Reduces food waste and environmental impact.Supports eco-friendly packaging and resource management.
ISO 13485:2016 Standard
Ensures quality, safety, and regulatory compliance in medical device manufacturing. Reduces product defects by up to 40%.Essential for manufacturers, suppliers, and distributors of medical devices.
GMP : Good Manufacturing Practices Certification
Ensures safe and hygienic food production.Prevents contamination, cross-contamination, and foodborne risks.Essential for food processing units, bakeries, and packaging plants.
HACCP: Hazard Analysis and Critical Control Points
Identifies and controls food safety hazards. Ensures hygienic food production and distribution.Reduces risk of contamination and recalls by up to 50%.
ISO Certification process for Medical Devices
- Application & contract
- Audit team Assignment
- Document view
- Certification Audit Independent review
- Notification of Certification
- Surveillance audit
- Re-Assessment
The certification process goes further. click here to view the next steps to the ISO certification Process
ISO certifications have huge significance across a varied range of industries. They not only help to improve the processes within the organization but also ensure a smooth flow of services throughout the supply chain.
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Benefits of ISO Certification for Medical Devices
ISO certification for medical devices can help ensure safety, effectiveness, and regulatory compliance. It can also improve efficiency and productivity, and enhance a company's brand reputation.
Why Choose Accredify Global for ISO Certification?
Accredify Global is a leading ISO certification body, operating in 95+ countries, offering:
- Certified auditors with expertise in the education industry.
- 30% faster certification process than competitors.
- Tailored compliance solutions.
- 24/7 support for audits, quality management & compliance.
- Affordable pricing & flexible certification plans.
FAQs
What ISO certificates are required for the Medical devices industry?
Answer: The most commonly required standards that are applicable for Medical Device Industries are as listed below:
- ✅ ISO 9001:2015 - Quality Management System.
- ✅ ISO 14001:2015 - Environmental Management System.
- ✅ ISO 45001:2018 – Occupational Health & Safety (OHS)
- ✅ ISO 50001:2018 – Energy Management System
- ✅ ISO 27001:2022 - Information Security Management System (ISMS)
- ✅ ISO 13485:2016 - Medical Devices Quality Management System (MDQMS)
- ✅ GMP : Good Manufacturing Practices Certification
- ✅ HACCP: Hazard Analysis and Critical Control Points
How do ISO regulations affect medical devices?
Answer: There is always a positive effect of ISO regulation on the Medical Devices. This is so because, The ISO certification for medical devices makes the production, development, and supply of products and services more effective and efficient and also helps in reducing the adverse impact of your activities on the environment. It gives confidence to the customers that the products that they are using are of premium quality.
How do we become ISO Certified for the medical devices ?
Answer: Achieving ISO Certification medical devices for is no big deal in today’s upgraded systems. The basic steps to get ISO Certification for medical devices are as follows: > 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.
How long is an ISO certificate valid for?
Answer: Generally, an ISO Certificate is valid for 3 years. And during this time period of 3 years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.
How can I apply for ISO Certification for medical devices
Answer:
Firstly, select the type of ISO certification you want for your medical devices.
Secondly, selecting a recognized and credible ISO certification body (ISO Registrar)
Thirdly, make an application in the prescribed form which should include liability issues, confidentiality, and access rights.
Fourthly, the ISO certification body will review all the documents related to various policies and procedures being followed in the organization. If there are any existing gaps, the applicant has to prepare an action plan to eliminate these gaps.
Then, the ISO registrar will conduct a physical onsite inspection to audit the changes made in the organization.
As soon as the certifying body approves your management system, you will be awarded the required ISO standard.
How much does it cost for ISO certification?
Answer: Basically, when you approach a 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.