ISO 13485 Certification
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ISO 13485:2016 is the quality standard stating the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices.
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 published in 2016 and hence, it is termed ISO 13485:2016.
ISO 13485 certification involves building a quality management system for medical devices by identifying 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 vast network of experienced auditors all over the world helps you achieve this certification in a time-bound and hassle-free manner.
What are the Principles of ISO 13485 Certifications?
- Customer focus – aiming to improve for the betterment of the interested parties and customers, this will help one sustain customers, increase customer base, and make sure to communicate their needs and expectations by monitoring throughout the organization.
- Leadership – to achieve quality objectives leaders need to establish unity of purpose which is by aligning their strategy, policies, procedure, and resources 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.
- Engagement of people – for efficiency involves people of all levels, this can be done by communicating with the employees their needs in the organization, sharing knowledge, and experience, and recognizing people’s contribution, learning, and improvement.
- 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.
- 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 how work happens with that track, reviewing and audit planning, implementation, recognizing and acknowledgment, which will result into anticipation of internal and external risks and opportunity, improved process performance.
- Evidence-based decision making – learn from mistakes, it is simply that decisions should be driven by evaluation of data, this will help one take better efficient solutions adding more, intuitions should never be neglected.
- Relationship management – manage relations with relevant interested parties such as providers, one can achieve this by keeping a well-managed supply chain that provides a stable flow of products and services, determining interested party relationship that needs to be managed,
ISO 13485 Benefits
ISO 13485 is helpful for organizations 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 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 the 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.
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 Certification Process
3 Steps to Certification
With the help of SIS Certifications, the certification process can take as little as 40 days to complete
Gap Analysis
- Assess your management system's compliance with the requirements of the applicable standard.
- Discuss what needs to be included in the project plan and agree on any remedial action.
- Identifying any non-conforming areas.
- Set the groundwork for a project plan.
Implementation
- ISO certification is an extensive procedure that necessitates knowledge and experience.
- SIS Certifications is not engaged in the implementation or preparation of documents to obtain ISO Certification.
- SIS Certifications does not participate in this implementation phase since it would jeopardize our integrity and impartiality as a certifying authority.
- Organizations need to dedicate the appropriate resources, time, and effort to implementing management systems and procedures.
Certification
- Application Form : Clients must fill out the basic data of the organization in the application form.
- Contract Review: Our quality team evaluates the client's requirements.
- Audit: Stages 1 and 2
- Decision Making : The DM team makes the decision to provide the certification.
- Stage One (documentation review) – At this stage, the auditors from the certification body verify that your documentation meets the requirements of ISO 13485.
- 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 standards clauses.
the certification process goes further. Click here to view the next steps in the ISO certification process
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: 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 fulfill customers' expectations.
Answer: Your certification body follows certain procedures and checklists to make sure that you have implemented all the necessary requirements.
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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