ISO 13485:2016 Certification

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 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 vast network of experienced auditors all over the world helps you achieve this certification in a time-bound and hassle-free manner.

ISO 13485 Certification Principles:

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.

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.

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.

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 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.

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.

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 Certification 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.

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.

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 to the requirements of ISO 13485 standard.

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 : First of all, you need to choose an internationally accredited certification body meeting all the requirements of IAS Accreditation such as OM Dhruv Management systems. Then an application shall be created, where all the rights and obligations will be included and will be confidential between both the applicants and the registrar. After that, the ISO auditor will review the relevant documentation related to various procedures followed in your organization. The auditors will identify gaps, and if there are any gaps you have to prepare an action plan in order to remove these gaps. Then, there will be initial certification audits which will be followed by : Stage I – where the auditors will check the changes made in your organization according to requirements. Stage II – where the auditor will do their final audit for the certification.
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.