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Get ISO 13485 Certification with expert Medical Devices Consultant

Get ISO 13485 Certification with expert Medical Devices Consultant


If your company is looking for an ISO 13485 Certification on quality management system (Medical Devices QMS) based standard, you might be overwhelmed with figuring out where to start. To help, our Medical Devices Consultant industry experts, have provided an overview of the steps that are needed to help you make sure that nothing is missed during your implementation and preparations for ISO 13485 certification:

Management Support is crucial for maximizing benefits for Precise Guidance from Expert Medical Devices Consultant –

This is the most critical. Without the support of management, your implementation of ISO 13485 will almost certainly fail. Plan your sales pitch well to convince your management that ISO 13485 is a good idea, and if you need some help take a look at the ISO certification Benefits Tutorial video.

Establish ISO 13485 Certification Project, Project plan and resources with vital inputs from Medical Devices Consultant expert -

Determine the cut off period by which you need to have the ISO 13485 certification in place. This would enable reverse engineering of the project and the importance of timelines including the early start-off date. Identify the project leader. Identify the products or services to be included in the scope of ISO 13485 certification. Do the costing. It includes implementation learning cost and Certification fee. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

Conduct of ISO 13485 Awareness Training by Medical Devices Consultant-

This is required to gain A to Z of the fundamentals of ISO 13485. We need to cover all the resources in the scope. This training is imparted in batches by specialists and industry experts. Evidence of training records needs to be maintained for demonstration during the ISO 13485 certification audit.

Identify the ISO 13485 Implementation team- ISO 13485 implementation can no longer be tasked to single person or group of few persons in the organization. The ISO 13485 Standard is premised on Risk Based thinking, and risk management must be done at the hands of respective departments and functions, such that head of the departments are the “ Risk-Owners. Therefore the implementation team would include Heads of the departments, deputies or other critical resources in each function, besides the central team. 

Conduct of ISO 13485 Implementation Training by Medical Devices Consultant -

This training is imparted by ‘specialist and industry expert’ to the implementation team identified by the organization. The ISO 13485 Implementation training is conducted in a workshop style covering implementation practical cases of your organization and its processes. This would last up to 7 days.

Define context, scope, and Policy – Defining the context, scope, and policy of your Medical Devices QMS will help to ensure you know the limits of what needs to be done so that you do not include areas of your business that might not have an effect on your system. The key tool to define the scope is the dependency matrix which will be the first document you will need to create for the Medical Devices QMS. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

Define RA & RT, Objectives, processes and procedures – Risk assessment and risk treatment is the backbone of ISO 13485 implementation. Medical devises QMS Objective help to conduct a dipstick check of the performance levels. Documentation will include the mandatory procedures defined by the ISO 13485 standard, but also any additional processes and procedures required by your company to ensure consistent and adequate results with respect to quality. The key is to define all the processes in your company and look at how they interact within your organization. It is in these interactions that problems can occur. The extent of documentation depends on size of the organization, complexity of the processes and competence of the people. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

Implement ISO 13485 processes and procedures – Often, these processes will already be in place at your company and will just need to be adequately documented to ensure consistent results. Not all processes need to be documented procedures, but it is important to decide which ones need to be in order to ensure compliant products and services. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

Conduct of ISO 13485 Internal Auditor training by Medical Devices Consultant –

ISO 13485 standard requires the organization to train a team of internal auditors who would perform cross audit on another on a regular basis. Internal Auditors need to be competent. To evidence the same, the organization needs a specialist Industry expert to impart ISO 13485 Internal Auditor training.

Conduct ISO 13485 internal audits – Before the Lead Auditors of certification body visits to audit your system, ISO 13485 mandates that you audit each process internally. This will give you a chance to make sure that the processes are doing what you had planned. You will also have a chance to implement the necessary corrective actions to fix any problems that you find. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

Closure activities and Corrective Action reports – This is the step where you find the root cause of any problems found during your measurements, internal audits and management review, deviations from the established processes, customer concerns and take action to correct the root cause. This is the key step toward Continual improvement, which is a main focus of having an ISO 13485 Medical Devices QMS. For an explanation of the corrective action process see the tutorial on CAPA. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

Conduct ISO 13485 management reviews – Just as it is important that management supports the implementation of ISO 13485, it is also important that they are fully involved in the maintenance of the Medical Devices QMS. Top Management needs to review specific data from the activities of the Medical Devices QMS in order to ensure that the processes have adequate resources to be effective and improve. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

Pre-assessment / ISO 13485 Gap Analysis by Medical Devices Consultant -

This is done by Specialist Industry expert, to help the organization in gap analysis, so that gaps identified during pre-assessment/ gap analysis are plugged before the organization Proceeds for Certification Audit. This is a very important step to raise the confidence level of the auditees.

Choose a certification body – This can be a very important step in how effective your implementation is. The certification body is the company that will ultimately come in to audit your Medical Devices QMS and decide if it is compliant with ISO 13485 requirements, as well as whether it is effective and improving.

Operate & measure the Medical Devices QMS – This is when you will collect the records that will be required in audits to show that your processes meet the requirements set out for them, that they are effective, and that improvements are being made in your Medical Devices QMS as needed. Certification bodies need this to happen over a certain length of time ( generally not less than 3 months), which they will identify, in order to ensure that the system is mature enough to show compliance. You would receive One hundred percent guidance and support from the Medical Devices Consultant. 

ISO 13485 Certification audit- Stage 1 – This is a review of your documentation by the certification body auditors to verify that, on paper, you have addressed all the necessary requirements of the ISO 13485 certification standard. The auditors will issue a report outlining where you comply and where there are problems, and you will have a chance to implement any corrective actions to address the problems. This may take place during the timeframe defined for the initial operation of the Medical Devices QMS.

ISO 13485 Certification audit- Stage 2 – This is the main audit when the certification body auditors will review the records you have accumulated by operating your Medical Devices QMS processes, including your records of internal audits, management review, and corrective actions.  From this review, which will take several days, they will issue a report detailing their findings and whether they have found your Medical Devices QMS to be effective and in compliance with the ISO 13485 certification requirements. The auditors will also make a recommendation for certification if you meet all requirements. If you have any major non-conformances, then you will need to take corrective action for these problems before certification can be recommended.

A good plan will help a lot when you implement ISO 13485 and work toward certification, so do take the time to plan and know what resources you need – this will save you time and resources later on.

Value-added Medical Devices Consultant Service

Accelerate learning with the expert Medical Devices Consultant Lead Auditors and Principal Trainers from the Industry. Learning from the "Specialist Expert" has many advantages:-

  • It will drastically change the way of thinking and the basic approach towards the Management System Standards.

  • You would cherish & Benchmark our training for a very long time to come.

  • No fictitious case studies you can not connect with.

  • Real-time examples, real-time scenarios you can quickly relate to.

  • Complete Focus on your systems, processes, and line of businesses.

  • 100% involvement and engagement of the participants

  • Learn to make the ISO Standard sweat to:-

A). Improve profits.

B). Reduce rework, defects, customer rejections, wastage,& cost of operation

C). Enhance customer delight

D). Reduce attrition of customers and employees

E). Enhance confidence of all stakeholders