ISO 13485 Certification : Consultants in SRI LANKA

ISO 13485 specifies requirements for quality management systems that can be used in an organization involved in one or more stages in the life cycle of a medical device including design and development, production, storage & distribution, installation & servicing and final decommissioning and disposal of medical devices. ISO 13485:2016 accreditation was established by ISO (International Organization for Standardization) and revised in the year 2016 to authenticate Quality Management System and security in medical devices. Due to continuous and rapid developments in its technologies and equipment in medical technology, Security and safety measures plays an important and vital part – this is where we require ISO 13485. 

The requirements of ISO 13485 can also be used by suppliers or other external parties providing products such as Raw materials, components and subassemblies, medical devices, sterilization services, distribution services and maintenance services. Adopting ISO 13485 provides a practical foundation for manufacturers, suppliers or the external parties related to the industry to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. The first step in getting your company ISO 13485 certified is to adapt to the QMS based on the requirements of ISO 13485 standards.

Once it’s is been done than hiring a recognized certification body to audit and approve your QMS as meeting the requirements of the ISO 13485 standard. Starting with prior approval from the management and identifying the customer requirements as per the industry involved for the QMS, you will need to start with defining your quality policy, quality objectives, and quality manual, which together define the overall scope and implementation of the Quality Management System. Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service.

  • To get management support prior to the start of the project.
  • Identification of the requirements – legal & regulatory, customers, external parties etc.
  • Defining the scope – setting the nature of work to be done and boundaries of implementation.
  • Documentation Work – To develop the Quality Policy, Quality Manual, processes & procedures.
  • Implementation – Set up the processes & procedures and to see their interaction.
  • Awareness Training Program – All personnel’s get an idea of the purpose of implementation and also any changes to be made in the processes they are part of.
  • Measuring the system – Collection of records and to check whether they meet the requirements set out for them.
  • Conduct Internal audit – Once the QMS is set and operated for the duration, internal audit needs to be done t ascertain whether they are functioning as per the requirements or needed corrective actions.
  • Management Review meeting – Records and data collected during the internal audit are to be examined and reviewed in the meeting to ensure all the resources required for the smooth functioning of the process are adequate.
  • Corrective actions- Root cause analysis are done and corrective actions taken for the problems discovered during measurement, internal audit & management review meeting.
  • Certification audit – External bodies are invited to do the final audit of the QMS.
  • It improves the image and credibility of the organization from the customer point of view.
  • By identifying and meeting customer requirements and needs means repetitive customer business and growth.
  • Process approach helps in integration of all the related process within the organization which results in improvement and hence resource management.
  • Decisions are based on good evidence, thus resources within the organizations are best targeted to get effective result improving organizational efficiencies and effectiveness.
  • As continual improvement being the main output of any QMS, so developing such culture within the organization always puts focus on the workforce for improving the processes hence increase in profit. 
  • By engagement of the workforce within the processes for continual improvement, better output and solutions can be achieved.
  • There are mainly three major challenges in implementing ISO 13485:-

    • Leadership – Leaders need to view their QMS as an essential part of business process rather a certification to meet the requirements of the customers. They set the tone for how the rest of the organization approaches towards the process.
    • Rumors & Gossips – General misconceptions and fear among the employees that the change in process would have an impact over their job should be changed. Proper communication by the top management about the QMS should be done among their workforce to remove the fear and enhances active participation.
    • Documentation overburden – The management should ensure practice over theory for successful implementation of the QMS. Primary objective of documentation should be to facilitate communication, improve operations, or make the compliances easier rather useless paperwork which becomes a challenge for implantation.

How Ascent can help you?

  • Our experts will guide you through the exact requirements of the documentation process as per the industry requirements removing useless paperwork and unnecessary documents.
  • Our highly professional training modules are designed on industry-specific need imparting a complete understanding and proper training to the personnel regarding the quality of the medical device that can solve quality issues easily.
  • Our solutions architect helps in imparting right education regarding coordination and motivation of management and employees which helps in achieving ISO 13485 standard conformity.
  • We believe in providing proper training, education to the employees. This helps in driving a motivation focus thus making QMS a regular habit for them which eradicates fear and dopes confidence.
  • Our technical team guides you through the entire ISO 13485 compliance and implementation till the achievement of certification.
  • We facilitate professional and stringent auditing services ensuring no failure during external audits.
  • Ascent works 24X7, to cater to the needs of its customers all over the world.


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