ISO 13485 Certification : Consultants in India and Sri Lanka

ISO 13485

ISO 13485 Certification : Consultants in India and Sri Lanka

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. The medical field is witnessing a continuous development in its technologies and equipment. It is also important for the world to secure safety measures for it.

ISO can be applied by any size of medical service provider throughout the life- cycle of the device. It is entitled in every stage of device life, from planning, production, supply, distribution, storage, installation, controlling, monitoring, maintain and even for post-production. It is not obligatory but still a necessity for medical service providers to be trusted by consumers, stakeholders and all the parties concerning to them.

ISO 13485 can be adopted by any organization manufacturing medical devices irrespective of its shape, size, age, and geographical location. It is currently implemented by the organization in 21 countries.

ISO have adopted process approach which follows PDCA act (Plan – Do – Check – Act) cycle which brings in a drive for continued perfection in the process of organization.

Requirements of ISO 13485 – 2016 :

  • Define adequate quality of design and development plan for medical devices.
  • Identification of Quality management process in medical device production and further process.
  • Consider customer’s requirements throughout the process.
  • Production of sterile medical devices.
  • Proper maintenance, control, and repair of medical devices.
  • Review quality of design and development in medical devices.
  • Meet documentation requirements fundamental to ISO 13485.
  • Safe distribution of medical devices.
  • An internal audit in the organization.

ISO have adopted process approach which follows PDCA act (Plan – Do – Check – Act) cycle which brings in a drive for continued perfection in the process of organization.

Benefits of 13485 :

  • ISO 13485 enables the establishment of Quality management system in medical device production, maintenance, and lifecycle process.
  • Improve the process of production and maintenance of medical devices.
  • Enhances effectiveness of medical devices
  • Ensures safety in medical devices.
  • Reduces operational cost.
  • Continuous Improvement in medical devices
  • Innate trust in stakeholders and customers
  • Validate customer satisfaction and wellbeing.
  • Encouragement of staff and employee training in medical service providers.

Problems faced in ISO 13485 :

  • Involvement of too much documentation process could be burdensome for the organizations.
  • Lack of adequate knowledge about ISO 13485 can cause lack of accreditation by the organization.
  • Insufficient knowledge regarding customer requirements creates hurdles in the achievement of the desired results.
  • Lack of commitment to establish, implement and maintain ISO 13485 based quality management system, results in non-achievement of desired results.
  • Adopting a bureaucratic and incompatible ISO 13485 system can prove painful, redundant and build fear in employs which can degrade their motivation.
  • Organizations may be trying their best, but still failing to reap the results. What they aren’t aware of is that they may not be having adequate resources with them or appropriate management solutions.
  • Auditing, Training and improving quality can cost you more than you can input, which makes most of the organization to step out of the process.
  • Unprofessional and incorrect offers given by Consultants, that displays a very wide range of pricing. This creates confusion and hampers the Consultant selection process.
  • The possibility that the Consultant guides through, and emphasizes on massive documentation which the organization cannot handle, and somehow isn’t the mandatory requirement of the international standard too.

How can Ascent help you?

  • Ascent experts guide you through proper documentation process of ISO 13485 without adding the burden of unnecessary documents on your organization.
  • Ascent provides complete understanding and proper training to personnel regarding the quality of the medical device that can solve quality issues easily. Ascent provides training based on the need of the organization and not unnecessary ones.
  • Ascent helps through imparting right education regarding coordination and motivation of management and employees help you achieve ISO 13485 standard conformity.
  • Ascent provides required training, education and confidence to employees thus making QMS a regular habit for them which eradicates fear and dopes confidence.
  • Ascent experts guide you about the inadequate resources that will resolve various problems in the failure of ISO 13485 conformity.
  • The Ascent Solutions Architect guides you through the entire ISO 13485 compliance and implementation till achievement of certification which will give you a sigh of relief.
  • Ascent facilitates in-depth and professional auditing services that are significantly more stringent than the audits done by certification bodies. This ensures no failure during external audits.
  • Ascent works 24X7, to cater to the needs of its customers all over the world. This gives you ample opportunity to demand our services even in the odd hours and holidays.
  • Ascent has a general practice of complete analysis before an offer is given. It is extremely improbable that the total expenditure goes beyond the budgeted figures unless there are special requirements from the client’s end. “Not a single penny extra”, is a general motto that each Ascent employee abides by.

Free Download Brochure : Free Download ISO 13485 2003/2016 Certification PDF

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