ISO 13485 consultants for ISO 13485 Certification, implementation and training. ISO 13485 Certification in India, Mumbai, Chennai, Hyderabad, Bangalore, Kolkata, Indore, Pune & Delhi.
ISO 13485 certification consultants in India, UAE, Saudi Arabia, Qatar, Oman, Kuwait, USA, Canada, Africa, Europe, UK and Middle East.
Lakshy Management Consultant Pvt. Ltd. is one of the largest and leading ISO 13485 consultants in India. We are a transnational ISO certification consultants with clients in India, USA, UK, Saudi Arabia, Kuwait, Middle East, Europe, Africa, Australia, Singapore, Hong kong, UAE, Qatar, Oman, Russia etc.. We provide quick, result oriented and easy to implement consulting and training for ISO 13485 certificatation.
We have been associated with organizations across the world for their ISO 13485 certification project. Whether you a small organization or a multinational corporate, our proven consulting solutions will ensure that you implement ISO 13485 standard in the most effective manner with timely project completion.
ISO 13485 quality management system implementation with the consultants and experts of Lakshy Management Consultant Pvt. Ltd. not only assures 100% successful ISO 13485 certification but also improves process performance and business operations.
Consultants of our organization partner your company in your quality management initiative through ISO 13485 certification to get your company ISO 13485 certified quickly with ease of implementation and in the most cost effective manner. We make sure that ISO 13485 standard implementation does not become just a documentation activity but it becomes a way of life for the organization that lays a foundation for Total Quality Management and quality conscious organizational culture.
We offer onsite consulting solutions and online consulting solutions for ISO 13485 certification. Our customers have been utilizing our services not only for initial certification consulting but also post certification consulting to ensure that our consultants regularly add value to the business processes of our customers and their process & quality standardization initiatives.
Our ISO 13485 certificate consulting services include awareness training, quality policy - objectives workshop, gap analysis, documentation design including manuals, procedures, work instructions, formats etc, implementation assistance & training, internal auditor training, lead auditor training, assistance in conducting internal audit, pre-assessment audit and everything required to ensure a 100% successful ISO 13485 certification audit within scheduled project completion time period.
Biggest benefit an organization gets out of ISO 13485 QMS is improved business process control through process standardization. No matter what benefits you are looking from ISO 13485 certification, we will make sure that your organization benefits from ISO 13485 implementation and certification.
ISO 13485:2016 is a quality management system requirements for medical devices and related services.
The organization should meet with customer and legal requirements the related to manufacturing medical devices and related services.
Recently, this standard was revised and released in the year 2016.
If you are already certified with old revision, just update the requirements/documents and implement 2016 new revision and get certified during surveillance or recertification audit.
ISO 13485 requirements are based on ISO 9001:2015 standards.
With a team of highly qualified consultants and trainers having vast industrial experience, Lakshy Management Consultant Pvt. Ltd. partners organizations across the world to implement and achieve ISO 13485 certification. Our consulting approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client organization.
We offer ISO 13485 training, implementation, consulting, gap analysis, documentation, internal audits, preassessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization get the best out of ISO 13485 quality management system. Our services are globally accepted, authoritative and benchmarked in the field of ISO 13485 QMS:
Contact us at firstname.lastname@example.org to get your organization ISO 13485 certified.
Upgrade from ISO 9001:2008 to ISO 9001:2015:-
Upgrade from ISO 14001:2004 to ISO 14001:2015:-
Upgrade from OHSAS 18001:2007 to ISO 45001:2018
ISO 13485 Lead Auditor Training
ISO 13485 Internal Auditor Training
ISO 13485 Implementation Training
ISO 13485 Awareness Training
Customer satisfaction improved
Well defined and documented procedures improve the consistency of output
Quality is constantly measured
Procedures ensure corrective action is taken whenever defects occur
Non conformity rates decrease
Non conformity are caught earlier and are corrected at a lower cost
Defining procedures identifies current practices that are obsolete or inefficient
Documented procedures are easier for new employees to follow
Organizations retain or increase market share, increasing sales or revenues
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