ISO 13485 certificate & ISO 13485 consultants for ISO certification. ISO 13485 certificate consultants and training in Delhi

ISO 13485 Audit

What is ISO 13485: 2003 Medical devices - Quality management systems?

The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. Whatever devices organization's produce, as medical device manufacturer/s, they have the responsibility to consistently deliver devices that are safe and effective. ISO 13485 is the international standard recognized for medical device regulations around the world.

In the field of medical products, devices and components, regulatory requirements and customer needs regarding quality are becoming ever-more stringent. Legal manufacturers and their global suppliers are expected to pro-actively comply with the highest standards and regulations. Certification is needed before entering new markets or before customers place orders. ISO 13485 is now the foundation for all regulatory requirements.

Gaining certification to ISO 13485 will help organization do business in this highly regulated sector. Whether organizations are looking to operate internationally or to expand locally to accommodate new business, ISO 13485 will help demonstrate to customers and regulators that they are committed to quality.

The regular assessment process will ensure that processes are continually checked for effectiveness and provide the opportunity to avoid unpleasant regulatory surprises. Certification to this standard can improve overall performance, remove uncertainty and widen market opportunities with complying to requirements

Benefits of ISO 13485 certification:-

  • Controlled consistency of manufactured products
  • Managed productivity and efficiency, controlling costs
  • Competitive advantage and increased marketing and sales opportunities.
  • Improved customer perception of the organization's image, culture and performance.
  • Improved stakeholder relationships - including staff, customers and suppliers
  • Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
  • Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
  • Reduced operating costs by improving resulting operational efficiencies
  • Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
  • Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

How can Lakshy Management Consultant help to get ISO 13485 Certification ?

Lakshy Management Consultancy is a leading provider of quality assurance and outsourcing solutions to manufacturers of parts and components in the automotive, medical device, electronics, home appliance and recreational vehicle industries. As a partner in quality, the company helps suppliers and OEMs identify root cause of quality problems, minimize defects, improve quality, increase efficiency and reduce costs associated with quality issues.

Lakshy Management Consultant Pvt. Ltd. provides proven, proprietary implementation and training support to assure that your organization meets applicable ISO 13485 requirements promptly and effectively. A certified ISO 13485 Quality Management System will • Assure you meet all customer quality requirements

  • Improve your organization's competitiveness
  • Eliminate waste
  • We have an enviable record of customerReduce risk
  • Control process variation

Lakshy Management Consultant Pvt. Ltd. ISO 13485 QMS Implementation Support is loaded with advantages for your organization. Basic Support provides a process- based, documented, implemented, audited Quality Management System (QMS), acknowledging all ISO 13485 quality requirements, ready for certification.

Full Support provides everything in Basic Support, plus we will train and mentor an Internal Quality Audit team for your organization. Lakshy Management Consultant Pvt. Ltd. will witness your certification audit, if you choose. Everything we provide meets one or more ISO 13485 requirements, including a quality manual unique to your organization, acknowledging all ISO 13485 requirements (no "gap assessment" required) documentation and implementation support for your value added quality management system development of a simple, effective document and record control system training of an Internal Quality Audit Team, if you choose a mentored, full system audit of the new quality management system (no registrar "preliminary assessment" required) corrective/preventive action support from the full system audit recommendation for an economical, effective registrar, if you choose our witness of your registration audit, if you choose We take the time necessary to custom fit all applicable ISO 13485 requirements to your organization. No "consultant" is as willing and able as Lakshy Management Consultant Pvt. Ltd. to take the time to build a QMS to both reduce your costs and "pass the audit," guaranteed.

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