ISO 13485 Certification Consultancy in India
ISO 13485:2016 Medical Devices - Quality Management System Requirements for regulatory purposes represent the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Though based on ISO 9001, ISO 13485 removes 9001's emphasis on continual improvement and customer satisfaction. In its place, emphasis is on meeting regulatory as well as customer requirements, risk management and maintaining effective processes. ISO 13485 standard is in part designed to produce a management system that facilitates compliance to the requirements of customers and, pre-eminently, various global regulators.
While being certified to ISO 13485 does not fulfill the requirements of either the FDA or other foreign regulators, the certification aligns an organization's management system to the requirements of the FDA's Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, ISO 13485:2016 certification serves to create a management system that can be thought of as a framework on which compliance to various regulatory and customer requirements have to be build.
This standard can be implemented by the industry, who wishes to:
1. Establish, implement, maintain and improve an Quality management systems Requirements for regulatory purposes;
2. Assure itself of conformity with its stated customer and regulatory requirements;
3. Demonstrate conformity with ISO 13485:2016 by
- Implementation of a Quality Management System with several enhancements;
- Risk Management approach to product development and product realization;
- Validation of processes;
- Compliance with statutory and regulatory requirements;
- Effective product traceability and recall systems
ISO 13485 Certification
Punyam.com offers ISO 13485 Certification consultancy services. ISO 13485:2016 certificate is issued by Certifying body, which is accredited to provide certificate under the ISO 13485:2016. The certificate is issued for the period of 3 years after successful completion of pre-assessment and registration (final) assessment. The certificate is valid till 3 years from the date of issue. Surveillance audits are conducted by the Certifying body within the period of 3 years at the interval of 9 Months or 12 Months depending upon the nature and size of the organization. Upon completion of 3 years, renewal audit is done for new 3-year cycle.
Punyam.com is a leading ISO 13485 consultant in India, having vast industrial experience in ISO 13485 consultancy and implementation of ISO 13485 system for all types of medical device manufacturing industries, such as surgical instruments, orthopedic implants, etc manufacturing companies.
Punyam.com follows below-mentioned steps to develop the ISO 13485:2016 Medical devices – Quality management system for its customers
1 .Micro level survey for each and every activity of the organization and preparation of detailed gap analysis report;
2. Preparation of applicable documents required by ISO 13485:2016, based on detailed study of all activities of the organizations, such as:
- ISO 13485 Quality Manual;
- ISO 13485 Quality Procedures (mandatory procedures required by the standard);
- Identification of applicable regulatory requirements and ensure compliance with the regulatory requirements;
- Standard Operating Procedures (SOPs) to control identified activities having risk potential to the human during the use of such medical devices;
- Formats to establish the objective evidence of implementation and to ensure control over all the activities;
3. ISO 13485 training to all levels of employees within the organization,
4. Help in effective implementation of ISO 13485 system by periodic visit till ISO 13485:2016 certification,
5. Conduct internal audit to check readiness for the certification.
6. Conduct management review meeting in presence of Top Management to guide the organization for effective implementation on all the issues related to Quality management systems Requirements for regulatory purposes,
7. Conduct mock drill for traceability of product as well as production recall, etc
- Customer satisfaction – through delivery of products that consistently meeting customer requirements as well as quality, safety and legal requirements.
- Reduced operating costs – through continual improvement of processes and resulting operational efficiencies.
- Improved stakeholder relationships – including staff, customers and suppliers.
- Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers.
- Improved risk management – through greater consistency and traceability of products and use of risk management techniques.
- Proven business credentials – through independent verification against recognized standards.
- Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
The key requirements of ISO 13485:2016 Medical Devices Quality Management System(QMS) are summarized below:
- A risk-based approach to the control of the processes.
- Control outsourced Written quality agreement is a must
- Validate the software applications prior to initial use and after changes to it.
- Medical device file
- Monitoring and control of the work environment
- Product realization
- Procedure for design and development
- Design and development file
- Contamination control of product.
- Procedure for servicing , where required.
- Validation of production process, and processes for sterilization and sterile barrier systems.
- Product identification by suitable means throughout product realization.
- Product traceability.
- Preservation of conformity of product during processing, storage, handling, and distribution.
- Feedback process and process for complaint handling.
- Notification to the appropriate regulatory authorities regarding adverse events etc.
Our Strength for Quality Management System Consultancy
- We have a team of highly- experienced ISO consultant and globally certified lead auditors for Consulting Services
- Our team is having graduate/master degree of Engineering/management having more than 15+ years of experience in management system implementation for clients.
- Our consultants provide handholding support to clients in development and implementation of policies, plans, controls, documentation and record-keeping as well.
- 1000+ Quality Management System implementation in various industries in 15+ countries.
- Implemented 7000+ Man-days QMS projects successfully
- We follow the latest standard industry best practices for QMS implementation
- 200+ Editable documents for various management systems have been sold to our global clients
- 1000+ personnel of clients and other individuals trained by our ISO 13485 consultants for awareness, system implementation and auditor training through online/class room.
- Our QMS consultants work with more than 50 leading International & National Certification Bodies such as BV; BSI; TUV; DNV; SGS; Lloyds; ISOQAR; NABL; IAS; UKAS, etc.
- Our clients had got benefits of continuous improvements and business excellence with use of our practical approach in consultancy projects.
- In our ready to use QMS documentation package we provide 150+ editable sample document templates with more than 400 pages.