ISO 13485:2016 QUALITY MANAGEMENT SYSTEM
What is ISO 13485 : 2016 QMS?
A successful implementation will demonstrate a company’s ability to supply Medical Devices and related services to customers that comply with regulatory requirements ISO 13485 is not just products focused, but it focuses instead on the processes, used to develop Medical Devices.
Keep in mind that you also need to comply with all relevant product and service-oriented technical standards and regulations in this area of expertise. Although ISO 13485 is based on ISO 9001 Quality Management Standard and uses the same numbering system.
ISO 13485 doesn’t include the ISO 9001 requirements related to continual improvement and customer satisfaction ISO 13485 also focuses more on how procedures regulate and control activity and process performance
Benefits of ISO 13485 : 2016 QMS Certification
Customer Satisfaction
Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.
Reduced Operating Costs
Continual improvement of processes and resulting operational efficiencies mean money saved.
Improved Stakeholder Relationship
Improve the perception of your organization with staff, customers, and suppliers.
Legal Compliance
Understand how statutory and regulatory requirements impact your organization and its customers.
Improved Risk Management
Greater consistency and traceability of products and services means problems are easier to avoid and rectify.
Proven Business Credentials
Independent verification against a globally recognized industry standard speaks volumes.
Who can be certified ISO 13485 : 2016 QMS?
ISO 13485 applies to organizations of all types and sizes, except where expressly stated otherwise. ISO 13485 contains requirements that are required for any organization in the medical device and pharmaceutical supply chain, including design, production, installation, storage, development, and service.
Injection
Testing Kits
Medical Furniture
Medical Equipment
IVD Instruments
Surgical Instruments
Dental Implants
Ortho Implants
Disposable Syringes Needles
Document required for ISO 13485 : QMS
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of ISO 13485 : QMS Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain a certificate of success in addition to enhanced performance.
The implementation process is described below:
Time Frame
Task
Process
Day 1
GAP Analysis
Certification Body
Selection
Cost Estimates
- Finding the GAP between existing system related to ISO requirements
- Selecting the appropriate certification body
- Based on the scope of your business & certification body you choose
Week 1
Developing Documents
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
- ISO Awareness training for the top management and staff
- Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to ISO requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the certification body
Week 12
Certification Issurance
- ISO certificates issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
ISO 9001 is the international standard that provides specifications for a quality management system that can be applied to any organization regardless of industry, product or service, or company size. ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices.
ISO 13485:2016 is a voluntary standard that defines quality system requirements which much of the rest of the world recognizes for developing and maintaining the system that caters to the medical device market.
How long does it take to achieve ISO 13485 certification if we have no system in place? Implementation usually takes 4-6 months for companies with fewer than 50 employees.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.