ISO 14155 - GOOD CLINICAL PRACTICES
What is ISO 14155?
The International Organization for Standardization (ISO) publishes the ISO standard for Good clinical practices (GCP) for the design, conduct, recording, and reporting of clinical studies with medical devices.
Conducting your clinical studies according to GCP is important not only to collect good quality data under ethical conditions but also for regulatory compliance in the European Union (EU) and rest of the world.
The EU Medical Devices Regulation (MDR) 2017/745 requires clinical investigations to be conducted according to GCP and directly references the ISO14155 standard. The US Food and Drug Administration (FDA) accepts clinical data collected outside the US for market applications under the condition that GCP has been followed. FDA recognizes the ISO 14155 standard for medical device trials. Other regions similarly recognize the GCP standard.
Benefits of ISO 14155 Certification
Leading to Better
Actionable Data
Product Quality
Improves customer confidence
Insight into your Supply Chain
Safety Assurance
Who can be certified ISO 14155 Certification?
Injection
Testing Kits
Medical Furniture
Medical Equipment
IVD Instruments
Surgical Instruments
Dental Implants
Ortho Implants
Disposable Syringes Needles
Document required for ISO 14155 Certification
- 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 14155 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 an accreditation body 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 ISO 14155 between existing system related to GDP 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 14155 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 14155 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 Body
- ISO 14155 certificates issued for 1 years
- Yearly Renewal Audit
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit