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

Check out the Who can be certified ISO 14155 Certification Video

Who can be certified ISO 14155 Certification?


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:

Day 1

GAP Analysis, Certification Body, Selection, Cost Estimates

• Finding the GAP between existing system related to ISO 14155 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

• Internal audits identifying nonconformities related to ISO 14155 requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities

Week 10

Certification Body
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

Year on Year

Yearly Compliance

• Support of Yearly documentation for audit

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The second revision of the standard was released in February 2011, the third revision and therefore current version of the standard was released in July 2020, ISO 14155:2020.