Punyam.com Introducing an ISO 14155 Certification Consultancy Service for Good Clinical Practice

Punyam.com recently announced of starting a new certification consultancy service for ISO 14155 good clinical practices for clinical Investigation of medical devices for a human subject. The first edition of the ISO 14155 standard was published in February 2003, and presently the third edition published in July 2020 is applicable for certification and regulatory purposes. ISO 14155 specifies general requirements planned to protect the rights and safety of human subjects to ensure the scientific conduct of the clinical investigation and the credibility of the results. This standard determines to describe the responsibilities of the sponsor and principal investigator and assist sponsors, ethics committees, regulatory authorities, and other bodies that are involved in the conformity assessment of medical devices.

Punyam offers ISO 14155 certification services that include support for the implementation of a management system for Clinical Investigation of Medical Devices for Human Subjects as well as system documentation and system implementation training for all employees of the organization. ISO 14155:2020 Certification is desired by organizations that want to perform better. After an organization is audited for successful implementation of the ISO 14155 system, the certification body, which is accredited to provide ISO 14155 Certification, issues ISO 14155 certificate. This certificate is issued for 3 years after successful completion of pre-assessment and registration assessment. The certificate is valid for 3 years from the date of issue. Surveillance audits are conducted by the certification body within 3 years, at the intervals of 3 months depending on the nature and size of the organization.

Applying clinical investigation of medical devices as per ISO 14155 standard the organizations can achieve the benefits with continuous improvements are like ISO 14155 certification helps to improve clinical practices and performances, successfully implemented system to ensures scientific conduct of the clinical investigation and credibility of the clinical investigation results, The ISO 14155 protects the rights, safety, and well-being of human subjects, and it well-defined responsibilities of the sponsor and principal investigator.

 

Why and Why not ISO/IEC 17025

The ISO/IEC 17025: 2005 standard was developed as a special purpose standard for laboratories to specify the general requirements for their technical competence. While the standard is generic, it also recognizes that for accreditation purposes, (i.e. for independent recognition of a laboratory’s competence to perform specific tests, or calibrations) the standard may require development of guidelines to explain its use in specific areas of testing or measurement.

ISO/IEC 17025 -2005 has two major components, namely management requirements and technical requirements. The management requirements are written in language relevant to laboratory operation but were developed to meet the systems requirements of ISO 9001-1994 and ISO 9002-1994.

WHY ISO / IEC 17025? : –

• Improved quality
• Improved efficiency, productivity and effectiveness
• Improved level of motivation, co-operation, workmanship and quality awareness
• Improved communication and quality information and greater quality awareness
• Greater control of processes and activities throughout organisation.
• An onward journey of improvement is possible on an on-going basis
• Provide hot tips on analysis of data as well as measure uncertainty and perfect record keeping.
• Provide guideline for doing testing and measurement in detail.
• Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc
• Establish the best system for the product storage and handling.
• Helps in dealing with issues of implementing the OSHA (Occupational, Safety, Health Assessment) laboratory standards as well as THE ACCREDITATION MEMBER BODY accreditation.
• Provide guidance for emergency response of laboratory for fire, radiation, chemical spillage, biological spill, and personal injury as well as reduce accidents.
• Helps in making complete training manual with details of all test procedures and it helps in training any new staff as well as consistency of Quality of testing is maintained in spite of high staff turnover

WHY NOT ISO / IEC 17025?

1. Do not want to spend money.
2. Monopoly supplier.
3. Do not want to export.
4. Customers do not care.
5. Unlimited resources.
6. Do not believe in involving people.
7. Do not want to train employees.
8. Enjoy fire fighting and quick fixes.
9. Believe – Quality does not pay.
10. Do not want to commit anything on paper.
11. Expect miracles to overcome challenge.
12. Have other sources of income and don’t want to grow.

ISO / IEC 17025: 2005 DOCUMENTATION: –

The total documentation for a comprehensive management system under ISO / IEC 17025 can be represented by the four-tier system in a pyramid shown in the figure – 1.

ISO/IEC 17025 4-Tire Documentation Structure

1. ISO 17025 Quality Manual:- It states the Quality Policy and describes the macro level Management     system including details for how the standard requirements shall be fulfilled in the company.
2. Quality Procedures: – It is normally called as middle management hand book and describes     department activity for a system approach to supply consistent Quality Product. They are     considered to be the core of the system documentation and confidential documents. They     describe how the tasks and functions of the various departments should be performed to meet     the requirements of the ISO / IEC 17025: 2005 standard and the Quality Policy of the     company.
3. Work Instructions / Operating Procedure: – These documents are required for the Testing     and or calibration purpose otherwise affects Quality of testing and or calibration
4. Quality Records, Forms:- Forms, records etc. are supporting documents used by the     company to record information for different procedures followed.

The global objectives of the implementation of ISO / IEC 17025 : 2005  are: –

• To establish Quality in testing and reliability
• To prevent risk
• To detect deviations
• To correct errors
• To improve efficiency
• To ensure data quality and integrity.

ISO 17025 consultant provides information about iso 17025 standard implementation and requirements. In the iso 17025 certification basic requirements is iso 17025 manual, iso quality procedure, SOP and quality system implementation.

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