What is ISO 17021-1?
National Accreditation Board for Testing and Calibration Laboratories (NABL) is a Constituent Board of Quality Council of India. NABL has been established with the objective to provide the Government, Industry Associations, and Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests/calibrations in accordance with ISO/IEC 17025:2017 and ISO 15189:2012 for medical laboratories. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size, and degree of independence.
Benefits of NABL Accreditation
Growth in business
Customer Satisfaction
Verification mechanism for continual improvements
Stimulate excellence and innovation
Legal Benefits
Enhance Sustainable Growth
ISO 17021-1:2015 Video
Who can be Certified ISO 17021-1:2015?
Certification Issuing Body
Certification Issuing Institute
Certification Issuing Agency
Inspection Body
Document required for ISO 17021-1:2015
- 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 17021-1:2015
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below:
Day 1
GAP Analysis, Cost Estimates, Application to Accreditation Body
• Finding the GAP between existing system related to Accreditation Body requirements
• Application to Accreditation Body
• Based on the scope of your business & Accreditation 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
• 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 Accreditation Body requirements. Management Review Meetings. Corrective and Preventive Action plan for nonconformities
Week 10
Accreditation 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 Accreditation Body
Year on Year
Yearly Compliance
• Support of Monthly & Quarterly Basis
ISO/IEC 17021 is a standard that was created for assessing certification bodies to ensure that they are competent and that they conform to all types of management systems. These organizations are usually called Certification Bodies (CBs) or registrars.