Certification In India

ISO 35001:2019 - Biorisk Management for Laboratories and other Related Organisations

What is ISO 35001:2019 Certification?

ISO 35001 defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories.

This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.

Benefits of ISO 35001:2019 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 35001:2019?

This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials.

Laboratories

Stores

Transports

Document required for ISO 35001:2019 Certification

The extent of Documented Information differs as per:

Role of Shamkris and Process of ISO 35001:2019

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

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit
MRM
CAPA

Week 10

Certification Body
Audit
N-C Closing

Week 12

Certificate Issued

Year on Year

Yearly Compliance

FAQ

The ISO 35001 is the first International Standard for a biorisk management system. It defines the requirements and guidance for laboratories or any other organization that handle biological agents to control and reduce any risks associated with their use.
 
“Biorisk management” is the effective management of risks posed by working with infectious agents and toxins in laboratories; it includes a range of practices and procedures to ensure the biosecurity, ​biosafety, and biocontainment of those infectious agents and toxins.