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.

Certified ISO 30401 Certification Video

Who can be certified ISO 30401:2018?

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

  • 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 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 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 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 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 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 certificates issued for 1 years

Year on Year

Yearly Compliance

• Support of Yearly documentation for audit

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.