ISO 35001 Biorisk Management System Certification Consultancy

Punyam.com, a well-known ISO 35001 Consultancy services provider in India, is having a vast experience in the implementation of Biorisk Management System and ISO 35001 Certification for any laboratory/ organisations that interact with biohazardous materials. Punyam’s ISO 35001 Consultants will provide you consultancy in the following manner:

1. Micro level survey of the client organisation and preparation of detailed Gap Analysis report.
2. Preparation of applicable documents required by ISO 35001:2019, based on the detailed study of all organisational activities, such as: ISO 35001 Manual, ISO 35001 Procedures (Mandatory procedures required by the standard), SOPs, and Formats to establish the objective evidence of implementation and to ensure control over all the activities.
3. ISO 35001 consultant provides training to all levels of employees within the organisation on the topics of ISO 35001, including PDCA cycle, process approach and Biorisk management system implementation.
4. Assist the client in formulating Biorisk management policy, development of objectives, targets and action plans, taking into account applicable legal and other requirements to which the laboratory/organisation subscribes
5. Providing guidance for the planning of activities by using a system approach to biorisk management
6. Assistance in effective implementation of the Biorisk management system by periodic visit
7. Internal audit training and assistance in conducting internal audit to check readiness for the ISO 35001 Biorisk Management System certification.
8. Conduct management review meeting in the presence of Top Management to guide the organisation for effective implementation for all the issues pertaining to Biorisk management system
9. Support in selection of certification body and application for certification.
10. Support during onsite adequacy audit and certification audit by certification body.

• Demonstrates to interested parties that your Biorisk management system is compliant with ISO 35001.
• Enables laboratory/organization to effectively identify, control and manage the biosafety or biosecurity risks related to your laboratory organization’s activities;
• Helps create biosafety or biosecurity risk awareness within laboratory/organization;
• Keeps people safe – protects and reassures employees, clients and patients;
• Reduces chance of accidents due to biohazards;
• Minimizes impact on the environment
• More efficient use of time and other resources
• Keeps laboratory test results reliable.
• Builds confidence in the process of the laboratory/organization.
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The requirements that an organisation/laboratory must fulfil in order to achieve ISO 35001 certification include, but not limited to the following:

• Aligning the mitigation of biosafety and biosecurity risks
• Biorisk management policy, development of Biorisk objectives and action plans
• Biorisk management committee and Biorisk management advisor
• Biorisk management program
• Biorisk hazard and/or threat identification, Biorisk assessment and risk mitigation
• Process to measure the effectiveness of the control measures for biorisk mitigation.
• Worker health program
• Personnel reliability measures
• Personnel security program.
• Control of suppliers
• A formal planning, design, and redesign process for the facility based on risk assessment
• Inventory, or itemized record, of biological materials
• Provision of suitable equipment, including PPE, based on the biorisk assessments
• Validated procedures for decontamination and inactivation
• Emergency response and contingency plans and procedures
• Plans to address safety and security incidents during transport
• Monitoring, review and internal audit of biorisk management system at planned intervals
• Identification of nonconformity and their causes
• Processes to determine and manage incidents and nonconformities, including reporting, investigating, and taking corrective action