Services

Services

At Biorisk Busters we aim to provide expert guidance and recommendations to our clients to help streamline their systems and prepare for accreditation.

What we can do for you…

  • ISO or other standard guidance and implementation advice (see below)

    • We welcome enquiries on any existing or new laboratory standards and programs

  • Assisting with preparation for accreditation through tailored recommendations

  • Risk management guidance

  • Laboratory Quality Management Systems guidance

  • Customised training program development and delivery to upskill your staff (in-person or online)

  • Guidance on pathogen specific programs and guidelines

    • For example, we have extensive experience in the WHO Poliovirus Global Action Plan, 4th Edition (GAPIV)

  • Assisting with managing change in the laboratory environment

  • Internal audits

  • Gap analysis

  • Facilitator services

  • Coaching and mentoring to assist clients in understanding and meeting accreditation requirements

Please note that engaging our services is not a certification and does not guarantee accreditation with external bodies.

Standards and Guidelines we have experience in:

AS/NZS 2243 Australian and New Zealand standard for safety in laboratories

ISO 5441 Competence requirements for biorisk management advisors

ISO 7446 Implementation guidance for biorisk management for laboratories and other related organizations

ISO 9000 Quality management systems - Fundamentals and vocabulary

ISO 9001 Quality management systems - Requirements

ISO 15189 Medical laboratories - Requirements for quality and competence

ISO 15190 Medical laboratories - Requirements for safety

ISO 17025 General requirements for the competence of testing and calibration laboratories

ISO 17043 Conformity assessment - General requirements for the competence of proficiency testing providers

ISO 19011 Guidelines for auditing management systems

ISO 31000 Risk management - Guidelines

ISO 35001 Biorisk management for laboratories and other related organisations

WHO Biosafety Manual

WHO Global Action Plan for Poliovirus Containment, 4th Edition (GAPIV)

WHO Laboratory Quality Management System Handbook

ICH E6(R3) Guidelines for good clinical practice

…And various other standards and guidelines that are referenced in the above

✗What we can’t do for you…

  • We currently do not advise on:

    • Animal facilities

    • Manufacturing (GMP)

    • Facility construction

    • GMOs