ISO 9001 ⚙️

September 25, 2015

BioSphere Analytics offers implementation, transition, and maintenance of ISO 9001:2015 systems.

While each company is unique, an implementation will typically occur as follows:

  1. Perform Gap Audit
  2. Establish Rolling Action Item List (RAIL)
  3. Develop Process Flow for Organization
  4. Document Management Functions
  5. Identify Risk and Opportunities throughout organization
  6. Complete all RAIL items
  7. Perform Internal Audit(s)
  8. Conduct Management Review
  9. Coordinate Stage 1 Audit (Registrar) [Documentation Audit]
  10. Coordinate Stage 2 Audit (Registrar) [Certification Audit]

All of our auditors are trained to leading industry standards to ensure quality knowledge and expertise!


To learn more about the details of ISO 9001:2015, visit our Knowledge Center here!
PPT - Process Update


We typically offer a special pricing packages (we try to accommodate as much as possible) for the basis of our work.  For any service, we will need to know how many employees are at your facility.

Typically, 1 auditor would be onsite for the initial Gap Audit.  This allows us to assess your facility, establish a baseline project cost estimate for an upcoming transition, and ensure that any ancillary concerns are addressed.  Most importantly, it allows for you to meet the team that will implement your Quality Management System!

For internal audit functions, an estimated project cost is generated using the number of employees onsite.  We are always looking to help clients and can create flexible plans to help address any of your needs.

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