Consulting

September 25, 2015

BioSphere Analytics offers implementation, transition, and maintenance of the following systems, based upon the ISO 9001 core system:

ISO 9001 ⚙️  |   AS9100 ✈️   |   IATF 16949 🚗   |   ISO 13485 🏥

 

ISO 9001:2015 (General Industry)
AS9100:2016 Rev D (Aerospace Industry)
IATF 16949:2016 (Automotive Industry)
ISO 13485:2016 (Medical Industry)

 

 

 

 

 

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

 

For any service, we will need to know how many employees are at your facility with the number of days be calculated by the table below:

Audit Day Table
(Example: A company with 72 employees would need 6 audit days)

Unless we are able to put together a special pricing package (please ask, we try to accommodate as much as possible), the following is a basis for our work.  We offer a daily rate of $1,300 for any work performed + cost of travel, lodging, and meals.  For implementation of AS9100, IATF 16949, or ISO 13485 we start the process with a Gap Audit

Typically, 1 or 2 auditors would be onsite for the initial Gap Audit (3 days x 2 auditors = 6 audit days).  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 estimated number of audit days from the table above with the same daily rate.  We are always looking to help clients and can create flexible plans to help address any of your needs.

In general, implementing AS9100, IATF 16949, or ISO 13485 follows the same process as ISO 9001 (the basis for all of these standards) with particular focus on different elements highlighted by each unique industry.

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