QMS Auditing Services
Services
QMS Auditing Services is here to help you with when a crisis situation exists and will resolve all issues that threaten the business or your Certifications and Registrations. We have successfully helped our clients by implementing corrective actions to solve the immediate nonconformance and preventative actions to prevent recurrence. We also provide surveillance of the effectiveness of the corrective and preventative actions when requested.
Contract Services
Temporary help for routine QMS services such as Quality Engineer or specialized help to resolve problems that the client is not staffed to handle.
Employee Gap Services
Short-term QMS services to fill gaps due to employee death, illness, retirement, termination, maternity leave, or FMLA.
Risk Management
Preparation of Risk Management Plans, Procedures, and Reports including ongoing identification of risks, assessment of probability and severity, treatment, and residual risk evaluation.
Warehouse Inspection
Sampling or screening of product due to customer complaints or suspect nonconforming product that have escaped the factory QMS system.
Supplier/Source Inspection
On-site inspection of variables and attributes at the external providers facility using procedures provided by the client.
Six Sigma
Training in the Six Sigma process and lead Six Sigma teams using toolset used by practitioners to solve difficult problems.
Test Witness
Ensure that all tests are performed in accordance with test procedures approved by the client.
Auditing
Conduct audits to standards such as ISO 9001, AS9100, ISO 13485, and other internationally recognized standards.
Assessments
Conduct internal assessments to the Medical Device Single Audit Program (MDSAP).
Training
Design training material and conduct training to ensure employee competency that include training effectiveness at planned intervals.
Consulting
Specialized assistance to solve problems in the areas of manufacturing, quality, regulatory, and supply chain.