Consulting Programs
Quality System Development
This program is focused toward clients that have no formal Quality Management System (QMS) as identified by the ISO family of specifications such as ISO9000, AS9100, ISO13485 or ISO17025.
Scope of an ISO9001:2000 standard QMS project will typically encompass;
Quality Manual design and development
Quality Objectives
Quality Policy
Standard Operational Procedures to support QMS
Procedure for documents
Control of Records
Internal Audits
Control of non-conformance
Corrective action
Preventative action
Development of records that include
Management Reviews
Employee Files, Education, Training, skills and experience
Customer Property
Calibration records
Internal audit results and follow-up actions
Documents for the authorizing release of product
Corrective/preventative action
Results of supplier evaluations
Policy/Procedure Review and Development
This program is designed for clients that have a Quality Management System (QMS) in place and do not have the internal resources or time to expand or maintain the QMS. Support service is provided as required or on a monthly or quarterly basis schedule to ensure continued compliance and benefit to the operations.
CAPA Development/Support
More focused toward the Corrective Action/Preventative Action (CAPA) activities when client required one or more of the following support
Root Cause investigative support
Backlog or process support
CAPA form design
Vendor/Supplier Qualifications
Assists clients in the purchasing activities in the development of approved supplier lists, questionnaire design, Supplier records and the approval schedules.
Quality Manual Development
Provide clients with the basic quality manual tied to their industry and scope of operations so they can expand and develop Quality System with their own resources.
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