ISO Implementation and Audit Services

The E2 Rapid Documentation System, the E2 Shop System Quality Module, ISO Training, and ISO Auditing allow your manufacturing organization to become thoroughly prepared to pass an ISO9001:2008, ISO13485, or AS9100 Certification Audit.

The Rapid Documentation System

The Rapid Documentation System provides all documentation required to implement a Quality Management System fully integrated with the E2 Shop System.

• Quality Manual
• Procedure for Control of Documents
• Procedure for Control of Records
• Procedure for Internal Audits
• Procedure for Control of Nonconforming Product
• Procedure for Control of Corrective Actions
• Procedure for Control of Preventative Actions
• Production Process Maps
• Internal Audit Program, Plan, Forms, and Report

 E2 Shop System Quality Module

 The E2 Shop System Quality Module provides evidence needed for ISO Audits.

• Document Control
• Nonconformances
• Corrective Actions
• Employee Training
• Work Center Maintenance
• Tooling Maintenance
 

ISO Training

 On-Site training prepares your organization for an ISO Certification Audit.

• Learn the requirements of each ISO clause.
• Determine the implementation methodology necessary to comply with each clause.
• Identify the objective evidence required to demonstrate compliance during a Certification Audit.
• Provide evidence from within the E2 Shop System and the Quality Management System Documentation generated by the Rapid Documentation System.
On-site and classroom training are available by RABQSA Quality Management System Auditors to enable your organization to perform its own Internal Audits.
 

ISO Auditing

 Shoptech’s RABQSA Quality Management System Auditors provide Pre-Assessment and Internal Audits.

• Pre-Assessment Audits are provided to determine readiness for ISO Certification Audits.
• Internal Audits are performed at periodic intervals to assess the health of your Quality Management System as required by ISO 9001:2008, AS9100 and ISO 13485.