Course Description

This exciting offering from JANAAC follows the Document Control for beginners training; this two (2) day course delves into process mapping, Risks in poor document management & designing and implementing a master list etc. through hands-on, in-depth workshops, which will allow the participants the opportunity to utilize the knowledge, and understanding gained to effectively maintain their quality management system.

Learning Outcomes and Topical Outline

1. How to establish a Document Management System, including the creation, review, approval, saving, and the publishing of internal documents.

2. How to map a process and create effective procedures or work instructions.

3. The basic document control requirements and misconceptions that will empower participants to challenge their existing or legacy Document Management Systems.

4. How to maintain and retain project documentation

5. The structure and components of a master list; the review and approval of such, as well as the distribution.

6. The similarities and differences in regard to document control and record keeping, among the most widely used ISO management system standards.

7. How to maintain and retain management system documentation, such as NCRs, Corrective Actions, Audit Plans and Reports, Management Review Meeting Minutes, Calibration Certificates, etc.

Pre-requisites

· Document Control for Beginners training

or

· Working knowledge of Quality Management Systems

Target Attendees

• JANAAC Assessors and potential Assessors

• All Accredited CABs and potential CABs seeking accreditation

• Quality Management team within entities seeking accreditation or a part of an already accredited entity

• Analysts and Technical Managers of Existing and prospective Testing and Calibration Laboratories, Medical laboratories

• Regulatory bodies

• Consultants

• Laboratory Customers

Areas of Focus

· Document Control in context

· Process mapping and writing techniques that lead to the creation of well-rounded documents.

· Document Control requirements across the ISO management system standards

· Managing electronic documents

· Security controls

· Designing and implementing a master list

· Designing, implementing and maintaining a records classification system

· Establishing and communicating roles and responsibilities, processes, procedures

· Risks in poor document management

· Document control and audits

· Integrating document and records management classification

· Emerging principles and practices in Document Management