You will learn how to design and develop laboratory documents and quality manuals. The quality manual will be examined as to its impact on laboratory operations and what purpose it serves. You will learn what information it should contain, what writing style is most effective, and how to keep your documents and quality manual up to date. This course also gives attendees the knowledge needed to establish an internal quality audit program as required by ISO 17025 and to initiate the sequence of activities involved in scheduling, planning, conducting, reporting on, and closing out internal quality audits. Participants will be able to employ effective techniques of auditing and the ability to develop the auditing procedures, scheduling, and recording systems needed to sustain the program. Attendees will receive practical instructions on the development, implementation, and long-term maintenance of an effective laboratory quality system. 

Day 1

ISO/IEC 17025:2005 What the Standard Requires

• Background of standard
• Objectives of ISO 17025
• Application of ISO 17025
• Management requirements
• Technical requirements
• Assurance of test results
• Proficiency
• Inter lab compression
• Measurement uncertainty
• Documentation requirements of ISO 17025
• How to prepare a quality manual
• How to determine the scope of accreditation

Day 2

ISO/IEC 17025:2005 What the Standard Requires

• Quality system
• Subcontractor quality
• Equipment control
• Maintenance
• Training
• Calibration
• Traceability
• Test procedures
• Sample preparation
• Nonstandard samples
• Environmental conditions
• Reports
• Document control, maintenance, storage and disposal
• The auditing and accrediting process

Day 3

Preparation of Documentation:

• Documentation Requirements
• How to design a quality manual
• Effective documentation control
• Auditing a sample quality manual

Day 4

Internal audits of the lab:

• What is an internal audit; why it's important
• What should it accomplish
• How should the program be organized; steps

Day 5

• How should effort be coordinated
• Establishing/managing audit program
• Planning/conducting the audit
• Effective questioning techniques

This Education Course will be of significant value to:

• Quality Managers, Lab Managers, Lab Assistants and Staff
• Analytical chemists
• laboratory managers/supervisors, quality
• control analysts
• quality assurance managers,
• Regulatory affairs managers.
• Who using HPLC and need to ensure that they are stability-indicating.