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Introduction
During this session we will look at:
Why we need to perform internal audits
What an internal audit is Who needs to be audited When audits are to be performed How to perform an internal audit
Benefits of Auditing
Can facilitate continuous improvement
Audit Objectives
To verify that the quality system:
Conforms to ISO 9001 Processes conform to requirements Helps the organization to satisfy its customers
Execution
Reporting Follow-up
Audit Requirements
Internal audits are required by ISO 9001
Must be conducted by personnel independent of responsibility for process being audited Results must be recorded Must follow organizational objectives Frequency is determined by organizational need
Scheduling Audits
All QMS processes are subject to auditing
Each process is audited at minimum once in a 12 month period Audit scheduling is performed by the Quality Management Representative The schedule is issued to Auditors & Auditees
Audit Scope
Full audit of the entire Quality System
How many auditors will be needed How will responsibilities be divided Appoint a lead auditor to keep the audit focused
Partial
Which departments or processes
Which clause of the standard
Audit Overview
The typical audit cycle will include:
Arranging a time and date for the audit A preparation stage Performing the audit on the scheduled date Compilation of the audit report Summary of non-conformance reports
Downstream
starting with the first process and flowing forward
Horizontal
across similar processes, e.g. auditing document control across all departments
Performing an Audit
Audit arrangement Audit preparation Performance of the audit
Audit Questions
Use open questions to ensure you get full answers:
What are outputs does this process create? How do you know which document to use? Who is responsible for this process? When something goes wrong, what do you do? Where do you find work instructions and procedures?
Open questions keep the auditee talking Avoid questions that illicit a yes or no response.
Recording Observations
Record location of observation List the names of interviewees and their position
Non-conformances
Issue a Corrective Action Request
Make sure it is thorough Note process ownership
Reporting to Management
Reports must be
thorough and specific objective
evidence based
reviewed by management
Summary
Audits are important because they:
Provide transparency Give a means for continual improvement
End of Presentation
Thank you for your time.