How to conduct Internal Quality Audit?

Plan your audit way ahead..

What is Internal Quality Audit?

Known as 1st party audit whereby the company aim to provide a mechanism for ensuring conformity to the quality system and to assist in the ongoing improvement to the system.
What is the objective?

Record the approved procedure (this protects it against the unexpected such as sudden illness)
Ensure the approved procedure is followed
Question existing procedures - has the context within which the procedure operates changed enough to make a revised procedure more effective and efficient?



What are the requirement of an audit?

• People
• Documentation
• Process

1. People
The internal audit should conducted by competent team and lead by skilled Internal audit Lead auditor. How to ensure this by having all the team member to attend Internal Audit Training. The lead auditor should has experience with quality assurance background,preferably has attended the Lead Quality Auditor/ Accessor course.

2.Documentation:

ISO9001:2015 Structural of new standard

• Section 1: Scope

• Section 2: Normative references

• Section 3: Terms and definitions

• Section 4: Context of the organization

• Section 5: Leadership

• Section 6: Planning

• Section 7: Support

• Section 8: Operation

• Section 9: Performance evaluation

• Section 10: Continual Improvement

Objective Evidence
Data Supporting the existence or verification of something.

Documented Requirement:

• Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
• Records of training, skills, experience and qualifications (clause 7.2)
• Product/service requirements review records (clause 8.2.3.2)
• Record about design and development outputs review* (clause 8.3.2)
• Records about design and development inputs* (clause 8.3.3)
• Records of design and development controls* (clause 8.3.4)
• Records of design and development outputs *(clause 8.3.5)
• Design and development changes records* (clause 8.3.6)
• Characteristics of product to be produced and service to be provided (clause 8.5.1)
• Records about customer property (clause 8.5.3)
• Production/service provision change control records (clause 8.5.6)
• Record of conformity of product/service with acceptance criteria (clause 8.6)
• Record of nonconforming outputs (clause 8.7.2)
• Monitoring and measurement results (clause 9.1.1)
• Internal audit program (clause 9.2)
• Results of internal audits (clause 9.2)
• Results of the management review (clause 9.3)
• Results of corrective actions (clause 10.1)

Objective evidence may verify:

• That specific requirements have been fulfilled.
• That requirements for specific use/application have been fulfilled.
• Suitability, adequacy and effectiveness to achieve established goals.
• Format may include hard or softcopy documentation, forms, record, verified statements of fact, observations or other information relevant to the audit.

3. Process:

Method of conducting an Internal audit process are as follows: 

• Identify Audit Scope
• Select Audit team
• Plan Initial audit meeting
• Audit team briefing
• Audit visit
• Feedback from auditees during visit
• Report to auditee for comment
• Confirm report
• Feedback of report from auditees

Other Administration stuffs:

1. Identify quality contacts (Quality Manager, Quality Engineer, Management Representative)
2. Identify auditee (if you are not familiar with the department, be sure to contact quality contacts at relevant department for direction)
3. Schedule an audit with auditee (you could schedule  pre-audit before going on full audit)

Once you have figure out all this, it should be easier to handle the internal audit.