This document provides information on conducting an ISO 9001 quality management system certified course. It discusses arrangements for the course, effective interviewing tips, considerations during interviews, the importance of observations, exercises to practice skills like preparing interview questions and identifying non-conformities from observations. It also covers post-audit activities like defining audit findings, grading non-conformities, writing non-conformity statements, and preparing the audit report.

1. ISO 9001
QUALITY MANAGEMENT SYSTEM
CERTIFIED COURSE

2. ARRANGEMENTS
• Evacuation Plan in case of emergency
• Smoking Policy
• Tea/ Lunch Breaks
• First Aid
• Seating/ Thermal Comfort
• Complaint Procedure
• Use of Cell Phones
D1LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 2
4/3/2024 7:54:18 AM

3. INTERVIEWING
• Confirm and gauge the understanding of workers
• Top Management Commitment
• Employees awareness
• Involvement and participation
• Subsequent to an observation/ document review
for clarification
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 3

4. EFFECTIVE INTERVIEWING TIPS
• Put interviewee at ease
• What evidence will be sought & why
• Open ended questions
• Rephrasing the question
• Create a friendly environment.
• Use of closed ended questions quite wisely
• Do not jump to the conclusions
• Listen carefully and with patience.
• Remain neutral
• Ask relevant question
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 4

5. INTERVIEW CONSIDERATIONS
• Fearful (Organizational issues)
• Over enthusiastic
• Language barrier
• Social and cultural issues
• Psychological issues
• Distractions/ interruptions
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 5

6. EXERCISE 11
You have recently carried out the mock onsite audit for
documented information. There were some non-
conformities and also some observation which needed
clarification from auditee. Prepare a questionnaire to
satisfy yourself as an auditor for making decision for non-
conformity or otherwise. Tutor will be interviewed by each
group
• Type: Group (Max 4 persons each group)
• Ref Doc: Relevant Documented Information, ISO
9001:2015 standard
• Purpose: To nurture and measure skills to ensure the
students can prepare effective audit questions and can
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017
6

7. OBSERVATIONS
• Very important part of evidence collection
• Auditor judgment is very crucial
• How processes work
• Compliance with the procedures
• Attitude of workers, managers and top
management towards quality
• Overall quality culture in the organization
• Resources available
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 7

8. EXERCISE 12
You have observed some scenarios/ actions
written in Doc 1A. Please assess the situation and
identify objective evidence to ensure if it is a non-
conformity or otherwise. Please mention relevant
ISO 9001:2015 Clause/ PMS QMS Doc Ref (As
applicable)
• Type: Individual
• Ref Doc: Doc 1A (Pg# 219-222), ISO 9001:2015
standard
• Purpose: To nurture and measure skills to ensure
the students can use observation as an important
tool for collecting objective evidences
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017
8

9. AUDIT TRAIL
•Not an NC itself
•Alarming situation
•Further investigation needed
•Extent of further investigation
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 9

10. EXERCISE 13
• Please analyze the situations given in Doc 2A to
ensure if there is a non-conformity or otherwise.
Please follow audit trails to confirm
• Type: Individual
• Ref Doc: Doc 2A (Pg# 223)
• Purpose: To nurture and measure skills to ensure
students can effectively follow audit trails
• Time : 45 Min for written response & 15 mins for
discussion
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 10

11. COMMUNICATION DURING THE
AUDIT
Between Lead Auditor and Auditee
• To apprise auditee about the audit progress
• For seeking evidences
• To ensure there is no surprise for auditee in
closing meetings
• Any concerns of audit team
• Any amendments required in audit plan
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 11

12. COMMUNICATION DURING THE
AUDIT
Between Lead Auditor and team
• To ensure audit progresses as planned
• To ensure quality of work for team
• To seek guidance from Lead Auditor
• Any concerns of audit team
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 12

13. QUIZ 6
Please confirm if the issue is internal or external to the
organization:-
• Employees Turnover
• Unions and Strikes
• Political Unrest
• Market Rumors
• Management change
• Legal requirements Changed
• Non-acceptance of QMS by employees
• Sabotage
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 13

14. QUIZ 6
CONT…
• Market competition
• Latest technological innovations
• Competency
• Availability of external providers
• Equipment downtime
• Employees’ morale
• Social, cultural and religious issues
• Lack of natural resources
15 Mins for students’ response and 10 mins for
discussion
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017
14

15. QUIZ 7
PG 74
• Identify the possible circumstances (Internal &
External) which may necessitate an organization
to change its QMS.
• 10 Mins for students and 10 mins for discussion
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 15

16. POST AUDIT
ACTIVITIES
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 16

17. AUDIT FINDINGS
Degree to which the organization’s management system
conforms to the criteria:-
• The compliance with documented QMS
• Non Compliance
• Non-conformity
• Major Non-conformity
• Minor Non-conformity
• Observations/ Improvement Opportunities
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 17

18. NON- CONFORMITY
Non-fulfillment of a
specified requirement of the
criteria/ documented QMS
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 18

19. GRADING NON-
CONFORMITIES
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 19

20. MAJOR NON- CONFORMITY
A major non conformity is when
-There is a absence of a required procedure or
total ineffectiveness in implementation of a
procedure
-Ineffectiveness of a key aspect of Quality
Management system
-A number of non conformities against the same
procedure
-Significant affect on the QMS
-Credibility of QMS is under question
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 20

21. MINOR NON- CONFORMITY
A minor non conformity is when
-There is a single isolated lapse in the
implementation of QMS
-There is no significant affect on the QMS
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 21

22. OBSERVATION/ IMPROVEMENT
OPPORTUNITY
An observation/ IO is raised by the auditor once
-There is a situation with potential non conformity
and requires clarification from the auditee to
ensure the effectiveness of QMS
-Observations/ IO’s are although not a binding on
Auditee to comply but they really add value in
QMS
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 22

23. NON-CONFORMITY STATEMENT
FEATURES
-Self explanatory
-Extent and type of corrective actions required
-Should elicit response
-Should be based on evidence and facts
-Should be numbered, dated and signed by the
auditee
-Significant
-Should not be a suggesting itself in statement
-Should not point the name of the persons
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 23

24. EXERCISE 14
• Please write non-conformity statements for the
scenarios mentioned in Doc 3A and grade them
into Major/ Minor as applicable
• Type: Individual
• Ref Doc: ISO 9001:2015 standard, Doc 3A
(Pg# 224)
• Purpose: To nurture and measure skills to
ensure the students can grade non conformities
• Time : 45 Min for preparation & 15 mins for
discussion
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017
24

25. AUDIT REPORT
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 25

26. AUDIT REPORT PREPARATION
• As required in the agreed audit programme
• Non- Conformities have been graded
• Audit team agreement on outcome
• The degree of conformance of QMS
• The effectiveness of the QMS
• Highlighting good practices and procedures
• Capability of the management review process
• Overall insight of QMS of the organization
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 26

27. AUDIT REPORT PREPARATION
• Audit team and auditee’s Reference
• The dates and locations of the audit
• Any unresolved diverging opinions
• Agreed follow-up action plans
• Statement of the confidential nature of the
contents
• Distribution list as agreed
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 27

28. AUDIT REPORT DISTRIBUTION
• Issued within agreed time
• If delayed, reasons must be mentioned
• dated, reviewed and approved, as appropriate
• Distributed as per audit plan
D4LAC9K1-15 REV 1 ISSUE DATE 15 MAR 2017 28