QMS Lead Auditor Course – Participant Handout

Exercise 0: QMS Terms & Definitions

Purpose:
To understand QMS related terms & definitions.

Duration:
10 minutes small group work
15 minutes classroom feedback discussion

Directions:
As small groups, fill in the crossword puzzle using clues provided.
QMS Lead Auditor Course – Participant Handout
QMS Lead Auditor Course – Participant Handout
 QMS Lead Auditor Course – Participant Handout

Exercise 1: Quality Management System Principles

Purpose:
To identify key features of the 7 quality management principles.

Duration:
10 minutes small group work
15 minutes classroom feedback discussion

Directions:
As small groups, review section 2.3 in the Introduction to ISO 9000:2015 or Handout 1.
Then review the features below and note the quality management principle they best
represent in the space provided.
 QMS Lead Auditor Course – Participant Handout

Feature: Principle:
Systematically defining the activities necessary to obtain a desired
result.
Link the organization’s objectives to customer needs and
expectations.
Ensuring that data and information are sufficiently accurate, reliable
and secure.
Promote establishment of improvement objectives at all levels of the
organization.
Pool and share information, expertise and resources with relevant
interested parties.
Empower people to determine constraints to performance and to take
initiatives without fear
Manage risks that can affect outputs of the processes and overall
outcomes of the quality management system.
Create and sustain shared values, fairness and ethical models for
behaviour at all levels of the organization
Manage processes and their interrelations as a system to achieve the
organization’s quality objectives effectively and efficiently.
Establish collaborative development and improvement activities with
suppliers, partners and other interested parties.
Communicate customer needs and expectations throughout the
organization.
Conduct surveys to assess people’s satisfaction, communicate the
results, and take appropriate actions
Make decisions and take actions based on evidence, balanced with
experience and intuition
Measure and monitor customer satisfaction and take appropriate
actions.
Ensure the necessary information is available to operate and
improve the processes and to monitor, analyse and evaluate the
performance of the overall system.
Provide people with the required resources, training and authority to
act with accountability

Self-evaluation of performance against personal objectives

Establishing relationships that balance short-term gains with long-

term considerations.
Determine, measure and monitor key indicators to demonstrate the
organization’s performance
Ensure people are competent to successfully promote and complete
improvement projects
 QMS Lead Auditor Course – Participant

Exercise 2: Process Approach

Purpose:
To identify input, activities, output and infrastructure of a process.
To understand interaction of processes.

Duration:
30 minutes small group work
10 minutes classroom feedback discussion

Directions:

You have gone for dinner with your family to a restaurant and ordered dinner for 4.
Prepare a process flow chart of the restaurant.
Identify the inputs, activities, outputs and infrastructure (i.e. raw materials, consumables,
utilities, machinery and manpower) of the process of the restaurant..
 QMS Lead Auditor Course – Participant

Exercise 3: Quality Management System Terms

Purpose:
To understand quality management terms.

Duration:
20 minutes in team of 2
10 minutes classroom discussion

Directions:

As individuals, using the definitions handout, review the terms and definitions and note
which definitions belongs to which term. Simply note the correct letter of the definition
next to the appropriate term.
 QMS Lead Auditor Course – Participant

Write the letter corresponding to the DEFINITION next to the TERM it

defines.

TERM DEFINITION
A. Set of interrelated or interacting activities which
1. Quality
transforms inputs into outputs
2. Continual
B. Non-fulfillment of a requirement
Improvement
3. Management C. Action to eliminate the cause of a potential
System nonconformity or other undesirable potential situation
D. Degree to which a set of inherent characteristics
4. Process
fulfills requirements
E. Demonstrated personal attributes and demonstrated
5. Effectiveness
ability to apply knowledge and skills

6. Nonconformity F. Effect of uncertainity

G.Combination of internal and external issues that can
7. Preventive
have an effect on an organization’s approach to
Action
developing and achieving its objectives
8. Corrective Action H. Recurring activity to enhance performance
I. Person or organization that can affect, be affected
9. Correction by, or perceive itself to be affected by a decision or
activity
10. Context J. Extent to which planned results are achieved

K. Establish policies and objectives and processes to

11. Efficiency
achieve those objectives
12. Risk L. Resources used to achieve result
M. Action to eliminate the cause of a detected
13. Interested Party
nonconformity or other undesirable situation
N. Information required to be controlled and maintained
14. Competence
by an organization
15. Documented
O.Action to eliminate a detected nonconformity
Information
 QMS Lead Auditor Course – Participant

Exercise 4: Auditing Context of the Organization (Clause 4)

Purpose:
To determine requirements for Context of the Organization

Duration:
30 minutes to complete the exercise
10 minutes classroom feedback discussion

Directions:

Clause 4.1, 4.2, 4.3, 4.4

In your teams
 Identify the requirements of any of the above clause allocated by the tutor to your
team
 Conduct Document Review of the Case Study provided to you and point out the
evidences you would look for while auditing any of the above clauses allocated by
the tutor to your team?
 QMS Lead Auditor Course – Participant

Exercise 5: Auditing Leadership (Clause 5)

Purpose:
To determine requirements for Leadership

Duration:
30 minutes to complete the exercise
10 minutes classroom feedback discussion

Directions:

Clause 5.1, 5.2, 5.3

In your teams
 Identify the requirements of any of the above clause allocated by the tutor to your
team
 Conduct Document Review of the Case Study provided to you and point out the
evidences you would look for while auditing any of the above clauses allocated
by the tutor to your team?
 QMS Lead Auditor Course – Participant

Exercise 6: Auditing Planning (Clause 6)

Purpose:
To determine requirements for Planning

Duration:
30 minutes to complete the exercise
10 minutes classroom feedback discussion

Directions:

Clause 6.1, 6.2, 6.3

In your teams
 Identify the requirements of any of the above clause allocated by the tutor to your
team
 Conduct Document Review of the Case Study provided to you and point out the
evidences you would look for while auditing any of the above clauses allocated
by the tutor to your team?
 QMS Lead Auditor Course – Participant

Exercise 7: Auditing Support (Clause 7)

Purpose:
To determine requirements for Support

Duration:
30 minutes to complete the exercise
10 minutes classroom feedback discussion

Directions:

Clause 7.1.2, 7.1.3, 7.1.4, 7.1.5, 7.1.6, 7.2, 7.3, 7.4, 7.5

In your teams
 Identify the requirements of any of the above clause allocated by the tutor to your
team
 Conduct Document Review of the Case Study provided to you and point out the
evidences you would look for while auditing any of the above clauses allocated
by the tutor to your team?
 QMS Lead Auditor Course – Participant

Exercise 8: Auditing Operation (Clause 8)

Purpose:
To determine requirements for Operation

Duration:
30 minutes to complete the exercise
10 minutes classroom feedback discussion

Directions:

Clause 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7

In your teams
 Identify the requirements of any of the above clause allocated by the tutor to your
team
 Conduct Document Review of the Case Study provided to you and point out the
evidences you would look for while auditing any of the above clauses allocated
by the tutor to your team?
.
 QMS Lead Auditor Course – Participant

Exercise 9: Auditing Performance & Evaluation (Clause 9)

Purpose:
To determine requirements for Performance & Evaluation

Duration:
30 minutes to complete the exercise
10 minutes classroom feedback discussion

Directions:

Clause 9.1, 9.2, 9.3

In your teams
 Identify the requirements of any of the above clause allocated by the tutor to your
team
 Conduct Document Review of the Case Study provided to you and point out the
evidences you would look for while auditing any of the above clauses allocated by
the tutor to your team?
 QMS Lead Auditor Course – Participant

Exercise 10: Auditing Improvement (Clause 10)

Purpose:
To determine requirements for Improvement

Duration:
30 minutes to complete the exercise
10 minutes classroom feedback discussion

Directions:

Clause 10.2, 10.3

In your teams
 Identify the requirements of any of the above clause allocated by the tutor to your
team
 Conduct Document Review of the Case Study provided to you and point out the
evidences you would look for while auditing any of the above clauses allocated
by the tutor to your team?
 QMS Lead Auditor Course – Participant

Exercise 11: ISO 9001:2015 Requirements

Purpose:
By the end of the activity delegates will be able to:
 Identify requirements that are included in ISO 9001.
 Give examples of business practices that are not specifically addressed in ISO
9001 but that may still form part of any ISO 9001 audit.
 Identify issues that are outside of the scope of an ISO 9001 audit.

Duration:
30 minutes to complete the exercise
20 minutes classroom feedback discussion

Directions:

This is a group exercise. You are provided with post-its, each with a business
requirement.

Your group’s task is to:

 Decide if the business practice is an ISO 9001 requirement.
 If so, to decide where on the ISO 9001 process model it fits and post it there.
 Keep separate the post-its relating to practices that are not included in the
standard.
 QMS Lead Auditor Course – Participant

Exercise 12: Auditing Terminology

Purpose:
To understand terms related to auditing based on ISO 19011.

Duration:
20 minutes in team of 2
10 minutes classroom discussion

Directions:

As individuals, using the definitions handout, review the terms and definitions and note
which definitions belongs to which term. Simply note the correct letter of the definition
next to the appropriate term.
 QMS Lead Auditor Course – Participant

Write the letter corresponding to the DEFINITION next to the TERM it defines.

TERM DEFINITION
A. Set of one or more audits planned for a specific time
1. Audit
frame and directed towards a specific purpose
2. Audit Criteria B. Extent and boundaries of an audit
3. Audit Evidence C. Organization being audited

4. Audit Findings D. Organization audited by a certification body (External)

E. Systematic, independent and documented process for
obtaining audit evidence and evaluating it objectively to
5. Auditee
determine the extent to which the audit criteria are
fulfilled
6. Auditor F. Organization auditing its own system (Internal)

7. Nonconformity G. Set of policies, procedures, or requirements

H. Outcome of an audit, provided by the audit team after
8. Audit Team
consideration of audit objectives and all audit findings
9. Audit Program I. Person with the competence to conduct an audit
J. Records, statement of fact or other information, which
10. Audit Plan
are relevant to the audit criteria and verifiable
K. Demonstrated personal attributes and demonstrated
11. Audit Scope
ability to apply knowledge and skills
12. 1st Party audit L. Organization or person requesting an audit

13. 2nd Party audit M. Description of the activities and arrangements

14. 3rd Party audit N. Non-fulfillment of a requirement

15. Competence O. Organization auditing its supplier (External)

P. One or more auditors conducting an audit, supported if
16. Audit Client
needed by technical experts
Q. Person who provides specific knowledge or expertise to
17. Audit Conclusion
the audit team
R. Results of the evaluation of the collected
18. Technical Expert
audit evidence against audit criteria
 QMS Lead Auditor Course – Participant

Exercise 13: Creating an Audit Plan

Purpose:
To give students practice in creating audit plans based on ISO 19011.

Duration:
30 minutes small group work
40 minutes presentation
20 minutes classroom discussion

Directions:

You have been asked to perform a certification audit of XYZ’s Quality Management
System. Now that the document review is complete, you can plan for the onsite audit, or
Stage 2 audit. In this audit, you will visit XYZ’s facilities to audit their quality management
system. Produce an audit schedule for a 2 day audit with 2 auditors. Be sure to
determine:

a) Appropriate lengths of time and who they will interview

b) How long each interview might take
c) Interim Meetings with Auditee
d) Time for opening and closing meetings.
 QMS Lead Auditor Course – Participant

Exercise 14: Creating Audit Checklist

Purpose:
To give students practice in developing audit checklists.

Duration:
40 minutes in small group
30 minutes presentation
20 minutes classroom discussion

Directions:

Prepare a checklist for a process-oriented audit in your group based on your assigned
process:
 Top Management Process
 Operation/ Project Management Process
 Human Resource Process
 Customer Service Process
 IT Process
 Finance/ Administration Process

Tip: Structure the checklist using columns labeled as follows:

 What is the requirement?
 What will you look at and/or whom will you talk to, to assess conformance with
the requirement?
 What will you look and listen for to prove conformance?
 Both ISO 9001:2015 requirements and Key Solutions PTE Ltd. requirements in
the case study should be covered

Present your checklist to the entire class.

 QMS Lead Auditor Course – Participant

Exercise 15: Conducting Opening Meeting

Purpose:
To give students practice conducting an opening meeting for an audit.

Duration:
30 minutes small group preparation
60 minutes presentation
30 minutes class discussion and summary

Directions:

 Each student of audit group will prepare the opening meeting agenda in accordance
with ISO 19011
 Refer Student Notes for opening meeting agenda
 Tutor will nominate one person from each group to present the opening meeting
 Other members will observe and ask questions for more clarification
 Tutor will represent the management in the opening meeting.
 QMS Lead Auditor Course – Participant

Exercise 16: Audit Role Play & Identifying Non-

Conformances

Purpose:
To understand the difference in the approach used when interviewing personnel at
different organizational levels.

Duration:
30 minutes small group preparation
30 minutes presentation (each group)
30 minutes class discussion

Directions:

The instructor will split the class into groups of 3-5 students each. You will take the role
of Auditor and Instructor will take the role of auditee for all groups. Instructor will assign
the Process/ Function to each group.
 Top Management Process
 Operation/ Project Management Process
 Human Resource Process
 Customer Service Process
 IT Process
 Finance/ Administration Process

Team will select a Team Leader from among themselves. Team Leader will then assign
the responsibilities to team members for auditing different processes from departments
allocated by Tutor to that team.

With the reference of case study provided, you will prepare for the audit as per the
allocated process. Depending on your role assignment, you are to audit the instructor
for the allocated time and determine the non-conformances or cases where further
investigation is required. You can use the checklist prepared in Exercise 14.

When your team is not engaged in the audit role play you all have to make observations
for the audit happening which shall be discussed at the end of each role play before the
Tutor’s final comments.

At the end of the role play, debriefing / discussion within the team should be done about
the findings / non-conformances observed in your process during the audit role play
conducted and categorizing them as major/ minor/ OFI and present them.
 QMS Lead Auditor Course – Participant

Exercise 17: Identifying Non-Conformities

Purpose:
To help students understand how to identify and categorize nonconformity statements
and link them to respective clause of ISO 9001:2015.

Duration:
60 minutes small group preparation
30 minutes class discussion

Directions:

The following 10 statement were presented by auditors. These statements are from
audits of different companies.

Identify if there is a non-conformance. If yes, identify the standard and clause number it
is violating. If no, then what further action should be taken by the auditor.

1. The auditor noted that on 3 consecutive days, work was interrupted due to
network problem.
2. Murray Finance Company’s process for vehicle loans requires the executives to
prepare the docket containing details of the applicant which is verified by the
Department Head prior to sanctioning. It was found that 7 loans had been
sanctioned in the last 15 days with no evidence of verification of the Department
Head.
3. Jeannette had placed an order for model FX-21 car in red colour to the
authorized car dealer. She had a request that the car has to be delivered by 15th
April positively, since she was leaving for a holiday from 17th April and wanted to
take the new car. The dealer had confirmed that the car would be delivered by
15th. Jeannette completed all the related forms and made the required payment.
When she called up on 14th morning, the car dealer informed that FX-21 was not
available and would take a month to get that model. Since Jeannette was in
urgent requirement of a car, she could take FX- 11 which any way was of
substantially lower price than FX-21. Jeannette requested the dealer to check if
he could get FX-21 from another dealer, but they said it was not possible.
Jeannette was in a dilemma as she had sold her old car just 3 days ago.
4. Written amendments to the work instruction for packing did not demonstrate
any formal authorisation. Document Change Note was not available to support
the amendments.
5. The auditor was auditing the purchasing department of Zestha Engineers and
asks how the new supplier for ZD45 items (bearings) was selected. The
purchasing executive explains that the regular supplier could not meet the
delivery date and the order was placed with a supplier that they had never used
 QMS Lead Auditor Course – Participant

before, because the supplier was known to the Purchase Manager. The
executive states that no other evaluation was carried out.
6. In the marketing department the auditor notes that the staff are receiving
orders/ delivery schedules from customers over the telephone and entering
details directly into the organization's computerized order processing system.
On enquiry, the auditor is told that there is no need for an independent review of
individual orders, because the marketing staff members are fully trained and the
database holds details of all regular customer specifications and requirements.
7. History record of Machine No. 105 showed that the machine was having frequent
breakdowns. The maintenance engineer informed the auditor that they replaced
the worn-out or broken parts with the best brand but they still had frequent
breakdowns.
8. In the Production Department, the auditor found Operator at work station PM-14
was working on a different specification than the others in the department. The
Supervisor informed that he had verbally communicated the specifications for
production for the day, to the operators and probably this operator had written the
specifications incorrectly.
9. Training record of James showed that he had received training on Six Sigma
Green Belt. When the auditor asked the training manager if the training provided
was effective, he replied that since the training was provided by a renowned
trainer, it should be effective.
10. The electronic goods trading organization had a fairly large Customer Service
Department which received customer complaints and resolved complaints. They
recorded all the complaints as well as the time taken to replace the item. When
they received the complaint, they checked with the warehouse, if the item was
not available, they forwarded the requirement to the specific manufacturing units
which were situated overseas. The auditor observed that at times, replacement
of items took 4 to 5 months. On questioning, the customer service manager
stated that atleast they are replacing the items, so what if it was taking long. No
other action was taken by the organization.
 QMS Lead Auditor Course – Participant

Exercise 18: Writing Non-Conformities

Purpose:
To help students understand how to write effective nonconformity statements.

Duration:
50 minutes small group preparation
20 minutes presentation
20 minutes class discussion and summary

Directions:

Having identified nonconformities within Key Solutions PTE Ltd. quality management
system, prepare a statement that describes the nature and features of the
nonconformity.

Individually, decide the appropriate wording for the situation assigned by the instructor.
Your nonconformity statement should be as concise as possible and drafted from the
activities in previous exercise.

Once the individual nonconformity statements have been drafted, each small team will
review the ones written by their team members and the Team Leader will present the
best written nonconformity their team can produce. You can use the forms on the
following pages to record the nonconformity statements from your team and the rest of
the class.
 QMS Lead Auditor Course – Participant Handout

Quality Austria Central Asia Pvt. Ltd. NC Number: …......

QMS Audit NONCONFORMITY REPORT
Name of the Organization:
Address of the Organization:

Process under Review: ISO 9001 Clause ref:

………………………………………. Date:
Category: ◻ MAJOR ◻ MINOR
Requirement:

Nonconformity and objective evidence:

Target Date of Action Submission:

Auditor: Auditee:
 QMS Lead Auditor Course – Participant

Exercise 19: Conducting Closing Meeting

Purpose:
To give students practice conducting a closing meeting for an audit.

Duration:
30 minutes small group preparation
60 minutes presentation
30 minutes class discussion and summary

Directions:

At the end of the audit, the Team Leader, supported by the audit team, is normally
required to give an immediate, yet comprehensive and balanced, verbal report. The
purpose is to present the audit findings and conclusions in a manner that they are
understood and acknowledged by representatives of the auditee.

The Team Leader will chair the meeting and cover an agenda that includes the points
raised in the course presentation on closing meetings.

Based on the information supplied by the instructor, prepare for a closing meeting and
make a formal presentation of all audit findings including the non-conformances
observed during the role play conducted during Exercise 16 to the top management
team of Key Solutions PTE Ltd.

Although it may not be typical, it will be necessary for each team member (except the
Team Leader) to present a nonconformity statement.

The Team Leader has to plan for the meeting, manage the meeting, and conclude the
meeting. He or she does not have to prepare a nonconformity report, only the audit
summary that is verbally presented.
 QMS Lead Auditor Course – Participant

Exercise 20: Preparing Audit Report & NC Closure

Purpose:
To help students understand how to prepare audit report and close NCs.

Duration:
40 minutes small group preparation
20 minutes class discussion and summary

Directions:

Prepare Audit Report which includes all the information as required and NC Report.
Review the NC Closures submitted by the Auditee and judge whether these closures
are acceptable or not for the below 3 cases:
.
 QMS Lead Auditor Course – Participant

Organization Name, Address

TYPE OF ACTION

Standard/Regulation: ISO 9001: 2015 Action No.: 01

☒ Standard, Clause: 8.3.2 a) ☐ Own specification ☐ Legal bases (e.g. laws)

SERIES OF ACTIONS

PART 1 – Findings by the auditor ☐ Minor or ☐ Major nonconformity

The following nonconformities require corrections and corrective actions:

1. Detected nonconformities:
The process of Design is not fully effective.

2. Requirement:
In determining the stages and controls for design and development, the organization shall consider: a) the nature,
duration and complexity of the design and development activities

3. Objective evidence:
The records for the Design Plan of Base Transceiver Station # 82 does not mention the no. of days required for designing
and installing the BTS # 82.

4. Agreed date for submission for part 2 to the Lead Auditor: 13.12.2017

Auditor: XYZ Date: 13.11.2017

PART 2 – Actions by the client

Please inform us about the causes and actions, as well as about the date on which the actions are to be taken/ have been taken.

4. Root cause analysis:

It is difficult to state.

5. Planned corrective Action

Expert advice upon BTS designing will be taken and duration will b analyzed and included in the design plan.

6. Corrective action / dates:

After much analysis the management concluded it is difficult to analyze as it depends upon various factors.

Name: JKL Date: 13.12.2017

PART 3 – Evaluation conducted by the auditor

Specification of possible further procedure:

6. Evaluation:
☐ The effective implementation of corrections and corrective actions has been evaluated, verified and accepted.
☐ The client’s plan regarding corrective actions has been evaluated and is accepted. Verification of the effective
implementation will be carried out in the course of the next audit (only possible in minor nonconformities).
☐ The corrective actions have not been implemented effectively.

Action status: ☐ closed ☐ open

Auditor: Date: select

 QMS Lead Auditor Course – Participant

Organization Name, Address

TYPE OF ACTION

Standard/Regulation: ISO 9001: 2015 Action No.: 02

☒ Standard, Clause: 7.2 cs) ☐ Own specification ☐ Legal bases (e.g. laws)

SERIES OF ACTIONS

PART 1 – Findings by the auditor ☐ Minor or ☐ Major nonconformity

The following nonconformities require corrections and corrective actions:

1. Detected nonconformities:
The process of Human Resources is not fully effective.

2. Requirement:
The organization shall: c) where applicable, take actions to acquire the necessary competence, and evaluate the
effectiveness of the actions taken;

3. Objective evidence:
The induction training for five new information security analyst of XYZ BACKGROUND VERIFICATION PVT. LTD. Is evidenced
and found up to the mark, however no evidence was found to verify effectiveness of the same..

4. Agreed date for submission for part 2 to the Lead Auditor: 13.12.2017

Auditor: XYZ Date: 13.11.2017

PART 2 – Actions by the client

Please inform us about the causes and actions, as well as about the date on which the actions are to be taken/ have been taken.

4. Root cause analysis:

The information security analyst recruited were highly experienced and post the induction training their feedback indicated
that they are very confident upon grasping the concepts taught in the training and ensure a very good performance. This
was accepted and no need for evaluating the effectiveness of the induction training was felt.

5. Planned corrective Action

The information security analyst recruited will be put forward to a questionnaire designed by the Top Management with an
intention to check the effectiveness of the induction training. It has been understood that recruiting highly experienced
doesn’t mean that there is no need to check the knowledge grasped during any training.

6. Corrective action / dates:

The procedure for evaluating the effectiveness for training has been modified and re-issued and in future these would be
applicable. This procedure is enclosed for reference:
A formal questionnaire consisting of 20 MCQs shall need to be answered post the induction training conducted irrespective of
the knowledge and skills of the people hired. Scoring a minimum of 70 % in the questionnaire will indicate effective grasping
of the induction training.

Name: JKL Date: 13.12.2017

PART 3 – Evaluation conducted by the auditor

Specification of possible further procedure:

 QMS Lead Auditor Course – Participant Handout

6. Evaluation:
☐ The effective implementation of corrections and corrective actions has been evaluated, verified and accepted.
☐ The client’s plan regarding corrective actions has been evaluated and is accepted. Verification of the effective
implementation will be carried out in the course of the next audit (only possible in minor nonconformities).
☐ The corrective actions have not been implemented effectively.

Action status: ☐ closed ☐ open

Auditor: Date: select

 QMS Lead Auditor Course – Participant Handout

Organization Name, Address

TYPE OF ACTION

Standard/Regulation: ISO 9001: 2015 Action No.: 03

☒ Standard, Clause: 7.5.1 ☐ Own specification ☐ Legal bases (e.g. laws)

SERIES OF ACTIONS

PART 1 – Findings by the auditor ☐ Minor or ☐ Major nonconformity

The following nonconformities require corrections and corrective actions:

1. Detected nonconformities:
The process of Calibration is not fully effective.

2. Requirement:
When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring equipment shall be: a) calibrated or verified, or both, at
specified intervals, or prior to use, against measurement standards traceable to international or national measurement
standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented
information

3. Objective evidence:
Photometer No. ABC which was installed in the reading area of library of XYZ college was not verified for being working since
past 6 months. On asking the admin staff for calibration records they said that they are not available.

4. Agreed date for submission for part 2 to the Lead Auditor: 13.12.2017

Auditor: XYZ Date: 13.11.2017

PART 2 – Actions by the client

Please inform us about the causes and actions, as well as about the date on which the actions are to be taken/ have been taken.

4. Root cause analysis:

Upon interviewing the librarian, she said that she has not been trained upon the functioning of Photometer to check the
amount of light.

5. Planned corrective Action

Librarian will be trained upon the functioning of photometer to check the amount of light.
Target Date: 30 Jan 2016 Responsibility : Librarian and Co- coordinator admin.

6. Corrective action / dates:

Librarian has been trained upon the functioning of photometer to check the amount of light.

Name: JKL Date: 13.12.2017

PART 3 – Evaluation conducted by the auditor

Specification of possible further procedure:

 QMS Lead Auditor Course – Participant Handout

6. Evaluation:
☐ The effective implementation of corrections and corrective actions has been evaluated, verified and accepted.
☐ The client’s plan regarding corrective actions has been evaluated and is accepted. Verification of the effective
implementation will be carried out in the course of the next audit (only possible in minor nonconformities).
☐ The corrective actions have not been implemented effectively.

Action status: ☐ closed ☐ open

Auditor: Date: select