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Participant Work Book

ISO 9001:2015 Auditor/ Lead Auditor Training Course

Course Number: C1196 Dates of Course: to

Venue of the Course: City: Country:

Participant Name (IN CAPITALS) : Signature:

: Instructions for Participants:

1) This Workbook shall be given to you on the first day and shall be taken back at the end of each day before you depart &
finally compiled on day 5 before the test begins.
2) This workbook dully filled ones shall, be used for your continuous assessment on every day. Please ensure that you submit
this workbook to the tutor(s), for daily continuous assessment at the end of each day.
3) On the last day, please return back the course feedback forms (dully filled in by you – for our reference and
improvements) and the IRCA written answer papers for the course.
4) Tips for SUCCESSFUL COMPLETION OF THE COURSE:

 Be attentive and be present on all days..all modules have to be attended;


 The course evaluation shall consider two aspects – your daily performance shall be monitored by the tutors and continuous
assessment and your score in written examination shall be considered for your final result of your success;ooo
 Every member should lead team in rotation for different exercises.
 Following are the List of Exercises :

# Exercise # Exercise
Documentation Audit – Performance
1 Introduction to Participants (Interviewing) 11
Evaluation
2 Terms & Definitions pertaining to Quality 12 Documentation Audit - Improvements
3 Mapping Management Principles 13 Facts or Inferences
4 Process Approach 14 Audit Plan Preparation
5 Documentation Audit – Management Issues 15 Audit Checklist Preparation
6 Documentation Audit – Context of Organization 16 Cases – NC Recordings
Role play ( Audit Interview Process &
7 Documentation Audit – Leadership 17
Recording NCs)
8 Documentation Audit – Planning & FMEA 18 Audit Report Preparation
9 Documentation Audit – Support 19 Audit Follow up – NC Closures
10 Documentation Audit – Operation

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 1 Introduction of Participants Exercise – 15 Minutes

YOUR PARTNER NAME :

Working Organization:

Designation:

Knowledge of ISO 9001:2015 :


(and Rank 1(Minimum) to 5(Maximum)

Any I/II/III Party Audit Experience:


(Rank 1(Minimum) to 5(Maximum)

Objective of attending this course:

Expectations from the course:

Any additional Information


(something interesting of yourself) :

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Terms & Definitions pertaining to Quality


Exercise 2 Exercise – 20 Minutes

# Mapping Quality # Quality Term


Description Terms
1 Ability to apply knowledge and skills to achieve
1 QUALITY
intended results.
2 Set of interrelated or interacting activities which
2 EFFECTIVENESS
transform inputs into outputs.
3 Action to eliminate the cause of nonconformity
3 PROCESS
and to prevent recurrence.
4 Need or expectation that is stated, generally DOCUMENTED
implied or obligatory. 4 INFORMATION
5 Information required be controlling and
maintaining by an organization and the medium 5 REQUIREMENTS
on which it is contained.
6 Effect of uncertainty on an expected result. 6 RISK
Set of interrelated or interacting elements of an
7 organization to establish policies and objectives 7 OUTSOURCE
and processes to achieve those objectives.
Extent to which planned activities are realized
8 and planned results achieved. 8 NON-CONFORMITY

9 intentions and direction of an organization as 9 MONITORING


formally expressed by its top management
make an arrangement where an external
organization performs part of an organization’s
10 function or process 10 POLICY

11 CORRECTIVE ACTION

12 COMPETENCE
MANAGEMENT
13
SYSTEM
14 INNOVATION
15 CONFORMITY

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 3 Mapping Management Principles Exercise – 20 Minutes

1. Customer Focus 2. Leadership 3. Engagement of people 4. Process Approach


5. Improvement 6. Evidence Based Decision Making 7. Relationship Management

S. Principle
No. (Srl.# -
Feature:
see
above)
1
Every input goes for process giving output
2 Ensuring that the bonded stores dispatch correct material to respective
customers
3
Motivating the factory personnel take care of Quality in production
4 Ensuring that the process interfaces are mapped adequately that the information
is transferred to process owners in effective and safe manner
5 The Quality and Purchase team considers the actual rejections during
inspections in supplier performance evaluations
6 The review of one year customer complaints indicated that % of complaints have
reduced, compared to previous year,
7 Helping the supplier in calibrating his measurement instruments, using master
instruments of the organization
8
Changing bicycles by motorcycles for faster and better service to customers
9 Motivating employees to suggest changes in the processes to reduce cycle time
and set examples
10 People accepting ownership of problems and their responsibility for solving
them.
11 The design manager is present at the commissioning site to make required
changes in the pressure controls based on the actual readings
12 Organization does II party audit on supplier as Customer wants to ensure the
organization supplier’s quality is maintained by performing a system audit
13
Identifying, understanding and managing interrelated processes as a system
14 Defining objectives in a manner by which the gap between objectives and
results reduce

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 4 Process Approach Group Exercise – 30 Minutes

Give the following information in the spaces provided for this bottling line (examples):
1. The inputs
2. Outputs
3. Monitoring & Measuring opportunities
4. Efficiency & Effectiveness
RESOUCES & METHODS

INPUTS BOTTLING OPERATION LINE OUTPUTS


Juice

MONITORING & MEASUREMENTS

INPUT Resources & Process OUTPUTS Effectiveness &


S Methods (Monitoring & Efficiency
Measurements)

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 5 Documentation – Stage 1 audit


Group Exercise – 45 Minutes

Read the Quality Apex Documented Information of Good Glass company MANAGEMENT ISSUES [including Scope &
Applicability]) and identify those issues which do not comply to the requirements of the standard (up to specific sub-clause) with
reference to chapter & page number of the Apex Documented Information

# Issue

Note If more points, use backside of the page

Exercise 6 Group Exercise – 45 Minutes


Documentation – Stage 1 audit
Read the Quality Apex Documented Information of Good Glass Company Context of Organization and identify those issues
which do not comply with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of
the Apex Documented Information

# Issue Apex Documented Standard


Information reference reference

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Note If more points, use backside of the page

Exercise 7 Documentation – Stage 1 audit Group Exercise – 45 Minutes

Read the Quality Apex Documented Information of Good Glass Company Leadership and identify those issues which do not
comply with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of the Apex
Documented Information.

# Issue Apex Document Standard


reference reference

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 8 Group Exercise – 45 Minutes


Documentation – Stage 1 audit
Read the Quality Apex Documented Information of Good Glass Company Planning and identify those issues which do not comply
with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of the Apex Documented
Information

# Issue Apex Standard


Document reference
reference

FMEA (Failure Mode Effect Analysis) PROCEDURES

Identify the scope of the FMEA. Is it for concept, system, design, process or service? What are the boundaries? How detailed
should it be?
Review the GGC FMEA procedure (Appendix 1) and audit the same for adequacy.

…………………………………………………………………………………………………………………

…………………………………………………………………………………………………………………

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 9 Group Exercise – 45 Minutes


Documentation – Stage 1 audit
Read the Quality Apex Documented Information of Good Glass Company Support and identify those issues which do not comply
with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of the Apex Documented
Information.

# Issue Apex Document Standard


reference reference

Exercise 10 Group Exercise – 45 Minutes


Documentation – Stage 1 audit
Read the Quality Apex Documented Information of Good Glass Company Operation and identify those issues which do not
comply with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of the Apex
Documented Information

# Issue Apex Document Standard


reference reference

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 11 Group Exercise – 45 Minutes


Documentation – Stage 1 audit
Read the Quality Apex Documented Information of Good Glass Company Performance Evaluation and identify those issues
which do not comply with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of
the Apex Documented Information

# Issue Apex Standard


Document reference
reference

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 12 Group Exercise – 45 Minutes


Documentation – Stage 1 audit
Read the Quality Apex Documented Information of Good Glass Company Improvements and identify those issues which do not
comply with the requirements of the standard (up to specific sub-clause) with reference to chapter & page number of the Apex
Documented Information

# Issue Apex Document Standard


reference reference

Exercise 13 Facts or Inference Group Exercise – 30 Minutes

Read the following cases and note the answer the following questions for the incidents:
1) Walker was doing an experiment (in lab) on biological changes in humans, when they tell lies. Walker was surprised to see the results of one test and
wanted to inform the professor of her university..but the telephone lines were dead..no mobile connectivity. Walker thought that since the weather was
very rough when arrived at the lab in the morning….looked out of the window and was surprised to see dark clouds and realized that it might be raining.
Took rain coat & test report and went out of the Laboratory and rushed towards the car, to reach the professor.

# Statement Judgment (Select by “X”) Reasons

1 Mr. Walker was surprised to the results of the


test in the university laboratory. Fact Inference
2 The weather outside was very rough when
Walker looked out of the window of the Lab. Fact Inference

3 Walker was experimenting on


biological changes in humans. Fact Inference
4 Walker took the test report to show to the
professor in rain. Fact Inference
5 Walker rushed towards his car with rain coat
and test report. Fact Inference

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

2) The swimming pool safe guard was beside the swimming pool and suddenly found that one boy fell into the pool (slipped on the edge). The guard
jumped into the pool to rescue the boy…on approaching the boy he realized that the boy knew swimming and he swim himself to one side and started
smiling..the guard also smiled….but suddenly the boy said “help” and fainted. He was taken out of the pool and given artificial respiration by the guard
and boy came to senses. The guard insisted for medical checkup by duty doctor and taken immediately for checkup.

# Statement Judgment (Select by “X”) Reasons


1 The Safe guard at the pool seen that the boy
slipped into the pool and jumped into the
water to save the Fact Inference
boy.
2 The boy suddenly said “help” and fainted
after coming out of the pool. Fact Inference
3 The boy himself swims to safety as he knew
Fact Inference
swimming.
4 Every one pulled out the boy out of swimming
pool when he fainted Fact Inference
5 The boy was taken to the duty doctor for
checkup, after he came to senses, as everyone Fact Inference
insisted for the same.

Exercise 14 Group Exercise – 75 Minutes


15 Min. for Presentation
Audit Plan Preparation
Considering the Quality Apex Document of Good Glass Company, prepare an audit plan, as per following guidelines:

1. Total man days = Calculate audit duration from IAF MD5 Table for 50 employees or take Four (minimum)
[One Man day = 8.30 hrs) or use audit duration as given by tutor.
2. Use all the personnel in your group as auditors (you can use auditor – 1, 2, etc.) as references, rather than actual
names.
3. Avoid if possible two people going for same process area audit.
4. Cover one Installation site also in the audit plan as they do execution as well.
5. The audit plan shall contain basic information as under:
a) The start time of each process area and the auditor allotted for that specific process area.
b) Allot 5 minutes as auditor’s brush up time in middle for effective smooth continuity and effective audit,
for information sharing and judgment on audit proceedings.
c) You can do this in two ways…one plan accommodating all process areas and auditors or separate plan for
each auditor, with distributing the process areas

MAKE THE AUDIT PLAN IN ROUGH ON THE NEXT PAGE & AS A GROUP ON THE FLIP
CHART(S) THE GROUP LEADER TO MAKE A PRESENTATION OF THE EXERCISE FROM
THE FLIP CHART

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Assessment Plan Date: 15th December 2015


Organization: M/s Good Glass Company
Scope: Design, Development, Manufacture and Installation of Glass Products For Infrastructure Applications

Objective of Assessment: To assess the conformity of quality management system w.r.t. ISO 9001:2015.

Criteria System(s)
Documented info
ref. (if any):
Team Leader: Audit Start Date Opening
Meeting
Team Audit End Date Closing
Member: Meeting
Audit Schedule

Date Client Function Auditor Time

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Exercise 15 Group Exercise – 145 Minutes


Preparation of Audit Checklist
15 min tutor review
Considering the ISO 9001 standard and Quality Apex Document of Good Glass Company, and using the organization structure,
prepare an Audit Checklist for a process area (department), allotted to you by the trainer.

Note: As you are aware, the word shall means “MANDATORY” and all the requirements after shall are action points to be verified in an
audit. Take this as a tip in preparing Audit Checklist

MAKE THE AUDIT CHECKLIST IN ROUGH ON THE NEXT PAGE & AS A GROUP ON THE FLIP
CHART(S) THE GROUP LEADER TO MAKE A PRESENTATION OF THE EXERCISE FROM THE
FLIP CHART

Clause # CHECK POINT (For Verification) Conclusion Evidences for


(Compliance / NC
NC)
Scope and Non-Applicability of requirements (with suitable justification)
4.1 Has the Organization Identified External C
and Internal Issues?
4.2 Does the Organization Monitor and Review
the External and Internal Issues?
5 Is the Quality Policy Established? C

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

Group Exercise – 60 Minutes


Exercise 16 Recording Non-conformities 15 Minutes for presentation
15 Minutes for Tutor Review
Please read the following cases and judge as under – please note you are an auditor assessing
this situation, that means you are standing there in the case and performing interview while auditing.
1. If you think there is a sufficient objective evidence of nonconformity then complete the Non-conformity notes provided in section “A”
and categorize the same as “Major” or “Minor”.
2. If you think there is not sufficient objective evidence of nonconformity then state the reasons in the section “B”. In the reasoning, also
state what must be further investigated before concluding your decision wither it is conforming or non-conforming.

Incident 1

In ABC Catering Company, once customer complaint was received as under:


“Our contract says that the quality of rice to be used for rice based dishes should be an “Indian Basmati rice only” and you would be giving proof
of calories should comply with specs. Sheet “ABC_SPEC 212 issue 2 dt. 12 Jan 2010” and you would be giving us a III Party laboratory test
report every quarter of the year…. we have not received any evidence till now. Last month we performed a system audit and were surprised to
note that the audit team raised the same issue in the form of Non-conformance report (NC – 15 Dt. 21 Dec.2010) which is not yet closed. Please
note the following:

Since our contract is for five years and one year has passed. We need to ensure that for next balance four years you would be providing us the
evidences of compliance of the same, for past three consignments and shall ensure that, you will continue to adhere to the contractual
requirements.
In the eventuality to adhere to requirements of point 1. Above soon, as per the discretion of our management, there may be a possibility that we
may not continue business with you as per the contract terms.

We are taking a stand on this, as need to submit these evidences to all our customers and all of them are concerned on this issue. We cannot afford
to lose our clients, as they are prestigious international airlines. This is very important for our business standard and reputation. Hope you realize
the criticality of the situation and comply to the requirements, ASAP.”

On this, ABC Company responded in the following manner:

“We have been sending by fax all the evidences to the number as defined in the contract..yes we did not confirm whether you received or not. We
have all the evidences of the faxes sent to you in our files and were shown to your auditors when they were here to perform the II party audits.
Please let us know if the fax machine is working or umber has changed or any other issue. Anyhow now onwards we shall be emailing the same to
your Quality department.
And also we shall be uploading all these evidences in our internal Intranet and giving you the password for access (only to authorized personnel
only - as identified by you), to avoid such issues recurring again.
The NCR – 15 clearly mentions that one report is missing which we agreed and responded back to your closure (after rectifying our recording
system) for closure and requested you to formally close the NCR which is pending from your side for acceptance of the actions and close out.

We assure you the best of services at all time to come. We thank you for this opportunity for improvement which we feel that without you
pointing out this; our communication system would not have been improved.”

Incident 2
While doing the audit of Sheet Metal components for various industry sectors, you found that one of the gauges (GO – NOGO) for final
inspection of circular product, was found to be broken from one of the sides. Upon asking the inspector using the gauge, replied that it was
supplied by the client & would be returned to the client with the last consignment. On verification of the Quality Apex Document, you also
detected that this company where you are presently auditing, had sought exclusion for Customer Property.

Incident 3
A company manufactures compasses for pleasure crafts. During the audit you observed that, to do the inspections of centricity of pin (The arrow
in the compass which points to north), the person lifts a liver to lift the pin up & visually verifies the parallel level of the pin with the surface. You
as an auditor observed that the person doing the job is wearing thick

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
glasses and his hands are shaking. On enquiry you came to know that the person is the senior most people & in the company since last 20 years &
very experienced in Compasses – the only inspector - his hands shake because of an illness. Through the complaints register you also establish
that nearly 3% of the consignments on an average, come back from the market and are replaced by the company free of cost. It was further
established by you that on re-verification of some of the samples from the stock, ready for delivery revealed that they also have problems of
centricity.
Note: A pleasure craft (speed boat) moves very fast in water compared to big ships which, even turns very slowly. The precision and swiftness of
the compass indications are the key quality norms for acceptability.

Incident 4
While review of Management Review Meeting minutes, recorded the issue as - The brand retail business started operations in one country and due
to local laws, they had to recruit local manpower, but their English was not good enough to sell the products to prospective customers, mainly
foreigners. This was identified during interview process also. Human Resources developed competency matrix and detailed job descriptions and
translated to local language. These local personnel had no problems in selling products to local community but failed to sell products to foreign
guests, due to problem in communication. As per the law there is a restriction in law that female employees will not interact with males & vice
versa. HR & Operational Management had this problem but was not able to balance the law and business requirements, for nearly a year due to
which the business targets were not been able to meet business objectives (sales & branding). This aspect was taken up for discussions in
Management Review and it was recorded in the minutes of meeting that local regulatory labor authorities would be contacted for solutions.

Incident 5
While auditing the Top Management area (internal audit process), you noticed that one of the internal audit NC reveals the fact of - the internal
audits frequency was annually and three internal audits results revealed that 70% of the Non- conformities were on Product Quality. You also
noted that there were no changes in the quality plan, inspection sampling plan & no trainings imparted in quality inspections.

Incident 6
The results of one of the student (with Srl. #: 098701) of a computer institute has appeared in the Final Evaluation for ORACLE 8 (Five months
diploma course). During the audit you as a member of audit team for ISO 9001:2015, you were to verify the records of the students. Following
were the facts which were revealed from the records (soft & hard copy):
The approved marks allotted on practical exercises test on computer were not traceable (neither in hard copy nor in soft copy form).
The answers for the test revealed that they were correct in the soft copy and the hard copy – the Srl.# is correct but the name was different on the
record.
There was also a letter from the student dated four months back (after the test) mentioning that his marks were not disclosed by the institute and
his new prospective employer wanted to verify the certificate and marks obtained – No corrective action records were evident.
One of the objectives of the institute was “TO BUILD CAREERS OF ATLEAST 75 % OF THE PASSED STUDENTS OF EACH BATCH
THROUGH THEIR PLACEMENT CELL.”

Questions in this section are designed to test student’s ability to analyse audit situations, evaluate audit evidence and apply knowledge of the audit
criteria correctly.

Students are also required to demonstrate their ability to write a well- constructed nonconformity statement that describes clearly the weakness or
failure of the management system, the audit evidence and the requirement(s) of the standard.

Note to marker:

To raise a nonconformity report when there is not sufficient audit evidence should be penalized and markers should normally award
zero mark.

To complete an audit investigation where there is sufficient evidence to report nonconformity can often be supported and be given
marks, normally up to a maximum of 7 marks from a possible 10 marks.

To be awarded marks a student must state clearly their reason for thinking there is not yet sufficient evidence to report the findings as a
nonconformity and describe the investigation they would follow to determine conformity or nonconformity; including audit trails and audit evidence
they would seek and for what purpose, quoting relevant ISO 9001 clause numbers.

Exceptionally, where there was some obvious ambiguity in the description of the audit situation or the student demonstrates logical argument,
knowledge of the subject and the answer shows an ability to make a reasoned judgement leading to a clear determination of conformity or
nonconformity marks up to the maximum available may be given.

Typical solutions for nonconformities follow a standard method of presentation: i.e. failure in the system (3 marks for identifying the failure), audit
evidence (3 marks for identifying the audit evidence) and requirements (1 mark for identifying the ISO 9001 clause and requirement). Alternative
structure or presentation of the nonconformity by a student is acceptable provided these three components of the nonconformity are clearly present
and the distribution of marks adhered to.

NON CONFORMITY NOTE Incident: 1

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Statement of Non Conformity

Evidence (reference of Process/Personnel/Documents) (WHERE):

Interview Name of The Employee,


Procedure Reference No. XXXXX,
Site Observation

Requirement (WHY):

Clause No. ISO Standard

Auditor Auditee Date

Comments:

NON CONFORMITY NOTE Incident: 2

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

NON CONFORMITY NOTE Incident: 3

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
Requirement (WHY):

Auditor Auditee Date

NON CONFORMITY NOTE Incident: 4

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

NON CONFORMITY NOTE Incident: 5

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

NON CONFORMITY NOTE Incident: 6

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

Exercise 17 Group Exercise –


Role Play – Interview Process 60 Minutes for study of GGC & referring the
previous exercises outcome (exercises 6 ,7 ,8 ,9, 10, 11,
12 & 13)
180 Min. for Role Play
45 Minutes for presenting audit findings
15 Minutes for Tutor Review

Teams to be made – Each Team will audit for the specific function allotted by tutor.
Tutor will act as Auditee.
Does the role play involving each team so that all get a chance for the LIVE AUDIT?

The group which is not auditing shall observe the other group while auditing and discuss their
observations and findings.

Process Area (Department) :

# CHECK POINT (For Verification) Conclusion Evidences for NC


(Compliance / NC) (Page # of Apex
Documented
Information)
1
2
3
4
5
6
7
8
9
10

Write NCRs for any Four in the prescribed format on subsequent pages

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Questions in this section are designed to test student’s ability to analyse audit situations, evaluate audit evidence and
apply knowledge of the audit criteria correctly.
Students are also required to demonstrate their ability to write a well- constructed nonconformity statement that
describes clearly the weakness or failure of the management system, the audit evidence and the requirement(s) of the
standard.
Note to marker:
To raise a nonconformity report when there is not sufficient audit evidence should be penalized and
markers should normally award zero mark.
To complete an audit investigation where there is sufficient evidence to report nonconformity can often be
supported and be given marks, normally up to a maximum of 7 marks from a possible 10 marks.
To be awarded marks a student must state clearly their reason for thinking there is not yet sufficient evidence to
report the findings as a nonconformity and describe the investigation they would follow to determine conformity or
nonconformity; including audit trails and audit evidence they would seek and for what purpose, quoting relevant ISO
9001 clause numbers.
Exceptionally, where there was some obvious ambiguity in the description of the audit situation or the student
demonstrates logical argument, knowledge of the subject and the answer shows an ability to make a reasoned judgement
leading to a clear determination of conformity or nonconformity marks up to the maximum available may be given.

Typical solutions for nonconformities follow a standard method of presentation: i.e. failure in the system (3 marks for
identifying the failure), audit evidence (3 marks for identifying the audit evidence) and requirements (1 mark for
identifying the ISO 9001 clause and requirement). Alternative structure or presentation of the nonconformity by a
student is acceptable provided these three components of the nonconformity are clearly present and the distribution of
marks adhered to.

NON CONFORMITY NOTE (Role Play) NC: 1

ISO 9001:2015 CLAUSE No:

Company documents Company documents MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

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NON CONFORMITY NOTE (Role Play) NC: 2

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

NON CONFORMITY NOTE (Role Play) NC: 3

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

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NON CONFORMITY NOTE (Role Play) NC: 4

ISO 9001:2015 CLAUSE No:

Company documents Area unit involved MAJOR / MINOR


[Strike out as required]

Failure (Nonconformity) (WHAT):

Evidence (reference of Process/Personnel/Documents) (WHERE):

Requirement (WHY):

Auditor Auditee Date

AUDIT REPORT PREPARATION


Exercise 18 Group Exercise – 40 Minutes for report preparation
40 Minutes for the reports presentation 10 Minutes for tut

Based on the audit done and findings recorded, plea (A flipchart se prepare Audit Report as below:

can be used in addition to the workbook)

ASSESSMENT REPORT

Name of Company (Organization): Good Glass Company

Address:

Contact Person: Position:


Alternate Contact Person: Position:
Registration Scope:

No. of Employees: No. of Shifts:


Company’s Key Documented Information Reference (if any):

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
Management Standard:
Assessment Type: Registration Assessment (Stage 2)
Assessment Commencement Date: Assessment Completion Date:
Assessment Team:
Name Status

Mandays : 4
Nonconformities raised during Assessment
NCR Ref. No. NC 01
Minor/Major Minor
Nonconformities raised during last visit
NCR Ref. No. NIL
Closed/Open

Areas Assessed :

Sales & Marketing


Production
Maintenance
HR & Admn
Stores

Audit Conclusion & Appropriateness of the Certification Scope

The Organization has implemented the requirements of ISO 9001:2015 satisfactory


and has been recommended for award of Certification.

The Scope of the Organization is verified and found fulfilling the requirements of
the standard.

**Disclaimer - Auditing & its conclusion is based on a sampling process of the available information**

Non-applicability of requirements (with suitable justification)

Clause: Customer Property


Justification: Not Accepted; Because the organization is using Micrometer provided by the Main
Contractor

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

QMS ASSESSMENT COMMENTARY


Context of the Organization

Leadership

Planning

Support

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Participant Work Book
ISO 9001:2015 Auditor/ Lead Auditor Training Course

Operation

Performance Evaluation

Improvement

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

ASSESSMENT COMMENTARY

The Organization has implemented the quality management system effectively.

(Write NA if this sheet if not applicable)


NONCONFORMITY REPORT Client Representative:
NCR Reference Details of nonconformity Management Standard
Reference
5.2 Inadequate evidence to GGC/QM/001

*Add more rows if required

RECOMMENDATION FOR CERTIFICATION


Congratulations, we are pleased to recommend certification for the scope detailed in Assessment Report:

Subsequently this Assessment Report Pack along with your satisfactory Corrective Action Plan and objective evidences (if
applicable) shall be reviewed independently with in BSCIC. Once the recommendations are found as sound, BSCIC will be pleased
to issue a Certificate of Registration. This will come along with the BSCIC Logo and Accreditation Mark. The conditions for use of
BSCIC Logo and Accreditation Mark have been stipulated and the same will be provided to you.

BSCIC believes in value added partnership with its clients, and we will be pleased to revisit your company for the Surveillance
Assessments for a visit every Year for 2 Manday per visit.

Details of Additional Locations and Activities for certification (If applicable)


Location 1 NA

Activity NA

*Add Rows for more

(Write NA if this sheet if not applicable)


Recommendation for Supplementary /Re-Assessment

1.The following have been considered as major concerns during this assessment visit--------NA

2. This assessment is based on random samples therefore nonconformities may exist which have not been identified.

For Registration Assessments:


3. A recommendation for certification cannot be made until the nonconformities have been cleared, following the
corrective action plan being submitted and a limited/full reassessment being satisfactorily completed.

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
Scope Assessed---------NA
4. The non-conformities identified indicate a breakdown in the management system to effectively control the activities for
which it was intended.
Immediate action is required to investigate the underlying cause of these non-conformities and implement effective,
corrective and preventive action. A plan to determine actions, time scales and responsibilities must be prepared and
submitted to Chief Executive for review, no later than ----/-----/------------------NA

5. Team recommends a Limited Supplementary Assessment for --- Manday(s) or a full Re-assessment for-------Manday(s).
The same could be conducted by ----/----/-------, upon satisfactory corrective action plan submitted by client to BSCIC’s Chief
Executive--------NA

6. Client to inform their readiness to BSCIC’s Chief Executive for the further assessment as in 4 above so that the same could
be satisfactorily planned & conducted.

(Write NA if this sheet if not applicable)


SURVEILLANCE ASSESSMENT(SA) PROGRAMME
(Write NA if any Area is not applicable. Please do not DELETE any ROW)
SA. Frequency 1 year
S.A. Conduct Number SA1 SA2 REA
Re Assess.

Man day(s) 2 2 3
MM / YYYY 12/16 12/17 10/18
Functions/ Areas / Site
  
Leadership
  
A resource assigned by top
management, the responsibility and
authority for 5.3 (a) to (e)
  
Planning / Risks and Opportunities
 
Requirements for products and services
  
Design & development of products and
services
 
Control of externally provided
processes, products and services
  
Production and Service provision
  
Performance Evaluation / Monitoring
and Measuring resources
 
HR related processes
  
Management Review
QMS Documented Information &   
Changes

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
Internal Audits   
Complaints Management   
Previous NCR & Corrective Actions   
Use of BSCIC Logo & Marks   
Re-assessment (Tick ) 
Legal (EMS & OHSAS specific)

Notice: 1. Fill the areas as per the client activities and processes. Mandatory fields are already mentioned.
2. Assessor to Pl.  in boxes indicating a full plan. This is required to be updated upon each Surveillance Assessment.

DECLARATION OF NON-CONFLICT OF INTEREST


I confirm that I have no consultancy or other commercial association with M/S Good Glass Company during the last two years
other than activities conducted under the direction of BSCIC.

BSCIC Registration Assessment Report Acceptance


The onsite Registration Assessment of M/S Good Glass Company was completed.

BSCIC through its Team Leader / Lead Auditor confirms the Confidentiality of the information received, Observed and Reported
by the Team BSCIC.

Team Leader / Lead Auditor by signing this sheet confirm the Non Conflict of Interests with the Organization.

This report and its full contents are completely understood and accepted.

Please sign below confirming acceptance of the assessment report’s contents

Signed for & on behalf of BSCIC Signed for on behalf of the client
Name: Name:
Date: Date:

Exercise 19 Audit Follow-up NC Closures Group Exercise – 20 Minutes for preparation


Minutes for reviewing & decision making
10 Minutes for Tutor Feedback

Review the closure submitted by auditee and judge weather this closure is acceptable or not, for the below three cases.
NON CONFORMITY NOTE - 1

PROCESS ACTIVITY ISO 9001:2015 CLAUSE


Environment for the operation Infrastructure & 7.1.3, 7.1.4 and 7.1.5
of processes and Calibration [A]

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ISO 9001:2015 Auditor/ Lead Auditor Training Course
Monitoring and Measuring
Resources
A
U
DETAILS OF NON-CONFORMITY D
Photometer No. ABC which was installed in the reading area of library of XYZ college was not I
verified for being working since past 6 months. Also a stack of book was blocking the window T
of library. Library was found apparently evident of lacking proper light.On asking the admin O
staff for calibration records they said that they are R
not available.
Requirement of the standard:
7.1.3 The organization shall determine, provide and maintain the infrastructure necessary for
the operation of its processes and to achieve conformity of products and services.
7.1.4 The organization shall determine, provide and maintain the environment necessary for
the operation of its processes and to achieve conformity of products and services.
7.1.5.2 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

AUDITOR : DAT E : 22nd January 2016


NAME : ABC SIGN
ROOT CAUSE PROPOSED ACTION
Upon interviewing the librarian, she said that she Books will be removed from the area in [B]
has not been trained upon the functioning of front of the window and librarian will A
Photometer to check the amount of light. be trained upon the functioning of U
photometer to check the amount of D
light. I
She had kept the stack in front of window since
T
those were old edition books and needed to be kept Target Date: 30 Jan 2016
E
separately. Responsibility : Librarian and Co-
E
coordinator admin

The students were comfortable with the amount of


light and never complained, they forgot to do so and
librarian said that she is not aware of the
functioning.

ACTION TAKEN
Books have been removed from the area in front of the window and librarian has been
trained upon the functioning of photometer to check the amount of light.

VERIFICATION OF ACTION TAKEN – □ Closed □Not Closed [C]


A
U
D
I
T
O
R

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

NON CONFORMITY NOTE - 2

PROCESS ACTIVITY ISO 9001:2015 CLAUSE


Designing Records of Designing 8.3.2 (a)
[A]
DETAILS OF NON-CONFORMITY
The records for the Design Plan of Base Transceiver Station # 82 does not mention the no. of A
days required for designing and installing the BTS # 82. U
D
I
Requirement of the standard: T
8.3.2 Design and development planning O
In determining the stages and controls for design and development, the organization shall R
consider:
a) the nature, duration and complexity of the design and development activities
AUDITOR : DAT E : 22nd January 2016
NAME : XYZ SIGN
ROOT CAUSE PROPOSED ACTION
It is difficult to state Expert advice upon BTS designing [B]
will be taken and duration will b A
analyzed and included in the U
design plan. D
I
ACTION TAKEN T
E
After much analysis the management concluded it is difficult to analyze as it depends upon E
various factors.

VERIFICATION OF ACTION TAKEN – □ Closed □ Not Closed [C]


A
U
D
I
T
O
R

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ISO 9001:2015 Auditor/ Lead Auditor Training Course

NON CONFORMITY NOTE - 3

PROCESS ACTIVITY ISO 9001:2015 CLAUSE


Human Resources Determining the effectiveness of 7.2 [A]
the training conducted
DETAILS OF NON-CONFORMITY A
The induction training for five new information security analyst of XYZ BACKGROUND VERIFICATION PVT. LTD. Is U
evidenced and found up to the mark, however no evidence was found to verify effectiveness of the same. D
I
T
Requirement of the standard: O
7.2 Competence R
The organization shall:
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken;

AUDITOR : DAT E : 22nd January 2016


NAME : ABC SIGN
ROOT CAUSE PROPOSED ACTION
The information security analyst recruited were highly The information security analyst recruited will be [B]
experienced and post the induction training their feedback put forward to a questionnaire designed by the A
indicated that they are very confident upon grasping the concepts Top Management with an intention to check the U
taught in the training and ensure a very good performance. This effectiveness of the induction training. It has been D
was accepted and no need for evaluating the effectiveness of the understood that recruiting highly experienced I
induction training was felt. doesn’t mean that there is no need to check the T
E
knowledge grasped during any training.
E

ACTION TAKEN
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.

VERIFICATION OF ACTION TAKEN – □Closed □ Not Closed [C]


A
U
D
I
T
O
R

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