Professional Documents
Culture Documents
19 Participant Workbook
19 Participant Workbook
Course Number: ISO 9001:2015 LA Dates of Course: 17 Sep 2022 to 25 Sep 2022
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:
# 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
Working Organization:
Designation:
14 INNOVATION
15 CONFORMITY
S. Principle (Srl.#-
No. Feature: see above)
1 4 Process
Every input goes for process giving output Approach
2 Ensuring that the bonded stores dispatch correct material to 1 Customer
customers respective Focus
3 3Engagement of
Motivating the factory personnel take care of Quality in production people
4 Ensuring that the process interfaces are mapped adequately that the information is 4 Process
transferred to process owners in effective and safe manner Approach
5 The Quality and Purchase team considers the actual rejections during inspections 6 Evidence
in supplier performance evaluations based Decision
Making
6 The review of one year customer complaints indicated that % of complaints have 5. Improvement
reduced, compared to previous year,
7 Helping the supplier in calibrating his measurement instruments, using master 7 Relationship
instruments of the organization Management
8 1 Customer
Changing bicycles by motorcycles for faster and better service to customers
Focus
9 Motivating employees to suggest changes in the processes to reduce cycle time and 2 Leadership
set examples
10 People accepting ownership of problems and their responsibility for solving them. 3Engagement of
people
11 The design manager is present at the commissioning site to make required changes 6 Evidence
in the pressure controls based on the actual readings based Decision
Making
12 Organization does II party audit on supplier as Customer wants to ensure the 1 Customer
organization supplier’s quality is maintained by performing a system audit Focus &
7 Relationship
Management
13 4 Process
Identifying, understanding and managing interrelated processes as a system Approach
14 Defining objectives in a manner by which the gap between objectives and results 5 Improvement
reduce
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
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
2 The scope at page no 6 does not contain the INSTALLATION Page no 5,6 & 22 C 4.3
activity, where in the page no of 5 product & services and at page
no 22GCC clause 8.5.1talks about installation
3 Quality policy does not contain the purpose at 5.2.1(a) as well as Page 9 of GGC Apex Cl 5.2.1
at the policy statement below of the GCC and the requirement of
5.2.1(d) for continual documented information improvement in
not addressed
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
Contractors are used for installation and interested parties do Page 7 4.2
not cover the same
Non Applicability and justification –NC- Justification for not Page 7 4.3/4.4
applicability(exclusion) not given for 8.5.1(f)
The scope at page no 6 do not contain the installation activity, Page 5,6 & 22 4.3
where in page no 5Product & service s at page no 22 clause 8.5.1
talks of installation
Outsourced process are defined in the context at page no 4 Read Page 4 4.3/4.4
as “The installation controls not linked with purchase (8.4)
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.
2 Quality Policy does not indicate the purpose at 5.2.1(a)as well as at the policy Page 9 5.2.1
statement below of the GGC and the requirement of 5.2.1(d) for continual
improvement is not addressed.
4 Responsibility authority though referred as Annexure A ,could not found in Page 9 5.3
the document
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
RBN Calculation is found erroneous and FMEA does not cover all relevant
processes of GCC and incomplete on action
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.
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.
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
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
2 External Providers performance analysis not addressed in analysis &Evaluation Page 21 Cl 9.1.3
3 Internal audit mentions the audit of IMS instead of QMS Page 22 Cl 9.2
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
1 Result of analysis & Evaluation not considered for continual improvement Page 23 10.3
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.
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.
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
Objective of Assessment: To assess the conformity of quality management system w.r.t. ISO 9001:2015.
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
Incident 1
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.”
“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 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
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
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 clearly describes 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 clearly state 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.
During the Audit, a customer complaint was noticed, that there is a discrepancy in customer
Communication on requirements for products and services pertaining to ISO 9001:2015 section 8.2.1 Clause C which
states obtaining customer feedback relating to products and services, including customer complaints.
Requirement (WHY):
ISO 9001:2015, section 8.2.1 Clause C which states obtaining customer feedback relating to products and services,
including customer complaints.
Comments:
NO NCR
During Audit, upon the site visit it was noticed that the organization
is using customer property where the organization claimed that
1. it was supplied by the client & would be returned to the client with the last consignment. No evidence of
documented information on property of customers or external providers.
2. On verification of the Quality Apex Document, the Company had sought exclusion for the Customer Property.
Requirement (WHY):
ISO 9001:2015 section 8.5.3 Para – 3 states the property of a customer or external provider is lost, otherwise found to
be unsuitable for use, the organization shall report this to the customer or external provider and retain documented
information on what has occurred ISO 9001:2015 section 4.3 of the organization’s quality management system shall
state the types of products and services covered and provide justification for any requirement of this international
standard that the organization determines is not applicable to the Scope of its quality management system.
During the Audit, it was observed that the appointment of competent persons including any required
Qualification is not determined.
Requirement (WHY): ISO 9001:2015 section 8.5.1.e states the appointment of competent persons, including any
required qualification.
During the Audit, it was observed while reviewing the “Management Review Meeting minutes “that the necessary
competence of person(s) doing work under its control that affects the performance and effectiveness of the quality
management system, ensuring these persons are competent on the basis of appropriate education, training or
experience.
Requirement (WHY):
(WHY):ISO 9001:2015 section 9.2.2.a states the organization shall plan, establish, implement and maintain the audit
program(s) including the frequency, methods, responsibilities, planning requirements and reporting by taking into
consideration the Importance of the processes concerned, changes affecting the organization and the results of the
previous audits.
Auditor Auditee Date
MAJOR
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.
To management
5.1.1a Please explain your role in taking responsibility and
accountability for QMS
5.1.1b What is your approach in providing a high level policy
and ensuring objectives
Management representative
4.1 What are the issues you identified in your department
4.2 Who are the interested parties within the organization
4.3 Please explain your QMS scope and applicability
4.4 Explain the process of your department
5.2 Can you explain the quality policy and your contribution to
achieve the same
5.3 What are your responsibilities and authorities
6.1 What risks and opportunities relate to your function and the
details of actions taken
6.2 What are the objectives of HR department and what is the
level of achievement
6.3 How do handle changes without affecting the integrity of the
system
7.2 Please explain your educational / training details
7..3 Please explain on what is your understanding about QMS of
your organization
7.4 How does you communication activities happen
7.5.1 Can you please explain your documentation for QMS
7.5.2 How do you handle creation and updation of
Issue 2, Rev.02 Apr 2016 Page 27
Participant Work Book
ISO 9001:2015 Auditor/ Lead Auditor Training Course
documents
7.5..3 What are the controls for documented information
8.7 What is the process for dealing with nonconformance in your
process and details if any
9.1 What all you monitor, measure, analyze in your process
9.2 Can you explain your internal process?
Frequency
Plan
Auditor qualification
Independence
Documentation
Actions
Reporting to management
10.2 Explain the corrective action process that you follow and
details of CA if any
10.3 What improvements you could demonstrate since last audit
Write NCRs for any Four in the prescribed format on subsequent pages
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
clearly describes 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 clearly state 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.
Requirement (WHY):
Requirement (WHY):
Requirement (WHY):
Requirement (WHY):
ASSESSMENT REPORT
Address:
Mandays : 4
Nonconformities raised during Assessment:
Areas Assessed :
**Disclaimer - Auditing & its conclusion is based on a sampling process of the available information**
Leadership
Planning
Support
Performance Evaluation
Improvement
ASSESSMENT COMMENTARY
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.
Activity NA
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.
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.
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
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.
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.
Signed for & on behalf of BSCIC Signed for on behalf of the client
Name: Name:
Date: Date:
Review the closure submitted by auditee and judge weather this closure is acceptable or not, for the below
three cases.
NON-CONFORMITY NOTE - 1
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.
NON-CONFORMITY NOTE - 2
NON-CONFORMITY NOTE - 3
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.