Nadin ELMenshawy-IsO 9001 - 2015-Issue 03 Rev 03 Jan 2024
Nadin ELMenshawy-IsO 9001 - 2015-Issue 03 Rev 03 Jan 2024
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 Audit on every day. Please ensure
that you submit this workbook to the tutor(s), for daily continuous Audit at the end of each day.
3) On the last day, please return the course feedback forms (dully filled in by you – for our reference
and improvements) and the IRCA written answer papers for the course.
Qualifications
Civil Engineer
2
Rank 1(Minimum) to 5(Maximum)
Expectations from the course: To gain insight knowledge of principle and managing of auditing
(a) Give the following information in the spaces provided for this bottling line (examples):
1. The inputs
2. Outputs RESOUCES & METHODS
3. Monitoring & Measuring opportunities
4. Efficiency & Effectiveness
INPUTS Resources Methods Process parameters OUTPUTS Criteria for Effectiveness & Efficiency
(Resources) (Monitoring &
Measurements)
Purchasing Purchase person Purchase Type of material and Empty Availability of bottle on time
information requisitions bottle size Bottle Correct size, material type
Empty bottle Cleaning UV cleaning and Visual inspection Cleaned No. of bottles accepted
machinery, drying bottle
Cleaned bottle water, detergent Visual inspection and Filled juice
Juice Filling of Juice weighing bottle Lead time of bottle filling and no. of bottles
Machinery Labelled accepted
Filled juice Visual inspection juice
bottle Placing the label bottle No. of bottles labelled and no. of defective
Labels and on the bottle labelled bottles
machinery
Tutor Marking: 1 mark for each Column min. 2 correct answers. 5 marks
max. for part a.
Tutor Marking: 1 mark for each Column min. 2 correct answers. 5 marks
max. for part b.
# Term Clause
1 mark for each answer. Max 5 marks for 5 or more correct answers
Read the QMS Apex Documented Information of Good Glass Company Leadership and identify sub-Clause out of
Clause 5
# Statement Sub-Clause
1 mark for each answer. Max 5 marks for 5 or more correct answers
1. Review the QMS Policy of Good Glass company and find out areas of concern, if any:
2. Select and state 4 Roles & Responsibilities for QMS to be communicated within the organization.
3 marks for each answer. Max 5 marks for both correct answers
Read the QMS Apex Documented Information of Good Glass Company Planning and identify sub clauses
out of Clause 6
3 marks for each correct answer. Max 5 marks for 2 or more correct answers
3 marks for each answer. Max 5 marks for both correct answers
# Statement Clause
1 mark for each answer. Max 5 marks for 5 or more correct answers
Tutor Marking: 2.5 marks for each non-conformity as in answers.
Read the QMS Apex Documented Information of Good Glass Company for Clause 7-Support and identify
3 marks for each correct answer. Max 5 marks for 2 or more correct answers
3 marks for each answer. Max 5 marks for both correct answers
B) Choose appropriate Sub-clause out of Clause 7 for each statement:
# Statement Clause
6. Consider the capabilities of, and constraints on, existing internal resources.
1 mark for each answer. Max 5 marks for 5 or more correct answers
Tutor Marking: 2.5 marks for each non-conformity as in answers. 10 max.
Exercise 8 Documentation – Stage 1 Audit Group Exercise – 45 Minutes
Read the QMS Apex Documented Information of Good Glass Company for Clause 8- Operation and
identify
# Term Clause
1. In determining the stages and controls for design and development consider
required verification and validation activities
1 mark for each answer. Max 5 marks for 5 or more correct answers
3 marks for each correct answer. Max 5 marks for both correct answers
Read the QMS Apex Documented Information of Good Glass Company Performance Evaluation and
identify clause 9
1. Statement Clause
a) results of analysis shall be used to evaluate conformity of products and services
b) organization shall conduct internal audits at planned intervals
c) Internal Audit program shall be established considering importance of processes &
results of previous Audit.
d) Ensure impartiality & objectivity of auditing process.
e) Management review is conducted to ensure suitability & adequacy of QMS.
f) management review shall be planned and carried out taking into consideration the
changes in external and internal issues that are relevant to the QMS
1 mark for each answer. Max 5 marks for 5 or more correct answers
Tutor Marking: 2.5 marks for each non-conformity as in answers. 10 max.
B) State examples from Gold Glass company:
1. Determine & state at least 5 items in QMS that need to be monitored and measured in the Good Glass
Company.
5 marks for each correct answer. Max 5 marks for 2 or more correct answers
Read the Quality Apex Documented Information of Gold Glass Company Improvements and identify
clause 10
1. Statement Clause
1.5 marks for each answer. Max 5 marks for 4 or more correct answers
2. Give examples of
opportunities for
improvements in QMS of GGC
with reference to
performance evaluation.
(Clause 9.1/9.2/9.3)
3 marks for each correct answer. Max 5 marks for both correct answers
AUDIT REPORT
Name of Company (Organization):
Accreditation: (NABCB/JAZ-ANZ/IAS/EIAC)
Address of the company:
SCOPE (4.3):
AUDIT CONCLUSION
It is required that action to be taken by review and revision of documents for the areas of concern
mention above.
Details of Additional Locations or Sites and Activities for certification (If applicable)
Location 1
Activity
2. A recommendation for next stage cannot be made until the nonconformities have been cleared, following the
corrective action plan being submitted and a Supplementary PRA being satisfactorily completed.
Scope Assessed:
3. 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 ----/-----/----------.
4. Team recommends a Supplementary PR Audit for --- Audit Day(s). The same could be conducted by
----/----/-------, upon satisfactory corrective action plan submitted by client to BSCIC’s Chief Executive.
5. Client to inform their readiness to BSCIC’s Chief Executive for the further Audit as in 4 above so that the same
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:
Considering the Quality Manual of Good Glass Company, prepare an audit plan, as per following
guidelines:
1. Total audit days are determined based on the number of employees and complexity of the organization and
guidelines given in IAF MD5 2019 Annex A to C. For this exercise we will consider Total audit days = Four
(minimum) [ One audit day = 8 hrs., starting at 9am).
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 and 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.
For tutor: The tutor to Scan the flip charts and send to the BSCIC. In case Scanning is not possible send
photographs.
The objective of the Audit: To assess the conformity of the quality management system (QMS) w.r.t ISO
9001:2015.
Criteria ISO 9001:2015 System Quality Manual Issue 01, Dt. Feb. 2018,
Documentation: Procedures Manual Issue 01, Dt. Feb. 2018
Team Leader: Audit Start Date Opening
Meeting
Team Member: Audit End Date Closing
Meeting
Audit Schedule
Date Client Function Auditor Time
(Hrs.)
Tutor Marking: 10 max. mark for right presentation of audit plan. Deduct 1 mark for any
important area missing or short duration less than 8 hours in total.
Issue 03 Rev 03 Jan 2024 Page 18 of 47
Participant Work Book
ISO 9001:2015 Auditor / Lead Auditor Course
Considering the Quality Manual 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 mean “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
4.3 Scope
4.4 Quality Management System and its processes
Leadership Areas
5.1.1 General
5.2 Policy
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.5.1 General
7.1.5.2 Measurement
traceability
7.1.6 Organizational
knowledge
7.3 Awareness
7.4 Communication
7.5.1 Documented
information
7.5.3 Control of
documented information
Operation Areas
8.2.1 Customer
communication
8.3.1 General
8.4.1 General
8.5.1 Control of
production and service
provision
8.5.4 Preservation
8.5.5 Post-delivery
activities
8.7 Control of
nonconforming outputs
Performance
evaluation Areas
9.1.1 General
9.1.2 Customer
satisfaction
9.3.1 General
9.3.2 Management
review inputs
9.3.3 Management
review outputs
Improvement Areas
10.1 General
10.3 Continual
improvement
Tutor Marking: 10 max. mark for right presentation of audit checklist. Award one mark each for each good
question including clause no. Deduct 0.5 mark for not mentioning clause no.
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 to 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:
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 evidence of compliance of the same, for past three consignments and
shall ensure that, you will continue to adhere to the contractual requirements.
2. 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
times.
We are taking a stand on this, as need to submit this evidence to all our customer’s 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 standards 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 faxing all the evidence to the number as defined in the contract. yes, we did not confirm whether you
received or not. We have all the evidence 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 is working or not or it has changed or any
other issue. Anyhow now onwards we shall be emailing the evidencing the same to your Quality department.
And we shall be uploading all these evidence in our internal Intranet and giving you the password for access (only to
authorized personnel only - as identified by you), to avoid such issues occurring again.
The NCR – 15 clearly mentions that one report is missing. which we agreed and responded back to your closures (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 always assure you the best of services to come. We thank you for this opportunity for improvement which we feel
that without you pointing this, our communication system would not have 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 inspections of circular product, was found to be broken from one of the sides. On 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 Manual, you also detected that this company where you are presently
auditing, had sought exclusion for Customer Property.
Incident 3
A company manufacturing 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 hands shaking. On enquiry you came to know that the person is the senior most person & in
the company since last 20 years & very experienced in Compasses – the only inspector - his hands shake because of
illness. Through the complaints register you also establish that nearly 3% of the consignments on an average, comes
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 to 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 details job descriptions and translated to local languages.
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 were 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 Management Representative area (internal audit process), you noticed that one of the internal
audit NC reveals the fact of - the internal audits frequency was annually and 70% of the three internal audit 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 Slr. #: 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 towards ISO 9001:2015, you
were to verify the records of this 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 (nor hard copy not 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 evidenced.
One of the objectives of the institute was “TO BUILD CARRIERS 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.
NON-CONFORMITY NOTE Incident: 1
Students are also required to demonstrate their ability to write a well- constructed nonconformity statement that clearly describes the
ISO 9001:2015 CLAUSE No: _____________
weakness or failure of the management system, the audit evidence and the requirement(s) of the standard.
Note to marker:
Company documents Area unit involved
MAJOR / MINOR
To raise a nonconformity report when there is not sufficient audit evidence should be penalized and markers should normally award zero
[Strike out as required]
mark.
Requirement:
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
Failure (Nonconformity):
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.
Evidence (reference of Process/Personnel/Documents):
Typical solutions for nonconformities follow a standard method of presentation: ie 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 andAuditor
the distribution of marks adhered to. Auditee Date
Comments:
Requirement:
Failure (Nonconformity):
Requirement:
Failure (Nonconformity):
Requirement:
Failure (Nonconformity):
Requirement:
Failure (Nonconformity):
Requirement:
Failure (Nonconformity):
Typical solutions for nonconformities follow a standard method of presentation: ie failure in the system (3 marks for identifying the failure),
audit evidence (3 marks
Issue for identifying
03 Rev 03 the audit evidence) and requirements
Jan 2024 (1 mark for identifying the ISO
Page 35 9001
of 47clause 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.
Participant Work Book
ISO 9001:2015 Auditor / Lead Auditor Course
Requirement:
Failure (Nonconformity):
Requirement:
Failure (Nonconformity):
Requirement:
Failure (Nonconformity):
Requirement:
Failure (Nonconformity):
8.5.6
8.6
8.7.1
8.7.2
9.1.1
9.2.1
9.2.2
9.3
10.1
10.2
10.3
1 Mark for each clause or part of a clause. Max 10 marks for all correct answers
Management Standard:
Audit Type:
Audit Commencement Date: Audit Completion Date:
Audit Team:
Name: Status
Lead Auditor
Team Member
Audit days:
Leadership
Planning
Support
Operation
Performance Evaluation
Improvement
Subsequently this Audit Report Pack along with your satisfactory Corrective Action Plan and
objective evidence (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 Audit for a visit every
Year for Audit Days per visit.
Activity
2. This Audit is based on random samples therefore nonconformities may exist which have not been
identified.
For Registration Audits:
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 reaudit being satisfactorily
completed.
Scope Assessed:
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 ----/-----/----------.
5. Team recommends a Limited Supplementary Audit for --- audit day(s) or a full Re-assessment for -----
audit day(s). The same could be conducted by ----/----/-------, upon satisfactory corrective action plan
submitted by client to BSCIC’s Chief Executive.
6. Client to inform their readiness to BSCIC’s Chief Executive for the further Audit in 4 above so that the
same could be satisfactorily planned & conducted.
MM / YYYY
Internal Audit
Complaints Management
Previous NCR & Corrective Actions
Use of BSCIC Logo & Marks
Re-Audit (Tick )
Legal (QMS specific)
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 confirms 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 Co.
Tutor Marking: 10 max. mark for right presentation of audit Report including correct
recommendation & follow up options. Award one mark each for writing the nonconformity. 2 marks
for B003, 2 marks for B029, 2 marks B007 & B020 & 2 marks for recommendation options/SAP.
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
Production Drilling Machine 7.6
[A]
DETAILS OF NON-CONFORMITY
The dial gage no. 45 does been used on Drilling machine does not have calibration status (as per A
procedure ABC_7.6 Rev 1) and on asking the operator replied that he does not know what U
calibration is. D
Requirement of the standard: I
T
Where necessary to ensure valid results, measuring equipment shall O
d) be identified to enable the calibration status to be determined; R
AUDITOR: DATE:
NAME: SIGN ___________
ROOT CAUSE PROPOSED ACTION
1. Operator did not understand the auditor The system of identification shall be [B]
2.. The system had stickers which came off replaced A
U
Target Date: 13 Dec 2022
D
Responsibility: QA Manager
I
ACTION TAKEN T
The sticker system is replaced by two paints. Red spot indicates the instrument has errors and E
user must consider the error factors and green spot indicates that the instrument has no errors. E
All have been trained on this new identification system with the error factors communicated to
users.
NON-CONFORMITY NOTE - 2
NON-CONFORMITY NOTE - 3
PROCESS ACTIVITY ISO 9001:2015 CLAUSE
Human Resources Induction Training for New Recruits 6.2.2 [A]
DETAILS OF NON-CONFORMITY A
The induction training records for all five security guards for level 5 (recruited 20 days’ back) are not evidenced as U
required by procedure MLS_HR_008 Rev.5 Paragraph 5.5. e) which states that all new recruits would be undergoing D
induction training program for minimum 2 days, within one week of their joining. I
T
Requirement of the standard: O
The organization shall: R
Tutor Marking: 3.3 mark for each correct CAP acceptance. 10 max. marks for the entire exercise.