ISO 9001 LA-Workshop Manual

Table of Contents
Workshop – 1 Context of the Organization.............................................................................2

ABC Pipe Manufacturing Private Limited............................................................................3
Workshop – 2 Identification of Risk and Opportunities.........................................................6
Workshop – 3 Audit Checklist – Leadership and Commitment..............................................8
Workshop – 4 Documented Information..............................................................................10
Workshop – 5 Audit Checklist –Procurement.......................................................................12
Workshop – 6 Quiz/Questionnaire........................................................................................14
Workshop – 7 Document Review..........................................................................................17
Workshop – 8 Audit Plan.......................................................................................................19
Workshop – 9 Collecting Audit Evidence..............................................................................21
Workshop – 10 Demonstration of Opening and Closing Meetings......................................22
Workshop – 11 Audit Follow-ups..........................................................................................23
Workshop – 12 Audit Role Play.............................................................................................28
AUDIT REPORT................................................................................................................... 29
Workshop – 13 Identification of Nonconformities...............................................................30
Scenario 1.......................................................................................................................... 31
Scenario 2.......................................................................................................................... 33
Scenario 3.......................................................................................................................... 34
Scenario 4.......................................................................................................................... 37
Scenario 5.......................................................................................................................... 39
Scenario 6.......................................................................................................................... 41
Scenario 7.......................................................................................................................... 43
Workshop – 14 Case Study - Audit Findings..........................................................................45
ATA Furniture Store...........................................................................................................46
Workshop Manual
9001:15-LA-WM Revision. 01, Date: Jan 2019 Page of
Workshop – 1
Context of the Organization
Instructions
Read the case in the next page and identify the following:
 The context of the organization.

 The scope and boundaries of the Quality Management System.
Time allowed
Reading and preparation: 20 minutes
Feedback 10 minutes
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ABC Pipe Manufacturing Private Limited
ABC Pipe Manufactures is one of the leading industrial manufactures of steel pipes and
fittings. The company has been in business for the last 15 years in the Middle East. Recent
Projects completed by the company are listed below:
 Pipe Sleeve Manufacturing Project for a US-based Client, Year 2018

 Pipe support manufacturing Project for Kuwait based Client, Year 2017
 Water Sewerage System Pipeline Project, KSA, Year 2016
ABC Pipe Manufacturing has a good infrastructure that includes the latest machinery and
equipment to support the production of pipes. Major processes include pipe manufacturing,
production, inspection, testing, shipment and release.
ABC Pipe Manufacturers has provided a good working environment to support its
workforce. The company has implemented the Occupational Health & Safety Management
System to ensure the safety of workers. In addition to first-aid kits, fire hose, fire
extinguishers and fire alarms are available everywhere in the facility.
Noise monitoring is carried out; noise-cancellation earphones are provided to employees
when it is required. Humidity and temperature monitoring devices are installed throughout
the facility.
ABC Pipe Manufacturing Pvt. Limited employs a dynamic, competent and talented
workforce of 1200 employees. ABC’s main goal is to meet customer expectations by
ensuring the quality and on-time delivery of its products and services.
ABC Pipe Manufacturer boasts annual sales to 31 Million Dirhams. To comply with the
quality policy, the organization has established a Quality Management System based on ISO
9001:2015. The company wants to include: (a pipe manufacturing, inspection and testing
facility and a sales and marketing department in one of its branches located in Kuwait) in
the scope of their Quality Management System. The company manufactures pipes based on
API 5L, so the ‘design and development’ part is not included.
The ongoing oil price market crisis has a huge impact on the oil-based economies of
countries in the Middle East. Consequently, it has caused a decline in funding governmental
projects leading to revenue loss in Pipe Manufacturers.
Current market surveys indicate instability in Dubai’s pipe manufacturing industry, but a
rebound, in the future. The technology in use by ABC can be further improved, causing a
breakthrough change in business. However, the process of the latest technology transfer is
still slow and may take 3-4 years to transform completely.
The management has more focus on providing quality products to customers in order to
fulfill their needs and raise their satisfaction rate. ABC core values include honesty, integrity
and commitment towards the achievement of organizational goals. The company has
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Established a rigorous hiring process, ensuring knowledgeable, competent and skilled
resources are hired. The annual monitoring program is in place for all employees to help in
identifying their training needs. On the other hand, there is no clear organizational structure
resulting in multiple reporting hurdles. High workload and inadequate ventilation facilities
result in employee dissatisfaction and low morale.
ABC Pipe Manufacturing has partnered with many leading steel suppliers throughout the
world. ABC is a private limited company with 8 investors, 5 local and 3 foreigners. ABC holds
annual meetings of investors, bankers, creditors, suppliers and other relevant interested
parties to address and discuss their concerns.
Head Quarter Address: 1st Industrial City Dubai, P.O. Box No.
10245 Contact Person: Mr. Frank Chaplin
Telephone No: (+971) 111-333-435
Fax: (+971) 48353511
Email: info@abcpipes.com
Website: www.abcpipes.com
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External Issues:
Internal Issues:
Interested Parties & their Needs and Expectations
Interested Party Requirements, needs or expectations
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Workshop – 2
Identification of Risk and Opportunities
Instructions
Identify all the relevant clauses of ISO 9001:2015 Standard that state the term ‘risks and
opportunities’. Provide the clause number and requirement.
Time allowed
Reading and discussion: 15 minutes
Feedback 15 minutes
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ALL ISO 9001:2015 CLAUSES STATING ‘RISKS AND OPPORTUNITIES’
S No. Clause No. Clause Requirement
10
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Workshop – 3
Audit Checklist – Leadership and Commitment
Instructions
 Prepare a comprehensive audit checklist, by using the provided checklist template to

evaluate Leadership and top management commitment, based on ISO 9001:2015 Clause
5 Leadership and its sub-clauses.
 For each checklist item, identify typical audit evidence that you expect to review during
the audit.
Output
 Be prepared to discuss your checklist items with class.
Time allowed
Workshop: 30 minutes
Feedback 15 minutes
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Audit Checklist
Claus Audit
Audit Questions/Requirements
e No. Evidence
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Workshop – 4
Documented Information
Instructions
 Identify all possible areas in ISO 9001:2015 standard which have requirements to
“maintain” and “retain” documented information.
 List down your findings in the template below.
Time allowed
Feedback 15 minutes
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Maintain Documented Information
ISO 9001:2015
S. No Requirement
Clause #
1
Retain Documented Information

ISO 9001:2015
S. No Requirement
Clause #
1
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Workshop – 5
Audit Checklist –Procurement
Instructions
 Working in assigned groups, prepare a comprehensive audit checklist, by using the

provided checklist template, to evaluate procurement, based on ISO 9001:2015.
 For each checklist item, identify relevant evidence.
 Be prepared to discuss your checklist items with class.
Time allowed
Feedback 15 minutes
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Audit Checklist
Claus Audit
Audit Questions/Requirements
e No. Evidence
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Workshop – 6
Quiz/Questionnaire
Instructions
 Read the statements on the next page and identify if the statements are ‘True’ or ‘False’.
 Indicate the clause number from ISO 9001:2015 that supports your conclusion on
whether the statement is true or false.
Time allowed
Feedback 15 minutes
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‘True’ or ISO 9001:2015
No. Statement
‘False’ Clause #
The organization is not required to ensure that the
implications of not conforming with the quality
1.
management system requirements are known to all the
people working under its control.
Organizational knowledge can include information such
2.
as intellectual property and lessons learned.
Leadership includes: ensuring responsibilities and

3. authorities for relevant roles are assigned, communicated
and understood within the organization.
A complaint from a customer can never be considered as

4.
a nonconformity under any circumstances.
The organization has to ensure that externally provided
5. or outsourced services are controlled under the quality
management system.
Design and development verification and validation are
6. no longer required to be taken into consideration during
design phase activities.
The quality policy has to be both, communicated
7.
internally and made available to the interested parties.
Machine repair & maintenance company can be an
8.
example of an external service provider.
Analysis of the degree of customer satisfaction is a
9.
requirement of the ISO 9001:2015.
Not applicable requirements (exclusions) can only be
10.
made from clause 8 (Operations).
Changes in internal and external issues are not required
11. to be discussed during the QMS management review
meeting.
Quality Policy must be available as documented
12.
information.
There are only two mandatory procedures now:
13.
Corrective Action and Management Review.
Customer satisfaction shall be reviewed in the
14. management review meeting to ensure that appropriate
decisions are made.
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‘True’ or ISO 9001:2015
No. Statement ‘False’ Clause #
In ISO 9001:2015 the terms “Documents” and “Records”

15. have been replaced by “maintain documented
information” and “retain Documented Information”.
A non-conforming product cannot be sent to the
16.
customer under any condition.
Traceability is established by physical identification

17. (labeling, tagging, barcoding) of a product, there is no
need to retain documented information for traceability.
Support clause covers resources, awareness,

18. communication and documented information
requirements of the QMS in ISO 9001: 2015.
Retaining documented information related to internal

19.
audit is a requirement of ISO 9001:2015.
Corrective Action on a Nonconformity may require the

20.
organization to update the risk and opportunities.
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Workshop – 7
Document Review
Delegates will be provided with an opportunity to perform document review activity.
Instructions
In the groups allocated by the tutor, delegates acting as a Team are required to review the
documentation supplied for ‘ABC American Manufacturing Company’ and identify any issues
with the documentation.
Each team will provide a briefing of the findings along with reference to ISO 9001:2015
clause requirements.
Time allowed
Feedback 20 minutes
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Document Review Report:
S. No. Comment
10
11
12
13
14
15
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Workshop – 8
Audit Plan
Instructions
 In assigned groups, develop a comprehensive audit plan. The tutor will guide you as to
which scenario to work on, can be ‘ABC American Manufacturing Company’.
 Use the audit plan template as a guide.
 Determine your Audit Team Leader, auditor and Technical Experts.
 Identify the processes to be audited and ensure those processes are covered in the plan
as well as all clauses of the standard.
Output
Be prepared to discuss your audit plan with the class. This activity involves a flipchart
Presentation.
Time allowed
Feedback 20 minutes
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AUDIT PLAN
Client
Representative
Certification Scope
Audit Type Standard(s)
Lead Auditor Audit Language
Auditor(s) Date(s)
Technical Expert(s) Location
AUDIT OBJECTIVES:
To confirm that the quality management system has been established and implemented in
accordance with the requirements of the audit standard.
Auditor/
Approx.
Process/Department/Scope/Activity to Be Assessed Team
Time
Member(s)
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Workshop – 9
Collecting Audit Evidence
Instructions
 Form groups as instructed by the tutor.

 Identify audit evidence from the listed ISO 9001:2015 clauses and sub-clauses:
o Clause 4
o Clause 5
o Clause 6
o Clause 7
o Clause 8
o Clause 9
o Clause 10
Outputs
Be prepared to discuss your audit plan with class. This activity may involve a flipchart
Presentation.
Time allowed
Feedback 20 minutes
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Workshop – 10
Demonstration of Opening and Closing Meetings
Instructions
Delegates are instructed to prepare in assigned groups agenda (checklist) for opening and
closing meetings as discussed during the session.
The instructor will ask each group to present one of the activity, while the other group will
observe and give feedback.
Time allowed
Preparation: 15 minutes
Demonstration: 30 minutes
Feedback 20 minutes
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Workshop – 11
Audit Follow-ups
Instructions
 After an audit, the NCRs or CARs raised have been addressed by the auditee’s
organization and returned back to the auditor for review.
You are the auditor, assess the effectiveness of the root cause and corrective actions
as proposed by the auditee.
 You have to decide whether Corrective action taken should be “Accepted” or
“Rejected”.
 Elaborate your decision as to why you have decided to accept or reject.
Time allowed
Feedback 20 minutes
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Job No. SA400000 Standard: ISO 9001 CAR No.01
Date: 9/1/2019 Auditor: John Doe
NCR Category: (Major / Minor) Major NCR
Title of Clause: Identification and
Clause No: 8.5.2
traceability
Non-conformance Detail:
During a visit to Warehouse, it was noted that item No. A104 and item No. B504 were
kept in the wrong racks inside the warehouse without proper segregation. Also, many
items inside Rack No # 04 had no identification number or traceability.
Auditor: John Auditee: Lee

Root Cause:
The warehouse is understaffed. The production is at its peak and the staff is working
overtime.
Corrective Action(s):
The Warehouse Manager arranged a training session for all the Warehouse staff on their
Warehouse storage procedure P#05. Items A104 and B504 have been properly stacked
and all items in Rack # 04 are now identified and traceable. Recent pictures which show
all items are properly stacked and identified are attached with the CAR form.
Auditor’s Decision:
Corrective Action Accepted Corrective Action Rejected
Justification/Comments for Acceptance or Rejection:
Auditor: Date:
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Job No. SA400000 Standard ISO 9001 CAR No.02
NCR Category: (Major / Minor) Minor NCR
Title of Clause: Control of Externally
Clause No: 8.4.1
Provided Processes, Products and Services.
During the audit, it was observed that the company is consistently purchasing key raw
materials from suppliers; ABC and XYZ in the record “SUPP-M04”. Upon further
investigation and following the audit practices, the auditor found out that supplier
evaluation and re-evaluation is not performed. The auditee's response was “I have an
understanding with their managers, and I trust them”.

Root Cause:
The procurement team believes that supplier evaluation is not necessary for the
company.
Revise the procedure to exclude the supplier evaluation and re-evaluation requirements.
Auditor: Date:
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Job No. SA400000 Standard ISO 9001 CAR No.03
NCR Category: (Major / Minor) Major NCR
Title of Clause: ‘Property belonging to
Clause No: 8.5.3 and 7.5 customers or external providers’ and
‘Documented information’
Crane # 05 which was rented for one year from an external provider was damaged
beyond repair. This event occurred because an untrained operator was handling the crane
in the absence of certified crane operator. Upon investigation, it was found that no
further action has been taken. The external provider has not been informed as well.
The standard states “When the property of a customer or external provider is lost,
damaged or 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.”

Root Cause:
The process related to trainings and communication were not clearly defined.
The procedure HR-04 related to induction training of the crane operators has been
revised to include a detailed training plan for all operators. The training records for all
operators are attached.
The procurement procedure PR-01 has also been updated to include reporting non-
compliance related to equipment to the external supplier.
Both procedures HR-04 and PR-01 are attached for review.
Date: Sign:
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Job No. SA400000 Standard 9001 CAR No.04
NCR Category: (Major / Minor) Minor NCR
Clause No: 9.3 Title of Clause: Management review
Management Review meeting was planned to be conducted twice a year. Records show
only one meeting was conducted last year.

Root cause:
Management review meeting was not held due to excess production work overload.
On 14th January 2019, management review meeting was held. Official Memo #485 was
issued. All relevant staff members participated in the review meeting which was chaired
by the CEO. Decisions and actions were recorded, all items as per the review input of
standard have been covered. Detailed minutes of the meeting are attached with the CAR.
Date: Sign:
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Workshop – 12
Audit Role Play
Delegates will be provided with an opportunity to conduct a live audit, gather evidence and
report findings.
Instructions
In a role-play, teams will be assigned the task to conduct an audit for the ABC Pipe
Manufacturing Company. To complete this activity, delegates can refer to the audit plan and
checklist they developed in previous workshops.
The following sequence is to be followed:
 Opening meeting (brief).
 Conducting audit (See details for conducting the audit below)
 Team review meeting
 Audit report preparation (summary)
 Closing Meeting (report the findings to auditee).
Conducting the Audit

Each team will have the opportunity to ask questions to the auditee team (role-play acted
out by the tutor) by using their checklists and audit plan for any particular area/function or
process of ABC Pipe Manufacturing Company. The tutor will give teams different scenarios
from the activities listed below:
 Management review.
 Operational Planning and control.
 Measurement traceability.
 Internal audits.
 Corrective actions.
 Trainings.
 Any other scenario as given by the tutor.
You will be expected to conduct an audit of the areas assigned to you in the role play against
the ISO 9001:2015 requirements. You should obtain audit evidence through observation,
questioning auditees and examining documents. The audit evidence should be noted on
your checklist and your findings are required to be presented in the closing meeting.
After completion of the closing meeting, the team has to write a professional audit report,
including details about audit findings as well.
Time allowed

Feedback: 30 minutes
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AUDIT REPORT
Company Name Job Number
Address Audit Type
Contact Person Name Position
Audit Standard(s)
Lead Auditor Auditor(s)
Audit Date Total Man-days
Audit Scope
Exclusion(s)
Major CAR(s) # Minor CAR(s) #
Audit Objective
Audit Summary and Findings
Lead Auditor: Audit date:
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Workshop – 13
Identification of Nonconformities
Instructions
 Read the scenarios.

 Identify if there is non-conformity in it or further investigation is required.
 In the case of non-conformity, fill in the non-conformity report.
 In case of further investigation requirements, complete the audit investigation form.
Time allowed
Feedback 30 minutes
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Scenario 1
During an internal audit, you are shown internal audit reports from the last audit. These
include a non-conformity report stating that three people in the purchasing department had
not been trained on the use of the approved supplier list. The corrective action taken was to
train those three employees. The audit report has been closed. The management
representative tells you that no further investigation was made as the corrective action was
obvious. The internal auditor had checked the training records of the staff concerned before
closing the reports.
NONCONFORMITY REPORT
Description of the non-conformity.
Relevant evidence.
ISO 9001:2015 clause and requirement.
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AUDIT INVESTIGATION TEMPLATE:
Reason why there is not yet sufficient evidence for reporting nonconformity.
Four audit trails (Questions) you would follow (ask), including, the evidence sought and
purpose (Clause).
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Scenario 2
In the purchasing department, the auditor asks how the new subcontractor for TMX pipes
was selected. The purchasing clerk explains that since our usual subcontractor was not
available, we had to consider a temporary new subcontractor – out of three options we
chose this one as it quoted the lowest price. The clerk states that no other evaluation was
conducted as time was limited; production was on hold due to the delay.
Relevant evidence.
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purpose (Clause).
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Scenario 3
During the audit of the management review activities required by the standard and the
company procedure, it was noted that a review meeting was held on the 14 th of January
2019. All the board members of the company apparently attended this review meeting and
lasted from 09:00 to 11:00 a.m. The agenda shows that all the required issues were
reviewed in the meeting. However, it was noted that the conclusions (review outputs) of the
meeting were recorded as:” there is no necessary improvement of the product related to its
ability to meet customer requirements”. The auditor reviewed the input of the management
review, which included summaries of customers feedback. The summaries show that the
organization’s customers have consistently informed that their end-users have complained
about the products visual appearance deteriorating (Paint chipping off within 6 months of
sale).
Relevant evidence.
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purpose (Clause).
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Scenario 4
During the audit of an engineering firm, the auditor asks the department head to bring the
quality manual, if they keep it. While reviewing the manual, the auditor reads the scope of
the firm, which includes engineering automation, testing equipment and design trim presses
and die-cast machines. The auditor notices that the scope does not mention any interested
party or their requirements. Then, the auditor asks why the interested parties are not
mentioned in the scope to which the department head replies that they have taken into
consideration their needs and requirements, but they are listed in the business plan of the
organization. The auditor also notices that the scope included clause 8.3 as an exclusion,
without any justification.
Relevant evidence.
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purpose (Clause).
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Scenario 5
While auditing in the receiving and inspection department, the auditor asked the supervisor
how he or his area inspected the incoming product. The supervisor immediately produced a
company instruction sheet indicating ten steps with check-off for the inspection of incoming
product. The auditor asked the supervisor if this was the most current version of the
instruction sheet. “Yes”, said the supervisor, “it was dated three months ago, it is current”.
The auditor asked for evidence that it was the most current one with the document control
listing. The document controller produced the latest list, in which the incoming product
instruction sheet was changed a month before. The supervisor stated to the auditor the
version of the sheet does not matter that much, as they are very thorough in checking the
incoming products and management doesn’t have a problem with this.
Relevant evidence.
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purpose (Clause).
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Scenario 6
During an audit of management review activities, the auditor notices from the minutes of
the management review meetings that none of the top management members attended the
meetings. When he inquires about it, the management representative explains that
management review has evolved into a two-step process, as it is difficult to get all of the
departmental and top managers available at the same time. The process is now that
departmental managers meet and conduct the first level of management review. Later, the
management representative prepares a summary report, including actions and
recommendations. This is passed round each of the top management team members for
comment, and the Managing Director, then, finally agrees on the action plan.
Relevant evidence.
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purpose (Clause).
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Scenario 7
In a garments factory, the auditor notices that a pressing machine was shut down. Upon
inquiring, the area manager stated that the pressing machines are used in the final stage of
the process before the product is released. Currently, our small cabinet press machine,
which is required to press the shirts before buttoning to avoid button marks on the
garments, has stopped working, he stated. The manager also commented that they are
swamped because customer orders are backed up, and the machine won’t be repaired for
another week. When asked if there was an equipment maintenance schedule, the response
was that their maintenance supervisor claims that a PM schedule is not required by the ISO
standard, and their policy is to “Fix when Broke”.
Relevant evidence.
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purpose (Clause).
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Workshop – 14
Case Study - Audit Findings
Instructions
Read the provided case study “ATA Furniture Store”. Identify and report your audit findings
with reference to ISO 9001:2015 Standard requirements.
Identification of Audit Findings:

Read the provided case study; you have to:
 Classify your audit findings as either major nonconformity, minor nonconformity or

opportunity for improvement.
 In case of non-conformity, write a proper nonconformity description.
Reporting Audit Findings:
 List all audit findings on the findings template provided.

 Present them in front of the class for discussion and feedback from the tutor.
Time allowed
Feedback 30 minutes
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ATA Furniture Store
ATA Furniture store is an organization located in Chicago, USA. It focuses on the production
of home and office furniture equipment. The organization is trying to establish its reputation
within the market by improving the quality of their products, thus aiming to certify the
organization with ISO 9001:2015. The audit is being conducted through a certification body
containing a Lead Auditor by the name of Ashley Sampson.
Ashley is greeted by the General Manager, Chris Taylor, in the morning of the Audit and is
informed about the company’s profile, and the recent success the organization has
witnessed financially. Upon the conclusion of their interaction, Chris assigns Rob, an
assistant, to be the guide for Ashley throughout the audit.
This Case study is the narration of the events that took place during the audit. The areas
which were covered during the audit were as follows: Quality Department, HR Department,
Design Department, and the Production Department
Opening Meeting
At 8:30 A.M, Rob guides Ashley to conference room # 1C, where she is introduced to the
Departmental Heads. After a brief introduction, Ashley spells out the objective of the audit,
and the criteria she will be auditing against. She further goes over the audit plan, informing
about her timings and activities. She gets a nod of approval and sets to embarks on her audit
by visiting the first department on the plan, the Quality Department.
Quality Department
Marshall Mekkin, the QA Manager, who is also the Quality Management System
Representative, welcomes Ashley and gives a brief description of the quality department. "I
am leading an experienced team of 10 employees within this department”, Says Marshall,
“We make sure that quality is maintained and routinely improved, in order to provide
enhanced customer satisfaction”. “In planning for our quality management system, we start
by identifying the risks and opportunities relating to our organization and then taking the
necessary actions to address them.”, he states.
“Do you keep a formal risk-register to document the risk assessment performed?” asks
Ashley. “Yes, we do, and we keep on updating the register as required,” replied Marshal.
Ashley then asks for the register, after taking a look at the assessment, she asks Marshal,
“what is the evidence that the plan mitigating the risk has been implemented and how the
effectiveness is measured?”
“As we have analyzed the risk and planned the actions, it is the responsibility of the
department manager to keep update on the actions taken and their effectiveness,” replied
Marshal. “Also we conduct internal audits at planned intervals, and from that, we are able
to seek out any major issues and eradicate them,” adds Marshall.
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Ashley writes down her finding and requests Marshall to provide her with the quality
manual. Marshall pulls out the quality manual, labeled ‘Master Copy’, from his desk and
gives it to Ashley for review. Ashley takes a glance on the manual and looks at the revision
history page. She notices on the page that procedure 8 was currently on Revision 5 and
Procedure 13 was on Revision 3. To verify if the correct revisions were provided in the
quality manual, she heads to the respective procedures and sees procedure 8 showing Rev
5, however, Procedure 13 was showing Rev 2.
“Oh you know, we had updated this quality manual, last week, it must have been a mistake
made by one of our employees, I will just drop an email to the employee to get the correct
revision in place”, notes Marshall.
Ashley then notices that the manual does not contain the quality policy, she asks if they
have a documented copy of the policy available.
“Oh yes – our policy is hung on the wall at the reception and is also available on our
website. We make sure all our employees understand it well,” replied Marshall. Ashley
notices that the quality objectives were also there on the wall next to the quality policy.
Ashley takes a look at the objectives and comments that they were relevant to the
organization and measurable.
“I am impressed by your ambitious objectives, it seems that the Management is committed
to becoming one of the best in the market”, adds Ashley.
Ashley, subsequently, inquires about the management review meetings.
“Well, you know, according to our Procedure #7, we conduct management reviews every six
months. Let me give you the records of our management review meetings,” replies
Marshall.
Marshall pulls out a file by the name MR-01-A and hands it to Ashley for review. Ashley pulls
out the latest three management reviews from the folder to review. She notices on the
attendance sheet that the upper management was available in the meetings, and the inputs
and outputs were clearly defined in all of the three documents she was reviewing. The dates
on the three most recent management review meetings were January 1, 2013, February 2,
2012, and June 8, 2011.
Lastly, Ashley requests to have a look at the records of the conducted internal audits. She is
provided with the file IA-01-C and she chose to read the second last audit conducted. In it,
she notices a few NCRs which were issued to the production department and jotted them
down on her notepad. She opens the last audit conducted and finds out that the NCRs which
were raised in the previous audits are closed successfully.
Ashley takes some time to write down all her findings in this department. She thanks
Marshall for accompanying her and asks Rob to take her to the next department, Human
Resources.
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Human Resources Department
Rob guides Ashley, through a secured entrance, to the HR department, where she is
introduced to Ms. Sonia Singh. “Pleasure to meet you, Ms. Ashley, please come with me to
my office”, greets Sonia.
While walking to her office, Ashley notices a few things such as employee of the month
board, pictures of company picnics, and trophies from inter-organizational competitions.
“You have an excellent work environment in this department”, says Ashley.
Ashley commences her Audit for the HR department and inquires about the headcount of
the organization.
“At ATA, we have divided our employees into two categories, office workers and
technicians. The office workers stand at 80 individuals, whereas, technicians have a
headcount of 120, so we are running a total of 200 employees”, proudly claims Sonia.
Ashley asks about the list of employees currently working as office workers and is provided
with files by the names of OF-EMP-01, OF-EMP-02, and OF-EMP-03. She selects OF- EMP-01
to review. In the file, she finds a list of 30 employees and selects M. Anderson and C. Bosh
to be taken out for review. She observes that for both employees, their responsibilities and
authorities had been clearly outlined in their job descriptions along with other information.
Ashley then inquires about the technicians, and if they had been given proper training for
using the equipment which they are expected to use.
“We provide training at the advent of their employment, and then when new technology is
introduced, we provide training for that, too”, answers Sonia.
Ashley requests to see the training records and is provided with a file by the name of TR-
001, which includes all the employees and the training they have received thus far. In the
file, she selects three employees 1. L. Cook 2. A. Kareem and 3. P. Carlesmo. For Cook and
Kareem, Ashley is able to find training records; however, for Carlesmo, the file was empty.
“Oh, there is a reason why his file is empty. Mr. Carlesmo is an individual encompassing 20
years of experience when we hired him three years ago. He already possessed the
knowledge of how to use the equipment which we have in store. He did not need any
training, as he is competent enough. Even when there is new equipment introduced, he
starts working on it, even when he has no clue how it works, whereas others are provided
training” claimed Sonia.
Ashley jots down her findings and appreciates Sonia’s support. She heads out to the next
department with Rob, the Design Department.
Design Department
Ashley is welcomed by Peter O’ Brian, who is the Design Lead of the organization. Peter
takes Ashley around the department, where Ashley is further introduced to the design team
working under Peter. Ashley notices that some employees had black screens with green,
blue and purple lines, depicting, that they are working on their drawings on AutoCAD. While
walking with Ashley, Peter discusses the whole process carried out in the design
department.
Peter points at the leftmost corner of the room and states, “that’s our planning squad.” The
Workshop Manual
planning team receives the requirements from the client and determines the following:
design stages, review verification and validation that apply to each stage, and the
responsibilities and authorities at each stage. Our most experienced team members work in
the planning team as they have a strong grasp of all the procedures. Peter then points
towards the rightmost corner of the room and states, “that’s our drawing squad”. The
drawing team works on their drawings after receiving information from the planning team.
Their output, drawings, are then submitted to me for verification. I make sure that the
design and development outputs have met the design and development inputs, make sure
the drawings comply with what was required.
They reach to Peter’s office, where Ashley notices a stack of drawings all over Peter’s desks.
Some even on the floor.
“Let me just pick the drawings up from the floor”, he replies embarrassedly. While Peter
was picking up the drawings, Ashley notices some of the drawings had an approved stamp
whereas others had obsolete Stamp.
“Can you brief me a little about which documents get the ‘approved’ stamp and which get
the ‘obsolete’ Stamp”, asks Ashley.
Peter informs her that the clients are continuously making changes to their requested
products.
Peter adds that the clients always make new changes, hence, once we prepare a drawing
and if the client comes back a few days later to request certain changes, then the drawing
we had created is of no use to us. What we do is, once the updated drawing is made, we
place an obsolete stamp on the previous one, and after a few days, we throw the drawing
with the obsolete stamp away. In the past, we were maintaining records of the changes, but
we feel it is pointless to keep them and it unnecessarily takes space. Ashley jots down some
notes and appreciates Peter for his time. She asks Rob to take her to the last department for
audit, the Production Department.
Production Department
At the production department, where Mr. Alex Nelson (the Production Manager) is guiding a
forklift towards the right direction into the storage area.
Ashley is told to wait in his office until he has finished the task in hand.
“Sorry to keep you waiting. We just completed this 4-seater sofa, and had to transfer it to
the storage room, to preserve, until it’s delivered to our client”, stated Alex. Ashley
requested to go to the equipment room, which has the given equipment used within the
organization. Alex introduces Ashley to Mr. Craig, who is responsible for the equipment.
Craig provides Ashley with a file by the name of EQ-C, which contained a total of 48 types of
equipment that had calibration dates, re-calibration dates, references and procedures to be
followed. Ashley skims through the re-calibration dates of a few equipment and noticed that
none of them had expired.
Ashley returns to Alex and asks, “Can you tell me about who is responsible for conducting
reviews of the customers’ requirements before committing to supply the furniture set?”
Alex pages Mr. Smith (Operational Manager), to report to the storage area and is
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responsible for all the specifications and requirements of the products. Mr. Smith is busy in
a meeting, but he will be here within 15 minutes.
“Sorry Madam, to keep you waiting,” says Mr. Smith. “We normally have the same clients
whom we provide our products; it has been so many years that we don’t need to perform
an actual review before placing the order. We know what they want and they trust us,”
explains Mr. Smith.
“Can you show me how defected material is handled and what actions the organization
takes regarding them?” requests Ashley.
“It’s funny you ask Ms. Ashley because just yesterday one of our technicians raised an issue
with one of the beds that was ready for delivery but luckily he spotted the defect before
delivering it and we were saved from a heavy lawsuit”, Mr. Smith.
Both men guide Ashley to the storage area where the beds are placed prior to delivery.
From a large sample of identical beds, Alex has no trouble locating the defected one. “How
were you able to identify the defected one from the others while placed within this room?”
inquires Ashley.
“It’s because our technician had just showed me this bed yesterday, I don’t suffer from short
term memory loss”, jokes Alex.
“This is the place from where the delivery truck picks up the beds to be delivered, what if he
gets confused and delivers the defected bed to a client”, asks an unenthusiastic Ashley.
“Oh no, it is made evident to all employees. We discussed it during lunch yesterday; the
delivery drivers are also made aware”, replies Alex. Ashley makes some notes on her
notepad and returns to the defected material and inquires about the root cause of the
defect.
“The defect in the bed which I just showed you, is a regularly occurring defect. Just two
weeks ago, we had the same defect, and we anticipate the same defect to occur next
month. We are not perfect, and we can make mistakes. Our organization has given us a
leeway of 5 defects per 100 beds made, we also give a 10% discount to the customers for
delayed delivery or a defected product.” replies Alex.
“Do you keep a document to record the action taken to fix the non-conformity and the
concession given?” asks Ashley.
“We don’t need to document it, as we straight away replace one bed from another and it is
usually under the leeway of 5 beds we are allowed. Regarding the discount, our manager
has allowed us to give concession depending on how upset the customer is.” smiles Alex.
Ashley, from the corner of her eyes, observes two men lifting a sofa into a truck for delivery.
“Why are they not using a fork-lift to lift the Sofa to the truck?” wonders Ashley. “We only
have two fork-lifts in our organization, one is being used elsewhere and the other is
unfortunately damaged, and since we have to get this sofa out urgently, we cannot wait for
the forklift to be free.” replies Alex.
Ashley heads to the truck with Alex and inquires about delivery and post-delivery activities.
Alex picks out a “Furniture Received” document from the dashboard of the truck and
explains it to Ashley.
“Our drivers get these documents signed, so both parties are made aware that the furniture
has been transferred from our facility to the client. We are maintaining the records of these
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documents, in case of any conflicts,” replies Alex.
Alex and Ashley return to Alex’s office, where Ashley asks how the organization is keeping in
touch with the clients post-delivery.
“We definitely remain in touch with our clients even after we have concluded business with
them; we send ‘Customer Feedback’ forms to our clients after a week of delivery and then
resend it on the 6th month after delivery. This way, we can affirm if we are keeping our
customers satisfied or not.” replies Alex.
Alex pulls out the “Customer Satisfaction” folder labeled CS-01-A from the cabinet and
provides it to Ashley for review. Ashley quickly goes over it and notices that the organization
is maintaining feedback forms, as Alex had stated. “Are these customer complaints and
feedbacks included in the management review?” asks Ashley.
“No, we do not normally include them as a management input, as there are other major
issues to be discussed. The HR department handles customer complaints and feedback,”
replies Alex.
Ashley takes a glance at her watch and notices it is 4:15 P.M. She expresses gratitude to Alex
for his time and heads to the conference room for the closing meeting.
Closing Meeting
Ashley initiates the closing meeting by expressing her immense gratitude to the organization
for their support. She reiterates the purpose and criteria of the audit.
Ashley, in a pleasant manner, talks about the strengths of the organization which she have
been witnessed. She encourages departmental heads on their outstanding work.
Lastly, Ashley, in a serious manner, expresses the non-conforming findings she had observed
during the audit. In her concluding statements, she states that, unfortunately, she will not
be issuing a recommendation for certification for ISO9001:2015 for ATA Furniture Store.
However, she reminds them that once the findings are closed, the organization will not have
any problems in obtaining the certificate.
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S. No. Findings (Major or Minor NCR) or Opportunity for Improvement. Clause No.
Workshop Manual

ISO 9001 LA-Workshop Manual

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Table of Contents

Workshop – 1 Context of the Organization.............................................................................2

 The context of the organization.

 Pipe Sleeve Manufacturing Project for a US-based Client, Year 2018

Interested Parties & their Needs and Expectations

Interested Party Requirements, needs or expectations

S No. Clause No. Clause Requirement

 Prepare a comprehensive audit checklist, by using the provided checklist template to

 Be prepared to discuss your checklist items with class.

Retain Documented Information

 Working in assigned groups, prepare a comprehensive audit checklist, by using the

Leadership includes: ensuring responsibilities and

A complaint from a customer can never be considered as

In ISO 9001:2015 the terms “Documents” and “Records”

Traceability is established by physical identification

Support clause covers resources, awareness,

Retaining documented information related to internal

Corrective Action on a Nonconformity may require the

 Form groups as instructed by the tutor.

Auditor: John Auditee: Lee

Corrective Action Accepted Corrective Action Rejected

Justification/Comments for Acceptance or Rejection:

Auditor: John Auditee: Lee

Corrective Action Accepted Corrective Action Rejected

Justification/Comments for Acceptance or Rejection:

Auditor: John Auditee: Lee

Corrective Action Accepted Corrective Action Rejected

Justification/Comments for Acceptance or Rejection:

Auditor: John Auditee: Lee

Corrective Action Accepted Corrective Action Rejected

Justification/Comments for Acceptance or Rejection:

Conducting the Audit

Workshop: 120 minutes

Audit Summary and Findings

Lead Auditor: Audit date:

 Read the scenarios.

Description of the non-conformity.

ISO 9001:2015 clause and requirement.

Description of the non-conformity.

ISO 9001:2015 clause and requirement.

Description of the non-conformity.

ISO 9001:2015 clause and requirement.

Description of the non-conformity.

ISO 9001:2015 clause and requirement.

Description of the non-conformity.

ISO 9001:2015 clause and requirement.

Description of the non-conformity.

ISO 9001:2015 clause and requirement.

Description of the non-conformity.

ISO 9001:2015 clause and requirement.

Identification of Audit Findings:

 Classify your audit findings as either major nonconformity, minor nonconformity or

Reporting Audit Findings:

 List all audit findings on the findings template provided.

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