Participant Workbook-IsO 9001 - 2015-Issue 03 Rev 03 Jan 2024
Participant Workbook-IsO 9001 - 2015-Issue 03 Rev 03 Jan 2024
Venue of the Course: United Arab Emirates City: Dubai Country: UAE
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.
(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 &
(Monitoring & Efficiency
Measurements)
Raw materials Juice concentrate, Procurement, Juice quality (pH, brix, Bottled juice - Juice meets quality standards (pH, brix,
water, bottles, quality checks, temperature) (sealed, labeled,
taste)
Equipment caps, labels inventory control - Bottle cleanliness and packaged)
- Accurate fill levels
- Cap and label quality
- Defect-free bottles
Manpower Filling machines, Preventive Efficient bottling
- Minimal material wastage
cappers, labelers, maintenance, Machine speed process and
Utilities conveyors calibration - Downtime frequency production
Maximum production output (bottles/hour)
schedules - Accuracy of filling levels reports
- Low downtime and breakdowns
Operators, - Seal tightness
- Accurate machine calibration
technicians, quality Training, SOPs, Smooth operation
inspectors quality assurance - Operator efficiency and consistent
Skilled and efficient workforce
- Training completion product quality
- Minimal human errors
Electricity, water, Supply monitoring, - Inspection performance
- Timely completion of tasks
compressed air energy control Utility-supported
- Energy consumption operation
Optimal energy and resource usage
- Water flow/pressure
- Minimal waste of utilities
- Air pressure for capping
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.
External Issue
1. External provider’s competence and availability.
2, External inspections/audits External
3,Transportation
2. State 3 Interested parties and their needs & 1, Customers – Value of money, High Quality, Quick
expectations from GGC response.
5. State 4 evidence to be verified for Internal audit, customer complaints, roles and
conformity of QMS in an organization. responsibilities, training and awareness.
# Term Clause
Clause 4.3 -
Determining
Scope to be maintained as documented information the scope of
2.
the quality
management
system
Road condition from seaport to Good Glass company Clause 4.1
3.
Clause 4.2 of
Supplier’s requirements for details of product to be supplied
4. ISO
9001:2015,
Contractual relationship for fulfilment of their needs 4.2
5.
Competence of people in the organization 4.1/7.2
6.
Legal Issues as needs od interested parties 4.1
7.
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. QMS Policy shall be maintained as documented information. Clause 5.2.1 - Establishing the
Quality Policy
2. Ensuring processes deliver their intended output Clause 4.4 - Quality
Management System and its
Boundaries
3. Promoting continual Improvement of QMS QMS is Clause 10.3 - Continual
Improvement.
5.1.1 I
4. Integrity of QMS is maintained when changes are planned in QMS
5.3
5. Roles & Responsibilities are assigned & communicated. Roles and responsibilities is
Clause 5.3 - Organizational
roles, responsibilities, and
authorities.
6. Commitment to satisfy applicable requirements Commitment to satisfy
applicable requirements is
Clause 5.1.1 - Leadership and
Commitment.
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.
1. Top Management
Responsibility: Ensure the QMS aligns with strategic objectives, leads continual improvement,
2. Quality Manager
o Responsibility: Oversee QMS implementation, maintenance, and improvement.
o Communication: Share process performance, audit results, and corrective actions with all
departments.
3. Process Owners/Department Heads
o Responsibility: Ensure their processes meet quality objectives and customer needs.
o Communication: Set performance targets and ensure teams understand their roles in
achieving quality outcomes.
4. Employees
o Responsibility: Follow QMS procedures, report issues, and contribute to improvements.
o Communication: Receive training on their roles and understand how they contribute to
quality.
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
1. List at least 3 reasons for addressing Ensure QMS effectiveness: Maintain consistent
risks and opportunities. product/service quality.
Increase customer satisfaction: Prevent issues affecting
delivery or quality.
Drive continuous improvement: Improve processes and
reduce failures
2. Find out & state 3 options to address Risk Mitigation: Preventive measures to reduce impact,
risks. e.g., better training.
Risk Transfer: Outsource or insure against risks, e.g.,
third-party suppliers.
Risk Acceptance: Monitor and accept low-impact risks if
mitigation costs are high.
3. Establish at least 3 QMS objectives for Risk Mitigation: Preventive measures to reduce impact,
the GGC. e.g., better training.
Risk Transfer: Outsource or insure against risks, e.g., third-
party suppliers.
Risk Acceptance: Monitor and accept low-impact risks if
mitigation costs are high.
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 the appropriate Sub-clause out of Clause 6 for each statement:
# Statement Clause
1. Determination of Risk & Opportunities that need to be addressed to achieve Clause 6.1: Actions to
continual improvement. address risks and
opportunities
2. The performance of the organization needs to be considered for addressing Clause 6.1: Actions to
Risk & Opportunities. address risks and
opportunities
3. Evaluation of effectiveness of actions to address risks and opportunities Clause 6.2: Quality
objectives and planning to
achieve them
4. How to integrate & implement the actions into business processes. Clause 6.1: Actions to
address risks and
opportunities
5. Actions to address risks and opportunities need to be proportionate to the Clause 6.1: Actions to
impact on product quality address risks and
opportunities
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. marks for entire exercise.
Exercise 7 Documentation – Stage 1 audit Group Exercise – 45 Minutes
Read the QMS Apex Documented Information of Good Glass Company for Clause 7-Support and identify
External Communications:
4. Supplier Communication: Communication of quality standards and
delivery requirements to suppliers.
5. Customer Feedback: Communicating with customers about
product feedback, complaints, and satisfaction surveys.
6. Regulatory Authorities: Communication with government agencies
to ensure compliance with industry regulations.
2. Give three examples of 1. Workplace Safety Environment: Safe working conditions with
environment for operation of protective equipment and signage.
processes 2. Production Area Layout: Organized layout for efficient
manufacturing and product flow.
3. Technology Infrastructure: Availability of necessary IT systems
and software to monitor and manage processes.
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
1. Review and approval for suitability & adequacy of created documented Clause 7.5.3: Control of
information. documented information
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.
marks for entire exercise.
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 8.3.2 –© Design and
required verification and validation activities development control
3. Organization shall control the unique identification of the outputs when 8.5.2 - Identification and
traceability is a requirement traceability
4. Establish criteria for the processes and acceptance of products and services 8.7.1-d - Control of
nonconforming outputs
5. Review of the requirements specified by the customers 8.2.3.1 - Determining
requirements for
products and services
6 Changes to requirements for products and services 8.2.4 - Change of
requirements for
products and services
7 when the property of a customer is lost, damaged, or otherwise found to be 8.5.3 - Property
unsuitable for use, the organization shall report this to the customer belonging to customers
or external providers
8 Determine and apply criteria for the evaluation, selection, monitoring of 8.4.1 - General
performance, and re-evaluation of external providers requirements
1 mark for each answer. Max 5 marks for 5 or more correct answers
1. Determine & briefly describe at Late Deliveries: Delivering products later than promised, causing
least 3 potential scenarios that problems for customers.
may result in customer dis- Defective Products: Products with cracks or defects that don't
satisfaction in the GGC. meet quality standards.
Wrong Products: Products that don’t match the customer's
order or needs.
2. List at least 4 areas/processes in GGC & QMS operational controls required in each area.
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 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:
marks for entire exercise.
1. Determine & state at least 5 items in QMS that need to be monitored and measured in the Good Glass
Company.
Product Quality: Thickness, clarity, and strength tests.
Customer Satisfaction: Feedback, complaints, and delivery performance.
Production Efficiency: Yield rates and equipment downtime.
Supplier Performance: Material quality and delivery reliability.
Compliance: Adherence to ISO standards and safety regulations
2 Prepare a checklist for auditing internal audit process of GGC:
1. Defined audit schedule and scope,
2. Independent auditors assigned,
3. Processes reviewed systematically.
4. Findings documented with evidence,
5. Audit report prepared promptly,
6. Findings categorized (e.g., observations, non-conformities).,
7. Corrective actions identified and tracked,
8. Follow-up audits conducted, Audit records maintained, Auditors trained and qualified.
3 State at least 4 retained documents information to audit performance evaluation of QMS.
Internal audit reports.
Management review minutes.
Customer feedback records.
Quality performance KPIs.
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
a) React to the non-conformity & take actions to correct it. 10.2.1 (A) 1 Corrective action
1.5 marks for each answer. Max 5 marks for 4 or more correct answers
B) State examples from Gold Glass company:
2. Give examples of Clause 9.1 (Monitoring & Evaluation):
opportunities for GGC could use advanced analytics tools to track production efficiency
improvements in QMS of GGC and product quality, identifying trends and areas for improvement.
with reference to
performance evaluation. Clause 9.1 (Monitoring & Evaluation):
(Clause 9.1/9.2/9.3) GGC could use advanced analytics tools to track production efficiency
and product quality, identifying trends and areas for improvement.
Corrective Action:
Long-term solution to address the root cause of a non-conformity.
3 marks for each correct answer. Max 5 marks for both correct answers
AUDIT REPORT
Name of Company (Organization): GGC-Good glass Company
Accreditation: (NABCB/JAZ-ANZ/IAS/EIAC)
Address of the company:
Contact Person: John Fred Position: Operation Manager
SCOPE (4.3):
The organization shall determine the 4.1 Internal and External Issues
boundaries and applicability of the
quality management system to (a) Internal Issues:
establish its scope. When determining The industrial cleaning equipment's suction system and filters are not
this scope, the organization shall Functioning effectively, resulting in glass dust particles in the glass cutting area.
consider:
a) the external and internal issues (b) External Issues:
referred to in 4.1
The municipality issued a memo to GGC due to the failure to obtain a Permit
b) the requirements of relevant
To Work (PTW) while performing excavation for maintenance. The excavation
interested parties referred to in 4.2
Area passes over municipal utility lines.
c) The products and services of the
organization. 4.2 Understanding the Needs and Expectations of Interested Parties
The organization shall apply all the
requirements of this International (c)
Standard if they are applicable within
the determined scope of its quality
The organization is required to monitor and review information
management system.
regarding the needs and expectations of interested parties, as specified
The scope of the organization’s quality
in Clause 4.2. However, during the audit, it was found that customer
management system shall be available
equity was not fully recorded in the Customer Enquiry Register.
and be maintained as documented
information.
The scope shall state the types of Product and Service Information Availability
products and services covered and
provide justification for any Detailed product and service information is not clearly available on the
requirement of this International company website as required. Customers must contact the company for
Standard that the organization each piece of information, which is inconvenient and could lead to
determines is not applicable to the dissatisfaction.
scope of its quality management
system. Opportunity for Improvement (OFI):
Conformity to this International
Standard may only be claimed if the Records of internal and external communications are not being
requirements determined as not being effectively tracked. These records should be systematically
applicable do not affect the reviewed and monitored at regular intervals to ensure better
organization’s ability or responsibility to communication and compliance.
ensure the conformity of its products
and services and the enhancement of
customer satisfaction.
POLICY (5.2)
Positive Observation:
The quality policy is available and maintained as documented information. It is
communicated, understood, and applied throughout Good Glass Company (GGC).
Additionally, it is made available to relevant interested parties as appropriate: Page: 08.
This will enhance awareness, understanding, and application of the policy across all levels
of the organization.
Good Observation:
Risk and Opportunity Addressed: GGC has identified and taken actions (e.g., improving
supplier evaluation, training) to address risks and opportunities.
QUALITY OBJECTIVES AND PLAN (6.2): OFI (Opportunity for Improvement):
Communicating Objectives: Improve how quality objectives are communicated to
6.2.1 The organization shall establish quality everyone in the organization.
objectives at relevant functions, levels and Updating Objectives: Set up a clearer process for updating objectives when needed.
processes needed for the quality management Major NC (Non-compliance):
system. The quality objectives shall: Objectives Not Measurable: Some quality objectives (Achieve a product defect rate) are
a) be consistent with the quality policy not measurable or don’t match the quality policy.
b) be measurable No Documentation: There is no documented information to support the quality objectives.
c) consider applicable requirements Good Observation:
d) be relevant to conformity of products and Clear Responsibility: Resources, responsibilities, and deadlines are defined for meeting
services and to enhancement of customer quality objectives.
satisfaction
e) be monitored
f) be communicated
g) be updated as appropriate.
The organization shall maintain documented
information on the quality objectives.
a) What will be done:
6.2.2 When planning how to achieve its quality Observation: Most quality objectives have defined actions, but some lack specific,
objectives, the organization shall determine: actionable steps.
a) what will be done OFI: Ensure that all quality objectives have detailed action plans with clear steps.
b) what resources will be required b) Resources required:
c) who will be responsible Observation: Resources (personnel, equipment, etc.) are identified for many
d) when it will be completed objectives, but not consistently for all.
e) How the results will be evaluated. OFI: Document resource requirements for all quality objectives, ensuring no gaps.
c) Who will be responsible:
Observation: Responsibility is assigned for most objectives, but some lack clear
ownership.
OFI: Assign clear responsibility for all quality objectives to ensure accountability.
d) When it will be completed:
Observation: Deadlines are provided for most objectives, but some lack specific
completion dates.
OFI: Include clear and specific deadlines for all quality objectives.
e) How the results will be evaluated:
Observation: Evaluation methods are defined, but some objectives lack measurable KPIs.
OFI: Define measurable evaluation criteria (KPIs) for all quality objectives to track progress
effectively.
7.1.1Has the organization determined and
provided the resources needed for the 7.1.1 - OFI and Observations
establishment,
Implementation, maintenance and continual
a) Internal Resources:
improvement of the quality management
system.
The organization has considered: Observation: The organization has considered existing internal resources, but
a) the capabilities of, and constraints on, resource limitations may not be fully assessed.
existing internal resources; OFI: Conduct a more detailed review of internal resource capabilities and
b) what needs to be obtained from external constraints.
providers
b) External Providers:
7.1.2 People
Has the organization determined and provided 7.1.2 - OFI and Observations
the persons necessary for the effective Observation: The organization has provided the necessary personnel for the effective
implementation of its quality management implementation and operation of the QMS. However, some roles may not be fully defined or
system and for the operation and control of its documented, leading to potential confusion in process control.
processes. OFI: Ensure clear role definitions, responsibilities, and qualifications for all personnel involved in the
QMS to enhance the effectiveness of process implementation and control.
Competence (7.2):
b) ensure that these persons are competent be gaps in training records or competence evaluations for equipment operator roles.
based on appropriate education, training, or OFI: Improve tracking of training and competence to ensure all staff have the necessary
experience skills and maintain proper documentation.
c) where applicable, take actions to acquire the
necessary competence, and evaluate the
effectiveness of the actions taken
d) Retain appropriate documented information
as evidence of competence.
Communication (7.4):
7.4 - OFI and Observations
The organization shall determine the internal
and external communications relevant to the Observation: The organization has identified key communications for the QMS but needs
quality management system, including: a clearer structure on who communicates, when, and how.
a) on what it will communicate
OFI: Create a clear communication plan to specify what, when, how, and who
b) when to communicate
communicates for better clarity and efficiency.
c) with whom to communicate
d) how to communicate
e) who communicates
providers However, some documented information on non-conformity, including action taken and
Preservation authority decision, needs to be more detailed.
Post-delivery activities OFI:
Control of changes-The organization shall retain Ensure that all non-conformity records are fully detailed, including the actions and
documented information describing the results authority decision.
of the review of changes, the person(s) Strengthen traceability and evidence for the release of products and services.
authorizing the change, and any necessary
actions arising from the review.
Release of products and services-The
organization shall retain documented
information on the release of products and
services. The documented information shall
include:
a) evidence of conformity with the acceptance
criteria
b) Traceability to the person(s) authorizing the
release.
9.1.3
9.1.3 Analysis and evaluation
Whether organization has analyzed and
evaluated appropriate data and information
arising from monitoring and measurement.
a) conformity of products and services; Clause 9.1.3: Analysis and Evaluation
b) the degree of customer Observation:
The organization analyzes data on product/service conformity and customer satisfaction. However,
there is no customer complaint and evaluation tracker in place.
OFI:
Implement a customer complaint and evaluation tracker to systematically monitor and assess
customer feedback and ensure continuous improvement.
satisfaction;
c) the performance and effectiveness of the
quality management system;
d) if planning has been implemented Clause 9.2: Internal Audit
effectively;
e) the effectiveness of actions taken to address 1. Internal Audit Program:
risks and opportunities; The organization has a documented internal audit program covering frequency, methods,
f) the performance of external providers; responsibilities, planning requirements, and reporting. Audits are planned for
g) The need for improvements to the quality production, HR, procurement, logistic and defined timelines (24th Aug-2024 to 27th Aug-
management system. 2024)
2. Audit Criteria and Scope:
Confirm the organization has clear audit criteria (ISO QMS-9001) and defined scope
(evaluating and checking QMS standards are met and properly implemented). Ensure
Internal Audit (9.2) alignment with organizational and regulatory needs.
3. Auditor Selection Criteria and Impartiality:
Verify that the organization has established that auditor selection includes competence and impartiality. Ensure auditors are
internal audit program including the frequency, independent of the areas they audit.
methods, responsibilities, planning 4. Reporting Audit Results:
requirements and reporting Check that audit results are reported to relevant management with findings, conclusions,
and corrective actions. Ensure reports are timely.
Verify the organization has 5. Retention of Audit Records:
- Defined the audit criteria and scope Verify retention of audit records (plans, reports, findings) according to retention policies.
- Auditor selection criteria and 6. Dates of Audits:
impartiality of the audit process Confirm that internal audits are conducted as per the planned dates and schedule.
- Plans to ensure that the results of the
audits are reported to relevant
management.
Plans to retain documented information as
evidence of the implementation of the audit
program and the audit results
OFI-1: Expand customer research to anticipate future needs and enhance product
10.1 General features.
Whether organization has determined and OFI-2: Introduce AI chatbots or self-service options for faster customer support.
select opportunities for improvement and
implement any
necessary actions to meet customer
requirements and enhance customer
satisfaction including
a) improving products and services to meet
requirements as well as to address future needs
and
expectations;
b) correcting, preventing or reducing undesired
effects;
c) Improving the performance and effectiveness
of the quality management system.
Minor NC:
Minor NC-1: Inconsistent use of management review outputs for QMS improvements.
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 No additional location and sites
Activity N/A
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
could be satisfactorily planned & conducted.
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: Shebeer Mattolavalappil Name: Mr. Fares Baddad
Date: 30-December-2024 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. 2023,
Documentation: Procedures Manual Issue 01, Dt. Feb. 2023
Team Leader: Shabeer Mattola Audit Start Date 22-12-24 Opening 9:30 am
(1) Meeting
Team Member: John Green (2) Audit End Date 24-12-2024 Closing 05:00 PM -05:30 PM
Ajeesh (3) Meeting
Thomas(4)
Audit Schedule
Date Client Function Auditor Time (Hrs.)
22-12-2024 Opening Meeting (all auditors shall available in opening meeting as required) Team 9:30 AM - 10:00
Leader AM
(Shabeer
Mattola)
Process Area 1: Quality Management (ISO 9001) Auditor 2 1.0
(John 10:00 AM-11:00
Green) AM
Process Area 2: Production Process (Manufacturing) 1) Shabeer 1.0
Mattola 11:00 AM-12:00
PM
Process Area 3: Installation Site (Execution) 3- 1.0
10:00 AM-11:00
AM
Auditor's Brush Up Time All Auditors 1:05 PM- 1:30
PM
Process Area 4: Customer Feedback & Complaint Handling Auditor 1 1.0
(John 1:30 PM- 2:30
Green) PM
Process Area 5: Procurement & Supplier Management Auditor 2 1.0
2:30 PM- 3:30
PM
Process Area 6: HR & Competency Management Auditor 3 1.0
3:30 PM- 4:30
PM
Process Area 7: Internal Audits & Corrective Actions Auditor 4 1.0
4:30 PM- 5:00
PM
Closing Meeting ( all the auditor) 1)Team 0.5
Leader 5:00 PM- 5:30
(Shabeer PM
Mattola)
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.
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
No
documented
process for
continuous
improvement
or
measurement
6.1 Actions to address Has the company identified risks and opportunities, and taken of QMS
risks and opportunities action? NC performance.
6.2 Quality objectives
and planning to achieve Are clear quality objectives set, and is there a plan to achieve
them them? Compliance
6.3 Planning of changes Are changes affecting the QMS planned and managed? Compliance
Support Areas
Clause # CHECK POINT (For Verification) Conclusion Evidence for
(Compliance / NC
NC)
evaluating and
selecting
external
providers
available but
selection
criterial not
reviewed as
External Providers: Is there a defined process for evaluating well
7.1.2 People and selecting external providers (e.g., suppliers, contractors)? Minor NC
Observation:
Resources for
monitoring and
Are the necessary resources for monitoring and measuring measuring
product conformity identified and maintained? conformity are
available but
Minor non may not always
7.1.5.1 General compliances be up-to-date.
Are measurement devices regularly calibrated, and is the
7.1.5.2 Measurement documentation kept up to date?
traceability Compliance
Observation:
Knowledge
needed for
processes and
conformity is
Knowledge: Is there a process to identify the knowledge identified, but
necessary to support the QMS and ensure conformity to gaps may exist
product/service requirements? in sharing or
7.1.6 Organizational Minor non retaining
knowledge compliances knowledge.
7.2 Competence the Are personnel responsible for QMS processes competent
organization based on education, training, skills, and experience? Compliance
Is there defined process of employee mobilization awards and
7.3 Awareness the awareness session are properly recorded. Compliances
Is there a defined process for internal and external
7.4 Communication communication relevant to the QMS? Compliances
7.5.1 Documented Is the communication structure clear, including what is
information communicated, when, by whom, and how? Compliances
7.5.2 Creating and Does the organization have a defined procedure for controlling
updating documented information? Compliances
7.5.3 Control of Has the organization identified all external documents needed
documented information for the effective operation of the QMS? Compliances
Operation Areas
8.1 Operational planning Does the organization plan, implement, and control the
and control processes needed to meet product/service requirements? Compliances
8.2.4 Changes to
requirements for Are changes to product/service requirements reviewed and
products and services communicated to relevant personnel? Compliance
Design process
is in place but
Are there controls in place to ensure that the design and lacks milestone
8.3.1 General development process meets requirements? OFI tracking.
Planning is
established,
but timelines
and resources
need clearer
8.3.2 Design and Are there? Planning is established and set timelines and definition.
development planning resources. OFI
8.3.3 Design and
development inputs Are inputs reviewed for adequacy and completeness? Compliance
8.3.4 Design and Are there controls in place to ensure that the design and
development controls development process meets requirements? Compliance
8.3.5 Design and Are design outputs clearly documented and meet the
development outputs requirements of the design inputs? Compliance
Design controls
are in place but
not
8.3.6 Design and Are changes to design and development controlled and consistently
development changes documented? OFI documented.
8.4.1 General
8.4.2 Type and extent of Does the organization determine the type and extent of
control control for external processes, products, and services? Compliance
Does the organization provide external providers with the
8.4.3 Information for necessary information for them to deliver products and
external providers services? Compliance
Improvement Areas
Are improvements tracked and monitored to ensure they are Compliance
10.1 General effective and lead to sustained benefits?
10.2 Nonconformity and Are corrective actions taken promptly when non-conformities are Compliance
corrective action identified, and are they proportional to the risk and impact?
The QMS is
reviewed by
management at
regular
intervals, but
the impact has
not been
10.3 Continual Does management regularly review the results of continual effectively
improvement improvement efforts and their impact on the QMS? OFI observed.
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.
1. If you think there is a sufficient objective evidence of nonconformity, then complete the non-conformity
notes provided in section “A” and categorize the same as “Major” or “Minor”.
2. If you think there is not sufficient objective evidence of nonconformity, then state the reasons in the section
“B”. In the reasoning, also state what must be further investigated before concluding your decision wither it is
conforming or non-conforming.
Incident 1
In ABC Catering Company, once customer complaint was received as under:
“Our contract says that the quality of rice to be used for rice-based dishes should be an “Indian Basmati rice only” and
you would be giving proof of calories should comply with specs. Sheet “ABC_SPEC 212 issue 2 dt. 12 Jan 2010” and
you would be giving us an 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.”
“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.
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 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 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.
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: 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 and the distribution of marks adhered to.
Comments:
The nonconformity relates to ABC Catering's failure to provide the required quarterly third-party lab test reports for rice
quality, as specified in "ABC_SPEC 212 issue 2 dated 12 Jan 2010." Additionally, an unresolved non-conformance report (NC-15)
from a previous audit remains open, showing a lack of timely corrective actions. The failure to verify if the customer received
the faxed evidence indicates poor communication practices.
Immediate corrective actions are needed to submit the lab reports on time, close the open non-conformance, and improve
communication with the customer to ensure compliance.
Failure (Nonconformity):
A broken GO-NOGO gauge was found during final inspection of circular products.
The inspector stated the gauge was provided by the client and would be returned with the last shipment.
However, the Quality Manual shows the company sought an exclusion for customer property, which should align with actual
practices. The broken gauge was not properly maintained, affecting the inspection process.
Evidence (reference of Process/Personnel/Documents):
Failure (Nonconformity):
The inspector’s shaking hands due to illness likely affected the accuracy of the centricity check on the compass pins.
3% of consignments were returned for replacement, indicating quality issues with centricity.
Samples from stock also showed centricity problems, highlighting a recurring issue.
Requirement:
Failure (Nonconformity):
The business was unable to meet sales and branding targets for nearly a year due to communication problems caused by local
manpower's lack of English proficiency.
Cultural and legal restrictions (female employees unable to interact with male customers and vice versa) were not addressed
effectively, leading to a failure to balance legal requirements and business objectives.
Despite HR creating a competency matrix and job descriptions, the operational management could not resolve the
communication and legal issues promptly, resulting in the business not meeting its targets for nearly a year.
Interviews and reports from HR and Operations regarding the competency and legal restrictions.
Auditor Auditee Date
Shebeer Mattolavalappil Jhon Green Date 22-12-2024
Requirement:
Failure (Nonconformity):
Untraceable Marks:
The marks for the practical exercises test were missing in both hard and soft copies.
Incorrect Student Name:
The correct serial number was listed, but the student’s name was incorrect in the records.
Unresolved Student Complaint:
A student letter, dated four months ago, mentioned unreported marks, but no corrective actions were taken.
Placement Objective Impacted:
The lack of proper documentation may hinder achieving the placement goal of 75% of students.
Documents: Student evaluation records (soft and hard copies), student letter
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.
NON-CONFORMITY
Students are also required to demonstrate their ability to write aNOTE (Role Play)
well- constructed NC: 1 statement that clearly describes the
nonconformity
weakness or failure of the management system, the audit evidence, and the requirement(s) of the standard.
Note to marker: ISO 9001:2015 CLAUSE No: _____________
To raise a nonconformity report when there is not sufficient audit evidence should be penalized and markers should normally award zero
Company documents Company documents MAJOR / MINOR
mark.
[Strike out as required]
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.
Requirement:
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,
Failure where there was some obvious ambiguity in the description of the audit situation or the student demonstrates logical
(Nonconformity):
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: ie failure in the system (3 marks for identifying the failure),
Evidence (reference
audit evidence of Process/Personnel/Documents):
(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.
ISO 9001:2015 CLAUSE No: 8.5.1 – Control of Production and Service Provision
Company Documents: Recruitment Process Manual, Candidate Interview Forms
Area/Unit Involved: HR Department, Recruitment Team
Failure (Nonconformity):
The interview process was not properly documented. Key steps, such as candidate feedback collection and selection decisions, were
missing or not recorded, resulting in a lack of transparency and the inability to justify hiring decisions.
Requirement:
Failure (Nonconformity):
The interview documentation, including candidate evaluation forms and feedback records, was not properly controlled. Some
documents were missing, and others were not properly dated or signed, indicating a lack of proper control over documented
information.
Requirement:
Interview panel members must be adequately trained and competent to conduct interviews in accordance with the company's
recruitment process and ISO 9001:2015 Clause 6.2.2.
Failure (Nonconformity):
There was no documented evidence that all members of the interview panel had received proper training or were assessed for
competence in conducting interviews, which could lead to inconsistencies or bias during the hiring process.
Exercise 16
Keywords Approach to understand ISO 9001 requirements Time: 75 Minutes
1 Mark for each clause or part of a clause. Max 10 marks for all correct answers
Audit Team:
Name: Status
Shebeer Mattolavalappil (Lead Auditor)
John Green (Team Member)
Robert Green (Team Member)
Max Pacher (Team Member)
Audit days: 2 day
Nonconformities raised during Audit
NCR Ref. No. NC-01, NC-02
Minor/Major Minor
Nonconformities raised during last visit
NCR Ref. No. N/A
Closed/Open 0
Based on the findings during the Stage 2 Audit, Good Glass Company has shown a strong commitment to quality
management and ISO 9001:2015 standards. While a few minor nonconformities were identified, the organization
demonstrates effective management practices in leadership, planning, support, operations, and performance
evaluation. The company is recommended for ISO 9001:2015 certification, provided that the identified
nonconformities are addressed within the agreed-upon timeframes.
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 2 Audit Days per visit.
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 re audit 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 24/01/2024
5. Team recommends a Limited Supplementary Audit for 1 audit day(s) or a full Re-assessment for 2 audit
day(s). The same could be conducted by 25/01/2025, 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.
01 / 2025,2026
The onsite Registration Audit 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 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.
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
DETAILS OF NON-CONFORMITY [A]
The dial gage no. 45 does been used on Drilling machine does not have calibration status (as per
procedure ABC_7.6 Rev 1) and on asking the operator replied that he does not know what
A
calibration is.
U
Requirement of the standard: D
Where necessary to ensure valid results, measuring equipment shall I
T
d) be identified to enable the calibration status to be determined;
O
AUDITOR: DATE: 24-12-2024 R
NAME: Shebeer 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: 24th Dec 2025
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.
Action should include training for all operators, proper traceability of calibration status,
and stronger preventive maintenance and inspection processes.
NON-CONFORMITY NOTE - 2
PROCESS ACTIVITY ISO 9001:2015 CLAUSE
Designing Validations of trainings 7.3.6
[A]
DETAILS OF NON-CONFORMITY
The validation records for the Design of training module # 76 (training security sniffer dogs) not A
evidenced as defined in the Design procedure. STAR_D_007 Rev.3 U
D
I
Requirement of the standard:
T
Records of the results of validation and any necessary actions shall be maintained (see 4.2.4) O
R
AUDITOR: DATE: 24th Dec 2024
NAME: Anita Gonzalvis SIGN ___________
ROOT CAUSE PROPOSED ACTION
1. It is difficult to validate Solution for this validation shall be [B]
analyzed and action taken A
U
ACTION TAKEN D
After many analyses the management (with help of external specialist) it was concluded it is I
difficult to validate. For such training modules where it would be difficult to validate, and an T
exclusion for 7.5.2 has been approved. The changes in Para 1.2 Application chapter of the E
manual is modified with exclusions and justification given. The procedure for Design E
STAR_D_007 Rev. 4 is released. Evidence enclosed for perusal: The Revised Manual &
Procedure.
The root cause and proposed action do not align. Therefore, the action needs to be reviewed and
is deemed inappropriate. It has not been closed.
NON-CONFORMITY NOTE - 3
PROCESS ACTIVITY ISO 9001:2015
Human Resources Induction Training for New Recruits CLAUSE [A]
6.2.2
DETAILS OF NON-CONFORMITY A
The induction training records for all five security guards for level 5 (recruited 20 days’ back) are not U
evidenced as required by procedure MLS_HR_008 Rev.5 Paragraph 5.5. e) Which states that all new D
recruits would be undergoing induction training program for minimum 2 days, within one week of I
their joining. T
O
Requirement of the standard:
R
The organization shall:
Tutor marking: 3.3 mark for each correct CAP acceptance. 10 max. Marks for the entire exercise.
conformity.