QMS LAC Continuous Assessment
QMS LAC Continuous Assessment
ISO 9001:2015
Continuous Assessment
Daily Student
No Assessment Exercises Points
Exercises score
1 Understanding of Quality Management 10
DAY 1 System
2 Documenting Management System 10
Requirements
3 Documented Information Review 25
DAY 2
4 Preparation of Audit Plan 20
5 Ethical conduct an auditor 10
DAY 3
6 Writing of Audit Checklist 20
7 Conducting Opening meeting 25
DAY 4
8 Practical Auditing 20
9 Writing Nonconformity 30
10 Conducting Closing meeting 25
DAY 5 11 Writing Audit Summary 10
12 Follow-Up Audit 10
Student’s assessment by the Tutor 25
For Tutor’s use, this document is for tracking student’s individual performance
during the course duration. Individual continuous assessment exercises are
recorded in this document.
The student needs 70% of the total score in these exercises to achieve a passing mark for
this course.
Day 1 - CA 1: Understanding Quality Management and ISO 9001 Standard. Answer the followings.
Choose the correct answer by encircling the corresponding letter. (10 points)
1. Management -
2. Quality
3. quality control
a) activities for control of the output after formal approval of its product configuration
information
b) part of quality management focused on providing confidence that quality
requirements will be fulfilled
c) part of quality management focused on fulfilling quality requirements
d) coordinated activities to direct and control an organization
4. quality assurance
5. quality improvement
6. system
The purpose of the QMS is to ensure that the company processes are consistently compliant
with the customer needs / requirements.
The purpose of implementing QMS Standard is to help the organization be more efficient and
improve the interested parties satisfaction.
But based on the presentation, one of the QMS Standard efine goals and objectives for quality.
Day 1 - CA 2: Quality Management System Process. Choose the correct answer by checking the
corresponding letter. (10 points)
1. What should organization need to consider 6. What process of QMS that provides
in planning, establishing, implementing and information on whether the QMS conforms to
maintaining an audit program? the organization’s own requirements for its
QMS?
a. frequency
b. method
a. Quality Management System Planning.
c. responsibilities
b. Procedures necessary to ensure effective
d. planning requirements and reporting
planning.
e. all of the above.
c. Legal and other requirements.
d. Internal Audit.
e. None of the above.
2. What issues should be verified in
evaluating the performance of QMS?
a. the process 7. When planning how to achieve the quality
b. customer evaluation objectives, what must organization determine?
c. what needs to be monitored and measured.
d. All of the above a. the need and expectation of external provider.
e. None of the above. b. how the results of planning will be evaluated
c. how to apply only the correction to
nonconformities.
3. What controlled conditions included in d. All of the above.
organization implementation of production e. None of the above.
and service provision?
8. What requirement of the organization that is
a. the availability of documented information necessary for the operation of process and
b. Those processes that define relation gained through experience?
between an organization and its a. organizational knowledge
customers. b. Support
c. All processes that have an impact on c. Monitoring and measurement
customer satisfaction d. all of the above
d. All of the above
e. none of the above
e. None of the above
5. What requirements of QMS that engagement 10. How will organization determine opportunities
of people enables provision of adequate for improvement?
human and other resources?
a. improving products and services to address
a. Leadership future needs and expectations
b. Organizational Knowledge. b. correcting, preventing or reducing undesired
c. Actions to address risks and opportunities. effects;
d. Support c. improving the performance and
e. none of the above. effectiveness of the quality management
system.
d. All of the above
e. None of the above.
TUV-SUD.ME/ Rev. No. Rev.Date:15.08. Page6 of 21
QCA073 01 19
QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment
Day 2. CA 3: Document Review (25 points) 1 point for inadequacy identified, .5 for adequacy
Adequate?
ISO 9001 Requirements √ if Yes or x State reason/s if found inadequate.
if No
4. Context of the organization
41 Understanding the organization and its
context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality
management system
4.4 Quality management system and its
processes
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities
and authorities
6. Planning
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning to
achieve them
6.3 Planning of changes
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
Using the Quality Management System manual of the case study company prepare an Audit plan for all
activities of URISE Packaging Corporation.
ORGANIZATION:
ADDRESS:
MANAGING DIRECTOR
Scope:
Audit Objective:
Audit Criteria:
1. IRCA code of conduct for auditor states “demonstrate sensitivity for the customs,
working practices, culture and personal beliefs of others”. Explain this statement
by an example when applied in auditing. (2 points)
2. What is the importance of the need for effective communication of the auditor with the
auditee? (2 points)
3. Give 2 examples on how an auditor can keep the need for the auditor’s confidentiality. (2
points)
4. As a professional competent auditor, give four ways on how you should behave. (4
Points)
Prepare an audit checklist for Auditing – role play to evaluate URISE Packaging Corp. UPCL by
preparing question opposite the description. Give the ISO 9001 clause at the end of each
question:
SN Description Checklist
Evaluate the auditee’s
understanding and
implementation of the
relationship between external
1 and internal issues, the relevant
requirements of relevant
interested parties, the actions to
address risks and opportunities,
and the quality management
system processes
needed to implement them
2 Evaluate the boundaries,
applicability and scope of the
quality management system,
including the types of products
and services
covered and justification for
any requirement not
applicable
3 Evaluate the auditee’s
determination of customer, and
applicable statutory and
regulatory requirements
d. is available to interested
parties.
c. Determining support
requirements, including
human resources; their
competence and awareness;
the infrastructure and work
environment; and the
monitoring and measuring
resources
d. Operational processes
including the determination
and review of requirements,
design and development,
production and service
provision and release,
external provision and
nonconforming outputs
e. Considered the external and
internal issues, the relevant
requirements of relevant
interested parties, and
determined the risks and
opportunities that need to be
addressed to give assurance
that the quality management
system can achieve its
intended result(s), prevent or
reduce undesired effects,
enhance desirable effects
and achieve continuous
improvement
10 Evaluate top
management’s
commitment to the quality
management system.
The students will present the closing meeting by team and the tutor shall score the performance of
each students individually according to the following criteria:
Award 5 points for each criteria: 5 – Excellent, 4 – Very Good, 3 – Good, 2 – Needs Improvement, 1 –
Poor. - (25 points)
TUTOR’S SCORE
Day 4. CA 8. Auditing Quality Management System against ISO 9001 requirements. (20 points)
With reference to the Audit plan and checklist you previously prepared for the case study
documents of UPCL, Audit the documents, manual and procedures and write your findings and the
evidences on the form. (20 points). If it meets the requirement mark Y on C and X if NC.
SN FINDINGS C NC
1
4 a.
b.
c.
d.
5 a.
b.
c.
d.
e.
f.
10
Nonconformity statement
Objective evidence
The students will present the closing meeting by team and the tutor shall score the
performance of each students individually according to the following criteria:
Award 5 points for each criterion: 5 – Excellent, 4 – Very Good, 3 – Good, 2 – Needs
Improvement, 1 – Poor. - (25 points)
TUTOR’S SCORE
AUDIT OBJECTIVE:
AUDIT CRITERIA:
Nonconformity Details:
Training Record for A. Smith (Purchasing Dept.) contains no evidence of training received in use of
revised Purchasing database.
Training Plan for 200y indicates that such training is necessary and to be given to all staff within the
Purchasing Department. ISO 9001 6.2.2 / Company Procedure CPQ 021 paragraph 6.4
Correction Done:
Amanda Smith was on vacation at the time training was provided to purchasing staff. Subsequently
she received ‘one to one’ training from the senior buyer and the Information Technology department,
however this was not recorded in her training records. Training record form has been amended to
indicate date and adequacy of training outcome.
Corrective Action(S):
The current training and record keeping process is considered to be fully satisfactory,
however the ‘Annual appraisal form’ will be amended to require a listing of any training
received by an individual over the past twelve months in order to capture and record any
training that may have accidentally not been recorded in the normal way. (immediate action).
Suggest a suitable approach that an auditor might take to verify that the corrective action
is effective in dealing with the root cause of the problem. (10 points)
Tutor’s Assessment
CRITERIA POINTS
Involvement, participation and contribution in class discussions. Reporting ability
and adaptability to different simulation.
Attitude, manner and suitability to become auditor and as audit team leader.
TOTAL