W8 Lecture 8958566270325886

QLTY 480
Quality Systems
Spring 2022 – week 8
Prof Boštjan Gomišček

Today’s Agenda
• Requirements for management systems – 2
• Virtual lab No2

Info:
“Certified Auditor Training & Qualification program

awareness Session”
from Thursday 24th Feb (5:15 pm - 06:00 pm)
Recording: https://vimeo.com/681391219/0cf6b50001
QLTY480 - Quality Systems - Virtual lab No2 - Week 8
Purpose:
The main purpose of the Virtual lab No 2 is to understand the
structure and content of the ISO 9001:2015 QMS manual
which is mostly defined by the requirements for the QMS ISO
9001:2015.
Aim:
The main aim is to get familiar with the structure and content of
the ISO 9001:2015 QMS and with some required parts of the
QMS manual.
Instructions & Guidelines:
After the successful accomplished awareness campaign you and

your department team was asked by the senior management
to continue working on the organization’s strategic goal to
prepare for and implement a Quality Management System
based on the ISO 9001:2015.
Therefore, your next sub-project was defined to continue

pursuing this strategic goal:
1. Writing up the Policy statement for your organization.
2. Assessing the development stage/maturity of you
organization in regard to the ISO 9001:2015 QMS
Requirements.
The management is expecting your team to present to them:
1. A well written Policy statement which will be aligned with

the mission, vision and operations of the organization
2. Assessment of maturity and readiness of (one of) the
ten (10) Requirements of the ISO 9001:2015 QMS.
You were asked to present the result of your new sub-project

within the next 2 weeks.
• Reflect on the materials and discussions during the first 8

weeks of the Quality Systems course.
• The team members (learners) are remaining the same.
• A Team Forum will be created, which should be used for the
entire communication within your team for any & all Virtual
Lab activities.
• Work on and write up a Policy statement as well as an
assessment of the maturity and readiness of your organization
based on the ISO 9001:2015 Requirements.
• Submission deadline for uploading the documents is on
March 13, 2022, at 9 pm.
Evaluation criteria:
• The quality of the content based on the literature review on

the Quality management Systems regarding the:
o Policy statement and
o ISO 9001:2015 Requirements as well as
o topics covered & discussed during the first 8 weeks of the
course.
• Interaction among the team members and communication on
the Team Forum.
Today’s Agenda
• Requirements for management systems – 2
• Virtual lab No2

Quality management system

Requirements for management systems
ISO 9001:2015 structure

Requirements for management systems
ISO9001:2015
CLAUSE 4 CLAUSE 5 CLAUSE 6 CLAUSE 7
CONTEXT OF THE LEADERSHIP PLANNING SUPPORT
ORGANISATION
• Factors relevant to • Commitment & • Risks & • Adequate resources
you accountability opportunities • Awareness &
• Interested parties • Apply the policy • Objectives communication
• QMS scope • Roles & • Changes to the QMS • Documented
• Specific responsibilities information
requirements or
“exclusions”
CLAUSE 8 CLAUSE 9 CLAUSE 10

OPERATION PERFORMANCE EVALUATION IMPROVEMENT
• Planning & control • Monitoring, measurement, • Nonconformity & corrective

• Product / service analysis, & evaluation actions
requirements • Internal audits • Continual improvement
• Design & development • Management review • Management review
• Control of external elements
• Provision & release of
products / services
• Non-conformances
Requirements for management systems -2
Requirements – “Shalls”
ISO, Annex SL
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
8 Operation
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8 Operation
9 Performance evaluation
9 Performance evaluation - General





10 Improvement
10 Improvement
10 Improvement
10 Improvement
10 Improvement
10 Improvement
10 Improvement
10 Improvement
Requirements
With the requirements we finished an overview and explanations of the

various sections and sub-sections which are building the ISO 9001:2015.
Done for today?
Thank you!
Questions???

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QLTY 480

Prof Boštjan Gomišček

• Requirements for management systems – 2

• Virtual lab No2

“Certified Auditor Training & Qualification program

from Thursday 24th Feb (5:15 pm - 06:00 pm)

Instructions & Guidelines:

After the successful accomplished awareness campaign you and

Therefore, your next sub-project was defined to continue

Instructions & Guidelines:

The management is expecting your team to present to them:

1. A well written Policy statement which will be aligned with

You were asked to present the result of your new sub-project

Instructions & Guidelines:

• Reflect on the materials and discussions during the first 8

• The quality of the content based on the literature review on

• Requirements for management systems – 2

• Virtual lab No2

Quality management system

ISO 9001:2015 structure

CLAUSE 8 CLAUSE 9 CLAUSE 10

• Planning & control • Monitoring, measurement, • Nonconformity & corrective

9 Performance evaluation - General

9 Performance evaluation - General

9 Performance evaluation - General

9 Performance evaluation - General

9 Performance evaluation - General

With the requirements we finished an overview and explanations of the

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