Module 3: What Is a Quality

Management System?

BUSD 2027
Quality Management
History and Evolution
Consider a medieval fruit stand:

Can
• Inspect colour
• Determine ripeness
• Inspect imperfections
• Random sample
• Taste
Cannot
• Determine
nutritional content
• Destroy product in
tests before sale

A means of quality control was needed.

Image: A fruit stand in Mauritius by Allan Brewer, available under a CC BY-2.0 licence at
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History and Evolution

Quality Control
• The quality of a finished product is inspected
before release
– Sampling plans
– Lot definitions
– Many inspection and testing methods

• Quality control is a misnomer

– No way to control quality at the inspection point
– Quality is “baked in” by this point
History and Evolution
Quality Assurance
• Assuring the quality of the product by controlling the
manufacturing process from whence the product
emerges
– Process-required standards
– Quality raw materials

Quality Control

Quality
Assurance

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History and Evolution

Quality Management
• “A company-wide approach to quality, with
improvements undertaken on a continuous basis
by everyone in the organization.”
(Dale, Bamford, & Van Der Wiele, 2016, p. 21)

• Quality is
– A partnership with suppliers and customers
– Everyone’s job
– Planned and built into every process
– Routinely reviewed
ISO 9001:2015
Standard
The International Organization for Standardization (ISO)
9001:2015 catalogues all the processes of an enterprise,
laying out the requirements of a system for managing
those processes to maintain and improve quality.

8 Key Principles
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. Systems approach to management
6. Continuous improvement
7. Evidence-based decision making
8. Relationship management
ISO 9001:2015
Standard
From Sales to Cash
To generate revenue and earn a profit, a company
must obtain and fulfill orders:
1. Create sales order
2. Create work order
3. Create pick list to instruct employees
4. Create packing slip and package products
5. Create shipping label and arrange for shipping
6. Invoice customer
7. Receive payment
ISO 9001:2015
Standard
From Requisition to Payment
Whether for-profit or not-for-profit, organizations need to
spend money to get supplies. Common steps in the
process include
1. Requisition
2. Create a purchase order
3. Acknowledgement
4. Pre-receiving
5. Receiving
6. Three-way match
7. Put-away
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ISO 9001:2015
Standard
Transforming Raw Materials into Finished
Goods
• Processes must be defined and documented to enable
training and ensure consistency.
• There must be measurement processes and a way to
maintain the measuring devices.
• Equipment must be trackable in terms of maintenance
records, inspection reports, and so on.
• The consumption of labour and the consumption or
provision of materials should be trackable.
ISO 9001:2015
Standard
Supporting Operations
In addition to the processes focused directly or indirectly
on product and service provision, there are processes
focused on the organization itself:
• Strategic and operational planning
• Resource provision and allocation
• Marketing and customer feedback
• Research, design, and
development
• Performance evaluation and
continual improvement

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ISO 9001:2015
Standard
Supporting Operations (cont’d)
Strategic and Operational Planning
• The collection of choices that determine the nature and
the business of the organization.
• The process of strategic and operational planning
includes the following general steps
(Bodley-Scott, 2010):
1. Recording basic beliefs and values
2. Exploring risks and opportunities
• External influences
• Strengths and weaknesses of the
organization
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ISO 9001:2015
Standard
Supporting Operations (cont’d)
Strategic and Operational Planning (cont’d)
3. Determining execution timeframe

4. Determining the strategy’s driving force

5. Choosing the scope of business activity

6. Determining the products, services, or markets with the greatest

potential

7. Determining the capabilities required to be successful

8. Defining the financial and non-financial goals for the strategy

9. Defining the required initiatives to build capability and achieve

goals
ISO 9001:2015
Standard
Supporting Operations (cont’d)
Resource Provision and Allocation
The organization will utilize resources in many forms
to achieve its goals, including:
• Human resources
• Financial and material resources
• Infrastructure and work environment
• Monitoring and measurement resources
• Corporate knowledge resources
ISO 9001:2015
Standard
Supporting Operations (cont’d)
Marketing and Customer Feedback
• Must be able to back up claims
• Supports organizational integrity and quality

Research, Design, and Development

• Innovation processes and learning should be recorded

Performance Evaluation and Continual

Improvement
• All business processes should be monitored and analyzed
for effectiveness
• Identifies opportunities for continual improvement
ISO 9001:2015
Elements
ISO 9001:2015 Elements

4 Context

5 Leadership

6 Planning

7 Support

8 Operation

9 Performance management

10 Improvement
ISO 9001:2015
Elements: Key Terms
Top Management
The senior leadership of the company, responsible
for setting strategy and representing the
organization to the public.

Organization
The collective body, including top management
and all of its employees, engaged in a common
purpose. An organization can be structured as
public, private, for-profit, or not-for-profit.
ISO 9001:2015
Elements: Key Terms
Business
Those activities that are core to the purposes of an
organization’s existence.

Interested Parties
Those parties, other than suppliers, customers, and
competitors, “that can have an effect or potential
effect on the organization’s ability to consistently
provide products and services that meet customer
and applicable statutory and regulatory
requirements” (ISO Copyright Office, 2015).
ISO 9001:2015
Elements: Key Terms
Requirements
The broad collective of needs and interests of customers,
interested parties, and regulatory bodies.

Products
Physical, tangible objects that can be shipped by the
organization and received by the customer.

Services
“The output of an organization with at least one activity
necessarily performed between the organization and the
customer, some portion of which is intangible” (ISO
Copyright Office, 2015).
ISO 9001:2015
Elements: Key Terms
Customer Property
Can include materials, components, tools and
equipment, premises, intellectual property, and
personal data.

Risks
“The (usually negative) effects of uncertainty that
come from a deficiency of information related to,
understanding, or knowledge of an event, its
consequence, or likelihood” (ISO Copyright Office,
2015).
ISO 9001:2015
Elements: Key Terms

Documented Information
Formerly “documents and records,” this is
the retained information (in any medium,
electronic or hard copy) that an
organization relies on for proof of
conformity with the Standard or storage of
the “recipe” for product and service
provision, or is the retained knowledge and
experience of the company.
ISO 9001:2015
Elements
Element 4: Context
Outlines the quality management requirements related to
the organization’s strategic planning activities. Annually,
an organization should
• Consider external and internal influences
• Consider interested parties relative to the organization
• Define the boundaries and applicability of the
organization’s QMS
• Confirm the requirements of the
Standard that are necessary
• Establish or review the QMS and
its processes
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ISO 9001:2015
Elements
Element 5: Leadership
• Top management is expected to operationally
support the QMS by
– Establishing a quality policy that supports the
strategic direction of the organization
– Ensuring that the policy is communicated and upheld
– Assigning specific responsibilities and authorities to a
QMS representative
– Ensuring integration of the policy into core business
processes
– Providing support resources
– Reviewing and revising the QMS as required
ISO 9001:2015
Elements
Element 5: Leadership (cont’d)
• The Standard also holds top management
accountable to a focus on customer service:
– Understanding customer requirements
– Understanding and meeting regulatory requirements
– Identifying and addressing risks to customer
satisfaction
– Maintaining employee focus on
customer satisfaction
– Measuring the level of customer
satisfaction and taking applicable
action
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ISO 9001:2015
Elements
Element 6: Planning
• When addressing and planning for risks,
define
– What actions will be taken
– What resources will be required
– Who will be responsible for completing the
actions
– When they will be completed
– How their effectiveness will be measured
ISO 9001:2015
Elements
Element 6: Planning (cont’d)
• The plan objectives should be
– Measurable
– Relevant
– Monitored,
communicated, and
updated
– Saved as documented
information

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ISO 9001:2015
Elements
Element 7: Support
Garbage in, garbage out

• Resources of sufficient quantity and quality must

be available in order to produce quality products
and services
– Raw materials  finished goods

• Quality includes on-time delivery; resources are

finite
• The Standard addresses aspects of resource
provision that support this
ISO 9001:2015
Elements
Element 7: Support (cont’d)
Infrastructure and Work Environment
• Raw materials, work in process,
finished goods, equipment, and
people need to be protected and
preserved
– Infrastructure
– Physical environment
– Psychosocial environment
• Determining, providing, and
maintaining infrastructure and the
work environment supports
quality
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ISO 9001:2015
Elements
Element 7: Support (cont’d)
Monitoring and Measurement Resources
• When monitoring and measuring are
used to verify the conformity of products
and services to requirements, the
organization will
– Provide the resources needed to ensure
valid and reliable results
– Ensure that the resources are suitable
– Maintain the resources
– Retain documented information (records)

Image: Sailors test Djibouti water quality by United States of America MC1 Eric Dietrich/U.S. Navy, Public domain, available at
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ISO 9001:2015
Elements
Element 7: Support (cont’d)
Monitoring and Measurement Resources
• Measurement equipment will be
– Calibrated, verified, or
both
– Identified to track its
status
– Safeguarded from
adjustments, damage,
or deterioration
Image: [Airman Derek Martin calibrates a pressure test gauge] by Airman Joan Kretschmer/US Navy, Public domain, available at
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001_Airman_Derek_Martin,_from_Southold,_N.Y.,_performs_a_calibration_procedure_on_a_pressure_test_gauge.jpg
ISO 9001:2015
Elements
Element 7: Support (cont’d)
Organizational Knowledge
• Determine the organizational knowledge
necessary for the operation of QMS
processes:
– Maintain organizational knowledge and experience
from
• Internal sources
• External sources
– Make it available, to the extent necessary
– Address changing needs and trends
ISO 9001:2015
Elements
Element 7: Support (cont’d)
People
• People are an organization’s most valuable asset,
but their abilities are finite.
• It is the organization’s
responsibility to provide
enough people to
– Implement the QMS
– Operate and control
QMS processes

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ISO 9001:2015
Elements

Element 7: Support (cont’d)

Competence
• People in the organization must be competent.
• It is the organization’s responsibility to
– Determine the necessary competence
– Provide a means of measuring competence
– Ensure that people are competent
– Take necessary actions to acquire competence.
ISO 9001:2015
Elements
Element 7: Support (cont’d)
Awareness
• Organizations need to ensure their employees
are aware of key information:
– The quality policy
– Relevant quality
objectives
– The value of their
contribution to the
QMS
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at https://commons.wikimedia.org/wiki/File:Employee_Honor_Award_Mark_Guinn;_NLA_Refuges_Complex_(5726626896).jpg
ISO 9001:2015
Elements
Element 7: Support (cont’d)
Documented Information
• To the extent necessary, the organization must maintain
and retain documented information.
• The Standard suggests the following elements:
– Physical leadership – Customer property
– Monitoring and measurement – Managing change
– Competence – Release
– Document control – Control of nonconformance
– Operations – Performance evaluation
– Design and development
– Product and service provision
ISO 9001:2015
Elements
Element 8: Operations
Operational Planning and Control
• Quality = 80% communication + 20% planning
• Each process must include a method for operational
planning to ensure that resources, equipment, and
personnel are prepared to deliver quality:
– Planning, implementing, and controlling the processes
needed
– Developing a plan
– Making changes to a plan
ISO 9001:2015
Elements
Element 8: Operations (cont’d)
Requirements for Products and Services
• The organization must determine
and manage the customer’s
expectations, including
– Customer communication
– Determining requirements for
products and services
– Reviewing requirements
– Documenting information about
requirements
– Making changes to requirements

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ISO 9001:2015
Elements
Element 8: Operations (cont’d)
Design and Development of Products and
Services
• Quality must be considered in making decisions
with regard to
– General items
– Planning
– Design and development inputs
– Design and development controls
– Design and development outputs
– Design and development changes
ISO 9001:2015
Elements
Element 8: Operations (cont’d)
Control of Externally Provided Processes,
Products, and Services
• Suppliers are partners, and are considered
part of the QMS with regard to
– Conformity to requirements
– Controls and evaluation carried out
– Monitoring, evaluating, and re-evaluating
performance
ISO 9001:2015
Elements
Element 8: Operations (cont’d)
Production and Service Provision
• Managing the quality of the processes, including
– Control of production and service provision
– Identification and traceability
– Property belonging to customers
and suppliers
– Preservation
– Post-delivery activities
– Control of changes

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ISO 9001:2015
Elements
Element 8: Operations (cont’d)
Release of Products and Services
• The organization will want to control all aspects of
product and service release, including
– Planning at appropriate stages to
verify that requirements are met
– Preventing the release of products
and services until planned release
activities have been completed
– Retaining documented
information on the release

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ISO 9001:2015
Elements
Element 8: Operations (cont’d)
Control of Non-Conforming Output
• Sometimes products or services do not meet customer
requirements. The organization will want to address
whether the issue occurred before or after delivery:
– During production or delivery: Ensure outputs that do
not conform are identified or controlled
– After delivery: Take appropriate action based on the
nature of the nonconformity
• Correction, segregation, containment, return, informing the
customer, obtaining authorization for acceptance of products
and services as-is
ISO 9001:2015
Elements
Element 9: Performance Evaluation
Monitoring, Measurement, Analysis, and
Evaluation
• Monitoring and measurement has been a part of
quality since the beginning and includes
– Determining what needs to be measured and/or
monitored
– Determining methods (type, timing, frequency)
– Evaluating performance
– Evaluating processes
– Employing consistency
– Proposing changes
ISO 9001:2015
Elements
Element 9: Performance Evaluation (cont’d)
Internal Audit
• Internal audits are conducted at planned intervals to
– Determine conformity to the QMS
– Determine conformity to ISO 9001

• For each audit, the organization

– Establishes criteria and scope
– Ensures objectivity and
impartiality
– Reports the results to relevant
management

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ISO 9001:2015
Elements
Element 9: Performance Evaluation (cont’d)
Management Review
• Helps the organization remain aware of its managerial
effectiveness through reviewing
– Status of actions from previous reviews
– Changes in external and internal issues, risks, and
opportunities
– Information on the performance and effectiveness
of the QMS
– Resource adequacy
– Opportunities for improvement
– Root cause(s) of nonconformity
ISO 9001:2015
Elements
Element 10: Improvement
Quality Management is not stagnant
• Continuous risk assessment
• Correction
• Re-organization
• Non-conformity reaction and control
• QMS management
• Documentation retention
Works Cited
Bodley-Scott, S. (2010). Strategic thinking in a post-
recessionary world [Webcast]. Retrieved from
http://www.kepner-tregoe.com/knowledge-
center/webcasts/strategic-thinking-in-a-post-
recessionary-world/

Dale, B. G., Bamford, D., & Van Der Wiele, T. (2016).

Managing quality: An essential guide and resource
gateway (6th ed.). Hoboken, NJ: John Wiley & Sons.

International Organization for Standardization. (2015).

ISO 9000:2015: Quality management systems—
Fundamentals and vocabulary (4th ed.). Geneva,
Switzerland: ISO Copyright Office.