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Lesson 10 ISO 9000 Quality Management System

The document presents an overview of ISO 9001:2015, a globally recognized standard for quality management systems aimed at improving organizational performance and customer satisfaction. It outlines the internal and external contexts affecting organizations, the importance of planning, risk management, and the roles of top management in implementing effective quality processes. Additionally, it emphasizes continual improvement and provides a case study of ABC Electronics Ltd. adopting ISO 9001 to enhance product quality and customer satisfaction.

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19 views32 pages

Lesson 10 ISO 9000 Quality Management System

The document presents an overview of ISO 9001:2015, a globally recognized standard for quality management systems aimed at improving organizational performance and customer satisfaction. It outlines the internal and external contexts affecting organizations, the importance of planning, risk management, and the roles of top management in implementing effective quality processes. Additionally, it emphasizes continual improvement and provides a case study of ABC Electronics Ltd. adopting ISO 9001 to enhance product quality and customer satisfaction.

Uploaded by

knnethmarzon
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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GROUP 9

PRESENTATION
GROUP MEMBERS:
SINGCOL, SAMANTHA
TALIBONG, GHIA
TEJEDOR, MONALISA
TERANTE, GENEBETH

OPERATIONS MANAGEMENT (MACC 213)


BSMA-MA21
INSTRUCTOR: Mr. JC LINNOR M. ORAIZ, CPA

DATE: NOVEMBER 18, 2024


ISO 9001:2015
ISO 9001 is a globally recognized standard for quality
management system (QMS) that helps organizations of all sizes
and sectors to improve performance, meet customer expectations,
and demonstrate commitment to quality by establishing,
implementing, maintaining, and continually improving QMS.

Implementing ISO 9001 means your organization has put in place


effective processes and trained staff to deliver flawless products
or services time after time.
CONTEXT OF THE
ORGANIZATION
THE INTERNAL CONTEXT MAY INCLUDE BUT IS NOT LIMITED TO:
Product and service offerings
Governance, organizational structure, roles, and accountability
Regulatory requirements
Policies and goals, and the strategies that are in place to achieve them
Assets like facilities, property, equipment, and technology
Capabilities understood in terms of resources and knowledge
Information systems, information flows, and decision-making processes
Relationships of the staff/volunteers/members
Organization’s culture
Standards, guidelines, and models adopted by the organization and
Form and extent of the organization’s contractual relationships.
The external context’s micro-environment consists of the
organization’s immediate operations and how they affect its
performance and decision-making. Some of the micro-
environmental context factors:
CUSTOMERS
EMPLOYEES/MEMBERS/VOLUNTEERS
SUPPLIERS
INVESTORS
MEDIA
COMPETITORS
Quality Management System
and its processes
Process
- is a set of interrelated activities that transform activity inputs
into outputs.

Process Approach
- is a management strategy that requires organizations to manage
their processes and the interactions between them.
All processes have:
inputs;
outputs;
operational control;
appropriate measurement & monitoring
Top management

- Is the person or group of people who directs and controls the


organization at the highest level.

- Their role also involved formulating policies, allocating


resources and ensuring compliance with regulations.
ORGANIZATIONAL
CUSTOMER ROLES,
FOCUS POLICY RESPONSIBILITIES
& AUTHORITIES
PLANNING
the process of establishing a systematic approach to achieve
quality objectives and improve a quality management system (QMS).

Planning includes;
a) risks and opportunities,
b) the setting of goals and objectives to achieve plans,
c) resources

Risk-based Thinking
refers to the approach that organizations should take to identify,
assess, and address risks that could affect the ability to meet
customer requirements and achieve desired outcomes.
Actions to address the risks and opportunities
Quality objectives and planning to achieve
them
Ensure that whatever objectives you implement
they are SMART:
• Specific
• Measurable
• Achievable
• Realistic
• Time-bound
SUPPORT
Refers to the various resources, processes, and activities
that enable an organization to implement, maintain, and
continually improve its Quality Management System
(QMS).
RESOURCES
Resources may include raw materials, infrastructure, finance,
personnel, and IT, all of which can be either internally or externally
provided.

1. People
2. Infrastructure
3. Environment for the Operation Processes
4. Monitoring and measuring resources
5. Organizational knowledge
COMPETENCE
- Determining competence is a necessity in any organization.

AWARENESS
- Employees must be made aware of the Quality Policy and its
contents.

COMMUNICATION
- Processes for internal and external communication need to be
established within the QMS.
OPERATION
- deals with the execution of the plans and processes that enable the
organization to meet customer requirements and design products and
services.

OPERATIONAL PLANNING AND CONTROL


- are the actions that an organization takes on to guarantee that its
resources are employed effectively and efficiently to achieve its goals.
REQUIREMENTS FOR PRODUCTS AND SERVICES

1. Customer Communication

This is essentially about how you relate to the customer, to include:


a) what you are selling;
b) how they can expect to be dealt with (e.g. formal
quote/email/letter/terms you will work under/within);
c) getting feedback from the customer;
d) looking after their property (e.g. premises whilst you are in there);
e) what plans you put in place for if something goes wrong.
2. Determining the requirements for products and
services
You must consider:
• Delivery
• Installment
• Service
• Warranty
• Applicable acts and regulations
• What to do when providing verbal contracts.
• For legal and industry norm;
• Elements the organization determines as necessary for their own
needs.
DESIGN AND DEVELOPMENT FOR PRODUCTS AND SERVICES
THE STEPS INVOLVED IN DESIGN AND DEVELOPMENT INCLUDES:
1. Planning
2. Inputs
3. Controls
4. Verification
5. Validation
6. Outputs
7. Changes

CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND


SERVICES
1. Type and extent of control
2. Information for external providers
PRODUCTION AND SERVICE PROVISION

In case of changes in the production and service provision process, the


organization must review and control the changes in order to ensure
continuing conformity with the requirements.

1. Control of production and service provision


2. Identification and traceability
3. Property belonging to customers or external providers
4. Preservation
5. Post-delivery activities
6. Control of changes
CONTROL OF NONCONFORMING OUTPUTS

Depending on the nature of the nonconformity, the organization


can take one or more of the following actions:

• correction
• segregation, containment, return, or suspension of the provision
of products and services
• informing the customer
• obtaining authorization for acceptance under concession
PERFORMANCE EVALUATION

The evaluation section covers monitoring,


measurement, analysis, internal audits, and
management review, requiring consideration of
measurement methods, analysis intervals, and data
reporting requirements.
Monitoring, Measurement, Analysis, and Evaluation
- The organization needs to determine what needs to be monitored and
measured, how, and when, as well as when the results will be analyzed.

Internal Audit
- There continues to be a need to carry out internal audits and to do it
effectively. The goal of an internal audit is not to determine nonconformity;
its goal is to check whether your QMS:
a) complies with the requirements of ISO 9001 and the requirements of your
organization.
b) is effectively implemented and maintained.
Management Review
- is a formal, structured meeting that involves top management and
takes place at regular intervals throughout the year.

At least once a year, the top-level management must review the QMS
in order to determine its:

• Appropriateness – does it serve its purpose and satisfy the needs of


the organization?
• Adequacy – does the QMS conform to standard requirements?
• Applicability – are activities performed according to procedures?
• Effectiveness – does it accomplish the planned results?
IMPROVEMENT
Improvement covers nonconformity and corrective action, as well
as continual improvement, all of which are outlined in clause 8 of
the current standard.

There is now a requirement for organizations to focus clearly on


customer satisfaction and customer needs, not only that but to look
for ways to improve:
a) products and services, now and for the future;
b) fixing and controlling issues to reduce things going wrong;
c) improving the QMS.
NONCONFORMITY AND CORRECTIVE ACTIONS
When something goes wrong you must:
1. react to it by
• do something / take action / fix it;
• deal with the impact it had (e.g. upset customer).
2. evaluate what went wrong to prevent it from happening again and check there are
no other similar issues that could happen.

CONTINUAL IMPROVEMENT
- is a key aspect of the QMS, to achieve and maintain the Quality
Management System’s suitability, adequacy, and effectiveness
regarding the organization’s objectives.
THE IMPETUS FOR CONTINUAL IMPROVEMENT MUST COME
FROM THE USE OF AS A MINIMUM:
• Policies;
• Risks and opportunities;
• Objectives;
• Analysis and evaluation of data;
• Audit results;
• Management review;
• Non-conformity and corrective action.
Consider using the PDCA
cycle (Plan, Do Check, Act)
to guide your continuous
improvement efforts. Once
you’ve identified the
improvement action to take,
you cycle through the PDCA
phases by planning the
action (plan), implementing
what is planned (do),
monitoring the process and
reporting results (check), and
taking any further actions to
improve if necessary (act).
CASE STUDY
ABC Electronics Ltd., a mid-sized enterprise in the
consumer electronics industry, faced challenges in
maintaining consistent product quality and meeting
customer expectations. To overcome these challenges
and streamline their processes, the company decided
to adopt the ISO 9000 series of quality management
standards, specifically ISO 9001 as part of its strategic
goal to improve efficiency and enhance customer
satisfaction.
THANK YOU
FOR LISTENING

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