Why implement a QMS?
ISO 9001 is a standard that sets out the
requirement for a quality management
system.
It
helps
businesses
and
organizations to be more efficient and
improve customer satisfaction.
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History of ISO 9001 revisions
ISO 9001:1987
Pubn
1st
ISO 9001:1994
7
years
ISO 9001:2000
6
years
8
years
ISO 9001:2008
9
years
ISO 9001:2015
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How is the standard structured?
Clause1
Clause2
Clause 3
Clause 4
Clause 5
Clause 6
Normative references
Terms and Definitions
Context of the organization
Leadership
Planning
Clause 7
Support
Clause 8
Operation
Clause 9
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Scope
Clause 10
Performance evaluation
Improvement
Facts
ISO 9001 provides a framework for implementing an QMS which
meets an organizations stakeholder interests and can help to:
1.
2.
3.
4.
5.
6.
7.
8.
Reduce liability and risk
Facilitate better business processes
Minimize waste and energy bills
Enhance company reputation
Improve Compliance
Meet concerns of interested parties
Gain International recognition
Improve marketing potential
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What is quality management all about?
Seven Quality Management Principles behind ISO 9001:2015
1.
2.
3.
4.
5.
6.
7.
Customer Focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
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Customer Focus
Meeting and exceeding customer needs is the primary focus of quality
management and will contribute to the long-term success of your
enterprise.
Some potential key benefits are:
1.
2.
3.
4.
5.
6.
7.
Increased customer value
Increased customer satisfaction
Improved customer loyalty
Enhanced repeat business
Enhanced reputation of the organization
Expanded customer base
Increased revenue and market share
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Leadership
Leaders establish unity of purpose and direction of the organization.
They should create and maintain the internal environment in which people
can become fully involved in achieving the organizations objectives
Potential key benefits are:
1. Co-ordination of the organizations processes
2. Communication between levels and functions of the organization
3. Deliver desired results
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ISO 9001:2015 QMS Structure
PLAN
Context of
the org.
Understan
ding of the
[Link] the
context
Understanding
the needs and
expectations of
interested
parties
Determining
the scope of
the QMS
Leadership
Leadership
and
commitment
Policy
Org. roles,
responsibiliti
es and
authorities
Planning
Support
Actions to
address risks
and
opportunities
Quality
objectives
and planning
to achieve
them
Planning
objectives
DO
CHECK
Operation
Performance
Evaluation
Resources
Competence
Operational
planning
and control
[Link]
products and
services
Design and
[Link]
products and
services
Awareness
Control of
externally provided
processes ,
products and
services
QMS and
its process
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Communication
Documented
information
Production
and service
provision
Release of
products and
services
Control of
nonconforming
outputs
ACT
Improvement
Monitoring,
measurement
,analysis and
evaluation
Internal
Audit
Management
Review
General
Nonconfor
mity and
corrective
action
Continual
Improvement
Scope
Fundamental concepts and principles of quality management:
1. Organizational seeking sustained success through
implementation of QMS
2. Customers seeking confidence in an organization's ability
3. Consistently provide products and services
4. Improve communication with interested parties
5. Providers of training, assessment or advice in QMS
6. Developers of related standards
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Clause : 3
Terms and Definitions
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Clause 3:Terms and Definitions
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
Terms related to person and people
Terms related to organization
Terms related to activity
Terms related to process
Terms related to system
Terms related to requirement
Terms related to result
Terms related to data, information and document
Terms related to customer
Terms related to characteristic
Terms related to determination
Terms related to audit
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Clause: 4
Context of the Organization
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Clause:4.1, Understanding the org. and its context
An organizations context involves its operating environment. The context must
be determined both within the organization (internal and external) to the
organization.
It is important to understand the unique context of an organization before starting
the strategic planning
To establish the context means to define the external and internal factors that the
organizations must consider when they manage risks
How it should respond in the form of a defined quality management system
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Clause:4.1, Understanding the org. and its context
The context of the organization relates to
Requires the organization to consider a wide spectrum of potential factors
which can impact on the management system , in terms of its structure ,
scope , implementation and operation.
a) Environmental conditions related to climate, air quality, water quality,
land use, existing contamination, natural resource availability and
biodiversity, that can either affect the organizations purpose, or be
affected by its outcome.
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Clause:4.1, Understanding the org. and its context
The context of the organization relates to
b) The external cultural, social, political, legal, regulatory, financial,
technological, economic, natural and competitive circumstances,
whether international, national and regional or local.
c) The internal characteristics or conditions of the organization, such as
its activities , products and services , strategic direction, culture and
capabilities (i.e. people, knowledge, processes, systems)
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Clause:4.2 Understanding the needs and expectations
of interested parties
Organization to determine the needs and expectations of interested
parties, both internal and external. Interested parties could include.
Past, present and future employees and their representatives
Customers and consumers
Suppliers, contractors, wholesalers and distributors
Competitors
Shareholders
Banks and financial/investment community
Insurance companies
Rating Agencies
Public authorities
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Clause:4.2 Understanding the needs and expectations
of interested parties
Legislators
Regulators
Politicians and opinion leaders
Neighbors and local community
Communities associated with supply chain organizations
Schools, academics and researchers
Professionals involved in environmental issues
Media Organizations
Non-governmental organizations
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Clause:4.3, Determining the scope of the quality
management system
Organization shall determine the boundaries and applicability of
the quality management system
Organization shall consider:
1.
2.
3.
4.
5.
External and internal issues
Relevant interested parties
Maintained as documented information
Ensure the conformity of its products and services
Enhancement of customer satisfaction
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Clause 5:
Leadership
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Clause:5.1, Leadership and commitment
Clause:5.1.2, General
Top management shall demonstrate leadership and commitment . By:
Ensuring (i.e. someone else can do it)
The quality policy and objectives are established for the quality management
system and are compatible with the strategic direction and context of the
organization.
The quality policy is communicated ,understood and applies within the
organization.
Integration of the quality management system requirements into the
organizations business processes
The resources needed and achieves its intended results for the QMS
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Clause:5.2, Quality Policy
Clause:5.2.1, Establishing Quality Policy
Set of principles stated as commitments in which top management
outlines the intentions of the organization to support and enhance its
quality performance.
Top management must be responsible for formulating the quality policy,
and must implement, document, communicate, and expect personnel to
comply with that policy.
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Clause:5.2, Quality Policy
Clause:5.2.2, Communicating Quality Policy
Seven basic commitments for the quality policy from the top
management :
a)
b)
c)
d)
Supports organization quality strategic decision
Framework of setting quality objectives
Fulfill the organizations compliance obligations
Continually improve the quality management system to
enhance environmental performance
e) Maintain a documented information
f) Communication within organization
g) Available to interested parties
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Clause:5.3, Organizational roles , responsibilities and
authorities
1. Top management must ensure that key responsibilities and
authorities are clearly defined and that everybody involved
understand their roles.
2. Defining roles is a function of planning, ensuring awareness
can then be achieved through communication and training
3. Organizations to use job descriptions or procedures to define
responsibilities and authorities
4. There is a clear expectation for consistent and appropriate
process ownership from top-to-bottom approach within an
organization.
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Clause 6: Planning
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Clause:6.1.1, General
Consideration needs to be specified to its identified internal and
external issues and the needs and expectations of its interested
parties and determine the risk and opportunities during planning.
1.
2.
3.
4.
Achieve its intended result(s)
Enhance desirable effects
Prevent, or reduce, undesired effects
Achieve improvement
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What is Risk based Thinking?
Risk-based thinking is something we all do automatically and
often sub-consciously.
The concept of risk has been implicit in ISO 9001:2015 and
more explicit and builds it into the whole quality management
system
Risk-based thinking is already part of the process approach
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What is Risk?
Risk is the possibility of events or activities obstruction of
achievement of an organizations strategic & operational
objectives.
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What is Risk based Thinking?
Risk-based thinking makes preventive action part of the routine
Risk is often thought of only in the negative sense
Risk-based thinking can also help to identify opportunities
This can be considered to be the positive side of risk
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Why should we adopt Risk-based thinking?
[Link] customer confidence and satisfaction
[Link] consistency of quality of goods and services
3. Establish a proactive culture of prevention and improvement
4. Successful companies intuitively take a risk based approach
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Why should we do ISO 9001:2015?
Analyze and prioritize the risks and opportunities in the organization
1. What is acceptable?
2. What is unacceptable?
3. Plan actions to address the risks
4. How can we avoid or eliminate the risk?
5. How can we mitigate the risks?
6. Implement the plan- take actions
7. Check the effectiveness of the actions- does it work?
8. Learn from experience continual improvement
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Clause:6.2 (6.2.1/6.2.2) Quality objectives and planning
to achieve them
Organization shall establish and ensure quality objectives
The quality objectives shall:
1.
2.
3.
4.
5.
6.
7.
8.
9.
Be consistent with the quality policy
Measurable
Applicable requirements
Enhancement of customer satisfaction
Monitored
Communicated
Updated as appropriate
Maintain documented information
Use 5 W 1 H principle while planning objectives
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Clause:7 Support
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Clause:7.1 Resources
Clause:7.1.2 People
Organization shall consider:
1. Persons necessary for the effective implementation of QMS
2. Operations and control of its processes
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Clause:7.1 Resources
Clause:7.1.3 Infrastructure
The organization shall determine:
Provide and maintain the infrastructure towards
conformity of products and services.
Infrastructure can include:
Buildings and associated utilities
Equipment ,including hardware and software
Transportation resources
Information and communication technology
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Clause:7.1 Resources
Clause:7.1.4 Environment for the operation of processes
The organization shall determine:
Provide and maintain the infrastructure towards conformity of
products and services.
Environment can be a combination of human and
physical factors, such as;
1. Social (e.g. non discriminatory , calm, non
confrontational)
2. Psychological (e.g. stress-reducing , burnout
prevention, emotionally protective)
[Link] (e.g. temperature, heat, humidity, light,
airflow, hygiene, noise)
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Clause:7.1 Resources
Clause:7.1.5 Monitoring and measuring resources & ([Link])
Measurement traceability
Measuring equipment shall be:
1.
2.
3.
4.
Calibrated protocol
Calibration status
Validity of previous measurement results
Safeguard from adjustments, damage or deterioration
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Clause:7.1 Resources
Clause:7.1.6 Organizational Knowledge
This knowledge shall be
1.
2.
3.
4.
5.
6.
Maintained
Made available to the extent of necessary
Changing needs and trends
Consideration of current knowledge
Necessary additional knowledge
Updates
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Clause:7.1 Resources
Clause:7.1.6 Organizational Knowledge
Organizational knowledge can be based on:
[Link] sources
[Link]
[Link]
[Link]
[Link] knowledge from customers or external
providers
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Clause:7.2 Competence
The organization shall:
[Link] competence of person(s)
[Link] the effectiveness of the actions taken
[Link] appropriate documented information as
evidence of competence
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Clause:7.2 Communication
The organizations shall determine the internal and
external communications
1. What it will communicate
2. When to communicate
3. With whom to communicate
4. How to communicate
5. Who communicates
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Clause:7.5 Documented Information
Clause:7.5.3 Control of Documented Information ([Link])
Standard shall be controlled to ensure:
[Link] and suitability for use
[Link] protected (e.g. from of confidentiality, improper
use, or loss of integrity)
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Clause:7.5 Documented Information
Clause:7.5.3 Control of Documented Information ([Link])
Organization shall address the following activities, as
applicable:
[Link], access, retrieval and use
[Link] and preservation, including preservation of
legibility
[Link] of changes (e.g. version control)
[Link] and Disposition
[Link] origin identified and controlled
6. Documented information retained-protected from
unintended alterations
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Clause:8 Operations
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Clause:8.1 Operational planning and control
The organization shall plan, implement and control the
processes by:
[Link] for products and services
[Link] criteria
[Link]
[Link] of products and services
[Link] conformity w.r.t product &service
[Link] planned changes
[Link] the consequences of unintended changes
[Link] processes
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Clause:8.2 Operational planning and control
Clause:8.2.1 Customer Communication
Communication with customers shall include:
[Link] relating to products and services
[Link] enquiries
[Link] or orders
[Link] changes
[Link] customer feedback
[Link] Complaints
[Link] or controlling customer property
[Link] requirements for contingency actions, when relevant
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Clause:8.2 Operational planning and control
Clause:8.2.3/[Link] Review of the requirements for products and
services
Organization shall retain documented information
[Link] of the review
[Link] new requirements for the products and services
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Clause:8.3 Design and development of products and services
Clause:8.3.1 General
Organization shall consider
[Link]
[Link] a design and development process
[Link] to provision of products and services
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Clause:8.3 Design and development of products and services
Clause:8.3.2 Design and development planning
Organization shall consider
[Link],duration and complexity
[Link] stages
[Link] and validation
[Link] and authorities
[Link] and external sources
[Link] interfaces between persons
[Link] of customers and users
[Link] provision
[Link] of control expected by customers and other relevant interested parties
[Link] information
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Clause:8.3 Design and development of products and services
Organization shall consider
[Link],duration and complexity
[Link] stages
[Link] and validation
[Link] and authorities
[Link] and external sources
[Link] interfaces between persons
[Link] of customers and users
[Link] provision
[Link] of control expected by customers and other relevant
interested parties
[Link] information
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Clause:8.4 Control of externally provided processes, products and
services
Clause:8.4.1 General
Organization shall consider:
[Link] and services from external providers
[Link] and services are provided directly to the customers(s)
by external providers
[Link] or part of a process, is a provided by an external
provider
Organization shall determine:
[Link] for the evaluation
[Link],monitoring of performance
[Link]-evaluation of external providers
[Link] information
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Clause:8.5 Production and service provision
Clause:8.5.1 Control of production and service provision
Organization shall implement:
[Link] of documented information
[Link] and use of suitable monitoring and measuring
resources
[Link] and measurement activities-acceptance criteria
[Link] and environment operation of processes
[Link] persons
[Link] and periodic revalidation(resulting output cannot be
verified)
[Link] to prevent human error
[Link] delivery and post-delivery activities
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Clause:8.6 Release of products and services
Organization shall consider & ensure:
[Link] arrangements , at appropriate stages
[Link] product and service requirements have been
met
[Link] shall not proceed until the planned
arrangements have been satisfactorily completed
[Link] information
[Link] criteria
[Link] to the person(s) authorizing the release
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Clause:9 Performance
Evaluation
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Clause:9.1 Monitoring, Measurement, Analysis and Evaluation
Organization shall determine:
[Link] for monitoring
[Link]
[Link]
[Link]
[Link] valid results
[Link] of QMS
[Link] information
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Clause:9.1 Monitoring, Measurement, Analysis and Evaluation
Clause:9.1.2 Customer Satisfaction
1. Organization shall monitor customers perceptions
2. Methods for obtaining, monitoring and reviewing
NOTE: Monitoring customer perceptions
Customer surveys
Customer feedback on delivered products
and services
Meetings with customers
Market-share analysis
Compliments
Warranty
Claims
Dealer reports
Clause:9.1 Monitoring, Measurement, Analysis and Evaluation
Clause:9.1.3 Analysis and Evaluation
Organization shall analyze &retain:
[Link]
[Link] satisfaction
[Link] and effectiveness
[Link]
[Link] and opportunities
[Link] of external providers
[Link] related QMS
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Clause:9.2/9.2.1 Internal Audit
Organization conforms:
[Link] internal audits at planned intervals
[Link] criteria
[Link] selection
[Link] and corrective actions
[Link] implemented and maintained
[Link] information
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Clause:9.3 Management review
Clause:9.3.2 Management review inputs
Organization shall consider:
1.
2.
3.
4.
5.
6.
7.
Actions status
Changes in external and internal issues
QMS performance and effectiveness
Customer satisfaction
Feedback objectives
Quality objectives
Conformity of products and services
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Clause:9.3 Management review
Clause:9.3.2 Management review inputs
Organizations shall consider:
8. Nonconformities and corrective actions
9. Results of monitoring and measurement
[Link] results
[Link] of external providers
[Link] of resources
[Link] of risks and opportunities
[Link] for improvement
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Clause: 10 Improvement
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Clause:10 Improvement
Clause:10.1 General
Organization shall determine improvement protocol in:
[Link] and services
[Link] future needs and expectations
[Link] , preventing or reducing undesired effects
[Link] and effectiveness of QMS
NOTE: Improvement can
include Correction
Corrective action
Continual improvement
Breakthrough change
Innovation
Re-organization
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Clause:10 Improvement
Clause:10.2 (10.2.1 & 10.2.2) Nonconformity and corrective action
When a nonconformity occurs, including complaints, the organization
shall:
1.
2.
3.
4.
5.
6.
7.
React to the nonconformity
Action to control and correct
Deal with the consequences
Action to eliminate the cause(s) of the nonconformity
Review the nonconformity
Analyzing the nonconformity
Causes of the nonconformity
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Clause:10 Improvement
Clause:10.2 (10.2.1 & 10.2.2) Nonconformity and corrective action
When a nonconformity occurs, including complaints, the organization
shall:
8. Where similar nonconformities exist
[Link] any action needed
10. Review the effectiveness of any corrective action taken;
[Link] risks and opportunities determined during planning
[Link] to QMS
[Link] of any corrective action
[Link] information as evidence
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Clause
4.1
Maintain
(procedure)
X
Retain (records)
X
4.2
4.3
4.4.1
4.4.2
5.1.1
5.1.2
5.2.1
5.2.2
5.3
6.1.1
6.1.2
6.2.1
6.2.2
6.3
Clause
Maintain(proce
dure)
Retain(records
)
7.1.1-4
[Link]
[Link]
7.1.6
7.2
7.3
7.4
7.5.1
7.5.2
[Link]
[Link]
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Clause
Maintain(procedu Retain(records)
re)
8.1
8.2.1/2.2
[Link]
[Link]
8.2.4
8.3.1
8.3.2
8.3.3
8.3.4-6
8.4.1
8.4.2
8.4.3
