ISO Flashcards
What does ISO stand for?
International Organisation for Standardisation
What is ISO9000?
ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size.
What do ISO standards provide?
Facilitate trade, share knowledge, define best practises
Provide solutions and achieve benefits for most industries.
What are the 7 Quality Management principles that relate to ISOs?
- Customer Focus
- Leadership
- People Engagement
- Process Approach
- Improvement
- Evidence-Based Decision Making
- Relationship Management
What is the purpose & benefits of QMP 1?
CUSTOMER FOCUS
The primary focus of quality management is to meet customer requirements and to strive to exceed
customer expectations.
Sustained success is achieved when an organization attracts and retains the confidence of customers
and other interested parties. Every aspect of customer interaction provides an opportunity to create
more value for the customer. Understanding the current and future needs of customers and other
interested parties contribute to the sustained success of the organisation.
What is the purpose & benefits of QMP 2?
LEADERSHIP:
Leaders at all levels establish unity of purpose and direction and create conditions in which people
are engaged in achieving the organization’s quality objectives.
Creation of unity of purpose and direction and engagement of people enable an organization to align
its strategies, policies, processes and resources to achieve its objectives.
What is the purpose & benefits of QMP 3?
PEOPLE ENGAGEMENT:
Competent, empowered and engaged people at all levels throughout the organization are essential
to enhance its capability to create and deliver value.
To manage an organization effectively and efficiently, it is important to involve all people at all levels
and to respect them as individuals. Recognition, empowerment and enhancement of competence
facilitate the engagement of people in achieving the organization’s quality objectives.
What is the purpose & benefits of QMP 4?
PROCESS APPROACH:
Consistent and predictable results are achieved more effectively and efficiently when activities are
understood and managed as interrelated processes that function as a coherent system.
The quality management system consists of interrelated processes. Understanding how results are
produced by this system enables an organization to optimize the system and its performance.
What is the purpose & benefits of QMP 5?
QMP IMPROVEMENT
Successful organizations have an ongoing focus on improvement.
Improvement is essential for an organization to maintain current levels of performance, to react to
changes in its internal and external conditions and to create new opportunities.
What is the purpose & benefits of QMP 6?
EVIDENCE-BASED DECISION MAKING:
Decisions based on the analysis and evaluation of data and information are more likely to produce
desired results.
Decision making can be a complex process, and it always involves some uncertainty. It often involves
multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is
important to understand cause-and-effect relationships and potential unintended consequences.
Facts, evidence and data analysis lead to greater objectivity and confidence in decision making.
What is the purpose & benefits of QMP 7?
RELATIONSHIP MANAGEMENT
For sustained success, an organization manages its relationships with interested parties, such as
suppliers.
Interested parties influence the performance of an organization. Sustained success is more likely to
be achieved when the organization manages relationships with all of its interested parties to
optimize their impact on its performance. Relationship management with its supplier and partner
networks is of particular importance.
What is the most notable change of ISO9001:2015
The entire document is now focused around
the idea of risk-based thinking; making risk management a central feature of the standard.
What Quality Principles does ISO9001:2015 focus on?
Strong customer focus
Motivation and implication of top management
The process approach
Continual improvement
What are the benefits of ISO9001:2015 / what does it provide?
All processes will be aligned and understood across the organisation and globally
It meets the statutory and regulatory requirements
Allows for expansion into new markets as ISO 9001 is a requirement before business can occur
Puts greater emphasis on leadership engagement
Helps address organizational risks and opportunities in a structured manner
Uses simplified language and a common structure and terms, particularly helpful to
organizations using multiple management systems
Addresses supply chain management more effectively
Is more user-friendly for service and knowledge-based organizations
What guidelines does ISO9001:2015 specify? (10)
- Scope
- Normative References
- Terms and Definitions
- Context of the Organization
- Leadership
- Planning
- Support
- Operation
- Performance Evaluation
- Improvement
