How Much Do You Know About Quality Management Systems ? - 15 Mins Quiz
Which one of the following is NOT a principle of Quality Management
Evidence-based decision making
Relationship management
Engagement of people
Auditing
The application of the process approach in a quality management system enables:
The consideration of processes in terms of added value
Leadership
Evidence-based decision making
Customer focus
To conform to the requirements of ISO 9001, an organization needs to :
implement what was planned
Take actions to improve performance, as necessary
Establish the objectives of the system and its processes
Plan and implement actions to address risks and opportunities.
ISO 9001:2015 specifies requirements for a quality management system when an organization:
Needs a quality management approach
Needs to address both risks and opportunities
Needs to demonstrate its ability to consistently provide products and services
Needs to determine the interested parties that are relevant to the quality management system
ISO 9001 is one of the most widely adopted International Standards in the world. With over 1 million certificates issued worldwide, it spans all sectors of commerce and industry. ISO 9000 was first published by ISO in 2015 h
TRUE
FALSE
ISO 9000 which describes
Fundamental concepts and vocabulary of the quality management standards.
Taking accountability for the effectiveness of the quality management system
Promoting the use of the process approach and risk-based thinking
Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system
How does a Quality Management System enhance customer satisfaction
By giving assurance that the quality management system can achieve its intended result(s)
Through the application of the processes determined by you as necessary for your operations, as well as the processes determined by the standard as necessary for continuous improvement
By providing a framework for setting quality objectives
By ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
In ISO 9001:2015 there are times when certain clauses may become not applicable.
TRUE
FALSE
Is it mandatory to purchase ISO 9000:2015 alongside ISO 9001:2015
YES , it is Mandatory
NO , it is not Mandatory
The terms and definitions used in ISO 9001:2015 are taken directly from ISO 9000:2015
TRUE
FALSE
When you write your quality management system documentation, do you have to use ISO 9000 exact terms ?
YES
NO
Which ISO 9001:2015 Clause intends to have a holistic approach to customer focus?
Clause 8 : Operation
Clause 7: Support
Clause 4 : Context Of Organisation
Clause 6: Planning
Top management shall establish, implement and maintain a quality policy that:
Is measurable
Provides a framework for setting quality objectives
Verification activities are conducted to ensure that the design and development outputs meet the input requirements
Any necessary actions are taken on problems determined during the reviews, or verification and validation activities
The quality objectives shall:
Determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system
Ensure that these persons are competent on the basis of appropriate education, training, or experience
Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken
Be relevant to conformity of products and services and to enhancement of customer satisfaction
Which ISO 9001 Clause applies to people, infrastructure and environment as much as physical resources, materials, tools etc
Clause 5 : Leadership
Clause 6 : Planning
Clause 7: Support
Clause 8 : Operation
The organization shall ensure that persons doing work under the organization’s control are aware of:
Documented information required by ISO 9001:2015
Documented information determined by the organization as being necessary for the effectiveness of the quality management system
The size of organization and its type of activities, processes, products and services
The implications of not conforming with the quality management system requirements
The organization shall determine the internal and external communications relevant to the quality management system, including:
Identification and description (e.g. A title, date, author, or reference number)
Who communicates
Storage and preservation, including preservation of legibility
Requirements specified by ISO 9001:2015
Which clause is all about having appropriate control over the creation and delivery your product or service
Clause 5 : Leadership
Clause 10 : Improvement
Clause 8 : Operation
Clause 6 : Planning
Communication with customers shall include:
Any applicable statutory and regulatory requirements
Establishing specific requirements for contingency actions, when relevant
Requirements for the products and services
Any new requirements for the products and services
The organization shall apply controls to the design and development process to ensure that:
Includes a commitment to satisfy applicable requirements
Documented information of these activities is retained
Is appropriate to the purpose and context of the organization and supports its strategic direction
Includes a commitment to continual improvement of the quality management system
The organization shall ensure that design and development outputs:
Describes any concessions obtained
Include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria
Identifies the authority deciding the action in respect of the nonconformity
Describes the actions taken
Which ISO 9001:2015 clause details the three main ways in which performance of a QMS is evaluated. The first being process monitoring and customer feedback, the second being through internal audits and the third being the management review.
Clause 4
Clause 5
Clause 6
Clause 9
Does ISO 9001:2015 require you to retain documented information for all your operational activities ?
True
False
The outputs of the management review shall include decisions and actions related to:
Conformity of products and services
Design and development changes
Opportunities for improvement
When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:
The organization can meet the claims for the products and services it offers
The interested parties that are relevant to the quality management system
The requirements of these interested parties that are relevant to the quality management system
Issues can include positive and negative factors or conditions for consideration.
Can statutory and regulatory requirements can be expressed as " Other Requirements " ?
YES
NO
When planning for the quality management system, the organization shall consider the issues referred to in :
Clause 6: Planning
Clause 10: Improvement
Clause 4 : Context Of Organisation
Clause 5 : Leadership
Does ISO 9001:2015 require an organisation to provide a work environment which is stress-reducing, burnout prevention, emotionally protective etc
YES
NO
SECTION 2: NORMATIVE REFERENCES IS ABOUT :
Documented Information
Customer Requirements
Legal & Other Requirements
Any other documents which are referenced within the management system standard
What is ‘Preventive action’
action taken to prevent a potential non-conformity or other undesired effect.
action taken to correct a mistake, or non-conformity, and to deal with any consequences.
Is about planning your objectives and actions taking into account the known risks and their potential effects
is a set of interrelated or interacting activities which uses inputs to deliver outputs.
What is the purpose of ISO 9000:2015?
Describes the fundamental concepts, principles and vocabulary of quality management
Provides guidance on the application of ISO 9001:2015
Provides guidance on how to achieve sustained success by a quality management approach
An international standard which acts as a model for quality assurance
Provides guidance on how to achieve sustained success by a quality management approach
How does ISO 9001 define Quality Assurance?
Part of quality management focusing on ensuring customer satisfaction
Part of quality management focusing on providing confidence that quality requirements will be fulfilled
A documented quality process to ensure quality is upheld throughout the full management system
Part of quality management focusing on ensuring management reviews the quality of all produce and goods
What does PDCA stand for?
Prepare, Do, Critique, Appraisal
Plan, Design, Confirm, Act
Plan, Do, Check, Act
Prepare, Do, Critique, Assess
What does Clause 6 of ISO 9001:2015 provide details of?
Operation
Leadership
Planning
Improvement
Which of the below is not one of the seven quality management principles?
Improvement
Leadership
Customer focus
Planning
How does ISO 9000 define “Management Systems”?
Set of interrelated or interacting elements of an organisation to establish procedures and outline these within documentation
Set of interrelated or interacting elements of an organisation to establish policies and objectives, and processes to achieve those objectives
Set of interrelated or interacting elements of an organisation to effectively record quality processes
Set of interrelated or interacting elements of an organisation to identify risks and improve efficiency
Who is responsible for reviewing the organisations quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organisation?
The auditee
Employees within the company
Top management
An external auditor
Within the ISO 9001:2015 standard, in 10.1, what examples of improvement are provided in relation to improving and implementing any necessary actions to meet customer requirements and enhance customer satisfaction?
Enhanced management processes, review of customer satisfaction, react to nonconformity and implementation
Continual improvement, enhanced customer service, re-organisation and risk analysis
Correction, corrective action, ongoing improvement, documentation review, risk analysis and continual review of the quality management system
Correction, corrective action, continual improvement, breakthrough change, innovation and re-organisation
How does ISO 9000:2015 define a Process?
Set of interrelated or interacting activities that use inputs to deliver an results that meet or exceed the ISO 9001 standards of quality
A full lifecycle of events which includes inputs such as materials and information, management, resources and outputs
A cycle which includes inputs, actions and outputs to ensure quality is met
Set of interrelated or interacting activities that use inputs to deliver an intended result
When planning the quality management system, organisations shall consider the issues and requirements referred to in 4.1 and 4.2 and determine the risks and opportunities that need to be addressed to
Give assurance that the quality management system can achieve its intended result(s)
Enhance desirable effects
Achieve improvement
All of the above
Which ISO standard provides Guidelines for codes of conduct for organisations, including guidance to an organisation in determining that is customer satisfaction provisions meet customer needs and expectations?
ISO 10007 Quality management systems
ISO 10012 Measurement management systems
ISO 10001 Quality management
ISO 10005 Quality management systems
Within ISO 9001:2015, what does “shall” indicate?
A recommendation
A permission
A capability
A requirement
In 9001:2015, what does clause 7.2 relate to?
Leadership and commitment
Competence
Documented information
Planning of changes
How can adopting a quality management system help an organisation?
Addresses risks and opportunities to enhance customer satisfaction
Improves its overall performance and provides a sound basis for sustainable development initiatives
Facilities opportunities to enhance customer satisfaction
All of the above
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