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Mastering ISO 9001:2015

Exercise - True/False Statements

The following sample of 50 statements relate to various ISO 9001 concepts, principles and requirements. Indicate whether these are true or false in the adjacent column. Please note that some statements are deliberately vague.

With the purchase of the "Understanding ISO 9001:2015 eCourse" you will get a total of 728 (you read that correctly!) True/False questions.

Here is an approach to answering these questions.

1.     For each statement provide two reasons why you think it is true or false.  

2.     Next go to your “Understanding ISO 9001:2015 eCourse” and find the clause or sub-clause where this statement is discussed and verify whether you were right or wrong. 

3.     Only check the PDF answer sheet provided with your eCourse materials after you have taken the first two steps listed above.  

4.     If you have a differing opinion perhaps because the statement was vague, send me an email supporting your position. 

5.     When you have answered all 728 questions you will know more than most QMS Consultants about this ISO 9001 Standard.








Improvement in systems and processes so that continual improvement of quality can be achieved is not a major purpose of ISO 9001 quality management systems



Customer requirements are often incorporated in “specifications”



Use of specifications guarantee that a customer’s requirements will be met consistently.



Quality system standards can substitute for relevant product requirements provided in technical specifications.



The management system of an organization is influenced by its specific objectives, products, processes and practices.



It is expected that organizations with similar products or services to have similar quality management systems.



ISO standards and guidelines are intended to be specific to economic or industry sectors, whenever possible.



The ISO 9001 standard provides guidance for quality management and general requirements for quality control



An organization should strive to improve the quality of its products as well as its operations



Ensuring product quality meets customer needs also ensures that internal management, employees and other stakeholders needs are met



An organization’s stakeholders have the same needs and expectations



Because of varying stakeholder needs such as quality, health & safety, environment protection and security, it is not required that management systems (to address these needs), be compatible.



The ISO 9001 QMS standard addresses quality system requirements as well as provide technical standards for product quality.



The ISO 9001 QMS standard provides quality system objectives to be met and guidance on controls to achieve them.



It is generally not typical for an organization to provide two or more generic product categories in its product offering



Besides meeting requirements, a product must also provide value to customers and other stakeholders.



A process must have inputs and outputs which may only exist in tangible form



Product value involves both quality and price and as such price is a facet of quality.



Every process involves people and/or resources in some way



Inputs, outputs and activities within the process are all capable of being measured and improved



A process serves no purpose if it does not add value to the output or organization



Not all work is accomplished by a process



Quality system management is accomplished by managing the structure and operation of processes as well as the quality of product and information flowing through them.



Every organization exists to accomplish value-adding work through a network of processes. The structure of the network is usually a simple sequential structure.



A fundamental basis of the ISO 9001 QMS standard is for organizations to create, improve and provide consistent quality of product through controlling its network of processes.



Every process should have an owner to clarify interfaces, responsibilities and authorities



To be effective, a QMS needs coordination and compatibility of its component processes and definition of their interfaces.



Management review of a QMS cannot take into account additional factors beyond the requirements of ISO 9001



Documented standard operating procedures are essential for maintaining the gains from quality improvement activities



The best time to implement a QMS is in response to demands by customers and other interested parties 



When implementing an ISO 9001 based QMS, all of the requirements listed in the standard must be selected and applied.



Organizations implementing a QMS based on ISO 9001 are required to be certified by a Registrar.



Organizations using ISO 9001 based QMS must demonstrate adequacy and effectiveness of the QMS as well as capability to achieve product conformity to specified requirements



As per ISO 9001 customers cannot allow an organization to delete certain quality system clauses and sub-clauses from its QMS.



Customers may not specify supplementary QMS requirements beyond those specified by ISO 9001



A service can have tangible as well as intangible components to it.



A service cannot be linked with the manufacture and supply of tangible product



Quality control is defined as the planned and systematic activities implemented within the QMS and demonstrated as needed to provide confidence that the organization will fulfill requirements for quality



As per ISO 9000 a product is generated by activities at the interface between an organization and the customer and by the organizations internal activities to meet the customer’s needs



Materials used in a process could include liquids and gases transported through pipelines and containers



A service can be delivered automatically with no human involvement or intervention



Product characteristics and/or quality characteristics are absolute and cannot be changed



Product quality relates to its ability to satisfy stated as well as implied needs 



As required by ISO 9001 qualification of certain processes may refer to demonstrating that specific personnel are competent to perform those processes



According to ISO 9001 the terms nonconformity and defect can be used interchangeably



Verification refers to checking conformance of product design and validation refers to checking conformance of the product design process – both to specified requirements



An organizations quality policy may be stated in qualitative and/or quantitative terms



Quality management is the responsibility of top management within the organization



According to ISO 9001, the terms quality planning and quality plans can be used interchangeably



A quality plan may be combined with a production plan to facilitate control of processes


ISO 9001 Home
◦  ISO 9001:2015 FAQ
◦  Purpose of the Standard
◦  Scope of the Standard
◦  Normative References, Terms and Definitions
◦  Context of the organization
◦  Understanding the needs of interested parties
◦  Determining the Scope of your QMS
◦  QMS and its processes
◦  Leadership and Commitment
◦  Customer Focus
◦  Quality Policy
◦  Organizational roles, responsibilities and authorities
◦  Risk Based Thinking
◦  Quality Objectives
◦  Planning For Changes
◦  Resources - General
◦  clause 7.1.2 -People
◦  clause 7.1.3 Infrastructure
◦  Environment for the operation of processes
◦  Measuring and Monitoring Resources
◦  Organizational Knowledge
◦  Competence
◦  Awareness
◦  Communication
◦  Documented Information
◦  Operational Planning and Control
◦  Customer Communication
◦  Determining requirements related to products and services
◦  Design and Development Planning
◦  Customer Communication
◦  Review of requirements related to products and services
◦  Design & Development Inputs
◦  True False Questions
◦  Sample Test Questions
ISO 9001 Consulting
◦  How To Select An ISO 9001 Consultant
◦  Compelling Reasons To Use An ISO 9001 Consultant
◦  What Services Can An ISO 9001 Consultant Provide?
◦  How To Select a Certification Body (Registrar)
◦  What Is The Process Approach?
◦  Useful Resources To Help You Implement ISO 9001
◦  What Are Outsourced Processes?
◦  What Are Quality Objectives?
◦  What Is Continual Improvement?
◦  What Is Customer Satisfaction?
ISO 9001 Implementation Guide
◦  Free Resources To Help You Implement ISO 9001
◦  Quality Policy
◦  Quality System Documentation
ISO 9001 Certification

Understanding ISO 9001:2008