Understanding ISO 9001:2008 Exercise 1 - True/False Statements The following statements relates 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. Be prepared to support your answer through discussion.
Statement 1
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9
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11 12
13
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16
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
True/ False False
Customer requirements are often incorporated in “specifications”
True
Use of specifications guarantee that a customer’s requirements will be met consistently.
False
Quality system standards can substitute for relevant product requirements provided in technical specifications.
False
The management system of an organization is influenced by its specific objectives, products, processes and practices.
True
It is expected that organizations with similar products or services to have similar quality management systems.
False
ISO standards and guidelines are intended to be specific to economic or industry sectors, whenever possible.
False
The ISO 9001 standard provides guidance for quality management and general requirements for quality control
False
An organization should strive to improve the quality of its products as well as its operations
True
Ensuring product quality meets customer needs also ensures that internal management, employees and other stakeholders needs are met
False
An organization’s stakeholders have the same needs and expectations
False
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.
False
The ISO 9001 QMS standard addresses quality system requirements as well as provide technical standards for product quality.
False
The ISO 9001 QMS standard provides quality system objectives to be met and guidance on controls to achieve them.
False
It is generally not typical for an organization to provide two or more generic product categories in its product offering
False
Besides meeting requirements, a product must also provide value to customers and other stakeholders.
True
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Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement 17
True/ False
A process must have inputs and outputs which may only exist in tangible form
False
Product value involves both quality and price and as such price is a facet of quality.
False
Every process involves people and/or resources in some way
True
Inputs, outputs and activities within the process are all capable of being measured and improved
True
A process serves no purpose if it does not add value to the output or organization
True
Not all work is accomplished by a process
False
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.
True
24
Every organization exists to accomplish value-adding work through a network of processes. The structure of the network is usually a simple sequential structure.
False
25
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.
True
26
Every process should have an owner to clarify interfaces, responsibilities and authorities
True
27
To be effective, a quality system needs coordination and compatibility of its component processes and definition of their interfaces.
True
28
Management reviews of quality management systems cannot take into account additional factors beyond the requirements of ISO 9001
False
29
Documented standard operating procedures are essential for maintaining the gains from quality improvement activities
False
30
The best time to implement a QMS is in response to demands by customers and other interested parties
False
31
When implementing an ISO 9001 based QMS, all of the requirements listed in the standard must be selected and applied.
False
32
Organizations implementing a QMS based on ISO 9001 are required to be certified by a Registrar.
False
33
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
True
18
19 20
21
22 23
©2010 Copyright Art Lewis – askartsolutions.com
Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement
True/ False
34
As per ISO 9001 customers cannot allow an organization to delete certain quality system clauses and sub-clauses from its QMS.
True
35
Customers may not specify supplementary QMS requirements beyond those specified by ISO 9001
False
36
A service can have tangible as well as intangible components to it.
True
37
A service cannot be linked with the manufacture and supply of tangible product
False
38
Quality control is defined as the planned and systematic activities implemented within the quality management system and demonstrated as needed to provide confidence that the organization will fulfill requirements for quality
False
39
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
False
40
Materials used in a process could include liquids and gases transported through pipelines and containers
True
41
A service can be delivered automatically with no human involvement or intervention
False
42
Product characteristics and/or quality characteristics are absolute and cannot be changed
False
43
Product quality relates to its ability to satisfy stated as well as implied needs
True
44
As required by ISO 9001 qualification of certain processes may refer to demonstrating that specific personnel are competent to perform those processes
True
45
According to ISO 9001 the terms nonconformity and defect can be used interchangeably
False
46
Verification refers to checking conformance of product design and validation refers to checking conformance of the product design process – both to specified requirements
False
47
An organizations quality policy may be stated in qualitative and/or quantitative terms
False
48
Quality management is the responsibility of top management within the organization
False
49
According to ISO 9001, the terms quality planning and quality plans can be used interchangeably
False
©2010 Copyright Art Lewis – askartsolutions.com
Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement
True/ False
50
A quality plan may be combined with a production plan to facilitate control of processes
True
51
Where services are offered in combination with product, it is necessary to have separate quality plans
False
52
Quality control ensures adequate control of processes, whereas quality assurance ensures that no nonconforming product gets shipped to customers
False
53
It is necessary that an organization use a QMS to implement quality management
True
54
Corrective and preventive actions are important tools to achieve quality improvement
True
55
Actions taken to eliminate the causes of an existing nonconformity must include correction as well as corrective action.
True
56
Repair and rework cannot be used interchangeably
True
57
A deviation authorization and a concession may be used interchangeably
False
58
It is generally understood that if customers needs and expectations are taken care, the interests of other stakeholders will be also be addressed
False
59
Only the inputs and outputs of processes can be measured
False
60
All processes are measurable in terms of customer satisfaction
True
61
In general, the extent of quality system documentation is inversely proportional to the education, training, experience and stability of personnel within an organization
True
62
An organization that is ISO 9001 certified must require some or all of its suppliers and subcontractors to also be certified to ISO 9001.
False
63
Each requirement in the ISO 9001QMS standard varies in importance from one type of activity to another and from one product to another
True
64
Since ISO 9001 requirements are generic, it is expected that application of QMS requirements to different products or businesses will be uniform
False
65
In demonstrating an effective quality management system, an organization needs to meet both the customer’s needs and expectations as well as its own
True
66
Since cost is not a quality factor, only benefits and risks should be considered by an organization in developing a well structured QMS
False
©2010 Copyright Art Lewis – askartsolutions.com
Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement
True/ False
67
The definition of nonconformity does not include product returned for repair or rework
False
68
Activities contributing to quality, whether directly or indirectly, should be defined and documented
True
69
Measures to control and coordinate the interface between different activities and processes should be defined
True
70
Management should identify quality related factors affecting market position and objectives relative to products, processes and associated services, in order to allocate organization resources on a planned and timely basis,
True
71
An organization’s quality objectives should relate to fitness for use, performance, safety and dependability
True
72
Resources to achieve quality objectives must be planned but there is no necessity to provide them on a timely basis
False
73
The scope of management reviews under ISO 9001 should include the impact of new technology and market strategies on the quality management system
True
74
Management must regularly monitor quality costs and other benchmarks to determine if the QMS is achieving its quality policy and objectives
True
75
In structuring an ISO 9001 QMS to suit it’s needs, an organization can exclude selective phases in the life-cycle of its products and related processes
False
76
It is necessary that an organization’s QMS documentation include narrative procedures, work instructions and other documentation, regardless of other factors
False
77
In ISO 9001 based QMS, quality planning should be viewed as the same as quality plans
False
78
An organizations quality policy should include policies and objectives related to products, processes, quality system and cost
True
79
Quality plans should specify on one document the quality objectives, practices, criteria, resources, operational sequence and quality activities related to a product or service
False
80
All customer requirements must be documented and agreed to by the customer and the supplying organization
False
81
The capability of an organization under ISO 9001 clause 7.2 only relates to its ability to produce and deliver quality product
False
©2010 Copyright Art Lewis – askartsolutions.com
Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement
True/ False
82
In order to ensure consistency of control, it is necessary that all customer orders be subject to the same contract review criteria before acceptance
False
83
Verbal orders received from customers do not need to be documented by the supplier
True
84
The ISO 9001 standard does not require marketing activities to be included within the scope of the QMS
False
85
Product safety, environmental and other regulations should also be considered in designing new product.
True
86
Design verification requires that the developed product be checked against the design input requirements
False
87
The design review activity should consider safety, cost, compatibility, quality acceptance criteria, prototype test results, etc
False
88
It is necessary that design changes be subjected to all design controls described in ISO 9001 clause 7.3
False
89
All design and development activities must be included in the design project plan and cannot be changed
False
90
Product validation cannot be completed until the customer approves the product
False
91
The design review activity must be conducted by personnel assigned to the design project
False
92
Documents retained for legal and knowledge purposes must be controlled to the same extent as active documents
False
93
ISO 9001 requires that all quality system documentation be made available to personnel at their specific work stations
False
94
The ISO 9001 standard requires the use of a master list to identify the current status of its documents
False
95
The ISO 9001 standard requires the use of an approved vendor list to ensure purchases affecting product quality, are made from approved suppliers and subcontractors
False
96
ISO 9001 requires that the impact of document changes should be considered, on product, process or quality system
True
97
If your subcontractor is ISO 9001 certified, it is not necessary for your organization to monitor its ongoing performance
False
©2010 Copyright Art Lewis – askartsolutions.com
Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement
True/ False
98
To ensure conformity of purchased product, clause 7.4 of ISO 9001 requires that all your organizations suppliers be evaluated in the same manner.
False
99
The ISO 9001 standard requires that a record be kept of the reasons why a change was made to documents.
False
101
If an organization accepts delivery of material based on conducting verification at source, it may not be necessary for it to conduct any receiving inspection
True
102
According to clause 7.4 of ISO 9001, purchasing documents must clearly describe the quality system requirements for all of its qualified suppliers
False
103
A list of approved suppliers constitutes sufficient objective evidence of acceptable suppliers.
False
104
Where customers provide product certification with customer supplied product, it is not necessary for your organization to conduct any further verification of such product
False
105
It may not be necessary to use physical identification methods if computer records are used to control the identity of product.
False
106
Product identification relates to details of manufacture to facilitate tracking of a nonconformity back to its source and containing the batch or lot
False
107
According to ISO 9001 it is not necessary to conduct in-process product verification if there is adequate control of manufacturing processes
False
108
According to ISO 9001, it is expected that all products be subject to the same inspections and tests
False
109
According to ISO 9001 it is required that acceptance criteria be described on the inspection record
False
110
There is no nonconformity if a company is unable to provide any organization charts to show it’s organization structure
False
111
It is a nonconformity if calibration status indicators are not affixed directly on measuring instruments used to verify product quality
False
112
It is a nonconformity if a customer is not notified when product is shipped to them, that was inspected and passed using defective measuring equipment
True
113
There is a nonconformity if a company allows it’s operators to use personally owned measuring devices
False
©2010 Copyright Art Lewis – askartsolutions.com
Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement
True/ False
114
It is a nonconformity if an organization does not have a designated quarantine area for nonconforming product
False
115
It is a nonconformance if an organization does not perform any audits on any of its suppliers
False
116
There is no nonconformity if material is released for urgent production without required receiving inspection being done
True
117
Statistical techniques should be used to identify adverse trends for products and processes before nonconformities actually occur
True
118
Correction of product nonconformities should not compromise the quality of adjacent, attached or incorporated product
True
119
Verification must be made as close as possible to the point of realization of the product characteristic
False
120
Manufacturing jigs, fixtures, test hardware, comparative references and process instrumentation that can affect product or process characteristics do not need to be controlled
False
121
Besides controlling measuring devices, the measuring process itself must be controlled
True
122
For fully automated processes, physical location of product is an acceptable method of assuring the inspection and test status of product
True
123
The inspection and test status of product is only required as a control until the time the product is shipped to the customer
True
124
ISO 9001 requires that nonconforming product be segregated, identified and put in an identified quarantined area
False
125
The ISO 9001 requirement for preventive action may be addressed by taking steps to prevent a root cause from happening again
False
126
The control requirements for storage in clause 7.5.5 of ISO 9001 includes conforming and nonconforming product
False
127
As per ISO 9001, an organization is not responsible for the protection of product quality after shipment, if the terms of delivery are FOB your organizations facility
False
128
The retention times for quality records required by clause 4.2.4 of ISO 9001are minimal time periods and therefore such records never need to be disposed off
False
129
As per clause 8.2.2 of ISO 9001, it is required that the frequency of audits of specific areas or departments be increased based on their status and importance
True
©2010 Copyright Art Lewis – askartsolutions.com
Understanding ISO 9001:2008 Exercise 1 - True/False Statements Statement
True/ False
130
There is a nonconformity if a company allows it’s operators to use personally owned measuring devices
False
131
As per ISO 9001, training of personnel should include permanent, newly hired and temporary personnel
True
132
According to ISO 9001, management should create an environment that fosters health and safety, involvement and help realize employee potential
True
133
Under clause 4.1 and 7.1 of ISO 9001, it may be necessary to apply some or all ISO 9001 requirements to control servicing activities
True
134
An organization that does not perform servicing activities cannot be certified to ISO 9001
False
135
The use of statistical techniques has limited application and benefit to the service sector
False
136
The use of statistical techniques is not applicable for the evaluation of qualitative data
False
137
Since SPC is a tool to verify the output of processing, it is viewed as a detective control rather than preventive
False
138
ISO 9001 requires that the standard of acceptability of product characteristics that have a subjective element, must be clarified
True
©2010 Copyright Art Lewis – askartsolutions.com
