Exam Exercise 1 - Multiple Choice Questions

ISO 19011 Auditor Training - Typical multiple choice questions worth one mark each. Only circle one answer for each
question.

1 Planning for a QMS audit requires:

a. establishing an audit schedule.
b. determining the scope of the audit.
c. considering prior audit results.
d. reviewing quality system documentation.
e. all of the above.

2 The information sought by a QMS auditor during an audit is:

a. Senior management commitment to the quality system
b. A list of nonconformities against the ISO 9001 standard
c. Conformity to specified audit criteria
d. Product shipped met customer requirements
e. All of the above

3 An audit plan is:

a. a facilities layout
b. a description of the activities and arrangements for an audit
c. a checklist of questions to be asked during an audit
d. a) and b)
e. b) and c)

4 The main purpose of the program of scheduled QMS audits is to:

a. resolve the problems in production.
b. reduce in process verification.
c. verify the effective implementation of the quality management system.
d. all of the above.
e. b) and c).

5 The “degree to which a set of inherent characteristics fulfills requirements” is the definition of:
a. quality assurance.
b. quality control.
c. quality.
d. all of the above.
e. none of the above.

6 The management representative must:

a. perform all tasks relating to the quality management system
b. chair the management review meetings
c. be a member of the organization’s own management
d. b) and c)
e. none of the above.

7 The audit team members should meet frequently to exchange information during the audit in order to:
a. ensure that all of the audit objectives are met.
b. ensure that as many nonconformities as possible are found.
c. evaluate the performance of each member of the team.
d. all of the above.
e. none of the above.
8 Internal audits are used to verify that:
a. products conform to technical specifications.
b. the quality management system is effectively implemented.
c. no nonconformities exist in the quality management system.
d. all of the above.
e. none of the above.

9 The frequency of third QMS party audits is determined by:

a. the Registrar and auditee
b. the Registrar and customer
c. the client
d. only a) and b)
e. only b) and c)

10 The primary purpose of an opening meeting is to

a. develop the plan for the audit.
b. introduce the audit team and confirm arrangements for conducting the audit.
c. determine what auditor and auditee resources are required to undertake the audit.
d. all of the above.
e. none of the above.

11 The evidence of a nonconformity identified during an audit should be

a. recorded in the auditor’s notes or checklist.
b. acknowledged by the management of the audited company.
c. capable of being checked later.
d. all of the above.
e. none of the above.

12 The output from management reviews of a QMS based on ISO 9001 should lead to decisions or actions related to:
a. Improvement in the effectiveness of the quality management system
b. Improvement of product related to customer requirements
c. Increased efficiency in use of resources
d. Only a) and c)
e. Only a) and b)

13 The number of auditors assigned to an audit and their related experience and qualifications should be dependent on:
a. the scope of the audit.
b. the time available to perform the audit.
c. the purpose of the audit.
d. all of the above.
e. none of the above.

14 Opportunities to take preventive action may be found by analyzing:

a) Records of internal and external audits
b) Market and service feedback
c) Product nonconformities and returns
d) All of the above
e) Only a) and b)

15 As per ISO 9001 requirements, the purpose of QMS records is to provide objective evidence of:
a) Product conformance
b) Process capability and quality system conformance and effectiveness
c) Conformance with environmental, health and safety requirements
d) All of the above
e) Only a) and b)
ISO 9001 Lead Auditor Training

Exam Exercise 2 - Multiple Choice Questions

ISO 9001 Lead Auditor Training - Typical multiple choice questions worth one mark each. Only circle one answer for each
question.

1 QMS audits are used to verify:

a. that employees are following procedures and work instructions.
b. that products passed all inspections and tests per the quality plans.
c. that the quality system has been effectively implemented and maintained.
d. that all work is carried out by competent personnel.
e. all of the above.

2 The coordinated activities to direct and control an organization with regard to quality is called:
a. management review.
b. quality management.
c. total quality management.
d. all of the above.
e. none of the above.

3 The non-fulfillment of a requirement is called:

a. an observation.
b. a nonconformity.
c. an audit finding.
d. all of the above.
e. none of the above.

4 If a major nonconformity is found during the audit, the QMS auditor should:
a. Stop further production till the nonconformance is corrected.
b. Notify the Quality Manager as soon as possible.
c. Notify customers that defective product is being shipped.
d. Call a meeting with senior management to address the problem.
e. All of the above.

5 The scope of a QMS audit is determined by:

a. The program manager and auditee.
b. The customer and the auditee.
c. The audit client and the audit team leader.
d. All of the above.
e. None of the above.

6 The Registrar auditor may verify completion of agreed corrective action by:
a. acceptance of a written response.
b. evaluation of submitted evidence.
c. partial re-audit of the corrective action at the auditee’s site.
d. all of the above.
e. none of the above.

7 The person responsible for developing the audit plan, communicating with the auditee, and directing team efforts in
preparing for and conducting the audit is:
a. the client.
b. the audit program manager.
c. the audit team leader.
d. all of the above.
e. none of the above.

8 A requirement in selecting an audit team is:

a. to select auditors who are impartial and objective.
b. to select only auditors who are certified by the RAB or equivalent body.
c. to ensure that one of the team is in a management position.
d. to ensure that at least one team member has expertise in the activity audited.
e. all of the above.

9 QMS audits may be used to:

a. assist in selecting suppliers and subcontractors.
b. verify conformity with contractual requirements.
c. assess the effectiveness of quality management systems.
d. find opportunities to improve the quality system.
e. all of the above.

10 The purpose of the ISO 9001 QMS standard is to:

a. Enhance customer satisfaction.
b. Continually improve the effectiveness of the quality management system.
c. Provide certification of product capability and conformance.
d. Only a) and c).
e. Only a) and b).

11 If an audit finds no nonconformities, the external auditor should:

a. Conclude that there are no nonconformities existing in the quality system.
b. Explain to the department manager that only a sample of activities was audited and there may be nonconformities that
the sample did not uncover.
c. Recommend to auditee management that future audits be restricted to follow-up of corrective actions on customer
complaints and specific quality problems.
d. Only a) and c).
e. Only b) and c).

12 A good approach when interviewing an auditee is to:

a. say notes will be taken of their responses as evidence that they are doing their job.
b. put the auditee at ease and encourage them to mark out existing nonconformities.
c. establish a good rapport with the auditee; ask short questions and listen.
d. only a) and c).
e. only b) and c).

13 Which of the following is a requirement of ISO 9001?

a. to have a quality assurance manager.
b. to have a documented procedure for determining quality system related costs.
c. to have a documented quality policy.
d. all of the above.
e. none of the above.

14 It is important that the outcome of management reviews should lead to:

a) Improvement in conformity with QMS requirements
b) Increased effectiveness of the QMS
c) Increased effectiveness and efficiency of the QMS
d) Only a) and c)
e) Only a) and b)

15 The nature and degree to which a supplier may demonstrate conformance to an ISO 9001 based QMS may vary in
accordance with:
a) The complexity and difficulty in designing and producing the product
b) The past performance of the supplier
c) The ability to judge product quality on the basis of final inspection and test alone
d) All of the above
e) Only a) and b)
ISO 9001 Lead Auditor Training

Exam Exercise 3 - Multiple Choice Questions

ISO 9001 Lead Auditor Training - Typical multiple choice questions worth one mark each. Only circle one answer for each
question.

1 "Focused on providing confidence that quality requirements will be fulfilled" is:

a quality assurance.
b quality management.
c quality control.
d all of the above.
e none of the above.

2 Lead auditors are responsible for:

a conducting the opening and closing meetings.

b reporting audit findings and conclusion.
c developing the audit program.
d only a) and b).
e all of the above.

3 The auditor has observed at least 8 purchase orders that were not reviewed and approved prior to issue. The auditor
should now:

a draw a conclusion and prepare a nonconformity report.

b take another sample to confirm the audit observation.
c tell the audited company that something should be done about purchase orders.
d all of the above.
e none of the above.

4 The document stating requirements related to activities or products is called:

a the inspection procedure.

b the specification.
c the quality plan.
d all of the above.
e none of the above.

5 According to ISO 9001, data must be analyzed for information on:

a customer satisfaction.
b employee satisfaction.
c supplier performance.
d only a) and b).
e only a) and c).

6 The primary information sought by an internal auditor during an audit is:

a senior management commitment to the quality system.

b a list of nonconformities against the ISO 9001 standard.
c conformity to the ISO 9001 standard.
d product shipped meets customer requirements.
e all of the above.

7 If a major nonconformance is found in an audit, the third party auditor should:

a request further production be stopped until the nonconformity is corrected.
b notify customers that defective product is being shipped.
c notify the Management Representative as soon as possible.
d call a meeting with senior management to address the problem.
e all of the above.

8 The management representative:

a is a director.
b is the quality assurance manager.
c ensures the quality management system is maintained
d all of the above.
e none of the above.

9 What records must be kept to comply with ISO 9001?

a records of employee competence.

b records of the measurement and monitoring of processes.
c records of design reviews.
d a) and c) above.
e b) and c) above.

10 The frequency of third party audits is determined by:

a) the Registrar and auditee.

b) the Registrar and customer.
c) the client.
d) only a) and b).
e) only b) and c).

11 If your company is ISO 9001 certified, this requires that your key suppliers:

a also be certified to the ISO 9001 standard.

b must be audited by your company.
c must have a quality management system.
d provide assurance that your company quality requirements are met.
e all of the above.

12 When evaluating quality management systems, essential questions that must be asked in relation to processes being
evaluated are:

a) Are the processes defined and their sequence and interaction determined?
b) Are the processes fully deployed and effectively implemented?
c) Are the processes effective and efficient in achieving planned results?
d) All of the above
e) Only a) and b)

13 At the closing meeting of a third party audit, the company’s General Manager asks about the outcome of the audit. The
lead auditor should tell the company:

a they have passed or failed.

b it is not a decision for the audit team.
c what recommendation will be made.
d all of the above.
e none of the above.

14 Any information pertaining to the quality of product or process, which can be verified through observation, interview
or review of records is called:
a) An observation
b) A finding
c) Objective evidence
d) A nonconformance
e) All of the above

15 The ISO 9000 family of standards and guidelines are intended to be used in the following situations:

a) Guidance for quality management

b) Contractual, between first and second parties
c) Second party approval or third party certification
d) All of the above
e) Only b) and c)
ISO 9001 Lead Auditor Training

Exam Exercise 4 - Short Essay Questions

ISO 9001 Lead Auditor Training - Typical short essay type questions are worth 5 marks each. Your response should cover
a breadth of several points as opposed to going into depth on one or two points. (Tip: Provide bullet point answers
covering 5-10 separate points)

1 Explain the characteristics of (and differences between) a first party, second party, and third party QMS audit.

2 A complete audit of an organization's QMS consists of two distinct stages. Briefly describe each of these stages.

3 An auditor is conducting a third party QMS audit and the guide that has been appointed to accompany him is called away
by his supervisor. After five minutes, the guide has not returned. What should the auditor do? What should the auditor not
do?

4 Identify five clauses where planning of QMS activities is required by ISO 9001 and briefly explain each planning activity.

5 State the typical objective evidence that could be gathered in order to verify conformity with the requirements of clause
7.6 of the ISO 9001 Standard. Your answer should contain at least five specific examples in order to illustrate your
understanding.

6 An experienced auditor has been instructed to carry out a QMS audit of a potential supplier. From initial contacts with the
supplier, it is learned that a formal documented QMS does not exist. List five steps the auditor could take in planning for such
an audit.

7 An auditor may experience delaying tactics while conducting an audit. Give two examples of such tactics and describe three
ways in which the auditor could deal with these situations.

8 State four advantages and one disadvantage of using checklists to perform a QMS audit.

9 At the closing meeting, the quality management representative (QMR) of the organization audited informs the auditor that
they have now written a procedure to correct a serious non-conformity that the Registrar auditor found on the first day of a
two-day external audit. The QMR proposes that the auditor examine the procedure during the meeting and then withdraw
the nonconformity report. How should the auditor respond?

10 List and briefly explain five different ways in which an auditor obtains objective evidence while performing a QMS audit.

11 Explain the purpose and benefits of a preliminary visit to a company by the audit team leader prior to a QMS audit.

12 Arriving for the closing meeting, at the conclusion of an audit in which numerous nonconformities have been recorded,
the auditor is told by the quality management representative that none of the senior managers who were contacted are
available to attend. What should the auditor do?

13 While in the warehouse during a third party QMS audit, the guide gets into a heated argument with the warehouse clerk
over the absence of inspection status labels on skids of paint pails being stored on the racks. The warehouse clerk claims
labeling is not necessary because the racks are a designated area for the paint pails to be kept until inspected and approved
by the inspection department. The guide turns to the auditor and asks for support. How should a third party auditor
respond?

14 At the opening meeting of a third party QMS audit, the management representative (QMR) of the audited company
informs the auditor that a recent internal audit has disclosed numerous deficiencies in control of calibration. Corrective
action is being planned. The QMR proposes the audit of the calibration department be deleted from the audit plan. How
should the auditor respond?

15 What objective evidence could be available in order to verify nonconformity with the requirements of clause 7.4 of the
ISO 9001 Standard?
ISO 9001 Lead Auditor Training

Exam Exercise 5 - Long Essay Questions

ISO 9001 Lead Auditor Training - Typical long essay type questions are worth 10 marks each. Your response should cover
some depth on the subject matter. (Tip: Provide a combination of narrative and bullet points covering around 200-250
words in your response)

1 Describe the responsibilities of a QMS auditor who is a member of a third party QMS audit team.

2 An audit is being planned on an organization that carries out purchasing activities and verification of purchased products.
Write an audit checklist of eight key controls that an auditor should cover during an audit of those activities. State the
relevant clauses of ISO 9001.

(Hint: For full credit, students should use a process based approach and address at least three different clauses of ISO 9001)

3 Describe the typical levels of QMS documentation. What objective evidence should be looked at to verify that QMS
documents are being controlled in conformity with clause 4.2.3 of ISO 9001?

4 List and explain the agenda items that a third-party QMS audit team leader should cover during the closing meeting with
the management of the organization being audited.

5 a) Clearly explain the steps that an auditee organization may take in responding with corrective actions to nonconformities
raised during a third party QMS audit.
5 b) What follow-up options are available to a third-party QMS auditor, to ensure that the auditee organization has
effectively carried out the corrective actions?

6 An audit is being planned on a company engaged in warehousing and distribution activities. Items are moved from the
receiving area and stored on racks in the warehouse using forklift trucks, until required for shipment. Write an audit checklist
of eight key controls that an auditor should cover during an audit of those activities. State the relevant clauses of ISO 9001.

(Hint: For full credit, use a process based approach and address at least three different clauses of ISO 9001)

7 List and explain the agenda items that a third party QMS audit team leader should cover during the opening meeting with
the management of the organization being audited.

8 An audit is being planned for a company that receives customer’s sales orders for products by telephone, fax, and e-mail.
The products are shipped directly to the customer from a warehouse using the company’s own trucks. Write an audit
checklist of eight key controls that an auditor should cover during an audit of those activities. State the relevant clauses of
ISO 9001.

(For full credit, students should use a process based approach and address at least three different clauses of ISO 9001)

9 What are the benefits of implementing a QMS that meets the requirements of ISO 9001? Identify and describe three
clauses of ISO 9001 that provide opportunities to improve the quality system and overall business performance.
ISO 9001 Lead Auditor Training

Exam Exercise 6 - Evaluation Of Audit Situations

ISO 9001 Lead Auditor Training - During the course of ISO 9001 QMS audits of various organizations, auditors will run into
a variety of situations where they will have to determine whether they have sufficient objective evidence of a
nonconformity or not, and report their findings. Each of the situation questions listed below is worth 10 marks on the
exam. Practise evaluationg these situations to sharpen your auditing skills.

Based on the information given, if you think the situation represents a nonconformity, then complete a nonconformity form
that includes the following information: Situation #; area/process being audited; applicable ISO 9001 clause #; whether the
nonconformity is major or minor; a clear description of the specific requirement that the situation is nonconforming
against; a clear description (finding) of the nonconformity itself, supported by relevant objective evidence.

OR, based on the information given, if you do not think there is a nonconformity, then clearly state your reason(s), and also
provide at least 3 further actions you would take to gather additional evidence of conformity or nonconformity (had you
been there performing the audit).

Here is a list of some typical situations for you to practise on.

Situation number 1
During a Stage One - QMS document review, the auditor notes that a company procedure, QAP 05, revision 3, states that
when testing raw material RH 2005 for acceptance, the results will be unreliable if the test samples are taken closer than 20
inches apart on the material. In the Receiving Inspection Lab, the auditor notices an inspector carrying out an acceptance test
on material RH 2005. The auditor asks the inspector how the sample position on the material is selected. The inspector
replies that they are taken 6 inches apart to avoid wasting material. Upon inquiring about his procedure, the auditor was
shown the inspector’s copy of QAP 05, revision 2 on a shelf near the inspector’s desk.

Situation number 2
In the ABC Inc, Medical Center, which is within the scope of QMS registration, the auditor asks to see the work instructions
for a nurse. There are no written instructions on how to administer first aid treatment for cuts and minor injuries, nor are
there any written instructions of what to do if a patient's heart stops beating. The guide says that ABC employs three nurses
all of whom have been professionally trained as Registered Nurses and have certificates of competence issued by a
recognized university teaching hospital.

Situation number 3
In the Wardens office, the auditor notices a binder entitled “Penal Institution Administration Practices” on the bookshelf and
asked whether these contained departmental procedures for the penitentiary. The warden confirms that the file does
contain these procedures, but adds hesitantly that this document is now on computer available to all supervisors at their
terminals for many of their activities. After selecting A2, B5, C3 and D4 from the binder, the auditor notes that they are all at
revision 1. The auditor asks the Warden to show them on the terminal. The computer version of B5, C3 and D4 are at revision
3. The other sections are at revision 1.

Situation number 4
In the maintenance department, the auditor notes that contrary to the company’s work instruction, TDWI 05 issue 3, which is
clearly displayed at all work stations, three of the ten people in the department are not wearing the company issued safety
glasses when operating machining equipment.

Situation number 5
In the purchasing department, the auditor notes that the staff are placing orders over the phone with suppliers using a
computerized purchasing system. On inquiry, the auditor is told that the staff has been fully trained and the database holds
details of all supplier contract specifications and, therefore, there is no need for an independent review of individual orders.
Situation number 6
In the quality manager’s office, the auditor asks to see the schedule for internal audits. This schedule shows that each of
the eight QMS processes are audited every six months. The auditor asks the quality manager how the frequency of audits
was decided. The manager says that when the system was set up three years ago, 6-month intervals were specified for all
processes. The company has kept to this original schedule. The auditor asks to see the file containing corrective action
requests (CARs). It lists 85 CARs for the past two rounds of internal audits. Of these, 65 CARs are in the production
department and the remainder are spread evenly over five other departments. Two departments received no CARs.

Situation number 7
In the shipping area, the auditor stops to look at six finished products, serial numbers X245 to X250, in individual cardboard
cartons. The auditor asked the shipper why the items are packed in corrugated cardboard instead of plastic containers as
required by packaging work instruction PWI 6, revision 2. The shipper replied that the shipping supervisor had instructed
them to use corrugated cardboard when they ran out of plastic containers three weeks ago.

Situation number 8
During the audit of the tool and die department of a major automotive component manufacturer, the auditor asked to see
the work instructions for the turning and milling operations. The toolroom foreman indicated that there were no work
instructions for these operations other than a router indicating operation name and equipment to be used. He added that
these operations were performed by operators that were highly experienced and certified in their respective trades.

Situation number 9
In the design department, the auditor sees three incomplete products on a desk. The design manager explains that these
products came from the production department because of problems in manufacture. There is no identification on any of the
three incomplete products or any indication of their inspection status. Further investigation by the auditor was unable to
locate any inspection records relating to the incomplete products.

Situation number 10
In the engineering department, the auditor is shown procedure SOP 7.3 which requires that all engineering drawings must be
signed off by the draftsman and the engineering manager prior to issue. He randomly examines a drawing, DWG 1446 rev 3
on the manager’s desk and noticed that the “drawn by” and “approved by” boxes on it were not yet signed off.
Later, in the mail room, he comes across the same drawing with a distribution list attached.

Situation number 11
In the receiving area, the auditor noticed a colour code chart for identifying raw steel bars used to make finished product.
Later in the storage area, he noticed a similar chart, but with an additional colour and a control block - C.C.Chart RM 2007 rev
2. When questioned, the material handler said that the chart is useful for quickly pulling out the right bars.
On examining the document master list, the auditor could not find this chart listed. When asked about this, the quality
manager stated that they had moved to a computerized system for identifying steel bars and the colour code charts were no
longer relevant.

Situation number 12
In the final assembly area, the auditor observed operators installing laser printer cartridges into desk top printers. When
asked about the inspection status of cartridges, the production foreman said that the cartridges had just come in; the
materials inspector had called in sick; this was a rush job and delivery commitments must be met.
On further investigation, the auditor found that a shipment of 200 printers from the same order had been picked up by the
customer just before noon that day.

Situation number 13
In the production supervisors office, the auditor examined a copy of procedure SOP 7.5 covering production control activities.
When comparing against the master copy, she noticed that on page 2, the organization chart had been changed, but not on
the master copy. When asked, the supervisor said that one of her material handlers had left the company and was not
replaced. Overall workload was reorganized and the organization chart was amended to reflect this.

Situation number 14
In the Quality Management Representative’s (QMR) office, the auditor flips through the management review minutes for the
past year. She noticed the last one was dated 28/11/08; the previous one dated 13/06/08 which made reference to a
22/02/08 review. When asked about the frequency of such reviews, the QMR said that they were done when senior
management is in town and definitely before an external audit. On reviewing 2007 records, the auditor noticed that
management reviews were held in May and October.
ISO 9001 Lead Auditor Training

Exam Exercise 7 - Writing nonconformities

The following statements were presented to management by a third party audit team at the conclusion of the QMS audit.
These statements are all nonconformities that have been poorly written by the auditors that found them.

Requirement 1: Based on what you have learned in this ISO 9001 Lead Auditor Training course, on collecting audit
evidence and reporting of nonconformity findings, identify why these statements are poorly written and how you would
have written them.

Requirement 2: Identify the ISO 9001 clause number that you think would be the most appropriate selection for the stated
nonconformity.

1. A copy of a machine set-up instruction/checklist MSU 1201 on how to set up machine #1201 was marked “not under
change control”.

2. In the Storage Room, stocks of food additives were found to be contaminated by fumes from extraction ducts that were
not airtight.

3. A written instruction requires the involvement of the quality department when labels need to be restored to course
binders that have lost their labels. The temporary personnel who said they restored labels were unaware of the approved
instruction and the method they described did not comply with it anyway.

4. No internal audit had been carried out on Human Resources, Maintenance, Sales Order Entry, Information Technology. The
Quality Manual (clause 4.2 states that audits will be carried out on all departments on a six-month basis as a minimum.

5. The work instructions for field service contracts JLL-0295/C, DCG-2596/A, and FG-18423/X did not communicate special
requirements due to lack of space on the work instruction form. The sales entry order clerk had been given no guidance as to
how to deal with such a contingency.

6. Therma-Glo (a material critical to product quality) does not have a purchase specification and there is no procedure for
quality verification of incoming material.

7. The jig fixture used for checking stamped plates on the production lines was badly maintained. Guide pins were unstable
causing misalignment and the reflection surface for underside inspection was very dirty.

8. Although amendments to sales orders are recorded on receipt in Sales, there is no method to ensure the changes are
implemented throughout the system.

9. It is a requirement that test containers used for the Avery weigh scale are approved and issued by the laboratory. There
were test containers being used on the filling lines that had not been so approved.

10. On the drum filling line, the requirement of 50 drums per hour to be inspected was not being met. An average of 10
drums per hour was inspected between 3 pm and 12 midnight.

11. Gel Sealant was being held longer than the 5 minutes allowed at pouring temperature and was not filtered before being
applied on the line.

12. The patient medical records for recent tests showed occasional hand-written alerations. These lacked an approving
signature or date.
 True/False Questions - Exercise 8
The following statements relate to various ISO guidelines and standards. Indicate
whether these are true or false. As some of these statements are deliberately vague, you
might consider your supporting logic to defend your true/false determination.

You must read "Understanding ISO 9001" along with this ISO 9001 Lead Auditor
training course to do this exercise. These statements relate to an ISO 9001 certified
organization or one planning to implement an ISO 9001 QMS.

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

2 Customer requirements are often incorporated in “specifications”

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

4 QMS standards can substitute for relevant product requirements provided in technical
specifications.

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

6 It is expected that organizations with similar products or services to have similar QMS's.

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

8 The ISO 9000 family of standards provides guidance for quality management and general
requirements for quality control.

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

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

11 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.

12 The ISO family of quality system standards address quality system requirements as well as
provide technical standards for product quality.

13 The ISO 9000 family of quality standards provide quality system objectives to be met and
guidance on achieving them.

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

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

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

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

18 Every process involves people and/or resources in some way

19 Inputs, outputs and activities within the process are all capable of being measured and improved
20 A process serves no purpose if it does not add value to the output or organization

21 Not all work is accomplished by a process

22 Quality management is accomplished by managing the structure and operation of processes as

well as the quality of product and information flowing through them.

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

24 A fundamental basis of the ISO 9000 family of standards is for organizations to create, improve
and provide consistent quality of product through its network of processes.

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

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

27 Management reviews of QMS cannot take into account additional factors beyond the
requirements of ISO 9001

28 First party internal audits may only be conducted by members of the organization

29 QMS audits should keep in mind the balance between the extent of documentation and the
extent of training

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

31 The ISO 9004 standard is intended for use in interpreting the requirements of the quality
assurance standards ISO 9001.

32 ISO 9004 provides generic guidelines for the application and implementation of the clauses in
the ISO 9001 quality assurance standard.

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

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

Registrar.

35 ISO 9004 can be used as a reference by an organization wishing to improve its effectiveness, but
only after it has implemented a formal QMS.

36 ISO 19011 provides guidance on the education, training and experience requirements for
certification of QMS and EMS auditing.

37 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.

38 Pre-contract and post-contract assessments of an organization's QMS may be conducted by the

customer, the customer’s agent or an agreed third party.

39 Organizations and their customers may not specify supplementary QMS requirements beyond
those specified by ISO 9001.

40 Quality control is defined as the part of quality management focused on ulfilling quality
requirements.
41 A service can have tangible as well as intangible components to it.

42 A product is generated by activities at the interface between an organization and the customer
and by the organization's internal activities to meet the customers needs.

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

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

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

46 According to the ISO 9000 family of standards, the terms nonconformity and defect can be used
interchangeably.

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

48 A company’s quality policy may be stated in qualitative or quantitative terms.

49 Quality management is the responsibility of top management within the organization.

50 According to the ISO 9000 family of standards, the terms quality planning and quality plans can
be used interchangeably.

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

52 Where services are offered in combination with product, it is necessary to have separate quality
plans.

53 Quality control ensures adequate control of processes, whereas quality assurance ensures that
no nonconforming product gets shipped to customers.

54 It is necessary that an organization use a QMS to implement quality management.

55 Corrective and preventive actions are important tools to achieve QMS improvement.

56 An audit observation may relate to either conformity or nonconformity to a specified

requirement.

57 Actions taken to eliminate the causes of an existing nonconformity must include a corrective as
well as preventive element.

58 Repair and rework can be used interchangeably as defined by the ISO 9000 family of standards.

59 A deviation authorization and a concession cannot be used interchangeably as defined by the ISO
9000 family of standards.

60 It is generally understood that if customers needs and expectations are taken care, the interests
of other stakeholders will be also be addressed.

61 Only the inputs and outputs of processes can be measured.

62 All processes are measurable in terms of customer satisfaction.

63 In general, the extent of QMS documentation is inversely proportional to the education, training,
experience and stability of personnel within an organization.
64 An ISO 9001 certified organization must require some or all of its suppliers to also be certified
to the ISO 9001 standard.

65 An organization may provide audit results from an audit done by a customer to the external
Registrar auditor, as evidence of demonstrating an adequate and effective QMS.

66 Each requirement of ISO 9001 will vary in importance for different organizations depending
upon their products and processes.

67 Since ISO 9001 requirements are generic, it is expected that application of QMS requirements to
different products and organizations will be uniform.

68 In demonstrating an effective QMS, an organization needs to meet both the customer’s needs
and expectations as well as it’s own

69 Since cost is not a quality factor, only process benefits and risks should be considered by an
organization in developing a well structured QMS.

70 The definition of nonconformity does not include product returned for repair or rework.

71 Activities contributing to quality, whether directly or indirectly, should be defined and

documented.

72 Measures to control and coordinate the interface between different activities and processes
should be defined.

73 An organization’s QMS quality objectives should relate to product fitness for use, performance,
safety and dependability.

74 Resources to achieve QMS quality objectives must be planned but there is no necessity to
provide them on a timely basis.

75 The scope of management reviews under ISO 9001 should include the impact of new technology
and market strategies on the QMS.

76 Management must regularly monitor quality costs and other benchmarks to determine if the QMS
is achieving its quality policy and objectives

77 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

78 It is necessary that an organization’s QMS documentation include narrative procedures and work
instructions for its operations.

79 In ISO 9001 based quality systems, quality planning should be viewed as the same as quality
plans.

80 An organization's quality policy must include policies and objectives related to products,
processes, QMS system and cost.

81 Quality plans should specify on one document the quality objectives, practices, criteria,
resources, operational sequence and quality activities related to a product or service.

82 All customer requirements must be documented and agreed to by the customer and supplier.

83 The capability of an organization under ISO 9001 clause 7.2 only relates to it’s ability to produce
and deliver quality product
84 In order to ensure consistency of control, it is necessary that all customer orders be subject to
the same contract review before acceptance

85 Verbal orders received from customers do not need to be documented by the organization.

86 ISO 9001 does not require marketing activities to be included within the scope of the QMS.

87 Product safety, environmental and other regulations should also be considered in designing new
product.

88 Design verification requires that the developed product be checked against the design input
requirements.

89 The design review activity should consider safety, cost, compatibility, quality acceptance criteria,
prototype test results, etc.

90 It is necessary that design changes be subjected to all design controls described in ISO 9001
clause 7.3.

91 All design and development activities must be included in the project plan and cannot be
changed.

92 Product validation cannot be completed until the customer approves the product.

93 The design review activity must be conducted by personnel assigned to the design project.

94 Service design verification, validation and review must address all three specifications – service
design, service delivery and quality control of the design process.

95 Documents retained for legal and knowledge purposes must be controlled to the same extent as
active documents.

96 ISO 9001 requires that all QMS documentation be made available to personnel at their specific
work stations.

97 It is a nonconformity if an organization does not use a document master list to identify the
current status of it’s documents.

98 It is not a nonconformance if an organization does not use an approved supplier list to ensure
purchases affecting product quality, are made from approved suppliers.

99 ISO 9001 requires that the impact of document changes should be considered, on product,
process or quality system.

100 If a subcontractor to your organization is ISO 9001 certified, it is not necessary for your
organization to monitor the subcontractor's ongoing quality performance.

101 To ensure consistency of conformity of purchased product, clause 7.4 of ISO 9001 requires that
all suppliers be evaluated in the same manner.

102 Clause 4.2.3 of ISO 9001 requires that a record be kept of the reasons why a change to a
document was made.

103 If a organization accepts delivery of material based on conducting verification at source, it may
not be necessary for it to conduct any receiving inspection.

104 According to clause 7.4 of ISO 9001, purchasing documents must clearly describe QMS
requirements for all suppliers on it's approved supplier list.
105 A list of approved suppliers constitutes sufficient objective evidence of acceptable suppliers.

106 Where customers provide product certifications with customer supplied product, it is not
necessary for the orgainzation to conduct any further verification of such product.

107 It may not be necessary to use physical identification methods if computer records are used to
control the identity of product

108 Product identification relates to details of manufacture to facilitate tracking of a nonconformity

back to its source and containing the batch or lot

109 According to ISO 9001 it is not necessary to conduct in-process product verification if there is
adequate control of manufacturing processes.

110 According to ISO 9001, relationships should be developed between in-process controls, their
specifications and final product specifications.

111 According to ISO 9001, it is expected that all products be subject to the same inspections and
tests.

112 According to ISO 9001 it is required that acceptance criteria be described on the product
inspection record.

113 There is no nonconformity if an organization is unable to provide any organization charts to

show it’s organization structure.

114 It is a nonconformity if calibration status indicators are not affixed directly on measurement
devices used to verify product quality.

115 It is a nonconformity, if a customer is not notified when product is shipped to them, that was
inspected and passed using defective measurement devices.

116 There is no nonconformity if an ISO 9001 certified organization allows it’s operators to use
personally owned measurement devices.

117 It is a nonconformity if an ISO 9001 certified organization does not have a designated
quarantine area for nonconforming product

118 It is a nonconformance if an ISO 9001 certified organization does not perform any audits on
any of it’s suppliers.

119 There is no nonconformity if material is released for urgent production without any receiving
inspection being done.

120 Statistical techniques should be used to identify adverse trends for products and processes
before nonconformities actually occur.

121 Correction of product nonconformities should not compromise the quality of adjacent, attached
or incorporated product.

122 Verification should be made as close as possible to the point of realization of the product
characteristic.

123 Manufacturing jigs, fixtures, test software, comparative references and process instrumentation
that can affect product or process characteristics do not need to be controlled.

124 Besides controlling measurement devices, the measuring process itself must be controlled.
125 For fully automated processes, physical location of product is an acceptable method of assuring
the inspection and test status of product.

126 The inspection and test status of product is only required to be maintained as a control, until
the time the product is shipped to the customer.

127 ISO 9001 requires that nonconforming product be segregated, identified and put in an
designated quarantine area.

128 The ISO 9001 requirement for preventive action may be addressed by taking steps to prevent a
root cause of a nonconformity from happening again.

129 The control requirements for storage in clause 7.5.5 of ISO 9001 includes both conforming and
nonconforming product.

130 As per ISO 9001, the organization is not responsible for the protection of product quality after
shipment, if the terms of delivery are FOB the organization’s facility.

131 The retention times for QMS records required by clause 4.2.4 of ISO 9001 are minimal time
periods and therefore QMS records never need to be disposed off.

132 As per clause 8.2.2 of ISO 9001, it is required that the frequency of audits of specific areas and
processes be increased based on their status and importance.

133 As per ISO 9001, training of temporary and subcontract personnel is not required.

134 The use of statistical techniques has limited application and benefit to the service sector.

135 The use of statistical techniques is not applicable for the evaluation of qualitative data.

136 Since SPC is a tool to verify the output of processing, it is viewed as a detective control rather
than preventive.

137 ISO 9001 requires that the standard of acceptability of product characteristics that have a
subjective element, must be clarified.