Contents of The ISO 9001:2008 Quality System Checklist: Questions

The ISO 9001:2008 Quality System Checklist Standard: ISO 9001:2008 Organization Audited:
Questions Documents Documented? Need to be? Y or N Implemented? Y or N

Guidelines for
(those relating to new/ revised requirements are in / Where to Interaction considered? Y or N In Use? Effective?
Auditing
italics and underlined) <Guideline statements> Look (cite source - give comments) Y or N (comments)
Contents of the ISO 9001:2008 Quality System Checklist Page Hyperlinks (click underlines) All links are active on the final product.
Page Hyperlinks (click underlines) 7 Product realization (title only)
This SAMPLE document includes 4 clauses of the standard. 27 7.1 Planning of product realization
7.2 Customer-related processes (title only)
You receive the Windows .doc file (with hyperlinks). You may edit this document.
28 7.2.1 Determination of requirements related to the product
For: Windows 2000 and higher, XP, Vista and Microsoft Word 2000 and later versions.
28 7.2.2 Review of requirements related to the product
4 Quality management system (title only) 29 7.2.3 Customer communication
2 4.1 General requirements 7.3 Design and development (title only)
4.2 Documentation requirements (title only) 30 7.3.1 Design and development planning
4 4.2.1 Documentation requirements General 31 7.3.2 Design and development inputs
8 4.2.2 Quality manual 31 7.3.3 Design and development outputs
9 4.2.3 Control of documents Click here to see sample 33 7.3.4 Design and development review
10 4.2.4 Control of records 33 7.3.5 Design and development verification
34 7.3.6 Design and development validation
5 Management responsibility (title only) 34 7.3.7 Control of design and development changes
13 5.1 Management commitment 7.4 Purchasing (title only)
14 5.2 Customer focus Click here to see sample 35 7.4.1 Purchasing process
15 5.3 Quality policy 36 7.4.2 Purchasing information
5.4 Planning (title only) 36 7.4.3 Verification of purchased product
17 5.4.1 Quality objectives 7.5 Production and service provision (title only)
18 5.4.2 Quality management system planning 38 7.5.1 Control of production and service provision
5.5 Responsibility, authority and communication (title only) 40 7.5.2 Validation of processes for production and service provision
19 5.5.1 Responsibility and authority 41 7.5.3 Identification and traceability
20 5.5.2 Management representative 42 7.5.4 Customer property
20 5.5.3 Internal communication 43 7.5.5 Preservation of product
5.6 Management review (title only) 44 7.6 Control of monitoring and measuring equipment
23 5.6.1 Management review General
23 5.6.2 Review input 8 Measurement, analysis and improvement (title only)
23 5.6.3 Review output 47 8.1 General
8.2 Monitoring and measurement (title only)
6 Resource management (title only) 48 8.2.1 Customer satisfaction
24 6.1 Provision of resources 49 8.2.2 Internal audit
6.2 Human resources (title only) 51 8.2.3 Monitoring and measurement of processes
24 6.2.1 General 52 8.2.4 Monitoring and measurement of product Click here
24 6.2.2 Competence, training and awareness 55 8.3 Control of nonconforming product
26 6.3 Infrastructure 57 8.4 Analysis of data
26 6.4 Work environment 8.5 Improvement (title only)
59 8.5.1 Continual improvement
The Checklist may be placed on a network system for access by auditors. 60 8.5.2 Corrective action Click here to see sample
61 8.5.3 Preventive action
This Checklist is included in the ISO 9001:2008 Auditor Training Course and Forms.
62 Instructions for adding a page and text to the Checklist
Auditor Name: Date: Audit Ref. Page 1 of 8

file: iso-9001-2008-checklist-sample-rev-2-20-09us.pdf ISO 9001:2008 Auditor Training Course and Forms 2009 ISO 9000 Checklist Audit page ___ of ___ pages
Guidelines for
Auditing
4.2.3 Quality management system Documentation requirements Control of documents Clause 4.2.3
Verify that the documented Document Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
4.2.3 Control of documents Document Control Control
____ Is there a documented procedure for procedure contains the procedure
document control? requirements a-g for
Does the procedure define the controls needed to: controlling:
__ a) approve documents for adequacy before they __ Quality Manual The Instructions Sample explains how to enter audit evidence on the Checklist.
are issued __ Documented
__ b) review, update and re-approve documents, as Procedures
necessary, __ Work Instructions
__ c) ensure that the current revision status of __ Product documentation
documents and document changes are identified (including drawings,
__ d) ensure that relevant versions of documents specifications, bills of
are made available at points of use material, parts lists,
<The relevant version of a document is the version production plans, control
that should be used for a task. The current revision of plans, etc.)
the document may not be the right one for the task.> __ External documents
__ e) ensure that documents remain legible and __ Other required QMS
easy to identify documents
__ f) ensure that documents that originate from out-
side the organization are identified and the
distribution of these documents is controlled
(applies to documents necessary for the planning and
operation of the quality management system)
__ g) prevent the unintentional use of obsolete
documents, and to clearly mark them with suitable
identification if they are kept for any purpose?
4.2.3. ___ Are required QMS documents controlled as ___ Review a sampling of All new and
defined in the document control procedure? new and revised revised
a) and b): Are new and revised documents: documents for evidence documents.
that the requirements for
___ reviewed for adequacy, and the review and approval of
documents are followed as
___ approved by authorized personnel prior to issue? defined in the procedure.
4.2.3 Are documents: ___ Ask a sampling of All controlled
employees how they know documents,
__ c) identified by their current revision status, they are using the right
__ d) the relevant version for the task and available document for the task.
at locations where they are needed ___ Test the document
distribution system at Master lists,
__ e) legible, readily identifiable and Distribution
retrievable? several locations: Ask for a
document used in the lists, etc.
department and check if it Return to Contents page.
(continued) is the current revision, is
retrievable and available.

Guidelines for
Auditing
4.2.3 Quality management system Documentation requirements Control of documents Clause 4.2.3 (continued)
4.2.3 Control of documents (continued) ___ Review external All Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
4.2.3 f) Are external documents documents (identified in standards,
____ identified, and their clause 4.2.1.d) for proper customer
identification and control. documents,&
____ distribution controlled? __ Do a sampling to statutory/
(applies only to external documents that the determine that documents regulatory
organization determines are necessary for the of external origin are documents
planning and operation of the quality mgt. system) current at multiple
(External documents are those that originate from distribution points.
outside the organization.)
4.2.3 g) Are obsolete documents: ___ Verify g) All obsolete
___ Review retained documents
____ identified and removed from places of use to obsolete documents for
prevent their use proper identification.
____ identified to prevent their use, if they are kept Identify any obsolete
documents not removed Return to Contents page.
for any purpose?
from place of use.

Guidelines for
Auditing
5.2 Management responsibility Customer focus Clause 5.2

5.2 Customer focus ___ Interview those Product Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
responsible for managing information
__ Does top management ensure that customer
customer-related process- brochures,
requirements are determined and met with the aim of
es to access the organiza- customer
enhancing customer satisfaction? (see 7.2.1 and
tion's strategy for determin- information,
8.2.1)
ing customer requirements contracts,
<7.2.1 and 8.2.1 are listed below for reference: > and that they are met with quality plans
the aim of enhancing
7.2.1 Determination of requirements related to the customer satisfaction. Are Note to Lead
product. The organization shall determine: strategies used getting the Auditor:
a) customer-specified requirements, including needed information? This clause
requirements for delivery and post-delivery activities Examples of customer- can be
Person(s) responsible for this activity: related processes are: audited with
___________________________________ Sales_________________ 7.2.1 & 8.2.1
Marketing _____________ They use
b) requirements not stated by the customer but Contract Admin. ________ same
necessary for stated use or known and intended use Customer Service_______ information.
Person(s) responsible for activity: Product Repair ________
__________________________________ Customer
___ Is data concerning complaints
customer needs and and/or
c) statutory and regulatory requirements related to
expectations collected and satisfaction
the product
analyzed? survey
Person(s) responsible for activity:
___________________________________ Collect customer results.
satisfaction analysis
d) any additional requirements determined by the reports. By interview, Internal
organization? or other means, determine: customer
Person(s) responsible for activity __ if action was taken to complaints.
___________________________________ resolve problems
__ improvements or
8.2.1 Customer satisfaction changes have been
Does the organization monitor information relating to made and are now part
customer perception as to whether the organization of the product or service
has met customer requirements? __ improvements or
Person(s) responsible for activity changes are planned for Results of
___________________________________ incorporation into the management
___ What methods has management determined for product or service reviews.
obtaining information related to customer perception Review any evidence of
as to whether product requirements have been met customer dissatisfaction to
and how this information will be used? determine if customer
Person(s) responsible for activity ______________ requirements are unknown
___ Are those who are assigned responsibilities or not being met.
(listed in 7.2.1 and 8.2.1) provided with adequate Is this done?
__Do Mgt. Review minutes Return to Contents page.
resources to accomplish the assigned tasks?
(Resources means people, time and money.) discuss how to improve
products and/or services?

Guidelines for
Auditing
8.2 Measurement, analysis and improvement Monitoring and measurement

8.2.4 Monitoring and measurement of product Clause 8.2.4
8.2.4 Monitoring and measurement of product Note: Monitoring and Quality plan
measurement activities Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
for product,
product characteristics the distinguishing required to determine Traveler
features of the product or service product or service
conformance to require- Inspection
___ Are product characteristics monitored and ments are identified during and Test
measured at appropriate stages of product realization planning activities. (a procedures
to verify that requirements for the product are met in requirement of 7.1 c.) and
accordance with the quality plan (traveler/work Review several quality instructions
order)? (see clause 7.1) plans for work in
progress and their
____ Are records of product conformity with associated test / inspection Quality
acceptance criteria maintained, and instructions. control plans
__ Does the quality plan and related
customer the person or organization that receives indicate where monitoring records
a product. and measuring should take
internal customer the next process that will place? Get a list of
perform a work or service activity __ Is acceptance criteria who is
clearly defined? qualified to
____ do records indicate the person(s) who __ Are the required perform audit
authorized the release of product for delivery inspection and tests monitoring,
to the customer? (see clause 4.2.4) performed and the results inspection
recorded? and
<Guideline: When auditing any process, you ___ Do records indicate measuring
check to see that defined monitoring and who released the product? activities in
measurement activities are taking place, and that __ Is the product or service all process
records with authorized release signatures are monitored and measured areas.
present.> at the stages indicated in
the quality plan?
Observe in-process Quality
Verify as applies to in-process inspection inspection operations. plans,
____ Is uninspected or checklists,
nonconforming product or traveler
prevented from being used
in the next processing In-process
stage? inspection
___ Is the inspection status process,
of the product maintained procedures
throughout all stages of and/or
production? relevant work
___ Are inspection instructions
personnel trained?
___ Are inspection Qualified
(continued) procedures available and inspector list Return to Contents page.
followed?

Guidelines for
Auditing
8.2.4 Measurement, analysis and improvement Monitoring and measurement of product Clause 8.2.4 (continued)
8.2.4 Monitoring and measurement of product RE: Final inspection Quality Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
(continued) Observe final inspection plans,
___ Are instructions for final audit
All questions on this page final inspection available? checklists,
apply to final inspection area ___ Are all activities in the or traveler
final inspection instructions
___ Is the release of product and delivery of service completed before product Final
to the customer held until the planned arrangements is released? inspection
(including inspections, tests, and measurements) ___ Is there is objective process,
have been satisfactorily completed, unless otherwise evidence that all the procedures
approved by an appropriate authority and, where acceptance criteria for the and/or
applies, by the customer? product have been met relevant work
before release? instructions
___ Do records show the
person(s) who authorized
the release of product or
objective evidence information based on facts
delivery of service to the
acquired through measurement, test, observation, or Employee
customer?
some other means that can be proven to be true. records or
___ Verify that inspectors list of
in the final inspection qualified
area are qualified. inspectors
Review a sample of
completed order records.
Records of
____ Do the completed
completed
orders/records show that
work.
all final inspection activities
stated in the quality plan /
procedures were
completed and that the
requirements for the
product were met?
___ Do the records show
the person(s) who
authorized release of the
product?
___ If records show a
situation where all
specified activities were
not performed before
release of product or
service delivery, did a
relevant authority (or, as
Return to Contents page.
appropriate, the customer)
approve the product
release?

Guidelines for
Auditing
8.2.4 Measurement, analysis and improvement Monitoring and measurement of product Clause 8.2.4 (continued)
8.2.4 Monitoring and measurement of product For services and repair: Quality
(continued) Observe services/repair: plans,
Verify as applies to service organizations ___ Are all verification final audit
activities specified in the checklists,
Verify as applies to product servicing and repair quality plan / procedures or traveler
inspection completed before the
service or product is
___ Is the release of product and delivery of service released?
to the customer held until the planned arrangements ___ Is there is objective
(including inspections, tests, and measurements) evidence that all product
have been satisfactorily completed, unless otherwise (or service) acceptance
approved by an appropriate authority and, where criteria have been met?
applies, by the customer? ___ Do records show the
the release of the product /
or delivery of the service to Employee
verification activities checks to make sure all
the customer? records or
requirements for the product were met.
list of
___ Verify that inspectors qualified
objective evidence information based on facts involved in service / repair inspectors
acquired through measurement, test, observation, or are qualified.
some other means that can be proven to be true.
Review a sample of Service
service or repair completed repair
orders and: inspection
____ Verify that all and final
activities specified in the inspection
quality plan / procedures process,
were completed and procedures
requirements for and/or
service/repair were met. relevant work
___ Do final inspection instructions
records indicate the
release of service/repair?
___ If records show a Records of
situation where all completed
specified activities were work.
not performed before
release of product or
service delivery, did a
relevant authority (or as
appropriate, the customer)
approve the product/
service release? Return to Contents page.

Guidelines for
Auditing
8.5.2 Measurement, analysis and improvement Improvement Corrective action Clause 8.5.2
8.5.2 Corrective action Verify that the documented Documented Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
procedure clearly defines Corrective
___ Is there a documented corrective action ___ requirements for Action a) Does the documented procedure state who is responsible for reviewing nonconformities
procedure that defines the requirements for: (a through f). procedure that originate from the sources listed here? The procedure may make reference to other
procedures or documents with this information. (as applies)
___ a) Is there evidence
___ a) reviewing nonconformities (including __ incoming materials
that the types of
customer complaints) Customer __ incoming subcontracted product
nonconformities in the
complaints, __ in-process/final inspection or test
far right column are
___ b) determining the root cause(s) of Internal audit __ nonconforming material review
reviewed and evaluated
nonconformities reports, __ sales or service concessions
to determine if action is
data
needed to prevent the __ audit nonconformity
___ c) evaluating the need for action to prevent analysis,
specific problems found __ customer complaints
recurrence of the nonconformities minutes of
from occurring again? __ product returns
management
___ d) determining the action needed and __ Do plans for corrective reviews __ warranty repairs
implementing the action action include considera- __ process related nonconformities
ation of: __ system related nonconformities
___ e) recording the results of action taken __ action to remove the
(see clause 4.2.4) nonconformity and prevent
recurrence in the short
___ f) reviewing the corrective actions taken term
to verify their effectiveness __ action to determine if Corrective
other product (or similar action
product) is affected that is records
____ Does the procedure require that the action in production, in stock or
taken on nonconformities must be appropriate being designed Management
to the effects of the nonconformities found? review
__ action to determine if action
the nonconformity applies records/
____ Does the organization take corrective to product or service minutes of
action to eliminate the causes of delivered in the past, and management
nonconformities in order to prevent their is action needed to reviews
recurrence? minimize the impact of the
defect on these customers
__ action to prevent the
<The following is a guidance note and not included in problem in the future.
the text of the standard.
___ e) Are there records Completed
Note: When the nonconformity is minor and isolated, Also see the instructions sample of how to enter audit evidence on the Checklist.
of the results of the Corrective
the risks or cost associated with taking
corrective action taken? Action
corrective action may not be justified.> Return to Contents page.
Request
___ f) Are corrective Forms
actions taken reviewed to
verify effectiveness? CPAR Log Click Browser back button (in top left corner) to Return


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The ISO 9001:2008 Quality System Checklist Standard: ISO 9001:2008 Organization Audited:

Questions Documents Documented? Need to be? Y or N Implemented? Y or N

Auditor Name: Date: Audit Ref. Page 1 of 8

Auditor Name: Date: Audit Ref. Page 2 of 8

Auditor Name: Date: Audit Ref. Page 3 of 8

5.2 Management responsibility Customer focus Clause 5.2

Auditor Name: Date: Audit Ref. Page 4 of 8

8.2 Measurement, analysis and improvement Monitoring and measurement

Auditor Name: Date: Audit Ref. Page 5 of 8

Auditor Name: Date: Audit Ref. Page 6 of 8

Auditor Name: Date: Audit Ref. Page 7 of 8

Auditor Name: Date: Audit Ref. Page 8 of 8

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