Iso 9001-2000 Checklist Sample-Web4

The ISO 9001:2000 Quality System Checklist Standard: ISO 9001:2000 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) <Guideline statements> Look (cite source - give comments) Y or N (comments)
Contents of the ISO 9001:2000 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. 26 7.1 Planning of product realization
You receive the Windows .doc file (with hyperlinks). You may edit this document. 7.2 Customer-related processes (title only)
For: Windows® 95, 98, 2000, and XP and Microsoft® Word 97 or later versions. 27 7.2.1 Determination of requirements related to the product
27 7.2.2 Review of requirements related to the product
Product Description and Order Information (see last page) 28 7.2.3 Customer communication
4 Quality management system (title only) 7.3 Design and development (title only)
2 4.1 General requirements 29 7.3.1 Design and development planning
4.2 Documentation requirements (title only) 30 7.3.2 Design and development inputs
3 4.2.1 Documentation requirements — General 30 7.3.3 Design and development outputs
7 4.2.2 Quality manual 31 7.3.4 Design and development review
8 4.2.3 Control of documents ← Click here to see sample 31 7.3.5 Design and development verification
9 4.2.4 Control of records 32 7.3.6 Design and development validation
32 7.3.7 Control of design and development changes
5 Management responsibility (title only) 7.4 Purchasing (title only)
12 5.1 Management commitment 33 7.4.1 Purchasing process
13 5.2 Customer focus ← Click here to see sample 34 7.4.2 Purchasing information
14 5.3 Quality policy 34 7.4.3 Verification of purchased product
5.4 Planning (title only) 7.5 Production and service provision (title only)
16 5.4.1 Quality objectives 36 7.5.1 Control of production and service provision
17 5.4.2 Quality management system planning 38 7.5.2 Validation of processes for production and service provision
5.5 Responsibility, authority and communication (title only) 39 7.5.3 Identification and traceability
18 5.5.1 Responsibility and authority 40 7.5.4 Customer property
19 5.5.2 Management representative 41 7.5.5 Preservation of product
19 5.5.3 Internal communication 42 7.6 Control of monitoring and measuring devices
5.6 Management review (title only) 8 Measurement, analysis and improvement (title only)
22 5.6.1 Management review — General 45 8.1 General
22 5.6.2 Review input 8.2 Monitoring and measurement (title only)
22 5.6.3 Review output 46 8.2.1 Customer satisfaction
47 8.2.2 Internal audit
6 Resource management (title only) 49 8.2.3 Monitoring and measurement of processes
23 6.1 Provision of resources
50 8.2.4 Monitoring and measurement of product ← Click here
6.2 Human resources (title only)
53 8.3 Control of nonconforming product
23 6.2.1 General
54 8.4 Analysis of data
23 6.2.2 Competence, awareness and training
8.5 Improvement (title only)
25 6.3 Infrastructure
56 8.5.1 Continual improvement
25 6.4 Work environment
57 8.5.2 Corrective action ← Click here to see sample
The Checklist may be placed on a network system for access by auditors. 58 8.5.3 Preventive action
This Checklist is included in the ISO 9001:2000 Auditor Training Course and Forms.
Auditor Name: Date: Audit Ref. Page 1 of 58

file: iso_9001-2000_checklist_sample-web4.pdf ISO 9001:2000 Checklist © 2003 Jane M. Birkenstock Audit page ___ of ___ pages
Guidelines for
Auditing
4.2.3 Quality management system — Documentation requirements — Control of documents Clause 4.2.3
4.2.3 Control of documents Verify that the documented Document Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
____ Is there a documented procedure for Document Control Control
document control? procedure contains the procedure
requirements a-g for
Does the procedure define the controls needed to: controlling:
__ a) approve documents for adequacy prior to use __ Quality Manual The Instructions Sample explains how to enter audit evidence on the Checklist.
__ Documented
__ b) review and update documents, as necessary,
Procedures
and re-approve them prior to issue
__ Work Instructions
__ c) ensure that changes and the current revision __ Product documentation
status of documents are identified (including drawings,
specifications, bills of
__ d) ensure that relevant versions of documents material, parts lists,
are available at points of use production plans, control
<The relevant version of a document is the version plans, etc.)
that should be used for a task. Note: the current __ External documents
revision of the document may not be the right one for __ Other required QMS
the task.> documents
__ e) ensure that documents stay legible and are
readily identifiable
__ f) ensure that documents of external origin are
identified and their distribution controlled
__ g) prevent the use of obsolete documents, and to
to suitably identify them 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 Master lists,
__ e) legible, readily identifiable and distribution system at Distribution
retrievable? several locations: Ask for a lists, etc.
document used in the
department and check if it
is the current revision, is Return to Contents page.
(continued) 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.
documents (identified in standards,
4.2.3 f) Are external documents clause 4.2.1.d) for proper customer
____ identified, and their identification and control. documents,&
__ Do a sampling to statutory/
____ distribution controlled? determine that documents regulatory
of external origin are documents
current at multiple
distribution points.
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
es to access the organiza- customer
of enhancing customer satisfaction? (see 7.2.1
tion's strategy for determin- information,
and 8.2.1)
ing customer requirements contracts,
and that they are met with quality plans
<7.2.1 and 8.2.1 are listed below for reference: > the aim of enhancing
customer satisfaction. Are Note to Lead
7.2.1 Determination of requirements related to the strategies used getting the Auditor:
product. The organization shall determine: needed information? This clause
a) customer-specified requirements, including can be
requirements for delivery and post-delivery activities Examples of customer-
audited with
Person(s) responsible for this activity: related processes are:
7.2.1 & 8.2.1
___________________________________ Sales_________________
They use
Marketing _____________
same
b) requirements not stated by the customer but Contract Admin. ________
information.
necessary for stated use or known and intended use Customer Service_______
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: results.
___________________________________ Collect customer
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
product or service reviews.
___ What methods has management determined for
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
or not being met.
___ Are those who are assigned responsibilities
(listed in 7.2.1 and 8.2.1) provided with adequate ← Is this done?
__Do Mgt. Review minutes
resources to accomplish the assigned tasks?
discuss how to improve Return to Contents page.
(Resources means people, time and money.)
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
Note: Monitoring and Quality plan
8.2.4 Monitoring and maeasurment of product measurement activities Evidence: Document #, Title, Rev / Person's Name, Title, Dept. /or other source ID.
for product,
required to determine Traveler
product characteristics — the distinguishing product or service
features of the product or service conformance to require- Inspection
ments are identified during and Test
___ Are product characteristics monitored and planning activities. (a procedures
measured at appropriate stages of product realization requirement of 7.1 c.) and
to verify that product requirements are met in Review several quality instructions
accordance with the planned arrangements? (see plans for work in
clause 7.1) progress and their
associated test / inspection Quality
____ Are records of product conformity with instructions. control plans
acceptance criteria maintained, and __ Does the quality plan and related
indicate where monitoring records
____ do records indicate the person(s) who and measuring should take
authorized the release of product? place? Get a list of
(see clause 4.2.4) __ Is acceptance criteria who is
clearly defined? qualified to
<Guideline: When auditing any process, you __ Are the required perform audit
check to see that defined monitoring and inspection and tests monitoring,
measurement activities are taking place, and that performed and the results inspection
records with authorized release signatures are recorded? and
present.> ___ Do records indicate measuring
who released the product? activities in
__ Is the product or service all process
monitored and measured areas.
at the stages indicated in
the quality plan?
Observe in-process Quality
___ Is product release and service delivery held until inspection operations. plans,
the planned arrangements have been satisfactorily ____ Is uninspected or checklists,
completed, unless otherwise approved by a relevant nonconforming product or traveler
authority and, where applicable, by the customer? prevented from being used
in the next processing In-process
Verify as applies to in-process inspection → 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 → or traveler
___ Are all activities in the
final inspection instructions
___ Is product release and service delivery held until Final
completed before product
the planned arrangements have been satisfactorily inspection
is released?
completed, unless otherwise approved by a relevant process,
___ Is there is objective
authority and, where applicable, by the customer? procedures
evidence that all the
and/or
acceptance criteria for the
relevant work
product have been met
instructions
before release?
objective evidence — information based on facts ___ Do records show the
acquired through measurement, test, observation, or person(s) who authorized
some other means that can be proven to be true. release?
Employee
___ Verify that inspectors records or
in the final inspection list of
area are qualified. qualified
inspectors
Review a sampling of
completed order records.
____ Do the completed Records of
orders/records show that completed
all final inspection activities work.
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
appropriate, the customer) Return to Contents page.
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 → final audit
___ Are all verification checklists,
activities specified in the or traveler
Verify as applies to product servicing and repair quality plan / procedures
inspection → completed before the
service or product is
___ Is product release and service delivery held until released?
the planned arrangements have been satisfactorily
completed, unless otherwise approved by a relevant ___ Is there is objective
authority and, where applicable, by the customer? evidence that all product
(or service) acceptance
criteria have been met?
verification activities — checks to make sure all ___ Do records show the
requirements for the product were met. person(s) who authorized Employee
product / service release? records or
objective evidence — information based on facts list of
acquired through measurement, test, observation, or ___ Verify that inspectors
involved in service / repair qualified
some other means that can be proven to be true. inspectors
are qualified.
Review a sample of
service or repair completed Service
orders and: repair
____ Verify that all inspection
activities specified in the and final
quality plan / procedures inspection
were completed and process,
requirements for procedures
service/repair were met. and/or
___ Do final inspection relevant work
records indicate the instructions
person(s) who authorized
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.
Completed
Note: When the nonconformity is minor and isolated,
___ e) Are there records Corrective
the risks or cost associated with taking
of the results of the Action
corrective action may not be justified.>
corrective action taken? Request
Forms Also see the instructions sample of how to enter audit evidence on the Checklist.
___ f) Are corrective
actions taken reviewed to CPAR Log Return to Contents page.
verify effectiveness?

Guidelines for
Auditing
Product Description and Order Information

Supplier:
ISO 9000 Checklist
3575 S. Bascom Ave. #2
Campbell, CA 95008 USA
Phone: (408) 371-9995
Contact: Jane Birkenstock
Email: janebirk@iso9000checklist.com
Product Description: ISO 9001:2000 Checklist Package (32 files) in A4 or US 8 1/2 X 11" format
ISO 9001:2000 Checklist (58 pages), Universal Items Checklist, Work Order Audit Checklist, Audit Steps Card, Auditing a Process, Work Order Audit,
Audit Plan Form, Document Review, Manager Interview Form, Records Review Form, Vocabulary and instructions for completing forms.
(See complete list of 32 files)
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The ISO 9001:2000 Quality System Checklist Standard: ISO 9001:2000 Organization Audited:

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

Auditor Name: Date: Audit Ref. Page 1 of 58

Auditor Name: Date: Audit Ref. Page 2 of 58

Auditor Name: Date: Audit Ref. Page 3 of 58

5.2 Management responsibility — Customer focus Clause 5.2

Auditor Name: Date: Audit Ref. Page 4 of 58

8.2 Measurement, analysis and improvement — Monitoring and measurement —

Auditor Name: Date: Audit Ref. Page 5 of 58

Auditor Name: Date: Audit Ref. Page 6 of 58

___ If records show a Records of

Auditor Name: Date: Audit Ref. Page 7 of 58

Auditor Name: Date: Audit Ref. Page 8 of 58

Product Description and Order Information

Payment methods accepted

Auditor Name: Date: Audit Ref. Page 9 of 58

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