UL's ISO 9000 Registration Program ISO 9001:2000 Quality System Checklist

Underwriters Laboratories Inc.
. ISO9001:2000 Audit
Checklist
THIS CHECKLIST IS FOR GUIDANCE ONLY

CONFORMACE WILL NOT ASSURE REGISTRATION
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UL’s ISO 9000 Registration Program

ISO 9001:2000
Quality System Checklist
Audit Date(s):
Facility:
Auditor:
Checklist

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Checklist

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4.1 QMS General Requirements Summary
Overall Quality Management System Effectiveness SummaryThe Assessor shall summarize the overall effectiveness
of the quality management system in accordance with the criteria below. The term effectiveness is defined as “The
extent to which planned arrangements are realized and planned results achieved”
Familiarize yourself with the following 10 questions prior to the audit, and complete this section at the conclusion
of the assessment, including any trends observed regarding data related to system effectiveness (Corrective
actions, internal audits) and data related to achieving Quality Policy Goals and Objectives. If no trends exist,
and the system is compliant, this must be clearly stated.
1. Was a QMS established, documented, implemented, maintained and continually improved in accordance with this
standard? Y N
2. Has the organization identified processes needed for the QMS and their application throughout the organization
(see 1.2)? Y N
3. Has the organization determined the sequence and interaction of QMS processes? Y N
4. Has the organization determined criteria and methods needed to ensure the effective operation and control of QMS
processes? Y N
5. Has the organization ensured the availability of resources and information to support the operation and monitoring
of QMS processes? Y N
6. Has the organization determined monitoring, measurement and analysis of QMS processes? Y N
7. Has the organization implemented actions necessary to achieve planned results and continual improvement of
QMS processes? Y N
8. Are QMS processes managed in accordance with this standard? Y N
9. Is control of outsourced processes identified within the QMS? Y N
10. Can Internal Quality Audit and Management Review be relied upon as an effective tool to evaluate quality
management system effectiveness? Y N
Additional Notes / Finding Workspace:

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4.2.1 General Documentation Requirements

Does the QMS documentation include documented quality policy and objectives, quality manual, documented
procedures required by ISO, documents identified by the organization to ensure effective planning, operation and
control of processes, and records required by this standard? Y N
Have any specific documentation objectives been established? (I.e. going paperless, internet expansion, streamlining,
etc. (5.4.1)) Y N
Note: Objectives are not necessarily needed for each requirement. Also, if an objective(s)exists for this requirement, please list in table for clause
5.4.1.
Describe any improvements related to QMS documentation? (e.g. Improved review cycle times, documentation
accessibility improvements, streamlining, etc)? Note: Improvement is not required in every area – lack of specific improvement in an
area is NOT a Finding.
4.2.2 Quality Manual

Does the quality manual include; scope of the QMS, justification for exclusions, documented QMS procedures or
reference, description of QMS process interaction (Note: Not all processes are required to be included in 4.2.2(c) description): Y
N
4.2.3 Control of Documents

Does the procedure for document control address the following for control of documents; approval prior to issue,
review, update and re-approval, changes and current revision status identification, relevant version available at points
of use, legible and identifiable external documents identified and distribution controlled, obsolete documents
identified, if obsolete documents, if retained – prohibited from unintended use? Y N
Sample from SOP’s, WI’s, forms, drawings, etc, including revisions, documents of external origin, etc and complete the following table. Sample
should include a few of each type of document.
Doc Id Type Revision Approval Review/up Changes Accessible Legible and External docs Obsolete
OK date Id’ed? ? Identifiable identified/dist Id’ed and
reprove controlled (if precluded
OK applicable_ from use.
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Doc Id Type Revision Approval Review/up Changes Accessible Legible and External docs Obsolete
OK date Id’ed? ? Identifiable identified/dist Id’ed and
reprove controlled (if precluded
OK applicable_ from use.
Additional notes/Finding Workspace:
4.2.4 Control of Records

Is there a method defined for control of quality records with respect to: Y N
- Identification
- Retrieval
- Storage
- Protect
- Disposition
- Retention Time
Are all records reviewed legible? Y N
Show sample of record checked in the matrix below. Minimum recommended sample size is 8 records.
Records Checked Retention Time defined (Y/N) Meets question above (Y/N)
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Records Checked Retention Time defined (Y/N) Meets question above (Y/N)
Additional Notes/Finding Workspace:
Section 5 – Management responsibility

Path:
Auditee:
Quality PolicyY N
A) Was the Quality Policy established by Top Management(5.1 b)? Y N
B) Does the quality policy include a commitment to comply with requirements and continually improve the
effectiveness of the QMS ( 5.3 b) ? Y N
Note that the exact wording "comply with requirements and continually improve the effectiveness of the QMS is not required to be
stated verbatim in the policy.
C) How does top management ensure the quality policy is appropriate to the purpose of the organization ( 5.3 a)?
Describe method (Note:Look for management review as possible method)
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Quality Objectives
Complete the following table. List quality objectives that were derived from the quality policy ( 5.3.c) (1) Each
quality policy statement does not require a 1 to 1match for corresponding objective – one objective may cover many
quality policy statement requirements (2) Quality objectives may be addressed during management review, and /or in
each department
Quality Where Includes Measurable? Consistent with Evidence of Objectives

objective (5.4.1) established in product? (5.4.1) (5.4.1) Quality Policy? QMS planning Achieved?*
Org? (5.1.c, (5.4.1) to meet quality
5.4.1) objectives?
(5.4.2.a)
Quality Where Includes Measurable? Consistent with Evidence of Objectives

objective (5.4.1) established in product? (5.4.1) (5.4.1) Quality Policy? QMS planning Achieved?*
Org? (5.1.c, (5.4.1) to meet quality
5.4.1) objectives?
(5.4.2.a)
*Are action plans available and being followed for objectives that were not achieved? Y N
Note: Action plans may include Corrective action, Continuous Improvement, management review action items, etc. If action plans are not
available, the following clauses should be investigated for possible action request:
5.1 (c). Did Top management effectively ensure that quality objectives were established?
5.4.1. Did top management effectively ensure that quality objectives were established at relevant functions?
5.4.2 (a). Planning of the quality management system must be carried out in order to meet quality objectives. Was this quality planning adequate?
5.6.1 requires the assessment of opportunities for improvement and changes to quality objectives. Was this carried out, and what were the results?

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Quality Management System Planning
Note: May be carried out in management review
How does Top management ensure that QMS planning is carried out? (5.4.2 a)
Describe Method:
Was effectiveness of the QMS Planning process verified? Y N

Note: verified via ISO 9000 implementation plans, management review records, existence of an ISO 9000 program, etc .
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QMS Changes
Select a minimum of 3 QMS changes, and verify that the integrity of the QMS was maintained during implementation(5.4.2 b). Look for impact of
change on QMS measurable to verify effectiveness of change management system
Nature of Change Date Implemented Integrity of QMS maintained (Y/N)?
MANAGEMENT REVIEW
Frequency:
Attendance (“Top Management per ISO 9000 3.2.7”) confirmed( 5.1 d, 5.6)? Y N
Note: Objective evidence of 8.4, 8.5.1, 8.2.1, 6.1, 6.3, 8.2.3, 8.1b and 8.1c may be seen in management review. If so,
complete any related sections of this checklist as management review is assessed.
Review Input 5.6.2
Note: Complete the table below. Y/N, tick marks, etc are acceptable as evidence of completion.
Date Results of Customer Process Status of Follow-up Changes Improvements
audits (Y/N)? Feedback performance, CA/PA(Y/N)? from previous affecting recommended
(Y/N)? product MR QMS(Y/N)? (Y/N)?
conformity items(Y/N)?
(Y/N)?
Review output 5.6.3

Note: Complete the table below. Y/N, tick marks, etc are acceptable as evidence of completion.
Date Improvement of effectiveness of Improvement of product related Resource needs (5.1.e)(Y/N)?
QMS and it’s processes (Y/N)? to customer requirements (Y/N)?
Management Representative reporting QMS performance and improvement needs? (5.5.2 b) Y N

Quality Policy and Quality Objectives assessed for possible changes and improvements?(5.6, 5.3 e) Y N
Do management review records and /or discussions with top management indicate that customer requirements are
determined and met with the aim of customer satisfaction?(5.2) Y N
Does management review confirm the continuing suitability, adequacy and effectiveness of the quality management
system? (5.6) Y N
4.1 Management Responsibility

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Communication Processes
How does Top management ensure that the quality policy is communicated and understood within the
organization(5.3d)?
Describe:
Were the above methods effectively implemented? Y N

Note: this question should not be answered until toward the completion of the audit. Verify during the course of your audit activities.
How does Top management communicate the importance of meeting customer, statutory and regulatory requirements
within the organization (5.1 a)?
Describe:

What communication processes are used to communicate QMS requirements throughout the organization (5.5.3)?
( i.e., Company intranet site, quality manual, training, etc)
Describe:

What communication processes are used to communicate QMS effectiveness throughout the organization (5.5.3)?
(i.e. Posting audit results, quality performance, complaints, etc)
Describe:

Does Top management ensure that responsibilities and authorities are defined and communicated within the QMS?
(i.e, quality manual, org charts, job descriptions, procedures, etc.) Y N
Has Top management assigned a member of management (does not have to be a member of top management) with
responsibility and authority to ensure processes need for the QMS are established, implemented and maintained? Y
N
How does the Management Representative ensure the promotion of customer requirements throughout the
organization (5.5.2 c)?(i.e. Meetings, training, QMS documentation, etc)
Describe:

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Have any specific communication objectives been established? (5.4.1) Y N
5.4.1.
Describe any improvements related to the communication processes (e.g. Intranet development, use of advanced
meeting planning or project planning tools, etc). Note: Improvement is not required in every area – lack of specific improvement in an
Addition Notes/ Finding Workspace
6 Resource Management
Path:
Auditee:
6.1 Provision of Resources: Describe the method used by the organization to determine and provide resources
(people and equipment) needed to implement the QMS and Enhance customer satisfaction by meeting customer
requirements. (Note: If addressed in clause 5, state such)
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6.2 Human Resources – Describe how the organization determines the necessary competency for personnel
performing work-affecting quality, and how the organization assures these competencies are met:
Complete the following table using personnel interviewed throughout the audit as your sample. Include a minimum of 8 personnel, with a cross
section of production personnel and office personnel. If less than 8 available, state such.
Number Date
1.
2.
3.
4.
5.
Differences Resolved Review/approval
Person Position Competency Competency Personnel aware of relevance and Records

defined? achieved? importance of activates maintained per
Y N (6.2.2 a) YN and contribution to quality 4.2.4? Y N
(6.2.2 b) objective achievement? Y N
(6.2.2 d)
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Person Position Competency Competency Personnel aware of relevance Records

defined? achieved? and importance of activates maintained per
Y N (6.2.2 a) YN and contribution to quality 4.2.4? Y N
Describe how the effectiveness of training/actions taken is determined:

Note: Description should include sampling of records
6.3 Infrastructure – Describe how the organization determines and provides the infrastructure needed to
achieve conformity of product including, where applicable (a) Buildings, workspace and associated utilities (b)
process equipment (hardware and software) and (c) Supporting services (transportation or communication. (Note: if
covered in 5.6, 6.1, 7.1 or 7.3, state such)
Is there a system in place to ensure suitable maintenance of infrastructure needed to ensure product conformity? Y
N
Are methods in place to identify which equipment requires maintenance? Y N
Should PM be required on processing equipment at defined intervals, complete the following table to show evidence sampled. Sample a minimum
of 6 records related to PM. If less than 6 records available, state such. If PM on processing equipment is not required, state such.
Equipment Type Date of record Frequency defined Method of PM defined Done per schedule(Y/N)?
(Y/N)? (Y/N)?
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6.4 Work Environment - Describe how the organization determines work environment needed to achieve
conformity to product requirements?Describe the process for review and communication – show 2-3 samples: (Note:
If covered in 5.6, 6.1 or 7.1 or 7.3, state such.)
Describe the management systems used to ensure work environment requirements are achieved. (e.g. project plans,
departmental meetings, internal audit)
Have any specific objectives been established for human resource, infrastructure or work environment? (5.4.1) Y N
5.4.1.
Describe any improvements related to the human resources, infrastructure or work environment (e.g. Enhanced
qualification or training techniques, development of 5S (housekeeping) program, new equipment purchase, plant
layout improvements, etc). Note: Improvement is not required in every area – lack of specific improvement in an area is NOT a Finding.
Additional Notes / Finding Workspace
Section 7 – Product Realization

7.1 Planning of product realization
Describe the suppliers product planning realization process, including the output:
Planning activities are normally focused on how new designs, processes or contracted activities are implemented into production. For example,
look at the process of how new P/N drive updated inspection requirements, BOM, etc (the production paperwork).
Sample a minimum of 3 projects and complete the table below, verifying that each entry is established. If less than 3 projects available, state such.
Project Date Quality Objectives Processes, Verification, Records for the
& reqmts documents and validation, realization process
resources specific to monitoring, and that product
the product inspection&test and meets requirements
acceptance criteria
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7.2 Customer Related Processes

Describe the processes used to determine and review requirements related to the product. Include description of how
this communication occurs with regard to product information, quotes, contracts, orders, amendments, feedback and
complaints.
Note: In some organizations customer requirements may be determined via Marketing and Business Planning processes. The ‘typical’ quote/order
environment may not be applicable. If this is the case, note such in your description and state “NA” for the applicable matrix (e.g.” Quote Matrix
is NA”). Also, note that requirements a-d of 7.2.1 must be included in your description.
Have any specific objectives been established for determining customer requirements and reviewing product
requirements? (5.4.1) Y N
5.4.1.
Describe any improvements related to the methods for determining customer requirements and reviewing product
requirements (e.g. Customer focus groups, benchmarking projects, competitive analysis, use of EDI, etc). Note:
Improvement is not required in every area – lack of specific improvement in an area is NOT a Finding.
Quotations
During quotation review (if applicable), are the requirements reviewed to ensure they are adequately defined (see
table)? Y N
Sample at least 3 quotes. If less than 3 available, state such. Note that with the exception of the quote number and date column, detailed
information is not required in the matrix. Yes/No, tick marks, etc are acceptable to show evidence of coverage.
Quote Number Date Customer Unstated Statutory and Additional Differences Commun Ability to meet
reqmts, but regulatory reqmts resolved? ication to requirements
including necessary reqmts determined? customer confirmed
delivery/post reqmts determined? ? prior to
delivery determined? commitment?
determined?
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Contracts
Are contracts received and reviewed against the quote? Y N
If verbal orders are taken, are they confirmed before acceptance? Y N
Sample at least 3 contracts. If less than 3 available, state such. Note that with the exception of the contract number and date column, detailed
Review Date Customer Unstated Statutory Additional Differences Communi Ability to

Number reqmts, including but and reqmts resolved? cated to meet
delivery/post necessary regulatory determined? customer? requirements
delivery reqmts reqmts confirmed
determined? determined? determined? prior to
commitment?
Customer Blanket POs

Are releases to a customer purchase orders reviewed? ? Some companies do not do blanket orders – if they don’t,
state such. Y NOtherwise show sample of review of 5 3-5 releases:
Number date
1.
2.
3.
4.
5.Describe System including customer communication method (Some companies do not do blanket orders – if they don’t, state
such.):
Sample at least 3 releases. If less than 3 available, state such. Note that with the exception of the release number and date column, detailed
Blanket PO Date Customer Unstated but Statutory and Additional Differences Communic Ability to
Number reqmts, necessary regulatory reqmts resolved? ated to meet
including reqmts reqmts determined? customer? requirements
delivery/post determined? determined? confirmed
delivery prior to
determined? commitment?
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Amendments
Is there a process for handling internally and externally generated amendments to a contract, including ensuring that
relevant personnel are made aware of the changed requirements? Y N
Describe the process for review and communication – show 2-3 samples:
Describe System (including customer communication method):
Sample at least 3 amendments. If less than 3 available, state such. Note that with the exception of the contract number and date column, detailed
information is not required in the matrix. Yes/No, tick marks, etc are acceptable to show evidence of coverage .
Contract Changed Date Communication of change Communicated to customer?
effective?
Customer Communication
Describe the arrangements for communicating with customers related to product information and customer feedback,
including customer complaints.
Note: Product information may include company technical information provided through direct mailing, help desks, internet or sales interaction.
Regarding customer feedback, ensure you check more than just the corrective action system. Customer feedback may come through the sales
function, customer service, servicing function or other parts of the organization that interact directly with the customer.
7.3 Design and development

Complete the table below. You must sample at least 2 design projects. If less than 2 completed projects available, state such. In this case, you
should try to piece evidence from multiple projects when testing effectiveness (e.g. verification from Project 1, Validation from project 2 –
assuming project 1 has not yet gone through validation).
Requirement Project1: Project2: Project3:

Development planning
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- D&D stages including review,
verification and validation included
- Responsibility and Authority defined
Inputs address the following:
- Functional and Performance
- Statutory and regulatory
- Info from similar designs where
applicable
- Other essential D&D requirements
- Reviewed for Adequacy (4.2.4)
- Conflicts resolved
Outputs address the following:
- Meets input requirements
- Appropriate info for purchasing,
production and service
- Contains/References product
acceptance criteria
- Characteristics essential for safe and
proper use included
Review
- Done per plan
- Include evaluation of results meeting
requirements
- Identify problems and necessary
actions
- Includes reps from functions
concerned
- Records Maintained
Verification
- Conducted per plan
- Confirm input to output
- Records maintained
Validation
- Conducted per plan
- Confirm product meets specific
application or intended use where
known
- Completed prior to delivery or
implementation where practical
- Records maintained
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4.4 Design
Design changes
Show sSample 3-4 changesbelow. If less than 34 available – state such. Provide specifics below:
Change # Date Rev & Approved prior Verified and Review evaluation of effects of Records
to implementation validated (if changes on constituent parts Maintained?
(Y/N)? appropriate) (Y/N)? and and delivered product
Have any specific engineering process objectives been established? (5.4.1) Y N

5.4.1.
Describe any improvements related to the design and development processes (e.g. Use of Modeling /Simulation
tools (FEA), Use of FMEA, Cycle time reduction, etc). Note: Improvement is not required in every area – lack of specific
improvement in an area is NOT a Finding.
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7.4 Purchasing
Describe how subcontractors are selected and evaluated on the basises of their ability to supply product in
accordance with the organizations requirements. Include in your description the criteria for selection, and
reevaluation, along with frequency of reevaluation. (Note: If grandfathering is used, the client must define grandfathering criteria and
a grandfathering date. Also ensure that different types of vendors –e.g. raw material, component parts, calibration services, etc are considered)
Sample 5-7subcontractors and complete the table. Make sure your sampling of suppliers is cross sectional (e.g. cal houses, components, raw
matls, subcontracted services (like heat treat, etc). Describe what happens when a supplier is having problems (e.g. SCAR, letter, delisting, etc).
Try to get a mix of suppliers brought on recently and older suppliers. If less than 5 suppliers available to sample, state such.Have quality records
been established and maintained of acceptable su
Name of Supplier Commodity Record of Record of re-
selection/evaluation Evaluation meets reqmts (Y/N – If Y, write
meets reqmts (Y/N – If Y, in date of records sampled)?
write in date of record
sampled)?
Have quality records been established and maintained of acceptable subcontractors? Y N

Does purchasing information describePO’s (electronic or paper) the product to be purchased, including, where
appropriate: Y N?
- requirements for approval of product, procedures, processes and equipment
- requirements for qualification of personnel, and
- quality management system requirements
Show sample in table below. If less than 3 available, state such. Note that with the exception of the PO#, date, and commodity, detailed
PO Commodity Requirements for Reqmts for QMS requirements Ensure the
approval of product, qualification of (Y/N)? adequacy of
procedures, processes personnel (Y/N)? specified
and eqmt (Y/N)? requirements(Y/N)?
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Verification of Purchased Product (Including Receiving Inspection activities where used)

Does the organization or it’s customer perform verification at the suppliers premises? Y N
If so, are verification arrangements and method of product release contained in the purchasing information (Note:
Could be in drawings, specs, PO’s, contract)? Y N
Describe how the organization has established and implemented inspection and other activities necessary for
ensuring that purchased product meets specified purchase requirements:
Sample previous records of receiving inspection and note results in table. If less than 6 records available, note such. Note that with the exception
of the part number, description, date and gage # columns, detailed information is not required in the matrix. Yes/No, tick marks, etc are acceptable
to show evidence of coverage. ( Ref. 8.2.4)
Part#: Description: Date: Criteria: Authority OK?
Additional notes/AR Workspace:
Have any specific purchasing process objectives been established? (5.4.1) Y N

5.4.1.
Describe any improvements related to the purchasing processes (e.g. EDI, Supplier rating Data collection
improvements, etc). Note: Improvement is not required in every area – lack of specific improvement in an area is NOT a Finding.
7.5.4 Customer Property

Describe how the organization controls customer property, including identification, verification, protection and
safeguarding:
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If customer property is lost, damaged or unsuitable for use, is the customer informed and records maintained? Y N
Note: In cases where customer property has been damaged, etc, show records sampled. If none, state such:
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7.5.1 Control of Production and Service Provision
Guidance for completing this Section: The following section is to be used to document your assessment of the
process (manufacturing or service). As many pages as necessary should be generated to complete this section.
The assessor should ensure their notes include information related to how the process is controlled (e.g. set-up and
first piece inspection in a manf. process is a control method). Assessor notes should describe process inputs (e.g.
material, drawings, batch cards, BOM’s, travelers), process activities (e.g. set-up, controls, in-process inspections)
and process outputs (parts, reports, etc).
Notes should include sampling of past records of in-process and final inspections for at least some of the areas you
assess. These should be represented in the 8.2.4 table of this checklist.
While secondary clauses do not have to be shown for every process area assessed, enough evidence should be
represented in the notes to show they were adequately sampled (e.g. If you did 5 manufacturing cells, address 7.5.3 in
3 cells).
Additionally, in cases where the company may operate a warehouse, the following flowchart should be used to assess
these activities (from the perspective of clause 7.5.5 requirements).
In order to ensure complete coverage of all requirements, we’ve included some memory jogger questions, with
“Yes/No” responses required. These are intended to ensure all requirements related to 7.5.1 and 7.5.2 are covered.
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Note: Inputs:
1)For information, consider drawings, specifications,
For Monitoring, consider SPC(8.1),
procedures, control plans, set-up sheets, routers, etc. and
in-process inspection (8.2.4), on-
other outputs of the product realization process (7.1)
going monitoring in cases of special
2) For materials, consider raw materials and components.
processes(7.5.2). Note: previous
Check 7.5.3 reqmts are met
records should be recorded in table
3) For resources, consider tooling, equipment,gaging
in 8.2.4.
personnel (also consider 6.2.2.d - awareness of
importance
Input(Info): During assessment

Monitoring/Measurement: of output, consider
product ID,
inspection/test
status (7.5.3),
handling,
packaging,
preservation, WIP
storage (7.5.5),
control of non-
conformity (8.3)
Input (Materials): Process: Outputs:
For process, consider

how the process is
controlled, including
techniques like set-up,
qualification of
personnel and
complaince with the
outputs of product
realization (7.1)
Input(Resources, e.g. eqmt,
personnel):
Improvement Efforts:
Use this methodolgy for each subprocess

(e.g. a paint process including pretreat,
paint and bake would have 3 flowcharts - Improvement efforts could address inputs, processes, outputs and
one for each subprocess). Note that 1 monitoring. For Improvement efforts, consider tie to objectives (7.1 or
flowchart may be used in cases of 5.4.1), and classic improvement efforts such as mistakeproofing, line
repetitive process (e.g. 1 chart for 10 balance, kiazen projects, etc. Note: there is no requirement to improve
stamping presses). every process (ref 8.5.1).
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7.5.1 Control of Production and Service Provision
Was production and or service carried out under controlled conditions, including, as applicable, the availability of
information describing product characteristics, availability of work instructions, as necessary, the use of suitable
equipment, the availability and use of monitoring and measuring devices, the implementation of monitoring and
measurement, and the implementation of release, delivery and post delivery activities? Y N
Describe how production is planned (e.g. is there a scheduling function.):
Note also that this is a likely input to the production process per the above flow chart. Assessor should verify planning process vs. goals of the
process (e.g. On time delivery))
Have any objectives been established for the planning/scheduling function? (5.4.1) Y N
5.4.1.
Describe any improvements related to the planning/scheduling function (e.g. Automation, MRP, forecast accuracy
improvement, etc). Note: Improvement is not required in every area – lack of specific improvement in an area is NOT a Finding.
7.5.2 Validation of processes for Production and Service Provision (Special Processes)
Have special processes been validated and did this validation demonstrate the ability of these processes to achieve
planned results? Y N
Have arrangement for these processes included, as applicable, (a) defined criteria for process review and approval (b)
equipment and personnel qualification (c ) Use of specific methods and procedures (d) requirements for records
(4.2.4) and (e) and revalidation? Y N
7.5.3 Identification and Traceability
Has the organization identified the product by suitable means throughout product realization, where appropriate? Y
N
Has the product status with respect to monitoring and measurement requirements been identified? Y N
Where traceability is a requirement, has unique identification of the product been controlled and recorded (see 4.2.4)
Y N
Sample materials and records to ensure the system for traceability effectively implemented. Do at least 5 records.
Component/Material Traceability OK (Y/N)?
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7.5.5 Preservation of Product

Is the conformity of product preserved during internal processing, including identification, handling, packaging,
storage and protection? Y N
Note: This should be assessed as part of 7.5.1/2 assessment.
Is the conformity of product preserved during delivery processing, including identification, handling, packaging,
storage and protection? Y N
Note: Use the flow chart above to record assessment details for warehouse activity.
7.6 Control of monitoring and measuring devices
Has the organization determined and provided monitoring and measuring devices needed to provide evidence of
product conformity? Y N
Note: Record evidence in flow chart.
Have processes been established which ensure monitoring and measurement are carried out in a manner that is
consistent with monitoring and measurement requirements? Y N
Note: Record evidence in flow chart.
4.11 CoComplete the following table. Be sure your sample is representative of a good cross section of gages in use.
No. Type loc freq Check Meth
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Sample should include gages calibrated in-house and those done by external cal labs. Note that with the exception of the gage # and date,
detailed information is not required in the matrix. Yes/No, tick marks, etc are acceptable to show evidence of coverage.
GAGE#: Type: Date of record Freq.: Process to cal Status NIST* Protected Safeguarded
(4.2.4) gage defined? identified from from
damage adjustments
and
deterioratio
n
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* If no standard is available, ensure the basis for calibration is recorded.

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Is there evidence of assessing and documenting the validity of previous test results when inspection equipment is
found to be out of calibration? Y N
List examples, if none, state such:
In cases where inspection equipment is found out of calibration, was appropriate action taken on the product as well
as the gaging? Y N
List examples, if none, state such:
When software is used in the monitoring and measurement of specified requirements, is the ability to satisfy the
intended application confirmed prior to initial use and reconfirmed as necessary? Y N
Have any specific gaging objectives been established? i.e. Outsourcing, transition to automated gaging,
implementation of statistical methods such as GR&R. (5.4.1) Y N
5.4.1
Describe any improvements related to the processes for control of measurement devices (e.g. Outsourcing, transition
to automated gaging, implementation of statistical methods such as GR&R, etc). Note: Improvement is not required in every
area – lack of specific improvement in an area is NOT a Finding.
Path:
Auditee:
8.1 General
Has the organanization planned and implemented the monitoring, measurement, analysis and improvement processes
needed to demonstrated conformity of the product, ensure conformity of the QMS and continually improve the
effectiveness of the QMS? Y N
Note: This requirement is embedded in 7.1 for product planning, 8.2.3 for processes, 8.2.4 for product, 8.2.2 for QMS and 8.5.1 for continuous
improvement, and overall in 5.6. Notes in these sections should address this requirement.
Are statistical techniques used (if applicable)? Y N
Note: If used, sample should be shown on the process flow chart or in the applicable business process where used (e.g. management review).
8.2.1 Customer Satisfaction

Describe how the organization monitors information relating to customer perception as to whether customer
requirements have been met. Include in this description, the methods for obtaining and using this information.
Note: Look for use of survey data, benchmarking and competitive analysis, customer meetings, use of complaint data, etc. in meeting this
requirement. Also note that this requirement may addressed elsewhere in the system (e.g. management review). If described elsewhere, state such.
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Is customer satisfaction data used as a measure of QMS performance? Y N
Have any specific customer satisfaction objectives been established? (5.4.1) Y N
5.4.1
Describe any improvements related to the processes for determining Customer Satisfaction (e.g. enhanced data
collection methods, use of benchmarks, etc). Note: Improvement is not required in every area – lack of specific improvement in an
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8.2.2 Internal Audit

Have documented procedures been established for planning, conducting, reporting results and maintaining records for
internal quality audits? Y N
Procedure#:__________________
Is there an internal audit schedule/plan that covers all elements of the quality system? Y N
Does the internal audit process include conformance to planned arrangements per the quality plan (7.1), requirements
of ISO9001:2000 and QMS requirements established by the organization, and is the audit system effectively
implemented and maintained? Y N
Are the audits scheduled based on the status and importance of the area or activity as well as previous audit results?
Y N
Are the audit criteria, scope, frequency and methods defined? Y N
Are internal audits performed by objective and impartial assessors (cannot audit their own work)? Y N
Are the people performing the audit qualified and/or trained as reqd by the procedure? Y N
Describe how the reqmt is met:
Are audit results recorded and brought to the attention of the responsible personnel? Y N
Document sample below, if less than 5 records available state such. Also, if corrective actions from IQA assessed in
8.5.2, no need to reassess. Note that with the exception of the date and CAR# columns, detailed information is not
required in the matrix. Yes/No, tick marks, etc are acceptable to show evidence of coverage.
Date: To Process Auditor Auditor CAR#: RCA: IMP Review? Timely?
Schedule? assessed Qualified Independent
Have any specific objectives been established for the internal audit program? i.e. training new auditors, long range
system improvements (5.4.1) Y N
5.4.1
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Describe any improvements related to the processes for internal audits (e.g. enhanced auditor training, development
of checklists, etc). Note: Improvement is not required in every area – lack of specific improvement in an area is NOT a Finding.
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8.2.3 Monitoring and Measurement of processes

Describe the methods for monitoring and where applicable, measurement of QMS processes (applies to all QMS
processes, not just product realization). Evidence of process monitoring and measurement is embedded in other areas of the standard,
and may be seen in 5.4.1, 5.6, 7.4 (sub-contractor performance) 8.2.1, 8.2.2, 8.3, 8.4, 8.5.1, 8.5.2 and 8.5.3.
Do these methods demonstrate the ability of the processes to achieve planned results and if not, is corrective action
taken? Y N
Have any specific process objectives been established? (5.4.1) Y N
5.4.1
Describe any improvements related to the processes for monitoring and measurement of processes (e.g. automated
measurement tools, expansion of monitoring categories, etc). Note: Improvement is not required in every area – lack of specific
improvement in an area is NOT a Finding.
8.2.4 Monitoring and measurement of product

In-process and Final product verification: From the process path flowchart, extend your sampling of in-process and
final inspection records, as required by the quality plan, in the following table:
Part#: Description: Type (in-process Date: Criteria (7.1) Authority OK (Y/N)?
or final) (Y/N)?

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8.3 Control of non-conforming product

Are the controls, responsibilities and authorities for dealing with Non-Conforming product documented in procedure?
Y N
Procedure reference#:______________
Describe how non-conforming product is identified and controlled to prevent unintended use or delivery. Include in
your description whether the organization (a) takes action to eliminate the non-conformity (b) authorizes it’s use,
release or acceptance under concession by a relevant authority and where applicable by a customer and/or (c) takes
action to preclude its original intended use or application:
Complete the following table by sampling past records of disposition. Note that with the exception of the part number and date, detailed
P/N: Date: Records of nonconformity, action taken and Reverification?
concession (if needed) confirm compliance with
documented procedure?
Describe how the organization takes action in cases where non-conforming product is detected after delivery or use
has started:
Have any specific nonconforming product objectives been established? (5.4.1) Y N

5.4.1
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Describe any improvements related to the processes for controlling and reducing non-conforming product (e.g.
Scrap, rework or repair reductions, disposition cycle time improvement etc). Note: Improvement is not required in every area –
lack of specific improvement in an area is NOT a Finding.
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8.4 Analysis of Data

Describe how the organization determines, collects and analyses appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of
the QMS can be made. Include in this description analysis of data related to customer satisfaction, conformity of
product, characteristics and trends of processes and products and supplier data.
Note:This activity may occur in many different places, e.g. management review, monitoring and measuring or processes, monitoring and
measurement of product, customer satisfaction, continual improvement, etc. If noted as part of the assessment of these processes, state such.
Have any specific data analysis objectives been established? (5.4.1) Y N

5.4.1
Describe any improvements related to the processes for collecting and analyzing data (e.g. new categories of information to
collect and analyze or new methods of collection, etc). Note: Improvement is not required in every area – lack of specific improvement in an area
is NOT a Finding
8.5.1 Continual Improvement

Describe the process for continual improvement in the organization and provide evidence by completing the
following matrix (note: matrix must include any improvements noted throughout the audit):
Describe the improvement and then check off the matrix entry it most closely related to (data/concept that drove need for improvement)
e
Improvement Quality Policy Quality Audit Results Analysis of Corrective Preventive Management
effort Objectives data Action Action Review
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8.5.2 Corrective action

Do procedures define the methods for handling corrective actions from the following sources:handling of the
following corrective actions from the following sources; internal audits, internal nonconformities (product, process &
quality system), customer complaints, and supplier nonconformities and do they include requirements for reviewing
nonconformities, determining the cause, evaluating the need for action, determining and implementing needed
actions, recording the results and reviewing actions taken? Y N
Procedure Ref:__________________
Describe the criteria when evaluating the need for action for each type of Corrective action:
Process:
Supplier:
Customer Complaint:
Internal Audit:
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Do corrective actions address root cause, actions taken and verification of effectiveness?
Complete the table below with 4-5 of each type of CA (IQA, Complaint, Internal, Subcontractor) and verify that
.corrective actions address root cause, actions taken and verification of effectiveness.
No. type Date RCA Impl VOE

1. IQA
2. IQA
3. IQA
4. IQA
5. CC
6. CC
7. CC
8. CC
9. Sup
10. Sup
11. Sup
12. Sup
13. Int
14. Int
15. Int
16. Int
Note: If less than 34 of any type – state such. Note that with the exception of the CAR# and date, detailed
If Internal audit CAR’s covered in 8.2.2, check here
CAR#: Type: Date: Reviewing Cause Implementation and Reviewing:

results recorded:
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Have any specific corrective action objectives been established? (5.4.1) Y N

5.4.1
Describe any improvements related to the processes for corrective action (e.g. problem solving methodologies, mistake-
proofing, inclusion of corrective action impact, etc). Note: Improvement is not required in every area – lack of specific improvement in an area is
NOT a Finding.
8.5.3 Preventive Action Note: If less than 3 records – state such.
Describe how the organization determines actions to eliminate the causes of potential nonconformities in order to
prevent their occurrence (Note: May relate to actions initiated from analysis of data (8.4), continual improvement (8.5.1), or management
review (5.6).
What data is used to detect potential causes of nonconformities?
Once need for a PAR is determined, ensure the steps required by the standard are conducted by completing the following table. If less than 3
samples available, state such. Note that with the exception of the PAR# and date, detailed information is not required in the matrix. Yes/No, tick
marks, etc are acceptable to show evidence of coverage.
PAR#: Type: Date: Reviewing Cause Implementation Reviewing:
and results
recorded:
Additional notes/Finding Workspace:
Have any specific preventative action objectives been established? (5.4.1) Y N

5.4.1
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Describe any improvements related to the processes for preventive action (e.g. use of Kiazen, use of FMEA, etc). Note:
Improvement is not required in every area – lack of specific improvement in an area is NOT a Finding.
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Path:
Auditee:
Previous Audit Finding Verification Page:

Finding No. Clause No. Corrective Action/Objective Evidence of “Closed” or New Finding
Implementation and Effectiveness No.
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LONG TERM STRATEGIC REVIEW
The following questions should be answered based on the analysis of prior audit reports. It is suggested that 3
to 4 internal audits be conducted before completing this page. Trends from management review, corrective
action, internal quality audits and customer satisfaction should be used to complete the following questions.
1. Have any audit findings been rewritten? YES NO

If yes, have the rewritten findings now been adequately addressed? YES NO
Explain if not adequately addressed, including why and there planned actions, if applicable.
2. Does the analysis of internal quality audit trends reflect continued effectiveness of the quality management
system?
Explain if no. YES NO
3. Do management review records indicate the continued effectiveness and improvement of the quality
management system? YES NO
If no, explain (including what management has done to ensure action was taken to resolve the issues):
4. Do corrective action records show continued compliance of the quality management system and that any
adverse trends have been adequately addressed? YES NO
If no, explain – including nature of any negative trends and planned actions.
5. Do customer satisfaction trends show acceptable levels, and have any adverse trends been adequately
addressed? YES NO
If no, explain – including nature of any negative trends and planned actions.
6. Has a serious quality system event (recall, extensive warranty claims, customer probation status initiated,
etc) occurred? YES NO
If yes, have the related issues been resolved? YES NO
List Audit Findings Numbers Generated From This Review Below:

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