Reference

Question Notes
Documents
4.1 General Quality System Requirements
Has the organization established, documented, implemented and
maintained a quality management system in accordance with the ISO 9001
Requirements
Is the Quality Management System (QMS) continually improving?
Does the organization:
1) Identified the process needed for the QMS throughout ISO9001 the
organization?
2) Determined the proper interaction between the process ISO9001 Is there
a flow chart that shows the process flow for the entire organization?
3) Determined and document criteria and methods to ensure ISO9001 that
the operations and process control are effective?
4) Have resources and information necessary to support ISO9001 the
operation and maintenance of their process.
5) Measure, monitor and analyze their processes?
6) Implement corrective and preventive actions needed to achieve the
planned results as documented in the quality plans?
7) Does the company have documentation to show continuous
improvement of their process?
Does the organization have documentation in accordance with the
requirements of the ISO 9001 Standard
How does the company control quality processes that are performed
outside of the ISO approved facility?
4.2 Documentation Requirements
4.2.1 General
Does the QMS documentation system include:
1) Quality Manual?
2) Documented company quality policy and quality objectives?
3) Documented level 1 and level 2 procedures as required by ISO 9001?
4) Document how the company can effectively plan, operate and control its
processes?
5) Creation and management of Records that demonstrate compliance the
ISO standard?
4.2.2 Quality Manual
Has a quality manual been created and maintained the includes:
1) The scope of the quality management system and any justification for
exclusion to the standard (such as obsolete product lines)?
2) Description of the interaction between the process of the quality
management system (usually in the form of a flow chart showing product
flow from design and order to delivery and service)?
3) The procedures required by the ISO standard or references to the
required procedure control numbers (usually the general statements are in
the quality manual and the detailed procedures are separate documents)?
4.2.3 Control of Documentation
Are all QMS documents (manuals, procedures, data sheets, work
instructions, records, and procedures) controlled (including revision
control, controlled access to originals, control of distributed copies)?
Does the company have a document control procedures that including:
1) Notification of the ISO approval body prior to implementation of any
change to a agency controlled document?
2) Approval, update and distribution processes for changes to all quality
documents (May be part of the ECO procedure)?
3) Ensure that the current revision documents (with no confusion about the
current revision) are available at the point of use?
4) Ensure that the documents remain legible and easily identifiable?
5) A process for controlling documents of external origin
6) Control of obsolete documents to assure they are not used in current
production.
4.2.4 Control of Records
Does the company create and maintain records ?
Does the company have records to provide evidence that the QMS is
effective (examples include management review records, corrective and
preventive actions logs, customer survey or feedback records)?
Has a documented procedure been written to define the following record
control mechanisms:
Identification and retrieval?
Storage and protection?
Retention time and Disposition?
This check list will cover management commitment, customer focus, quality policy and
management review. This section will require participation from the top management and from
the quality representative. The quality representative should be the best source for information
about the management reviews.
 Reference
Question Notes
Documents
5.0 Management Responsibility
5.1 Management Commitment
Has top management provided evidence of its commitment to the
development and maintenance of the QMS including
a) Communication of the importance of meeting the customer regulatory
and legal requirements.
b) maintaining and communicating the quality policy.
c) Ensuring that quality objectives are established and routinely evaluated.
d) Routinely (once per year minimum) conducting management reviews of
the QMS.
e) Ensuring the QMS is given adequate resources.
5.2 Customer Focus
How does top management ensure that customer requirements are
determined and their needs are meet?
What program exists to increase customer satisfaction?
5.3 Quality Policy
How does top management ensure that the quality policy:
a) meets the need of the organization
b) Continuously improves
c) Is communicated and understood throughout the organization ( Has the
entire organization been trained on the QMS)
d) is periodically reviewed
5.4 Planning
5.4.1 Quality Objectives
Are the Quality objectives consistent with the quality policy?
Are the quality objectives measurable ?
Are quality objective set for appropriate levels of the organization?
5.4.2 Quality Management System Planning
How has top management assured that the resources needed to achieve the
quality objectives are identified and planned?
If the output from planning objectives documented (ex. work instructions,
procedures, quality manual, quality plans, etc)?
5.5 Responsibility Authority and Communication
5.5.1 How has top management ensured that the responsibilities and
Authority are defined and communicated within the organization (Org
Charts and/or Quality responsibly defined in training records)?
5.5.2 Management Representatives
Has top management assigned member of management who have the
responsibility and authority ( and which document defines these tasks):
Ensuring that processes are established, implemented and maintained
(usually engineering and quality personnel)?
Reporting to top management on the status of the QMS including areas that
need improvement (usually presenter of the QMS status in the management
review meeting)?
Promote the critical nature of meeting the customer’s requirements in every
level of the organization (usually the quality or customer service manager)?
5.5.3 Internal Communication
How does top management ensure that communication of quality issues is
communicated throughout the organization (what process or document
defines this flow)?
5.6 Management Review
Does Management review the QMS at planned intervals to ensure the
effectiveness of the plan ?
Are records of the management review kept maintained as quality records?
Are the minimum requirements for a management review described in a
procedure?
Does the management team meet at least once per year?
5.6.2 Management Review Input
Does the management review include the all of the following sources for
quality information:
Customer feedback? What procedure describes how customer feedback is
gathered and presented?
Result of both internal and external audits (including findings and follow-
up items)?
Action items from previous management review meeting?
Corrective and preventive actions?
Any significant items that could affect the QMS (changes in personnel,
training requirements, new products, etc...)?
Product conformity and process performance metrics?
5.6.3 Management Review Output
Is the feedback from the management review tracked to ensure that quality
is continuously improving (maybe using corrective and preventive actions
system)?
Are the outputs from the management review given the proper resources
for corrective and preventive action?

This audit check sheet covers section 6 of the standard so it is focused on Human resources. It is
a very short piece of the overall requirements but training is heavily audited area. The standard
requires all employees to be trained OR qualified. All employees should be trained on their
standard operating procedures, the use of the quality system, and how to be audited. This
checklist also covers Infrastructure and work environment. This audit may require the attendance
of the management representative, personnel, and a production or service manager
Reference
Question Notes
Documents
6.1 Human Resources
Are all employees who effect the quality of product or services qualified or
trained to ensure consistent output?
Has the organization provided appropriate training to satisfy the customer
requirements?
What quality records show training requirements (does the requirement
include a training interval)?
What records show that training is completed?
Has the company provided quality awareness training for employees of the
importance of quality, the quality system, and the importance of meeting
the quality objectives and the customer requirements?
Are records maintained to prove that all employees are either trained or
qualified to perform their job in accordance with quality standards?
6.2 Infrastructure
How does the organization maintain equipment used to control the quality
of the products and services?
How does the organization control hardware and software used in the
production of product?
How does the organization assure that the building and environment are
maintained in order to provide consistent quality?
6.3 Work Environment
How does the organization assure that the environment is sufficient to
provide consistent product conformity?

This check sheet includes questions on product realization (production) and order entry including
all customer contacts. It also includes design control, purchasing control, inventory control and
control of measuring equipment.

Because the checklist touches so many areas and will require interviewing so many different
people, you may want to split this audit between different people or different days. You will need
to get access to production personnel, design engineers, purchasing personnel, order entry and
inventory people.
Reference
Question Notes
Documents
7 Product Realization
7.1 Planning
Is the planning of product realization process integrated into the entire
quality system? (specifically management review)
Are the following being reviewed during the product planning:
a) Quality objective, Product specification
b) The need for additional processes, resources, and documentation
c) Requirements for verification, validation, monitoring, inspection, and
test requirements
d) Are record maintained for all stages of the development process
7.2 Customer Related Processes
Has the organization determined the:
a) Requirements specified by the customer including delivery and post-
delivery activities (training and installation, support, etc)
b) Requirements not specified by the customer but necessary to use the
product for its intended purpose (proper application, safe operation,
integration with other products )
c) Regulatory and statutory requirements related to the product
d) Any additional requirements determined by the organization (limitations,
warranty, special requirements)
7.2.2 Review of the requirements related to the product
Are the requirements reviewed prior to commitment to the customer
(acceptance of contracts or change orders)
Does the company have the following information prior to commitment:
a) Full product specification
b) Contract or order requirements difference from previous orders
c) Ability of the organization to meet the customer requirements
Are the order review and actions from the order review recorded and
maintained as a quality record?
Is the critical order information 100% complete prior to acceptance?
Are changes to the product requirement (including change orders)
communicated to all appropriate levels of the organization?
7.2.3 Customer Communication
What system does the company use for customer communication of:
a) Product specifications and information (salesmen, web site, spec sheets)
b) Inquiries, contracts, change orders and new orders
c) Customer feedback including customer complaints (like Corrective and
Preventive Actions)
7.3 Design and Development
Are product design and development activities planned and controlled?
Using what documents?
Does the design and development plan (sometimes called a quality plan)
include:
a) Different stages of development
b) Design reviews at appropriate stages
c) Verification of the design to the design specifications
d) Validation (official sign-off) of the design against the critical
specifications
e) Responsibilities and authorities of personnel involved in the design
process
How are the interfaces between different groups defined and managed to
ensure proper communication?
Is the planning output updated as the design progresses (ex: revision
control of specification)
7.3.2 Design and Development Inputs
Are inputs relating to the product design requirement defined documented
and maintained as a record (sometimes call a design specification)?
Does the design and development input include:
a) Functional and performance requirements?
b) Applicable statutory, regulatory, and legal requirements?
c) Applicable information for previous designs (are they learning from their
mistakes)?
d) Other requirement essential to design and development
Are the design inputs review for overall integrity, quality and completeness
(design review)?
Are incomplete, conflicting and ambiguous requirements correct?
7.3.3 Design and Development Outputs
Are the outputs of the design and development process in a form that
allows for verification against the design and development inputs?
Does the design and development output:
a) Meet or exceed the design and development input (
b) Include appropriate information for fabrication, purchasing, production
and service of the product?
c) Contain and reference product acceptance criteria
d) Specify the product characteristics that are essential for the safe and
proper use (limitation)?
7.3.4 Design and Development Reviews
Are systematic reviews completed at suitable stages in accordance with the
design and development plan?
Do design reviews evaluate the ability of the design to meet the ?design
specification??
Do design reviews identify problems and propose necessary corrective
actions?
Do design reviews include appropriate representatives from all the areas
affected by the design?
Are results of design reviews maintained as quality records?
7.3.5 Design Verification
Is the design verified against the product design specifications?
Are the verification results maintained as quality records?
7.3.6 Design Validation
Is the design validated by qualified personnel?
Is the design validation performed to confirm that the product meets the
design specification?
Is validation testing completed prior to delivery of the product?
Are the results of the validation testing maintained as quality records?
7.3.7 Design Control
Are design specification changes identified and recorded?
Do design changes include evaluation of effects on subcomponents and
existing products in the field?
Are design specification changes reviewed, verified and validated before
implementation?
Are design specification changes recorded and maintained as a quality
record?
7.4.1 Purchasing Control
How are the purchasing processes controlled to ensure that the purchased
products and services conform to the specifications or requirements? What
is the procedure number?
How are critical safety-related parts or key components and services given
special attention?
Are suppliers selected and evaluated based on their ability to supply
conforming product?
How does the organization establish criteria for selection and evaluation of
suppliers?
Are supplier periodically re-evaluated to determine their compliance with
the requirement of the company?
Are evaluations maintained as quality records?
Are copies of corrective actions sent to suppliers maintained as quality
records?
7.4.2 Purchasing Control
Does the purchasing information describe the requirements for approval of
products, procedures and equipment?
Does the purchasing information describe the requirements for a quality
management system (including ISO 9000 or equivalent)?
How are the specifications for purchased parts and services checked prior
to communication to the supplier?
7.4.3 Verification of Purchased Product
Are inspection and incoming testing requirements specified to ensure that
purchased parts conform to the specification (Give an example)?
Are inspection and incoming testing requirements specified in the
purchasing information whenever the inspection or incoming testing is
completed by the supplier (Give an example)?
7.5.1 Control of Production and Service Provision
Is information about the product requirements available to production and
service personnel?
Are work instructions used where required?
Is suitable equipment available to production and service personnel?
Is monitoring / measuring equipment available to production and service
personnel?
Is information about the release, delivery and post delivery (installation and
service) available to production and service personnel?
7.5.2 Validation of Processes for production and service provision
Does the company validate products and service to assure no latent
failures?
Are process validated against the quality plan?
Are criteria for review and approval of production and service processes
defined?
Is production and service equipment approved for use?
Are production and service personnel qualified for the appropriate
processes?
Are record requirements established as part of the quality plan?
Are plans made for re-validation if required?
7.5.3 Identification and Traceability
Is the product uniquely identified throughout the product realization
(production process)?
Is the product status (conforming/non-conforming) identified with respect
to measurement and monitoring requirements?
When traceability is required, is the product uniquely identified and
controlled?
Is the unique identification information maintained as a quality record?
7.5.4 Customer Property
Does the company ever maintain customer property (including units return
for service)?
Does the company exercise care with customer property while it is in the
control of the organization?
Is customer property identified, verified, and protected?
If the customer property is lost, damaged or found unsuitable for use, is the
condition recorded, reported to the customer, and is this information
maintained as a quality record?
7.5.5 Preservation of product
How is the product preserved during internal processing and delivery?
Is the product identified during processing?
Do preservation activities include handling, packaging, storage, and
protection?
Are preservation activities applied to component and sub-assemblies?
7.6 Control of Measuring and Monitoring Devices
Has the company determined the monitoring and measurement
requirements needed to ensure conformity of the product to the
requirements?
Have processes been established (and documented) to ensure that
monitoring and measurement are carried out in a consistent manner?
Is measurement and monitoring equipment calibrated or verified at
specified intervals prior to use?
Is measurement and monitoring equipment calibrated or verified against
traceable international or nation standards (where ever possible)?
Is measurement and monitoring equipment adjusted or re-adjusted as
necessary?
Is measurement and monitoring equipment identified with a calibration
status?
Is measurement and monitoring equipment safeguarded against improper
adjustment that could invalidate the measurements?
Is measurement and monitoring equipment protected from damage and
deterioration during usage, maintenance and storage?
Has the company ever shipped, installed, or sold any product that was later
found to be invalid due to measurement or monitoring errors? If so, were
the action recorded (and maintained as a quality record)?
Are records of calibration and verification results maintained as quality
records?
Where computer software is used for monitoring and measurement is the
software confirmed prior to initial use?
Is computer software (used in products) periodically reconfirmed?
Section 8 of our internal audit checklist is mainly focused on monitoring, measurement and
analysis of quality data. Other key areas in part of the internal audit include customer
satisfaction, internal audits, non-conforming materials management and analysis of data.
Remember that analyzing data about non-forming materials, inspection reports and final testing
result are all good forms of SPC.

The last section is about continuous improvement. The key to showing continuous improvement
is to have a good engineering change order system that builds record to demonstrate that the
organization is doing corrections of known problems and performing preventive actions to make
the products and the quality system better.

Because the checklist touches so many areas and will require interviewing so many different
people, you may want to split this audit between different people or different days. You will need
to get access to production personnel, design engineers, purchasing personnel, order entry and
inventory people.
Reference
Question Notes
Documents
Does the company perform monitoring, measurement, analysis and
improvement processes to ensure conformity of the product?
Does the company perform monitoring, measurement, analysis and
improvement processes to ensure proper operation of the quality system?
Does the company continuously improve the effectiveness of the quality
management system?
Where does the company use statistical techniques to evaluate the product
and quality system?
8.2 Monitoring and Measuring
8.2.1 Customer Satisfaction
Is information about customer perception and the ability of the company to
meet the customer requirements monitored by the organization?
What systems are used for obtaining and using information relating to
customer satisfaction?
8.2.2 Internal Audits
Are internal audits performed at periodic planned intervals to determine if
the quality system conforms to the ISO 9001 requirements?
Are internal audits performed to determine if the quality system is
effectively implemented and maintained?
Does the internal audits plan take into consideration previous audit results
(follow up)?
Is the audit criteria, scope period and method define in a document?
Do auditors ever audit their own work?
How does auditor selection and auditor performance ensure objectivity and
impartiality in the audit process?
What system is in place to ensure that audit non-conformities and their
causes are corrected and eliminated without undue delay?
Do follow-up audit activities include verification of the actions taken and
reporting of the results?
8.2.3 Monitoring and Measurement of Processes
Are suitable methods used to assure that the company processes meet the
customer requirements?
Do these methods demonstrate the ability of the processes to fulfill the
quality plan?
Are corrective actions taken when planned results are not achieved?
8.2.4 Monitoring and Measure of Product
Are product characteristics monitored and measured to confirm that the
product meets the requirements?
Is monitoring and measuring the product done at an appropriate stage in the
product realization (production process)?
Is evidence of conformity with the acceptance criteria documented and
maintained as a quality record?
Are records maintained to indicate the person authorizing the release of the
product?
Are all planned activities completed prior to the release of the product
(unless otherwise approved by the relevant authority or customer)?
8.3 Control of nonconforming Product
How Is nonconforming product identified and controlled to prevent
unintended usage or delivery?
What documented procedure establishes controls, assigns authority and
responsibility for processing of nonconforming materials?
Are actions taken to eliminate the source of nonconforming products?
What process is used to authorize use, release or accept nonconforming
product with concessions?
Are records maintained identifying the non conformities and any
subsequent actions taken to use the product with concessions?
When non-conforming product is corrected, is it subject to re-verification
or re-tests to confirm conformity?
If non-conforming product is detected after delivery or use, is appropriate
action taken by the organization to correct the problem?
8.4 Analysis of Data
Is appropriate data collected and analyzed to demonstrate the effective of
the quality management system and continuous improvement system?
Is the data from multiple sources like product, process, quality system,
customer or information from other relevant sources?
Does the analysis of this data provide information about customer
satisfaction
Does the analysis show conformance to the product requirements?
Does the analysis show trends of process and products including
opportunities for continuous improvement (corrective and preventive
actions)?
Does the analysis provide information about the performance and trend for
suppliers?
8.5 Improvement
8.5.1 Continual Improvement
What systems does the organization use to continually improve the
effectiveness of their QMS?
Are results of audit, management reviews, corrective and preventive
actions, and analysis of data used for continuous improvement of the QMS,
processes and products?
8.5.2 Corrective Actions
Are corrective actions taken to eliminate the cause of nonconformities and
to prevent further nonconformities?
Are corrective actions appropriate based on the non conformities
encounters?
What is the documented procedure for reviewing nonconformities
including customer complaints?
What is the documented procedure for determining the cause of
nonconformities?
What is the documented procedure (part of a documented procedure) for
determining the implementing actions?
Are corrective actions recorded and maintained as a quality record?
Are corrective actions reviewed to confirm that the action was successful?
8.5.3 Preventive Actions
What procedure describes how the organization takes actions to eliminate
potential non conformities before they happen?
What is the documented procedure for determining potential
nonconformities?
What is the documented procedure for determining the cause of
nonconformities?
What is the documented procedure (part of a documented procedure) for
determining and implementing actions?
Are preventive actions recorded and maintained as a quality record?
Are preventive actions reviewed to confirm that the action was successful?

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According to the website, some of these are only “partial” checklists, as they offer the full ones
for sale.