3-Year ISO 9001 Internal Audit Schedule

Section Notes Target Date Target Date Target Date

4.1 General 12/5/2009 4/5/2010 4/5/2011
4.2 Documentation 12/5/2009 4/5/2010 4/5/2011

5.1 Management Commitment 12/5/2009 4/5/2010 4/5/2011

5.2 Customer Focus 12/5/2009 4/5/2010 4/5/2011
5.3 Quality Policy 12/5/2009 4/5/2010 4/5/2011
5.4 Planning 12/5/2009 4/5/2010 4/5/2011
Responsibility, Authority,
5.5 and Communication 12/5/2009 4/5/2010 4/5/2011
5.6 Management Review 12/5/2009 4/5/2010 4/5/2011
6.1 Provision of Resources 12/5/2009 4/5/2010 4/5/2011
6.2 Human Resources 12/5/2009 4/5/2010 4/5/2011
6.3 Infrastructure 12/5/2009 4/5/2010 4/5/2011
6.4 Work Environment 12/5/2009 4/5/2010 4/5/2011
Product Development
7.1 Planning 12/12/2009 10/1/2010 10/1/2011
Customer Related
7.2 Processes 12/12/2009 10/1/2010 10/1/2011
7.3 Design and Development 12/12/2009 10/1/2010 10/1/2011
7.4 Purchasing 12/12/2009 10/1/2010 10/1/2011
Production and Service
7.5 Provision 12/12/2009 10/1/2010 10/1/2011
Control of measuring and
7.6 Monitoring Devices 12/12/2009 10/1/2010 10/1/2011
Measurement, Analysis,
8.1 and Improvement 12/12/2009 10/1/2010 10/1/2011
8.2 Monitoring and Measuring 12/12/2009 10/1/2010 10/1/2011
Control of Non-conforming
8.3 Product 12/12/2009 10/1/2010 10/1/2011
8.4 Analysis of Data 12/12/2009 10/1/2010 10/1/2011
Cont Improvement
including Preventive and
8.5 Corrective Actions 12/12/2009 10/1/2010 10/1/2011
The audit check sheet starts with section 4 so that the numbering of all header is synchronized with the ISO 9001:2008 version of the standar
numbers of procedures and QM sections that demonstrate compliance for each area.
Section 4 is great place to start an internal audit because it address the "big picture" items. If there are any non-conformances from a section
sections 5 through 8. This will save a lot of effort documenting the same problem over and over.

Question
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
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?
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
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 customers 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 effect 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?
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?

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?

6.3 Work Environment

How does the organization assure that the environment is sufficient the provide consistent product
conformity?
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)
HowResponsibilities and between
are the interfaces authorities of personnel
different groupsinvolved
defined in themanaged
and design process
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?
Howsupplier
Are does the organization
periodically establish criteria
re-evaluated for selection
to determine and evaluation
their compliance with of
thesuppliers?
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 tracibility 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 process 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?
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?
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 is 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 nonconforming product is corrected, is it subject to re-verification or re-test to
confirm conformity?
If nonforming 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?
1:2008 version of the standard. While audting, list documentation

conformances from a section 4 audit, fix the problems before auditing

Reference
Notes
Documents