AuditChecklist 020211

Department:
Locations Sampled:
MAJOR
Minor
Comment
Relationship with ISO 9001:2008 D
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This is what the standard is requesting we document, define, prove, and/or
record. A description of the types of expectations (shown to the left) is
embedded electronically in the cell for each expectation as a comment.
(Italics tends to identify a note or summary of what is being covered
somewhere else.)
This is where we note the location of the answer to the
EXPECTATION in our system. Grayed out boxes do
not require a response, as they will be addressed in the
sections referenced. When the SYSTEM TRAIL entry
is BOLD ITALIC , this is a required record for the
records control procedure addressed in 4.2.4.
Evidence reviewed and/or issues identified.
(black font is comment/evidentiary, blue is
opportunity for improvement, and red is a
nonconformance [issue that must be resolved]) C
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General questions during all audit a a a Do you know your Quality Policy? What does it mean?
What are the organization quality objectives?
How do you contribute to meeting organizations quality objectives?
Who is the ISO Management Representative?
Do you think you have received adequate training?
4.2.1 Documentation
Requirements
4.2.2 Quality Manual
Does the Organization have a documented Quality Manual?
Does the organization have stated Quality Policy & Objectives?
Does the organization have the 6 required procedures stated by the
standard?
What other additional Documents does the organization provide to show
effective planning, operation & control of its processes?
Does the quality manual describe the scope of the QMS?
Does the quality Manual describe the interaction between processes?
Does the quality Manual identify exclusions, if any?
4.2.3 Control of Documents Does the organizations Document Control procedure address the following:
- Approval of documents
- Review of documents
- Revision control of documents
- proper identification controls of documents
- reapproval of documents, as necessary
- control of external documents
- control of obsolete documents to prevent unintended use. If so, how?
Does the organization have a Master Document list? If so how is it controlled
& managed?
Does the Master Document List identify all the organizations documents with
accurate information?
Does the Master Document List include external documents?
4.2.4 Control of Records Does the organization have a documented Records control procedure that
addresses the following?
- identification controls for records
- strorage requirements for records
- protection requirements for records
- retreival/access controls for records
- retention policy for records
- define disposition of records after their intended use
Are the records legible & identifiable?
Do the records have proper revision controls?
Does the organization has a records control list? If so, does it address all the
required controls for records?
Audit Summary:
System Strength:
System Weakness:
EXPECTATION DEFINED SYSTEM TRAIL AUDITOR COMMENTS
Intelex NC # & CA #
SUMMARY OF AUDIT RESULTS
Phone:
Email:
TYPE OF
EXPECTATION
Intelex Audit Report #
Name:
(Contact)
AUDITORS
FINDING
Audit Scope/Criteria:
(e.g., area(s) being audited, applicable clauses from
ISO 9001, applicable Administrative Directive
requirements, state or federal regulations, etc.)
Fax:
FINDINGS
Quality Management System Audit Checklist
(a cumulative audit report/summary and management summary)
LEAD AUDITOR DEPARTMENT CONTACT INFORMATION/AUDIT PLANNING
TO
AUDIT DATE
(RANGE)
CLAUSE
242206875.xls.ms_office COD-FRM-009 Revision: 4 08/23/10 1 of 7
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5.1 Management Commitment Does the organization have an established Quality Policy?
Does the organization have a established Quality Objectives?
How does the organization provide effective communication of customer,
statutory & regulatory requirements?
Does the management conduct Management review meetings?
Does the organization provide resources for effective operation of its
processes?
5.3 Quality Policy Is the documented quality policy appropriate for the purpose of the
organization?
Does the quality policy include a commitment to comply with requirements?
Does the quality policy include a commitment to continual improvement?
5.4 Planning Did the organization establish documented quality objectives, including
product-related ones, at all relevant functions and levels?
Are the quality objectives measurable & consistant with the quality policy?
What QMS planning activities are used to establish the following:
- identify processes needed
- determine sequence & interaction of processes
- methods and criteria needed to show effective operation & control
- availability of resources & information ncecessary for support operations
- monitor, measure & analyze processes
- implement actions necessary to achieve planned results and continual
improvement
- establish controls for outsourced processes
How does the organization plan to maintain the integrity of the QMS when
changes occur?
5.5 Responsibility, authority and
communication
How are responsibilities & authorities estblished within the organization? Does
it have an ORG chart?
Did the organization appoint an Management Representative?
What kind of responsibilities & authority does the Management
Representative has in achieving the following:
- establish, implement & maintain processes needed for effective QMS
- report to management on the performance of the QMS & any improvements
necessary
- promote awareness of customer requirements throughout the organization
What kind of communication channels are established regarding the
effectiveness of the QMS?
5.6 Management Review Are Management Reviews conducted at planned intervals to ensure the
continued suitability, adequecy & effectiveness of its QMS?
Are records of Management Review minutes maintained?
Does the Management reviews take into account of the following?
- results of previous audits
- customer feedback/complaints
- process performance (Objectives) & product conformity (NCR's)
- status of corrective & preventive actions (CA/PA's)
- follow-up actions from previous management reviews
- changes that could affect the QMS
- recommendations/opportunities for improvement
Does the result of Management Reviews provide the following:
- improvement of the effectiveness of the QMS & its processes
- improvement of product/service in relation to its customers
- address resource needs
6.0 Resource Management
6.1 Provision of Resources
Are the resources needed to implement, maintain & continually improve the
effectiveness of the QMS & its processes determined & being provided?
Are resources needed to enhance customer satisfaction determined & being
provided?
6.2 Human Resources Is the competence of the personnel affecting quality of the product/service
determined in relation to their education, training, skills and experience?
Are the personnel affecting quality are being provided with training?
Is the training effective? How is it evaluated?
Does staff understand the importance of their training and how their activities
contribute to the quality objectives of the organization?
Are records of education, training, skills & experience properly maintained and
readily available?
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6.3 Infrastructure
6.4 Work Environment
Are necessary infrastructure (buildings; work space & associated utilities;
equipment - both hardware & software; supporting services - transportation,
communicationsetc) provided & maintained to ensure product/service
conformity to requirements?
Does the organization determine & manage the work environment (conditions
such as lighting, ventilation, clealinesses of work spaces...etc) necessary to
achieve conformity of product/service requirements?
7.0 Product Realization
7.1 Product Planning
Are the processes needed for product/service realization identified, planned,
developed & implemented?
Are product related Quality Objectives established?
Are the following identified, established & implemented in relation to the
product/service:
- processes
- resources
- documents
- verifications, validations, monitoring, Inspection & test activities
- criteria for acceptance
Are the product/service specific records identified, established & maintained
(per 4.2.4)?
5.2 Customer Focus
7.2 Customer Related Processes
How does the organization determine customer requirements, including
delivery & post-delivery requirements?
How does the organization address unstated customer requirements?
How does the organization determine statutory, regulatory & any other
additional requirements determined by the organization?
Are all product/service requirements identified, reviewed & confirmed prior to
acceptance of order/contract?
Does the organizations ability to fullfill the customer requirements
established?
Show that relevant documents are amended & communicated to all involved
parties when product/service requirements have changed after acceptance of
order/contract?
Are proper records of reviews, changes & customer communication
maintained?
When the customer provides no documented statement of requirement, does
the organization confirm the requirements before acceptance?
Are proper communication channels established for handling customer
feedback & customer compliants?
7.3 Design
7.3.1 Design & development
planning
Does the organization has established plan & controls for design &
development?
Does the design & development plan identify the design changes?
Does the design & development plan identify reviews, verifications &
validations required at each stage?
Does the design & development plan identify the roles, responsibilities &
authority?
Does the design plan establish effective communication plan?
7.3.2 Design & development inputs Are the design inputs identified & records maintained?
Does design inputs include the following:
- functional & performance requirements
- statuatory & regulatory requirements
- inputs ffrom previous similar designs, where applicable
- any other essectial requirements as needed
Are the design inputs reviewed for adequecy (requirements are complete,
unambiguous and not in conflict with each other)?
outputs
Are the design outputs reviewed & verified to meet design inputs?
Are the design outputs approved prior to release?
Does the design outputs show appropriate information for purchasing,
production and/or service, as applicable?
Does the design outputs provide appropriate reference to product acceptance
criteria?
Does the design outputs specify the characteristics of the product that are
essential for its safe & proper use?
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review
Are systematic design reviews being conducted at planned stages?
Does the design reviews evaluate the ability of the results to meet
requirements?
Does the design reviews identify problems & propose necessary actions?
Are appropriate personnel involved in the design reviews? (representatives of
functions & stackholders)
Are the records of design reviews properly maintained?
verification
Are design verificaton activities planned & conducted at appropriate stages?
Does the design verification ensure that outputs met design requirements?
Are the records of verificaion & any necessary actions properly maintained?
validation
Are design validation activities planned & conducted at appropriate stages?
Does the design validation ensure that the product/service met its intended
purpose?
Where applicable, is the design validation conducted & performed prior to its
delivery or implementation?
Are the records of validation & any necessary actions properly maintained?
changes
Are design changes reviewed, verified/validated and approved before
implementation?
Does the review of design changes include its effect on constituent parts and
product already delivered?
Are the records of the results of design changes and any necessary actions
properly maintained?
7.4 Purchasing What type and extent of controls does the organization has over its suppliers?
Does the organization has controls established for any outsourced processes
or products?
Is supplier evaluation criteria established? How often are suppliers evaluated?
Are records maintained on supplier evaluations?
Does the purchaing information describe the product/service to be
purchased?
Does the purchasing information describe the following:
- requirements for approval of product/service, procedures, processes and
equipment?
- requirements for qualification of personnel?
- requirements of Quality Management System? (such as a purchasing
procedure or policies)
How does the organization verify the adequecy of the purchasing
requirements prior to communicating them to supplier?
What kind of inspection or other activities are established to verify that the
purchased product meets the purchasing requirements?
7.5 Production and Service
provision
7.5.1 Control of production and
service provision
Does the organization has the available information that describes the
characteristics of the product/service?
Does the organization have the necessary work instruction needed to carryout
production and service provsion?
Does the organization use suitable equipment for carrying out production and
service provision?
Does the organization use & maintain measuring & monitoring equipment
where needed?
How does the organization control the release, delivery and post-delivery
activities?
7.5.2 Validation of processes for
production and service provision
Does the organization have any special processes where the output of the
process cannot be verified by subsequent monitoring or measurement?If so,
how does the organization address the following:
- validation of such processes to achieve planned results
- defined criteria for review and approval of those processes
- approval of equipment or personnel related to those processes
- use of methods and procedures for those processes
- any requirements for records
- revalidation of those processes when changes occur to those processes
Are proper records maintained including records of revalidation of any such
processes?
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7.5.3 Identification and traceability Where necessary, does the organizaton address traceability requirements?
Is the product/service identified using suitable means throughout its
realization process?
Is the product status identified with respect to monitoring and measurement
requirements?
Where traceability is a requirement, are proper records maintained?
7.5.4 Customer property Does the organization identify customer property while it is under the
organization's control or use?
How is the customer property safegaurded & protected while it is under the
organization's control or use?
If any customer property is lost, damaged or otherwise found to be unsuitable
for use, how is this reported to the customer?
How are records maintained in relation to handling of customer property?
7.5.5 Preservation of product How does the organization handle the preservation requirments of the
product/service (or its constituent parts) during its internal processing &
delivery?
Does the preservation process address the following:
- identification methods of the product/service
- handling methods of the product/service
- packaging requirements for the product/service
- storage requirements for the product/service
- protection requirments for the product/service
Does the organization use monitoring & measuring devices to prove evidence
of conformity?
Does the organization establish processes to enable performance of
monitoring & measuring activities that are consistent with the monitoring &
measuring requirments?
Does the organization identify the calibration needs for these measuring &
monitoring devices?
Does the organization establish the criteria & frequency of calibration for
these measuring & monitoring devices?
Are the calibration requirements/methods traceable to a known International
or national standard?
If there is no known standard, how does the organization perform calibration
of such devices?
Are the measuring or monitoring equipment adjusted or re-adjusted as
necessary?
What kind of controls are in place to safegaurd adjustments that would
invalidate the measurement result?
How can the calibration status of these devices be identified? (Is there a
calibration log or a calibration sticker on these devices?)
How are these calibrated devices protected from damage and deterioration
during handling, maintenance and storage?
When a device is found to be out-of calibration, how does the organization
assess & record the validity of the previous measuring results?
How type of actions does the organization take on any equipment or product
when a out-of-calibration situation occurs with the measuring device that is
used?
When using computer software as part of the measuring & monitoring
activities, is the ability of this application confirmed prior to initial use and
reconfirmed as necessary?
8.0 Measurement, analysis &
improvement
8.1 General
How does the organizaton demonstrate the following:
- conformity of product/service
- conformity to Quality Management System
- continually improve the effectiveness of the Quality Management System
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
What methods does the organization use to collect customer perception?
How does it use that information?
7.6 Control of monitoring and
measuring devices
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8.2.2 Internal audits Does the organization has an internal audit procedure?
Does the Internal audit procedure define roles, responsibilities & authority for
planning, conducting audits, & reporting audit results?
Are internal audits conducted at planned intervals to determine the
effectiveness of the QMS?
Does the internal audit criteria include status, importance & results of previous
audits of the audit area?
Does the audits define the following: Audit criteria, scope, audit frequency &
audit methods?
Are the audits conducted in a manner that ensures impartiality and
objectivity?
Are the audit records properly maintained?
Does the audit area take appropriate actions in a timely manner when
nonconformities are identified?
Does follow-up activities of the audit include verification of actions? Are the
results of these verification recorded?
8.2.3 Monitoring and measurement
of processes
What methods does the organization have in place to measure & monitor
their processes?
Does the organization take necessary corrective actions when its processes
are found not to achieve planned results?
8.2.4 Monitoring and measurement
of products
How does the organization measure & monitor product/service
characteristics?
Does the organization identify the appropriate stages for monitoring &
measuring of product/service?
Does the organization maintain proper records to show evidence of
conformity of the product/service?
Does the organization ensure that all monitoring & measuring activities are
completed before the product is released?
8.3 Control of Nonconforming
product
How does the organization identify & segregate nonconforming material?
What measures/controls does the organization have to prevent unintended
use or delivery of onconforming product?
Does the organization define the responsibilities and authorities in relation to
dealing with nonconforming product?
Does the organization perform the following:
- take action when nonconformace is detected
- authorize its use, release or acceptance under concession by relevant
authority
- take action to preclude its original intended use or application
Are proper records for nonconformances maintained including for any
subsequent actions taken?
Does the organization reverify product/service once the nonconformance is
corrected?
How does the organization deal if nonconformance is detected after the
product/service is delivered?
8.4 Analysis of Data Does the organization collect & analyze appropriate data to demonstrate the
suitability & effectiveness of the QMS?
How does the organization utilize this data to evaluate continual improvement
in the effectiveness of the QMS?
Does the organization collect and analyze data in relation to the follwoing:
- Customer satisfaction
- conformity of product/service requirements
- characteristics and trends of processes & products
- suppliers
8.5 Improvement
8.5.1 Continual Improvement
Does the organization use Quality policy, objectives, audit results, analysis of
data, management reviews, corrective and preventive actions to continually
improve the effectiveness of the QMS?
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8.5.2 Corrective action Does the organization have a corrective action procedure?
Does the procedure address how to handle the following:
- review nonconformities including customer complaints
- determine the cause of nonconformities (root cause analysis)
- evaluate the need for action to prevent reoccurance
- determine and implement necessary actions
- maintain records of results of the action taken
- review corrective action taken
Does the procedure describe the responsibilities & authorities in relation to the
corrective action process?
Are the corrective actions performed in a timely manner?
Are the results of the corrective actions verified & approved by proper
authority before they are closed?
8.5.3 Preventive action Does the organization have a preventive action procedure?
Does the procedure address how to handle the following:
- determine potential nonconformities and their causes
- evaluate the need for action to prevent occurance
- determine and implement necessary actions
- maintain records of results of the action taken
- review preventive action taken
Does the procedure describe the responsibilities & authorities in relation to the
preventive action process?
Are the preventive actions performed in a timely manner?
Are the results of the preventive actions verified & approved by proper
authority before they are closed?

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