Internal Quality Audit Checklist ISO 13485:2003 & ISO 9001:2000

QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003
Instructions And Notes:
This checklist is set up to evaluate a quality system against two possible specifications, ISO 9001:2000 or ISO 13485:2003. Check the
appropriate box under Quality System on page 1. If the quality system being evaluated is not designed to be compliant with one of these
specifications, check Other, note the specification it is compliant to, and use the checklist for ISO 9001:2000.
Items with an
in the paragraph column denote an item where a record is mandatory per ISO 9001:2000 or ISO 13485:2003. The
organization may define other documents as quality records in addition to these for a variety of reasons. All quality records should be
retained per a definite schedule, available for review, and meet the other requirements of question 6.
Questions 8 and 9 must be asked of Top Management. These are denoted in bold italics to provide a visual cue of this requirement.
Certain questions require a description or explanation rather than a yes/no check box. These should be completed and not left blank.
Most questions provide a spot for notes or comments. However, the back of each page may be used for more detailed notes. If this is done,
the question number that the notes on the back refer to must be recorded!
Question 11 should be asked of numerous people and an overall judgment formed about the effectiveness of the communication of the quality
policy.
Any portions of section 7 deemed N/A must be excluded in the scope statement of the organizations QA Manual. Unless specifically
excluded in the QA Manual, it must apply.
Some questions listed are unique to or not applicable to ISO 13485:2003; because they either exceed ISO 9001:2000, or are not applicable to
medical devices. Items unique to ISO 13485:2003 have both the paragraph numbers and the requirements enclosed in a grey box, and are
printed in a sans serif font. For example:
4.2.4 Note: Record retention is lifetime of the product, but no less than two years after product release.
When auditing to ISO 9001:2000, the sections applicable only to ISO 13485:2003 (items in grey boxes) may be ignored. In some cases, but
not all, N/A is added to clarify intent/necessity of an item. When used, the N/A designation is in addition to the text being in grey boxes.
C:\Documents and Settings\Skip\Work\MP&E\Quality Systems Audit Checklist.doc
Page i

Company Audited: _____________________________________________________________
Date: ______________________________
Company Contact(s):
Quality System: (check one)

ISO 9001:2000
ISO 13485:2003
Other
_____________________
AMS Auditor(s):
No.
1
Applies To:
9001 13485 Question
4.1
4.1
Does a written QA Manual exist?
4.2.2
4.2.2
4.1
4.1
4.2.1
4.2.1
Response / Notes
Yes date of latest revision:
Does the Scope statement take any

exceptions to the base specification?
Are any production processes
outsourced?
If yes, are the processes documented
and otherwise controlled?
Yes Is the justification adequate?

No, all sections apply.
Yes
No
Yes
No If yes, how?
Are outsourced processes verified?
Yes
No If yes, how?
Is there a documented quality policy?
Yes
No
Are the following required procedures

documented?
Document Control
No
Yes
No
Check box if each exists; record procedure # and revision date of current
procedure:
#:
Revision date:
Control of Records
#:
Revision date:
Internal Audits
#:
Revision date:
Control of Nonconformity
#:
Revision date:
Corrective Action
#:
Revision date:
Page 1 of 28
No.
5
Applies To:
9001 13485 Question
4.2.1
4.2.1 Are Quality Records maintained per
&
&
the documented procedure?
4.2.4
4.2.4
Note: The record type may vary by
business and industry.
4.2.4
Preventive Action
4.2.3
4.2.3
4.2.3
#:
Revision date:
Response / Notes
Record:
Retention Period:
Kept?
Yes
No
Yes
No
Yes
No
List key types of records retained.
Yes
No
Note: Record retention is lifetime of

the product, but no less than two years
after product release.
Yes
No
Yes
No
Are controlled documents:

Approved prior to release?
Re-approved after revision?
Revision level identified on the
document?
Available at the point of use?
Legible and readily identifiable?
Destroyed or suitably identified
once obsolete?
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
No
Is approval done by the original

approving function, or a designated
function with access to pertinent
background information?
Yes
No
Is the retention period for at least

one copy of obsolete test and
manufacturing documents defined
to be the lifetime of the product, but
no less than two years?
Yes
No
Page 2 of 28
No.
7
Applies To:
9001 13485 Question
4.2.4
4.2.4 Are quality records:
Legible?
Identifiable?
Retrievable?
Protected during storage to
prevent/minimize degradation?
5.1
5.2
5.1
5.2
N/A
Are appropriate records retained?

Note: The record type may vary by
business and industry.
Has / does Top Management:
Conduct periodic QMS reviews?
Have a written quality policy?
Defined objectives?
Ensure the availability of
resources?
Communicate the above items?
How does Top Management ensure a
customer requirements are met?
Response / Notes
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Note: Questions in bold italics are to be asked of Top Management.

Yes
No
Yes
No
Yes
No
Yes
No
Yes
Describe:
No
Do these activities enhance customer

satisfaction?
Note: Enhancing customer
satisfaction is not a
requirement of ISO
13485:2003.
Page 3 of 28
No.
10
Applies To:
9001 13485 Question
5.3
Does the quality policy wording
include:
Note: Exact wording may vary.
N/A Commitment to continuous or
continual improvement?
Commitment to meeting
requirements (stated, implied,
customer, regulatory, etc.)
5.3
Commitment to maintain the

effectiveness of the QMS?
Response / Notes
Yes
No
Yes
No
Yes
No Note: If this question applies, then the first bullet in this

question does not apply.
Is the quality policy reviewed

periodically for suitability?
Is the quality policy communicated to
and understood by employees?
Note: Response to the last two
questions should include some
elements of the quality policy.
11
5.4
12
5.4.1
Is there evidence of defined quality

objectives?
Are the objectives:
Established for relevant functions?
Established at relevant levels?
Measurable?
Consistent with the quality policy?
Yes
No
Note number of employees asked and the number that can not answer the
following questions:
number asked
# without answer
What is the quality policy?
What does it mean to you?
How does it affect your job?
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
Page 4 of 28

No.
13
14
Applies To:
9001 13485 Question
5.4.2
Have the objectives and other planning
been documented?.
5.5.1
5.5.1
15
5.5.2
5.5.2
Response / Notes
Yes
No
Are changes to the QMS made in a

controlled manner?
Are responsibilities defined and
communicated?
Yes
No
Yes
No
Has the interrelation of all personnel

who manage, perform and verify work
affecting quality been established?
Yes
No
Does quality have the independence

and authority to perform their tasks?
Yes
No
Yes
Yes
No
No
Yes
No If yes, explain how:
Yes
No If yes, list Examples:
Has / does a Management

Representative:
Been designated?
Report to Top Management about
QMS performance?
Ensure the awareness of regulatory
and customer requirements?
Explain below:
Name:
Note: Regulatory requirements

apply only to ISO 13485:2003.
16
5.5.3
5.5.3
Have effective communications been

established within the company?
17
5.6.1
5.6.1
Does Management review include:

Quality Policy?
Quality objectives?
Opportunities for improvement?
17 continues on next page
Yes
No
Yes
No
Yes
No
17 continues on next page
Page 5 of 28

No.
17
cont
18
19
Applies To:
9001 13485
5.6.1
5.6.1
cont
cont
5.6.2
5.6.3
Question
Is Management Review performed at
planned intervals?
Does input to Management Review
include:
Results of audits:
o internal
o external
Customer feedback?
Process performance and product
conformity?
Status of preventive and corrective
actions?
Follow up actions from previous
Management Reviews?
Significant changes that could
affect the QMS?
Recommendations for
improvement?
Response / Notes
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
5.6.2
5.6.3
Note: All items are required.

Is there evidence of documented
review output (minutes, memo, etc.)?
Yes
No
If yes, does it include decisions/actions

related to:
Improvement in the effectiveness
of the QMS?
19 Continues on next page
Yes
No
New or revised regulatory

requirements.

Page 6 of 28

No.
19
cont
20
Applies To:
9001 13485 Question
5.6.3
5.6.3 Improvements needed to maintain
the effectiveness of the QMS?
cont
Product improvements?
Resource needs?
6.1
Does the company determine and
provide needed resources to:
Continually improve the
effectiveness of the QMS?
Ensure customer satisfaction is
enhanced?
6.1
21
22
6.2.1
6.2.2
6.2.1
6.2.2
Maintain the effectiveness of the

QMS?
Meet regulatory and customer
requirements?
Are personnel performing work

affecting product quality competent
based on one or more of:
Education?
Training?
Skills?
Experience?
How has the organization:
Determined the necessary
competency for personnel?
Provided training?
Evaluated the effectiveness of its
actions?
Ensured personnel are aware of
their roles in the QMS?
Maintained training records
Response / Notes
Yes
No
Yes
Yes
No
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
Yes
Yes
No
No
No
Yes
No
Page 7 of 28

No.
23
24
Applies To:
9001 13485 Question
6.3
6.3
Does the organization determine,
provide, and maintain adequate:
buildings & facilities
process equipment
supporting services
6.4
Response / Notes
Yes
Yes
Yes
No
No
No
6.3
Have documented requirements

established for maintenance
activities, including their frequency,
when such activities or lack thereof
can affect product quality?
Yes
No
6.4
Is the work environment adequate for

product quality & conformity?
Note: Worker comfort/safety are not a
requirement.
Yes
No
6.4
Have requirements for health,

cleanliness and clothing of personnel
been established where contact
between personnel and the product or
work environment could adversely
affect product quality?
Yes
No
Are work environment conditions

monitored and controlled per
documented procedures where work
environment conditions may affect
product quality?
Yes
No
Have personnel that are required to

work temporarily under special
environmental conditions within the
work environment appropriately trained
or supervised by a trained person?
Yes
No


Page 8 of 28

No.
24
cont
25
Applies To:
9001 13485 Question
7.1
If appropriate, have special

arrangement been established and
documented for the control of
contaminated or potentially
contaminated product to prevent
contamination of the other product, the
work environment or personnel?
Yes
No
7.1
Are realization processes documented?
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
Yes
No
Yes
No
Has the organization determined (as

appropriate):
Product requirements and quality
objectives?
Have processes been established to
the appropriate level? (by part
number if necessary)
Verification and validation activies
such as monitoring, inspection, test
activities, etc?
Product and/or process
conformance records?
7.1
26
7.2.1
Response / Notes
6.4
cont
7.2.1
Have requirements for risk

management throughout product
realization been documented?
Are records of risk management
retained?
Has the organization determined:

Specified product requirements
(including delivery and post
delivery activities)?
N/A

Page 9 of 28

No.
26
cont
27
Applies To:
9001 13485 Question
7.2.1
7.2.1 Requirements not specified by the
cont
cont
customer, but necessary for
intended use?
Statutory/regulatory requirements?
Additional requirements?
7.2.2
7.2.2
7.2.2
Are product requirements reviewed

before:
Submitting quotes?
Accepting orders and change
orders?
Does the review ensure:
Product/service requirements are
defined?
No
No
N/A
N/A
Yes
Yes
No
No
N/A
N/A
Yes
No
N/A
Yes
No
N/A
Requirements differing from those

previously stated are resolved?
The company has the ability to
meet the requirements?
Confirmation of requirements (i.e.
no verbal orders)?
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Are records of review available?

7.2.3
Yes
Yes
Product requirements are

documented?
28
N/A
Response / Notes
Yes
No
Established communications with

customers relating to:
Product information?
Yes
No
N/A
Page 10 of 28
No.
28
cont
Applies To:
9001 13485
7.2.3
7.2.3
cont
Cont
7.2.3
Question
Inquiries, contracts &
amendments?
Customer feedback & complaints?
Advisory notices?
Response / Notes
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Note: Design & development requirements (section 7.3) are not a part of this audit checklist.
7.4.1 Are Purchasing processes controlled?
29
7.4.1
Yes
No
N/A
7.4.1
Have documented procedures been

established to ensure purchased
product conforms to specified
purchase requirements?
Yes
No
N/A
Does the type and extent of control

depend upon the effect of subsequent
realization processes?
Yes
No
N/A
Are Suppliers selected based upon their

ability to supply product to the
companys requirements?
Yes
No
N/A
Are supplier selection records

maintained?
Yes
No
N/A
Yes
Yes
Yes
No
No
No
N/A
N/A
N/A Frequency:
Are the following defined:

Selection criteria?
Evaluation criteria?
Frequency of re-evaluation?
Page 11 of 28

No.
30
Applies To:
9001 13485
7.4.2
7.4.2
Question
Is information used to purchase items
sufficient to describe the product?
Do Purchasing documents include (if
appropriate):
Requirements for approval of
product, processes, and equipment?
Personnel qualification?
Quality Management Systems
requirements?
7.4.2
31
7.4.3
7.4.3
7.4.3
32
7.5.1
Response / Notes
Yes
No
N/A
Yes
No
N/A
Yes
Yes
No
No
N/A
N/A
Are purchasing documents ensured to

be adequate prior to communication to
the supplier?
Yes
No
N/A
Has the organization maintained

Purchasing information and records to
maintain applicable traceability
requirements in 7.5.3.2?
Yes
No
N/A
Is purchased product identified and

inspected or verified prior to use?
Yes
No
N/A
If source inspection is performed, have

procedures for it been defined?
Yes
No
N/A
Are records of verification maintained?
Yes
No
N/A
7.5.1.1 As applicable, are product and/or

services controlled by:
Defined product characteristics?
Work instruction availability?
Yes
No
N/A
Yes
No
N/A
Page 12 of 28

32
cont
7.5.1
cont
7.5.1.1
cont
7.5.1.1
Availability of documented
procedures, documented
requirements, work instructions,
and reference materials and
reference measurement
procedures?
Yes
No
N/A
Suitable equipment?
Appropriate measuring devices?
Activities are monitored and
measured?
Implemented release, delivery and
post delivery activities?
Yes
Yes
Yes
No
No
No
N/A
N/A
N/A
Yes
No
N/A
Implementation of defined
operations for labeling and
packaging?
Yes
No
N/A
Yes
No
N/A Note: A batch may be a single medical device.
Yes
Yes
Yes
No
No
No
N/A
N/A
N/A
Yes
No
N/A
Yes
No
N/A
Have records of each batch of medical

devices been created and maintained?
Do they include:
Traceability per 7.5.3?
Identify the amount manufactured?
Identify the amount approved for
distribution?
33
N/A
Are batch records verified and

approved?
7.5.1.2 Have requirements for product
cleanliness been established if:
Product is cleaned by the
organization prior to sterilization
and/or its use?
Page 13 of 28

No.
33
cont
Applies To:
9001 13485 Question
N/A 7.5.1.2 Product is supplied non-sterile to
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
If appropriate, has the organization

established documented requirements
which contain acceptance criteria for
installing and verifying installation of
the medical device?
Yes
No
N/A
If the customer requirements allow

installation by other than the
organization, have documented
installation and verification
requirements been supplied?
Yes
No
N/A
Are records of installation and

verification performed by its
organization or authorized agent
maintained?
Yes
No
N/A
If servicing is a specified requirement,

have documented procedures, work
instructions, and reference materials
and reference measurement
procedures been established for
performing servicing activities and
verifying servicing activities meet
requirements?
Yes
No
N/A
Response / Notes
be subjected to a cleaning process

prior to sterilization and/or its use?
Product is supplied to be used nonsterile and its cleanliness is of
significance in use?
Process agents are to be removed
from product during manufacture?
Page 14 of 28

No.
33
cont
Applies To:
9001 13485 Question
N/A 7.5.1.2 Are records of installation and
verification performed by the
Response / Notes
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
organization or its authorized agent

maintained?
Are records of process parameters
maintained for the sterilization process
for each batch of product sterilized?
If yes, are the records traceable
to each batch of devices?
34
7.5.2
7.5.2
Are processes validated by one or more

methods listed below:
Established review and approval of
processes?
Approval of equipment and
qualification of personnel?
Are processes, where the output
can not be subsequently monitored
or measured, validated and records
kept?
Is the possible necessity of revalidation considered?
7.5.2.1 Has the organization established

documented procedures for validation
of software (and changes to such
software or its application) for
production and service that affect the
ability of the product to conform to
specified requirements?
Page 15 of 28

No.
34
cont
Applies To:
9001 13485
No
N/A
Are records of validation retained?
Yes
No
N/A
Have documented procedures been

established for sterilization processes?
Yes
No
N/A
Are sterilization processes validated

prior to initial use?
Yes
No
N/A
Are records of validation retained?
Yes
No
N/A
Is product identified throughout its

realization?
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
7.5.3.2 Has a documented procedure defining

the extent of product traceability and
the records required been

established?
Yes
No
N/A
Where traceability is a requirement, is

the unique identification of product
controlled and recorded?
Yes
No
N/A
7.5.3
7.5.3.1 Does a documented procedure exist

for product identification?
Is there a documented procedure to
ensure that medical devices returned
to the organization are identified and
distinguished form conforming
product?
Response / Notes
Yes
35
Question
7.5.2.1 Is such software validated prior to

Cont initial use?

Page 16 of 28

No.
35
cont
Applies To:
9001
13485
7.5.3 7.5.3.2
cont
cont
7.5.3.3
Question
Response / Notes
If components, materials and work

environments could cause the medical
device not to satisfy its specified
requirements, have these been
defined for inclusion in traceability
records?
Yes
No
N/A
Does the organization require that its

agents or distributors maintain records
of the distribution of medical devices to
allow traceability?
Yes
No
N/A
Are such records available for

inspection?
Yes
No
N/A
Do the records include the name and

address of the shipping package
consignee?
Yes
No
N/A
Are the monitoring and measurement

status of the product identified?
Yes
No
N/A
Yes
Yes
Yes
Yes
No
No
No
No
N/A
N/A
N/A
N/A
To ensure that only product that has

passed all required inspections and
tests (or released under an authorized
concession) has been dispatched,
used or installed, is product status
maintained throughout:
Production?
Storage?
Installation?
Servicing?
Page 17 of 28

No.
36
Applies To:
9001
13485
7.5.4
7.5.4
37
38
7.5.5
7.5.5
7.6
7.6
N/A
7.6
Question
Has a standard confidentiality
agreement been signed?
Response / Notes
Yes
No
N/A
Is AMS supplied property supplied?

If yes, is it properly:
Identified?
Protected?
Maintained?
Yes
No
N/A
Yes
Yes
Yes
No
No
No
N/A
N/A
N/A
Is lost/damaged AMS property

recorded and reported?
Do shelf life requirements apply?
If yes, are they followed?
Does a procedure exist covering
internal processing and delivery
regarding:
Preserv. of product conformity?
Identification?
Handling?
Packaging?
Storage?
Protection?
If yes, does it apply to constituent parts
of products?
Are appropriate product/process
measurements identified?
Yes
No
N/A
Yes
Yes
No
No
N/A
N/A
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Yes
No
N/A
Are calibration procedures

documented?
Yes
No
N/A
Are proper measurement devices used?
Yes
No
N/A

Page 18 of 28

No.
38
cont
Applies To:
9001
13485
7.6
7.6
cont
cont
Question
Are measurement devices calibrated at
specified intervals?
Response / Notes
Yes
No
N/A
Are results of calibrations recorded?
Yes
No
N/A
Are calibrations traceable to NIST?

If not, is the basis of calibration
recorded?
Yes
Yes
No
No
N/A
N/A
Are items positively identified?
Yes
No
N/A
Are items safeguarded against

unauthorized adjustment?
Yes
No
N/A
Protected from damage during

handling, maintenance & storage?
Yes
No
N/A
Are measurement results since the last

calibration assessed if the current
calibration is out of tolerance?
Is appropriate corrective action
taken?
Yes
No
N/A
Yes
No
N/A
Yes
No
N/A
Is software used for monitoring and

measurement of requirements is
confirmed to satisfy the intended
application prior to initial use and reconfirmed as necessary?
Page 19 of 28

No.
39
Applies To:
9001
13485
8.1
8.1
N/A
Question
Has the Organization planned and
implemented a system for monitoring,
measurement analysis, and
improvement processes to:
Demonstrate product conformity?
Ensure QMS conformity?
Continually improve the QMS?
8.1
Yes
No
8.2.1
N/A
Does this include the determination of

appropriate statistical techniques and
the extent of their use?
Is customer satisfaction monitored?
Yes
No
N/A
8.2.1
Is information relating to whether

customer requirements are met
monitored?
Yes
No
Yes
No
Yes
No
Yes
No
N/A
40
Maintain the effectiveness of the

QMS?
Applies Applies Have methods for obtaining and using

the information been developed?
N/A
8.2.1
Does the company use a documented

procedure for a feedback system to
provide early warning of quality
problems?
If yes, is this information used
as an input into the corrective
and preventive action
processes?
Response / Notes
Yes
Yes
Yes
No
No
No
Yes
No
Page 20 of 28

No.
41
Applies To:
9001
13485
8.2.2
8.2.2
Question
Are internal audits performed at
planned intervals?
Does the internal audit system:
Assure that the system conforms to
the planned implementation and
ISO 9001:2000?
Verify that the system is effectively
implemented and maintained?
Consider the results of previous
audits?
Factor in the status and importance
of the activities and areas to be
audited?
Does a procedure exist that defines:
The audit scope?
Audit Frequency?
Methodologies to be used?
Responsibilities for conducting
audits?
Requirements for recording and
reporting results to management?
Are audit records maintained?
Response / Notes
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
No
Are audits conducted by personnel

other than those performing the work?
Yes
No
Have audit personnel been trained in

auditing techniques?
Yes
No
41 Continues on next page.


Page 21 of 28

No.
41
cont
42
Applies To:
9001
13485
8.2.2
8.2.2
cont
cont
8.2.3
8.2.3
Question
Is there evidence that corrective action
is taken without undue delay?
Do follow-up actions include:
Verification of actions taken
Reporting to management of the
verification results?
Have suitable methods for monitoring
and measurement of QMS systems
been determined and applied?
Yes
Yes
No
No
Yes
No A
Yes
No
Yes
Yes
No
No
Yes
No
Are there documented procedures for

monitoring product?
Yes
No
Is product verification done at

appropriate stages of the process?
Yes
No
Are QMS processes and procedures

monitored to ensure that requirements
are met?
43
8.2.4
8.2.4
N/A
8.2.4
Response / Notes
Yes
No
Is corrective action taken if:

Planned QMS results are not met?
Necessary to assure product
conformity?
Are product characteristics monitored
and measured to verify that product
requirements are met?
Page 22 of 28

No.
43
cont.
Applies To:
9001
13485
8.2.4
8.2.4
cont.
cont.
N/A
N/A
8.2.4
N/A
Question
Are all verification steps:
Identified and documented to
assure that they occur as planned?
Are records of acceptance
maintained?
Do the records identify the person
responsible for release?
Response / Notes
Yes
No
Yes
No
Yes
No
Is product ever released prior to

completion of all verification
activities?
If yes, under what circumstances?
Yes
No
Yes
No
Does product release and service

proceed before the planned
arrangements (see 7.1) have been
satisfactorily completed?
Yes
No
For implantable devices, does the

company record the identity of the
personnel performing any inspection or
testing?
Yes
No
Page 23 of 28

No.
44
Applies To:
9001
13485
8.3
8.3
N/A
8.3
Question
How is nonconforming product
handled: (check all used)
Action is taken to eliminate or
correct the nonconformity.
Use or acceptance is sought under
concession by relevant authority
(including the customer if
applicable).
Taking action to preclude the
original use of the product by:
o re-grading product
o scrapping product
Authorizing its use, release or

acceptance under concession only
if regulatory requirements are met?
If yes, are records of the
identity of personnel
authorizing the concession
maintained?
Are all corrected nonconformities reverified?
Are records maintained of nonconformities, including any subsequent

actions taken or concessions?
Are appropriate actions taken if a
nonconformity is discovered after
delivery? Note: describe actions taken.
Response / Notes
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Page 24 of 28
No.
44
cont.
45
Applies To:
9001
13485
8.3
N/A
cont.
8.4
N/A
8.4
8.4
Question
Response / Notes
If product is reworked, is the process

documented in a work instruction that
was authorized and approved using
the same procedure as the original
work instruction?
If yes, was a determination made
and documented of any adverse
effect of the rework upon the
product?
If yes, was the determination
made prior to authorizing the
procedure?
Yes
No
Yes
No
Yes
No
Does the organization determine,

collect and analyze appropriate data to
provide information about:
QMS suitability and effectiveness?
Customer satisfaction?
Feedback per 8.2.1?
Product conformity?
Characteristics of processes and
products, including their trends?
o Including opportunity for
preventive actions?
Suppliers?
Yes
No
Yes
Yes
No
No
Yes
No
Yes
Yes
No
No
Yes
No
Yes
No
N/A
8.4
Is there a documented procedure?
Yes
No
N/A
Are records of the results of the

analysis of data kept?
Yes
No
Page 25 of 28

No.
46
Applies To:
9001
13485
8.5.1
N/A
46-a
N/A
Question
Is continual improvement made
through the use of the following items:
The quality policy
See
46-a Quality objectives
below. Audit results
Data analysis
Corrective and preventive actions
Management review
8.5.1
See 46
above.
Has the company identified and

implemented changes necessary to
ensure and maintain the continued
suitability and effectiveness of the
QMS through the use of the following:
The quality policy
Quality objectives
Audit results
Data analysis
Corrective and preventive actions
Management review
Have documented procedures for the
issue and implementation of advisory
notices been established?
If yes, are they capable of
being implemented at any
time?
Response / Notes
Describe findings:
Describe findings:
Yes
No
Yes
No
Yes
No
Yes
No
Are records of all customer complaint

investigations maintained?
If investigation determines that
activities outside the company
contributed to the customer complaint,
is relevant information exchanged
between the two companies involved?
Page 26 of 28

No.
46-a
Applies To:
9001
13485
8.5.1
N/A
See 46
above.
Question
For any customer complaints that are
not followed up by corrective and/or
preventive action:
Was the reason authorized per
5.5.1?
Were records maintained?
If reporting of adverse events is
required by national or regional
regulations, do documented
notification procedures exist?
47
8.5.2
8.5.2
N/A
8.5.2
N/A
8.5.2
Does the documented corrective action

procedure include:
Review of nonconformities and
customer complaints?
Determining the causes of
nonconformities?
Evaluating the need for corrective
action to prevent recurrence?
Determining and implementing
needed corrective action?
o
N/A
8.5.2
Recording results of action taken?

o
Does this include updating

documentation if appropriate?
Does this include results of the
investigation?
Review of corrective actions taken?

o Does this include effectiveness
Response / Notes
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
of the actions taken?
Are the actions taken appropriate for

the problem encountered?
Page 27 of 28

No.
48
Applies To:
9001
13485
8.5.3
8.5.3
Question
Response / Notes
Does the documented preventive action
procedure include:
Yes
No
Determining potential
nonconformities and their causes?
Yes
No
Evaluating the need for preventive
action to prevent occurrence?
Yes
No
Determining and implementing
needed preventive action?
N/A
8.5.3
No
Recording results of actions taken?
Yes
No
Does this include results of the

investigation?
Yes
No
Yes
No
Yes
No
Yes
No
N/A
8.5.3
Does this include updating

documentation if appropriate?
Yes
Review of corrective actions taken?

o Does this include effectiveness
of the actions taken?
N/A
8.5.3
Are the actions taken appropriate for

the potential problems?
Comments:
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
_______________________________________________________________________________________________________________________
Page 28 of 28

Internal Quality Audit Checklist ISO 13485:2003 &amp; ISO 9001:2000

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Instructions And Notes:

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Quality System: (check one)

Does the Scope statement take any

Yes Is the justification adequate?

Are outsourced processes verified?

Is there a documented quality policy?

Are the following required procedures

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

List key types of records retained.

Note: Record retention is lifetime of

Are controlled documents:

Is approval done by the original

Is the retention period for at least

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Are appropriate records retained?

Note: Questions in bold italics are to be asked of Top Management.

Do these activities enhance customer

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Commitment to maintain the

No Note: If this question applies, then the first bullet in this

Is the quality policy reviewed

Is there evidence of defined quality

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Are changes to the QMS made in a

Has the interrelation of all personnel

Does quality have the independence

No If yes, explain how:

No If yes, list Examples:

Has / does a Management

Note: Regulatory requirements

Have effective communications been

Does Management review include:

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Note: All items are required.

If yes, does it include decisions/actions

New or revised regulatory

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19 Continues on next page

QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Maintain the effectiveness of the

Are personnel performing work

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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

Have documented requirements

Is the work environment adequate for

Have requirements for health,

Are work environment conditions

Have personnel that are required to

24 Continues on next page

24 Continues on next page

QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003

If appropriate, have special

Are realization processes documented?

Has the organization determined (as

Have requirements for risk

Has the organization determined:

Internal Quality Audit Checklist ISO 13485:2003 & ISO 9001:2000

Internal Quality Audit Checklist ISO 13485:2003 & ISO 9001:2000