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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.

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Page i

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


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:

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

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

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

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.

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

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?

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


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?
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Yes
No
Yes
No
Yes
No
17 continues on next page
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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003


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.

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


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

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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

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


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

24 Continues on next page


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


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)?
26 Continues on next page

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N/A

26 Continues on next page


Page 9 of 28

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


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?
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Yes
No
N/A
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Page 10 of 28

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

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


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?
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Yes
No
N/A
Yes
No
N/A
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QUALITY SYSTEM AUDIT CHECKLIST: ISO 9001:2000 & ISO 13485:2003


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


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?
33 Continues on next page

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?

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


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


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?

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


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?

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


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

38 Continues on next page


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38 Continues on next page

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


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?

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


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?

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Response / Notes

Yes
Yes
Yes

No
No
No

Yes

No

Page 20 of 28

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


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.


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41 Continues on next page.


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


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?

43 Continues on next page.

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43 Continues on next page.

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


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

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


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.
44 Continues on next page.
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Response / Notes

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

44 Continues on next page.

Page 24 of 28

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

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

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


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


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


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:

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