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

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

C:\Documents and Settings\Skip\Work\MP&E\Quality Systems Audit Checklist.doc Page i

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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Company Audited: _____________________________________________________________ Date: ______________________________

Company Contact(s): Quality System: (check one)

ISO 9001:2000 ISO 13485:2003

AMS Auditor(s): Other _____________________

Applies To:

No. 9001 13485 Question Response / Notes

1 4.1 4.1 Does a written QA Manual exist? Yes date of latest revision: No

2 4.2.2 4.2.2 Does the Scope statement take any

exceptions to the base specification?

Yes Is the justification adequate? Yes No

No, all sections apply.

3 4.1 4.1 Are any production processes

outsourced?

If yes, are the processes documented

and otherwise controlled?

Are outsourced processes verified?

Yes No

Yes No If yes, how?

Yes No If yes, how?

4 4.2.1 4.2.1 Is there a documented quality policy?

Are the following required procedures

documented?

Document Control

Control of Records

Internal Audits

Control of Nonconformity

Corrective Action

Yes No

Check box if each exists; record procedure # and revision date of current

procedure:

#: Revision date:

#: Revision date:

#: Revision date:

#: Revision date:

#: Revision date:



Preventive Action #: Revision date:

Applies To:


5 4.2.1

&

4.2.4

4.2.1

&

4.2.4

4.2.4

Are Quality Records maintained per

the documented procedure?

Note: The record type may vary by

business and industry.

List key types of records retained.

Note: Record retention is lifetime of the product, but no less than two years after product release.

Record: Retention Period: Kept?

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

6 4.2.3 4.2.3

4.2.3

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?

Is approval done by the original approving function, or a designated function with access to pertinent background information?

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

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No



Applies To:


7 4.2.4 4.2.4 Are quality records:

Legible?

Identifiable?

Retrievable?

Protected during storage to prevent/minimize degradation?

Are appropriate records retained?

Note: The record type may vary by

business and industry.

Yes No

Yes No

Yes No

Yes No

Yes No

8 5.1 5.1 Has / does Top Management:

Conduct periodic QMS reviews?

Have a written quality policy?

Defined objectives?

Ensure the availability of resources?

Communicate the above items?

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

Yes No

Yes No

Yes No

Yes No

Yes No

9 5.2 5.2

N/A

How does Top Management ensure a

customer requirements are met?

Do these activities enhance customer

satisfaction?

Note: Enhancing customer

satisfaction is not a requirement of ISO 13485:2003.

Describe:



Applies To:


10 5.3

N/A

5.3

Does the quality policy wording

include:

Note: Exact wording may vary.

Commitment to continuous or continual improvement?

Commitment to meeting requirements (stated, implied,

customer, regulatory, etc.)

Commitment to maintain the effectiveness of the QMS?

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.

Yes No

Yes No

Yes No Note: If this question applies, then the first bullet in this question does not apply.

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?

11 5.4 Is there evidence of defined quality

objectives?

Yes No

12 5.4.1

Are the objectives:

Established for relevant functions?

Established at relevant levels?

Measurable?

Consistent with the quality policy?

Yes No

Yes No

Yes No

Yes No



Applies To:


13 5.4.2 Have the objectives and other planning

been documented?.

Are changes to the QMS made in a

controlled manner?

Yes No

Yes No

14 5.5.1

5.5.1

Are responsibilities defined and

communicated?

Has the interrelation of all personnel who manage, perform and verify work affecting quality been established? Does quality have the independence and authority to perform their tasks?

Yes No Explain below:

Yes No

Yes No

15 5.5.2

5.5.2

Has / does a Management

Representative:

Been designated?

Report to Top Management about QMS performance?

Ensure the awareness of regulatory and customer requirements?

Note: Regulatory requirements apply only to ISO 13485:2003.

Yes No Name:

Yes No

Yes No If yes, explain how:

16 5.5.3 5.5.3 Have effective communications been

established within the company?

Yes No If yes, list Examples:

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



Applies To:


17

cont

5.6.1

cont

5.6.1

cont

Is Management Review performed at

planned intervals?

Yes No

18 5.6.2

5.6.2

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?

New or revised regulatory requirements.

Note: All items are required.

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

19 5.6.3

5.6.3 Is there evidence of documented

review output (minutes, memo, etc.)?

If yes, does it include decisions/actions

related to:

Improvement in the effectiveness of the QMS?

19 Continues on next page

Yes No

Yes No




Applies To:


19

cont

5.6.3

cont

5.6.3

Improvements needed to maintain the effectiveness of the QMS?

Product improvements?

Resource needs?

Yes No

Yes No

Yes No

20 6.1

6.1

Does the company determine and

provide needed resources to:

Continually improve the effectiveness of the QMS?

Ensure customer satisfaction is enhanced?

Maintain the effectiveness of the QMS?

Meet regulatory and customer requirements?

Yes No

Yes No

Yes No

Yes No

21 6.2.1 6.2.1 Are personnel performing work

affecting product quality competent

based on one or more of:

Education?

Training?

Skills?

Experience?

Yes No

Yes No

Yes No

Yes No

22 6.2.2

6.2.2 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

Yes No

Yes No

Yes No

Yes No

Yes No



Applies To:


23 6.3 6.3

6.3

Does the organization determine,

provide, and maintain adequate:

buildings & facilities

process equipment

supporting services

Have documented requirements established for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality?

Yes No

Yes No

Yes No

Yes No

24 6.4 6.4

6.4

Is the work environment adequate for

product quality & conformity?

Note: Worker comfort/safety are not a

requirement.

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? Are work environment conditions monitored and controlled per documented procedures where work environment conditions may affect product quality? 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

Yes No

Yes No

Yes No




Applies To:


24

cont

6.4 cont

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

25 7.1

7.1

7.1

Are realization processes documented?

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?

Have requirements for risk management throughout product realization been documented?

Are records of risk management retained?

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No Yes No

26 7.2.1 7.2.1 Has the organization determined:

Specified product requirements (including delivery and post

delivery activities)?


Yes No N/A




Applies To:


26

cont

7.2.1

cont

7.2.1

cont Requirements not specified by the

customer, but necessary for

intended use?

Statutory/regulatory requirements? Additional requirements?

Yes No N/A

Yes No N/A

Yes No N/A

27 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?

Product requirements are documented?

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)?

Are records of review available?

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

28 7.2.3 Established communications with

customers relating to:

Product information?


Yes No N/A




Applies To:


28

cont

7.2.3

cont

7.2.3

Cont

7.2.3

Inquiries, contracts & amendments?

Customer feedback & complaints?

Advisory notices?

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.

29 7.4.1

7.4.1

7.4.1

Are Purchasing processes controlled?

Have documented procedures been established to ensure purchased product conforms to specified purchase requirements?

Does the type and extent of control

depend upon the effect of subsequent

realization processes?

Are Suppliers selected based upon their

ability to supply product to the

companys requirements?

Are supplier selection records

maintained?

Are the following defined:

Selection criteria?

Evaluation criteria?

Frequency of re-evaluation?

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 Frequency:



Applies To:


30 7.4.2 7.4.2

7.4.2

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?

Are purchasing documents ensured to

be adequate prior to communication to

the supplier?

Has the organization maintained Purchasing information and records to maintain applicable traceability requirements in 7.5.3.2?

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

31 7.4.3 7.4.3

7.4.3

Is purchased product identified and

inspected or verified prior to use?

If source inspection is performed, have

procedures for it been defined?

Are records of verification maintained?

Yes No N/A

Yes No N/A

Yes No N/A

32 7.5.1 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




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?

Suitable equipment?

Appropriate measuring devices?

Activities are monitored and measured?

Implemented release, delivery and post delivery activities?

Implementation of defined operations for labeling and packaging?

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?

Are batch records verified and approved?

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 Note: A batch may be a single medical device. Yes No N/A Yes No N/A Yes No N/A

Yes No N/A

33

N/A 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?


Yes No N/A




Applies To:


33 cont

N/A 7.5.1.2

Product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use?

Product is supplied to be used non-sterile and its cleanliness is of significance in use?

Process agents are to be removed from product during manufacture?

If appropriate, has the organization established documented requirements which contain acceptance criteria for installing and verifying installation of the medical device? If the customer requirements allow installation by other than the organization, have documented installation and verification requirements been supplied? Are records of installation and verification performed by its organization or authorized agent maintained? 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 Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A




Applies To:


33 cont

N/A 7.5.1.2

Are records of installation and verification performed by the 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?


Yes No N/A

34 7.5.2

7.5.2

7.5.2.1

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 re-validation considered?

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? 34 Continues on next page

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A




Applies To:


34

cont

7.5.2.1 Cont

Is such software validated prior to initial use? Are records of validation retained? Have documented procedures been established for sterilization processes? Are sterilization processes validated prior to initial use? Are records of validation retained?


Yes No N/A

Yes No N/A

Yes No N/A

35 7.5.3

7.5.3.1

7.5.3.2

Is product identified throughout its

realization?

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?

Has a documented procedure defining the extent of product traceability and the records required been established?

Where traceability is a requirement, is

the unique identification of product

controlled and recorded?


Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A




Applies To:


35

cont

7.5.3

cont 7.5.3.2 cont

7.5.3.3

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? Does the organization require that its agents or distributors maintain records of the distribution of medical devices to allow traceability? Are such records available for inspection? Do the records include the name and address of the shipping package consignee?

Are the monitoring and measurement

status of the product identified? 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?


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



Applies To:


36 7.5.4

7.5.4 Has a standard confidentiality

agreement been signed?

Is AMS supplied property supplied?

If yes, is it properly:

Identified?

Protected?

Maintained?

Is lost/damaged AMS property

recorded and reported?

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

Yes No N/A

37 7.5.5 7.5.5 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?

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

Yes No N/A

38

7.6

N/A

7.6

7.6

Are appropriate product/process

measurements identified?

Are calibration procedures documented?

Are proper measurement devices used? 38 Continues on next page

Yes No N/A

Yes No N/A

Yes No N/A 38 Continues on next page



Applies To:


38

cont

7.6

cont

7.6

cont

Are measurement devices calibrated at

specified intervals?

Are results of calibrations recorded?

Are calibrations traceable to NIST?

If not, is the basis of calibration

recorded?

Are items positively identified?

Are items safeguarded against

unauthorized adjustment?

Protected from damage during

handling, maintenance & storage?

Are measurement results since the last

calibration assessed if the current

calibration is out of tolerance?

Is appropriate corrective action

taken?

Is software used for monitoring and

measurement of requirements is

confirmed to satisfy the intended

application prior to initial use and re-

confirmed as necessary?

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

Yes No N/A

Yes No N/A



Applies To:


39 8.1

N/A

8.1

N/A

8.1

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? Maintain the effectiveness of the

QMS?

Does this include the determination of

appropriate statistical techniques and

the extent of their use?

Yes No

Yes No

Yes No

Yes No

Yes No

40 8.2.1

N/A

Applies

N/A

N/A

8.2.1

Applies

8.2.1

Is customer satisfaction monitored?

Is information relating to whether customer requirements are met monitored?

Have methods for obtaining and using

the information been developed?

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?

Yes No

Yes No

Yes No

Yes No

Yes No



Applies To:


41 8.2.2

8.2.2 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?

Are audits conducted by personnel

other than those performing the work?

Have audit personnel been trained in

auditing techniques?

41 Continues on next page.

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




Applies To:


41

cont

8.2.2

cont

8.2.2

cont

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?

Yes No

Yes No

Yes No

42 8.2.3 8.2.3 Have suitable methods for monitoring

and measurement of QMS systems

been determined and applied?

Are QMS processes and procedures

monitored to ensure that requirements

are met?

Is corrective action taken if:

Planned QMS results are not met?

Necessary to assure product conformity?

Yes No A

Yes No

Yes No

Yes No

43 8.2.4

N/A

8.2.4

8.2.4

Are product characteristics monitored

and measured to verify that product

requirements are met?

Are there documented procedures for monitoring product?

Is product verification done at

appropriate stages of the process?


Yes No

Yes No

Yes No




Applies To:


43

cont.

8.2.4

cont.

N/A

N/A

8.2.4

cont.

N/A

8.2.4

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?

Is product ever released prior to

completion of all verification

activities?

If yes, under what circumstances?

Does product release and service proceed before the planned arrangements (see 7.1) have been satisfactorily completed? For implantable devices, does the company record the identity of the personnel performing any inspection or testing?

Yes No

Yes No

Yes No

Yes No

Yes No Yes No

Yes No



Applies To:


44 8.3

N/A

8.3

8.3

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 re-

verified?

Are records maintained of non-

conformities, including any subsequent

actions taken or concessions?

Are appropriate actions taken if a

nonconformity is discovered after

delivery? Note: describe actions taken.


Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No




Applies To:


44

cont.

N/A 8.3 cont.

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

45 8.4

N/A

N/A

N/A

8.4

8.4

8.4

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? Is there a documented procedure? Are records of the results of the analysis of data kept?

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No



Applies To:


46 8.5.1 N/A

See

46-a

below.

Is continual improvement made

through the use of the following items:

The quality policy Quality objectives Audit results Data analysis Corrective and preventive actions Management review

Describe findings:

46-a N/A

See 46

above.

8.5.1

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?

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?

Describe findings: Yes No

Yes No

Yes No

Yes No



Applies To:


46-a N/A

See 46

above.

8.5.1

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?

Yes No

Yes No Yes No

47 8.5.2

N/A

N/A

N/A

8.5.2

8.5.2

8.5.2

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 Does this include updating

documentation if appropriate?

Recording results of action taken? o Does this include results of the

investigation?

Review of corrective actions taken? o Does this include effectiveness

of the actions taken?

Are the actions taken appropriate for

the problem encountered?

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No Yes No

Yes No Yes No

Yes No



Applies To:


48 8.5.3

N/A

N/A

N/A

8.5.3

8.5.3

8.5.3

8.5.3

Does the documented preventive action

procedure include:

Determining potential nonconformities and their causes?

Evaluating the need for preventive action to prevent occurrence?

Determining and implementing needed preventive action? o Does this include updating

documentation if appropriate?

Recording results of actions taken? o Does this include results of the

investigation?

Review of corrective actions taken? o Does this include effectiveness

of the actions taken?

Are the actions taken appropriate for

the potential problems?

Yes No

Yes No

Yes No

Yes No

Yes No Yes No

Yes No Yes No

Yes No

Comments:

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

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