ISO 9001:2000 General Requirements Monitoring, Measurement and Improvement

Reviewer Checks

Reviewer Checks

Planning the Process Audit

Define key inputs and resources for each of the
processes to be reviewed. Use process documentation,
flowcharts or SIPOC diagrams to identify these.
Process
Key Inputs and Resources

Determine the processes/activities to be included in the scope

of the audit. The scope may be provided as part of an audit
schedule or plan, or it may need to be developed by the audit
program manager. List the process(es) below:
Processes
Document No.
Internal Audits
Corrective & Preventive Action
Customer Satisfaction Monitoring
Analysis of Data
Continual Improvement
Consider the following information relating to the processes to
be examined.
Previous audit results related to the selected processes
Current process metrics relating to the selected processes
Significant corrective actions or complaints relating to the
selected processes
Auditee management
Other (list) _____________________________________

Based on your review, add, delete, or modify the

questions on this checklist to focus your evaluation
and to incorporate local requirements and inputs.
Recognize that most of the requirements that must be
verified will be called out in local procedures and
instructions.
Corrective Actions and Current/Recent problems
List any problems, CARs, or items from previous
audits that should be evaluated or verified during this
audit.
Problems noted for later examination:

Review the core process metrics relating monitoring,

measurement and improvement.
Metric
Recent Performance
Trend
1.
2.
3.
4.
5.
Objectives and/or targets to review:
1.

2.

2003 Joe Kausek & Associates

Internal Audit Program

Interview the Audit Program Manager (APM).
Do we have a procedure for internal audits? Ask to
see the procedure. Note the numbers and revision
date for later confirmation of document control.

Procedure

Ask the (APM) for a copy of the audit schedule.

Select several audits as test objects for the
remainder of this evaluation.

Report
No.

How is the schedule of internal audits determined?

Is it dynamic? Does it reflect status and importance
of the areas being reviewed?

Training and Awareness

How are auditors trained? Have they been provided
with training on the standard used by the
organization? Have they been trained in the process
approach? Have they accomplished any internal
qualification requirements? Do they audit their own
work?

Review the audit procedure to identify specific

roles, responsibilities and authorities of auditors.
Pay attention to responsibilities for planning,
reporting and recommending corrective action.
Interview several auditors about these
responsibilities. Are they aware of them?

Rev. Date

List audit reports sampled below.

Can you walk me through our process for

scheduling, planning, conducting and reporting
audits? Follow along in the procedure. Pay
particular attention to/or ask about the following:

Are audits formed around processes, as opposed to

elements? Are all core processes reflected? Are
supporting processes reflected? Although not a
stated requirement of the standard, audits should be
process based. Generate an OFI if not.

No.

Auditor Name

Process
Independent Qualified
Based?
Auditors?
Auditors?
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

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Evidence of
Training?
Yes No

Awareness of
Responsibilities?
Yes No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes
No. Audits Scheduled to Date

No

Yes No
No. Completed

Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the
specific requirement violated.

Are the audits being accomplished roughly per the

schedule?

ISO 9001 8.2.2

2003 Joe Kausek & Associates

Audit Performance
Examine the audit reports selected as samples. Are the
audits thorough? Do they consider inputs and resources
into the process as well as results? Do they consider
process effectiveness? Is there evidence that auditors
target specific areas where there are problems or poor
performance? Note your results in the right-hand
column.

List audit reports sampled below.

Report
No.

Are audit findings reported? Are the write-ups clear?

Are they provided to area management?

Effectiveness
External Audit
Is timely follow up provided to audit findings? This is a
critical verification. Review the corrective actions issued
as a result of the audits. Look for overdue, outstanding
corrective actions. Check no for any audits where there
are outstanding, overdue corrective actions.

Clear
Performance
Findings?
Focused?

Timely
Followup?

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

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Date

No. of Systematic
And Significant
Findings

1.

______

2.

______

No. of These
Identified by
Prior Internal
Audits
______
______

3.
______
______
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the
specific requirement violated.

Are the audits effective? Compare internal audit findings

to the findings of external audits (customers, registrar,
etc.). Did external audits find systematic weaknesses that
the internal audits did not?

ISO 9001 8.2.2

2003 Joe Kausek & Associates

Corrective & Preventive Action

Interview the Corrective Action Coordinator. Ask him or
her:
Do we have a procedure(s) for Corrective and
Preventive Action? Ask to see the procedures. Note the
numbers and revision date for later confirmation of
document control.
Ask the Coordinator for the action log. Select several
CARs as test objects for the remainder of this evaluation.
Can you walk me through our process for generating
and following up on corrective action? Follow along in
the procedure. Pay particular attention to/or ask about
the following:

Review the corrective action files. Is there evidence that

corrective actions are being used effectively? Are
corrective actions being used to drive improvement
beyond audit findings? Generate a finding if CARs are
only generated by audits.

Is the corrective action process effective in preventing

recurrence of problems? Review the last 6 12 months
of corrective actions. Is there a pattern of repeated
occurrence of problems (same description of problem,
same root cause)?

Procedure

No.

Rev. Date

Corrective Actions Evaluated

CAR
No.

Root Cause
Determined?

Timely Action
Taken?
Recurrence?

_________

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

Yes

No

Yes

No

_________

Yes

No

Yes

No

Yes

No

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Yes

No

Yes

No

Yes

No

_________

Yes

No

Yes

No

Yes

No

_________

Yes

No

Yes

No

Yes

No

Examples of Preventive Action

Are corrective actions being responded to in a timely

fashion? Look for overdue, outstanding corrective
actions. Is there follow up or new action/dates assigned?

Are there examples of preventive actions? Is the program

being used to prevent problems?

Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the
specific requirement violated.

Is there evidence that error proofing is a tool in both

corrective and preventive action? Note this is not a
requirement for ISO 9001, but should be a goal.
Consider an OFI if no evidence of error proofing is
evident.
ISO 9001 8.5

2003 Joe Kausek & Associates

Customer Satisfaction Monitoring

Ask the auditee what methods and measures are used to
monitor customer perceptions of how well we meet or
met their requirements. Check off those below that are
collected and analyzed.
Direct measures (list) based on customer feedback
(performance report cards, etc.).

Direct measures based on surveys, trailer cards and other

solicitations of customer satisfaction.

Indirect measures of satisfaction (awards, recognitions).

Indirect measures of customer dissatisfaction
(complaints, returned product, problem reports, ppm
quality, etc).
Are the above sources of information systematically
analyzed and reported?

The focus of this evaluation is verification that all sources of

information relating to customer satisfaction are collected and
considered during analysis of data for corrective, preventive
and continual improvement actions. Note that customer
satisfaction metrics are also reviewed during the Management
responsibility audit. This review, with the management
representative or other person who owns the process, is more
comprehensive.
Procedure No. __________________ Rev. _________
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the
specific requirement violated.
Metric

Performance

1.

Good

Poor
Action

Good Poor
Yes No

2.

Good

Poor
Action

Good Poor
Yes No

3.

Good

Poor
Action

Good Poor
Yes No

4.

Good

Poor
Action

Good Poor
Yes No

5.

Good

Poor
Action

Good Poor
Yes No

6.

Good

Poor
Action

Good Poor
Yes No

7.

Good

Poor
Action

Good Poor
Yes No

Are these measures trended over time?

Are these measures broken out by customer and/or

product?
Have any objectives or targets been assigned to customer
satisfaction performance?

Review the performance based on the measures used and

objectives/targets set. Is the performance satisfactory? Is
it improving?

For areas where performance is not satisfactory or is

trending in the wrong direction, have actions to correct
the performance been identified? Are they specific?
Have responsibilities and timeframes been established?

Trend

Comments and Findings

Reference ISO 9001 8.2.1

2003 Joe Kausek & Associates

Analysis of Data
Ask the auditee, beyond customer satisfaction
monitoring (reviewed in the last set of questions) what
other sources of information do we use to tell us where
we may need to take action to improve our QMS? Verify
the following sources of information are used:
Product conformity (ppm, 1st pass yield, etc.)

Process performance (metrics stated in quality system

procedures, diagrams, etc.)

Supplier quality performance

Supplier delivery performance

Opportunities for preventive action (e.g. FMEA,

preventive action requests)

Other (list) ___________________________

Other (list) ___________________________
Is the information above analyzed and trended?

This evaluation checks to see that all of the various sources of

information relating to QMS performance are systematically
collected, analyzed, and used to support action.
Procedure No. __________________ Rev. ___________
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the
specific requirement violated.
Metrics with poor performance

Reported?

Action?

1.

Yes

No

Yes

No

2.

Yes

No

Yes

No

3.

Yes

No

Yes

No

4.

Yes

No

Yes

No

5.

Yes

No

Yes

No

6.

Yes

No

Yes

No

Examples of proactive (i.e. preventive) action to improve the

system based on analysis of data:

Review the trends and performance information. Are any

not performing well or trending in the wrong direction?

Is there evidence of actions being taken in response to

the metrics, especially for those where performance is
lacking?

Comments and Findings

Is the information systematically and routinely

summarized and reported to the top management team?
When/how often? Note that as a minimum it should be
reported during management review.

2003 Joe Kausek & Associates

Continual Improvement
This checklist must be completed by the organization,
based on the continual improvement strategies and
methods used in the organization. Some of these
methods may include:

Six Sigma

Lean

Value Analysis

Kaizen

Poka-Yoke
Evaluation items would include how projects are
selected, approved, conducted, reported and
documented. Especially important would be evaluation
of the benefits gained and whether the gains were
maintained over time.
Also important is the process used to collect and analyze
data to identify improvement opportunities.
Consider a separate checklist for each strategy/method
employed. Use any local procedures or instructions
where they exist. If documented procedures do not exist
for these programs then interview program champions to
determine core requirements.

The organization will be effecting continual improvement, by

definition, if it complies with the other requirements of the standard.
This evaluation looks at other improvement programs being used to
drive performance. The auditor is seeking to verify that these
programs, whatever they may be, are being used in a systematic
fashion to ensure maximum results. The auditor is looking to assess:
1. What is the program?
2. Is it defined? Is it formalized? Is it systematic?
3. Is the program being followed/used as intended?
4. Are results being obtained?
Procedure No. _________________ Rev. ______
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the
specific requirement violated.
Program

Formalized?

Followed?

Results?

1.

Yes

No

Yes

No

Yes

No

2.

Yes

No

Yes

No

Yes

No

3.

Yes

No

Yes

No

Yes

No

4.

Yes

No

Yes

No

Yes

No

Comments and Findings

ISO 9001 8.5

2003 Joe Kausek & Associates