Introduction www.iso-9001-checklist.co.

ukProcess

The process assessment is not a strict requirement in ISO 9001:2015 but it will help to substantiate your audit programme and to introduce
Step 1 Enter the process name(s) in cells 'B27' to 'B48'.
Once you have entered the process name(s), they will copy through to the relevant sections of the remaining worksheets.
Step 2 Assess the criteria for ranking the status of processes.
1= Low All performance indicators, metrics, objectives, audit results, etc. show stability and consistently achieve targets;
2 = Medium Minor problems exist, minor process or product changes planned;
3 = High Poor performance/adverse trends, expected results not achieved;
4 = Critical Metrics are non-conforming. Any process with major audit finding in past 12 months.
Step 3 Assess the criteria for ranking how well the process is performed.
1= Low Consistently applying documented practice, possible benchmark performer;
2 = Medium Current practices conform but are not documented;
3 = High Practices are applied inconsistently;
4 = Critical Practices are non-conforming.
Step 4 Assess the criteria for ranking the importance of processes.
1= Low Little to no risk of adversely affecting customer satisfaction, product quality, delivery, or profitability;
2 = Medium Adverse effect on customer satisfaction, product quality, delivery, or profitability;
3 = High Likely have a significant adverse effect on customer satisfaction, product quality, delivery, or profitability;
4 = Critical Likely cause safety or regulatory compliance issues.
Step 5 The audit frequency indicators will transfer to the other work sheets within this workbook for future r
An audit should be scheduled at least once per year unless otherwise justified;
An audit should be scheduled within 12 weeks and an additional audit within 6 months;
An audit should be scheduled within 4 weeks with an additional audit after 12 weeks and then reoccurring quarterly.

Audit Programme
Step 6 Enter the start and finish date for each planned, or additional audit, based on the frequency shown by
Please note that Columns A, B & C will automatically populate with information form the 'Process Assessment' worksheet.
Only enter information in the grey coloured cells in Columns 'E', 'F', 'G' & 'H'.
The formulas will then colour the relevant date/day cell(s) in the programme.
Please note that all cells between 'I7' & 'I96' to 'ACA7' & 'ACA96' contain a hidden '0' which is required for the 'date cell' shading formula -
Begin auditing your system and processes, using the internal audit checklist.
Audit Findings Tracker
Step 7 From the 'Findings Summary' of the Audit Checklist, copy and paste the grey coloured cells into the co
Please note that Columns 'A', 'B' & 'C' will automatically populate with information from the 'Process Assessment' worksheet.
Remember that when pasting data from the internal audit checklist into the tracker to select 'paste without formatting' from paste options
Audit Findings Charts
Step 8 Copy and paste the charts into your internal audit reports or management review reports.
Please note that the grey coloured columns will automatically populate with data from the 'Audit Findings Tracker' worksheet.

Non-conformity & Corrective Action Tracker
Step 9 Issue corrective actions to process owners. Monitor progress and verify close-out.
Please note: the drop down box menu in Column 'B' is based on the processes that you entered in the 'Process Assessment' worksheet.
ww.iso-9001-checklist.co.ukProcess Assessment

audit programme and to introduce risk based thinking into your audit process.

ng worksheets.

nsistently achieve targets;

profitability;

y, or profitability;

hin this workbook for future reference during the next steps.

urring quarterly.

ed on the frequency shown by the indicators.

sment' worksheet.

for the 'date cell' shading formula - DO NOT DELETE!

grey coloured cells into the corresponding cells in the tracker.

ssessment' worksheet.
hout formatting' from paste options menu.

nt review reports.
Tracker' worksheet.

close-out.
cess Assessment' worksheet.
 www.iso-9001-c
Process Assessment
Step 1 Enter the process name(s) in cells 'B27' to 'B48'.

Once you have entered the process name(s), they will copy through to the relevant sections of the remaining worksheets.
1= Low All performance indicators, metrics, objectives, audit
Step 2 Assess the criteria for ranking the status of 2 = Medium Minor problems exist, minor process or product chan
processes.
3 = High Poor performance/adverse trends, expected results n
4 = Critical Metrics are non-conforming. Any process with major
1= Low Consistently applying documented practice, possible
Step 3 Assess the criteria for ranking how well the 2 = Medium Current practices conform but are not documented;
process is performed.
3 = High Practices are applied inconsistently;
4 = Critical Practices are non-conforming.
1= Low Little to no risk of adversely affecting customer satisf
Step 4 Assess the criteria for ranking the 2 = Medium Minor adverse effect on customer satisfaction, produ
importance of processes.
3 = High Likely have a significant adverse effect on customer s
4 = Critical Likely cause safety or regulatory compliance issues.
Audit frequency indicators will transfer to An audit should be scheduled at least once per year unless othe
Step 5 the 'Audit Programme' and the 'Audit
An audit should be scheduled within 12 weeks and an additional audit within 6 months;
Findings Tracker' for reference.
An audit should be scheduled within 4 weeks with an additional audit after 12 weeks
Perceived Process Ranking

Audit Ref. Process Name

Critical 4, High 3, Medium 2, Low 1

Status Practices Importance

IA001 Quality Management System 2 1 3
IA002 Document Control 1 1 2
IA003 Design & Development 3 2 3
IA004 Manufacturing 1 2 3
IA005 Customer Service 1 2 2
IA006 <enter process name/description>
IA007 <enter process name/description>
IA008 <enter process name/description>
IA009 <enter process name/description>
IA010 <enter process name/description>
IA011 <enter process name/description>
IA012 <enter process name/description>
IA013 <enter process name/description>
IA014 <enter process name/description>
IA015 <enter process name/description>
IA016 <enter process name/description>
IA017 <enter process name/description>
IA018 <enter process name/description>
IA019 <enter process name/description>
IA020 <enter process name/description>
IA021 <enter process name/description>
IA022 <enter process name/description>
Perceived Effects on QEH&S Ranking
Critical 4, High 3, Medium 2, Low 1

Quality Environment H&S

3 1 1
2 1 1
3 2 2
3 2 2
2 1 1

Customer Complaints
Actual No. of Complaints

Quantity
0
0
0
0
2
 Any Known Corrective Actions
Internal CA (Audits/N/Cs) External CA (Audits/N/Cs)

Quantity Quantity
0 0
0 0
1 0
2 0
0 1

Process
Status

Indicator
 www.iso-9001-checklist.co.uk

s, metrics, objectives, audit results, etc. show stability and consistently achieve targets;
or process or product changes planned;

e trends, expected results not achieved;

ng. Any process with major audit finding in past 12 months.
umented practice, possible benchmark performer;
but are not documented;

nsistently;
ming.
ly affecting customer satisfaction, product quality, delivery, or profitability;
ustomer satisfaction, product quality, delivery, or profitability;

dverse effect on customer satisfaction, product quality, delivery, or profitability;

latory compliance issues.
once per year unless otherwise justified;
within 6 months;
ional audit after 12 weeks and then reoccurring quarterly.
01-checklist.co.uk

udit results, etc. show stability and consistently achieve targets;

hanges planned;

ts not achieved;
ajor audit finding in past 12 months.
ible benchmark performer;
ed;

atisfaction, product quality, delivery, or profitability;

oduct quality, delivery, or profitability;

er satisfaction, product quality, delivery, or profitability;

es.
otherwise justified;

eks and then reoccurring quarterly.

 www.iso-9001-checklist.co.uk
Audit Programme

Step 6 Enter the start and finish date for each planned, or additional audit, based on the frequency shown by the indicators.

An audit should be scheduled at least once per year unless otherwise justified;
An audit should be scheduled within 12 weeks and an additional audit within 6 months;
An audit should be scheduled within 4 weeks with an additional audit after 12 weeks and then reoccurring quarterly.
Please note that Columns A, B & C will automatically populate with information form the 'Process Assessment' worksheet.
Only enter information in the grey coloured cells in Columns 'E', 'F', 'G' & 'H'.
The formulas will then colour the relevant date/day cell(s) in the programme.
Please note that all cells between 'I7' & 'I96' to 'ACA7' & 'ACA96' contain a hidden '0' which is part of the 'date box' shading formula - DO NO
Begin auditing your system and processes using the internal audit checklist.

Audit Ref. Process Name Indicator Type Start

Planned 19-01-16

IA001 Quality Management System Additional 03-02-16

Additional 15-02-16
Additional
Planned

IA002 Document Control Additional

Additional
Additional
Planned

IA003 Design & Development Additional

Additional
Additional
Planned

IA004 Manufacturing Additional

Additional
Additional
Planned

IA005 Customer Service Additional

Additional
Additional
Planned

IA006 <enter process name/description> Additional

IA006 <enter process name/description>
Additional
Additional
Planned

IA007 <enter process name/description> Additional

Additional
Additional
Planned

IA008 <enter process name/description> Additional

Additional
Additional
shown by the indicators.

quarterly.
nt' worksheet.

te box' shading formula - DO NOT DELETE!

11-01-16 18-01-16 25-01-16

Finish Duration Complete
11-01-16

12-01-16

13-01-16

14-01-16

15-01-16

16-01-16

17-01-16

18-01-16

19-01-16

20-01-16

21-01-16

22-01-16

23-01-16

24-01-16

25-01-16

26-01-16
(Yes/No)

20-01-16 1 day

05-02-16 2 Day
17-02-16 3 Day
27-01-16

28-01-16

29-01-16

25-01-16
30-01-16

31-01-16

01-02-16

02-02-16

03-02-16

04-02-16

05-02-16

01-02-16
06-02-16

07-02-16

08-02-16

09-02-16

10-02-16

11-02-16

12-02-16
08-02-16

13-02-16

14-02-16

15-02-16

16-02-16

17-02-16

18-02-16

19-02-16
15-02-16
 www.iso-9001-checklist.co.uk
Audit Findings Tracker
Step 7 Using the 'Findings Summary' section from the Internal Audit Checklist.docx, copy and paste grey the coloured cells into the co

Please note that Columns 'A', 'B' & 'C' will automatically populate with information from the 'Process Assessment' worksheet.

Clause ► 4.1 4.2

Audit Ref. Process Name Indicator Question No. ►

1 2 3
Criteria ▼

OFI 1
IA001 Quality Management System Minor N/C 1
Major N/C
OFI 1
IA002 Document Control Minor N/C 1
Major N/C
OFI

IA003 Design & Development Minor N/C

Major N/C
OFI

IA004 Manufacturing Minor N/C 1

Major N/C
OFI

IA005 Customer Service Minor N/C

Major N/C
OFI

IA006 <enter process name/description> Minor N/C

Major N/C
OFI

IA007 <enter process name/description> Minor N/C

Major N/C
OFI

IA008 <enter process name/description> Minor N/C

Major N/C
OFI

IA009 <enter process name/description> Minor N/C

Major N/C
OFI

IA010 <enter process name/description> Minor N/C

Major N/C
OFI

IA011 <enter process name/description> Minor N/C

Major N/C
OFI
IA012 <enter process name/description> Minor N/C
Major N/C
OFI

IA013 <enter process name/description> Minor N/C

he coloured cells into the corresponding cells below.

worksheet.
Context of the Organization
4.2 4.3 4.4 4.4.1 4.4.2

n 4.0
4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Sectio
1 1 3
1 2
1 1
1
1 1 3
0
1 1
1 1 2
0
1 1
1 1 3
1 1
0
1 1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
 Leade
5.1.1 5.1.2 5.2.1 rship

25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42

1 1

1
1
1 1

1
1 1

1
1
1
1
 www.iso-9001-checklist.co.uk
Audit Findings Charts
Step 8 Copy and paste the charts into your internal audit report or management review report.

Please note that the grey coloured columns will automatically populate with data from the 'Audit Findings Tracker' worksheet.
Quality Management System Compliance
Clause
Quality Management System Compliance Charts
Processes Compliance
Total Minor Total Major Total Audit
N/C N/C Findings
Audit Ref. Process Name Total OFI

IA001 Quality Management System 22 11 13 46

IA002 Document Control 2 5 0 7

IA003 Design & Development 2 4 0 6

IA004 Manufacturing 2 4 2 8

IA005 Customer Service 2 2 1 5

IA006 <enter process name/description> 0 0 0 0

IA007 <enter process name/description> 0 0 0 0

IA008 <enter process name/description> 0 0 0 0

IA009 <enter process name/description> 0 0 0 0

IA010 <enter process name/description> 0 0 0 0

IA011 <enter process name/description> 0 0 0 0

IA012 <enter process name/description> 0 0 0 0

IA013 <enter process name/description> 0 0 0 0

IA014 <enter process name/description> 0 0 0 0

IA015 <enter process name/description> 0 0 0 0

IA016 <enter process name/description> 0 0 0 0

IA017 <enter process name/description> 0 0 0 0

IA018 <enter process name/description> 0 0 0 0

 IA019 <enter process name/description> 0 0 0 0

IA020 <enter process name/description> 0 0 0 0

IA021 <enter process name/description> 0 0 0 0

IA022 <enter process name/description> 0 0 0 0

4.1 2 2 0
4.2 0 2 0
4.3 1 3 0
4.1
4.2
0
Context of the Organization
2 2 0
2 0
4.4 0 0 1
4.4.1 3 3 1
4.4.2 0 1 0
4.3
1 3
4.4
0 1
4.4.1
3 3
4.4.2
0 1

0
OFI
Minor N/C Major N/C
1
###
5.1.1 6 3 2
Leadership
5.1.2 0 2 0
5.2.1 0 0 0
5.2.2 0 0 0
5.3 1 0 1
5.1.1
5.1.2
0
5.2.1
0
5.2.2
0
6 3 2
2 0
OFI
Minor N/C Major N/C
6.1.1 1 0 0
6.1.2 0 0 1
6.2.1 0 1 0
6.2.2 0 1 1
6.3 0 1 0
6.1.1
6.1.2
0
6.2.1
0
6.2.2
0
6.3
0
Planning
1
1
1
1 1
1
0
OFI
0 Minor N/C
Major N/C

0
7.1.1 1 0 0
Support
7.1.2 0 0 0
7.1.3 0 0 0
7.1.4 0 0 0
7.1.5.1 0 0 0
7.1.5.2 0 0 0
7.1.1
1 0
7.1.2
0
7.1.3
0
7.1.4
0
7.1.5.1
0
7.1.5.2
0
acker' worksheet.

Total Audit
Findings
Process Compliance Chart

46 Audit Findings per Process

22 11
2
2
2 4
2 2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Total OFI Total Minor N/C Total Major N/C

7 Quality Management System

6 Document Control 5

8 Design & Development 4

Manufacturing

5
Customer
Service

0
<enter process name/description>

0
<enter process name/description>

0
<enter process name/description>

0
<enter process name/description>

0 <enter process name/description>

0
<enter process name/description>

0 <enter process name/description>

0 <enter process name/description>

0 <enter process name/description>

<enter process name/description>

0
<enter process name/description>

0
<enter process name/description>

0
<enter process name/description>

<enter process name/description>

0
<enter process name/description>

0 <enter process name/description>

0
<enter process name/description>

0
13
 0

1
Non-conformity & Corrective Action Tracker www.iso-9001-checklist.co.uk

Step 9 Issue corrective action reports to process owners to initiate the close-out of any non-conformances. Monitor progress and verify close-out.

Please note: the drop down box menu in Column 'B' is based on the processes that you entered in the 'Process Assessment' worksheet.
CAR Ref. Process Name CAR Type How was it identified?

CAR001 Design & development Minor N/C Audit - Internal

CAR002 Manufacturing & warehousing Major N/C Feedback - Customer
CAR003
CAR004
CAR005
CAR006
CAR007
CAR008
CAR009
CAR010
CAR011
CAR012
CAR013
CAR014
CAR015
CAR016
CAR017
CAR018
CAR019
CAR020
CAR021
CAR022
CAR023
CAR024
CAR025
CAR026
CAR027
CAR028
CAR029
CAR030
CAR031
CAR032
CAR033
CAR034
CAR035
CAR036
CAR037
CAR038
CAR039
CAR040
CAR041
CAR042
CAR043
CAR044
CAR045
CAR046
CAR047
CAR048
CAR049
CAR050
CAR051
CAR052
CAR053
CAR054
CAR055
CAR056
CAR057
CAR058
CAR059
CAR060
CAR061
CAR062
CAR063
CAR064
CAR065
CAR066
CAR067
CAR068
CAR069
CAR070
CAR071
CAR072
CAR073
CAR074
CAR075
CAR076
CAR077
CAR078
CAR079
CAR080
 www.iso-9001-checklist.co.uk

conformances. Monitor progress and verify close-out.

he 'Process Assessment' worksheet.

Description of the CAR Non-conformance Report
Ref. (If applicable)
Design review minutes not authorized prior to release to client Not applicable
Incorrectly shipped item NCR001
 Root Cause Description of Corrective Action

Version control - using superseded template Department to ensure templates are updated
Item was mis-identified prior to storage Warehousing to investigate and correct labelling errors
Date Assigned Assigned to Target Closed-out
Completion (Yes/No)
01-01-16 Jane Doe 20-01-16 Yes
20-02-16 John Doe 07-03-16 No
 How was Close-out Verified? Date Close-out
Verified
Visually confirmed that the correct template is available and is being used 30-01-16