This document provides a checklist for auditing processes to assess compliance with ISO 9001:2015. The checklist includes questions addressing process definition, resources, execution, monitoring, and improvement. Scoring criteria are provided to rate audit findings as compliant, opportunity for improvement, minor nonconformance, or major nonconformance. The checklist is intended to ensure audits are conducted systematically and consistently.
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
ISO 9001-2015 clause 10.2 is different from ISO 9001-2008 corrective action requirements, i tried to capture the updated requirements and with a suggested format for deal with the updated requirements.
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
Global Manager Group provides presentation on IMS auditor training that helps organization to learn how effective auditing of integrated management system as per ISO 9001, ISO 14001 and ISO 45001 requirements which gives you maximum benefits and increase health safety efficiency in the organization with IMS Certification.
For more information visit https://www.globalmanagergroup.com/
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
ISO 9001-2015 clause 10.2 is different from ISO 9001-2008 corrective action requirements, i tried to capture the updated requirements and with a suggested format for deal with the updated requirements.
Quality Management System awareness for all ANUPAM RAY
I covered benefit and utilization ISO 9001:2015 standard, 8 quality principle, Root cause analysis, what is ISO, and basic auditing principle. Kindly comment and let me know how I can improve this.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
Global Manager Group provides presentation on IMS auditor training that helps organization to learn how effective auditing of integrated management system as per ISO 9001, ISO 14001 and ISO 45001 requirements which gives you maximum benefits and increase health safety efficiency in the organization with IMS Certification.
For more information visit https://www.globalmanagergroup.com/
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
How to successfully implement ISO 9001:2015 with a minimal documents approachPECB
The webinar covers:
• Replacing the Quality Manual
• Replacing All Other Procedures
• Checking Yourself to Ensure You've Met All Requirements
Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.
Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68
Many organizations can benefit from developing ISO 9001 Quality Management Systems (QMS) to improve the effectiveness and efficiency of their business operations.
ISO 9001 Quality Management Systems: Implementation and Integration features the author’s patented Three Step Process – “Identify, Insure, Improve,” in use since 1995 and developed, tested, and applied in actual business situations. It also explains how to integrate ISO 9000, ISO 14000 and OHSAS 18000 programs. This guide is a valuable resource for companies wanting to update their QMS or become certified for the first time.
ISO 9001 Quality Management Systems: Implementation and Integration is used by Quality Assurance/Quality Control Managers, EHS Managers, Risk Managers, Consultants, Loss Control and Operations Managers within manufacturing and service organizations.
Connie FarrisProject Performance and Quality Assurance(M.docxmargaretr5
Connie Farris
Project Performance and Quality Assurance
(MPM357-1902A-02)
Jason Lewis
Introduction
Several quality improvement process tools and techniques exist. They include Lean thinking, Value stream process mapping, Kaizen (The Japanese word for Continuous Improvement), Five Ss (separate, straighten, scrub, standardize, systematize), Kanban Primary and Task Response. In this paper, different strategies or philosophies for quality improvement in business shall be discussed. The tools and techniques that shall be compared are: Lean thinking, Kaizen and Five Ss (separate, straighten, scrub, standardize, systematize)
Comparison
All the techniques aim at improving quality of production processes. They involve the production units and department. All need planning and allocation of resources strategically.
Contrasting
Kaizen is a Japanese word for Continuous Improvement. The philosophy states that everything can be improved continuously. It involves employees in the improvement of quality processes. Workers give their feedback on the criteria and important reviewing issues in the performance of workers, supervisors and managers alike. It bases on many suggestions from employees from all ranks in the organisation. They are expected to consider and implement them with a key goal of improving managerial performance. The system encourages workers to provide suggestion, fosters employee education so that they are informed about improvement, and lastly it encourages employee efficiency (Pinto et al., 2018).
Lean Thinking on the other hand is a technique of quality process improvement aims at improving productivity, quality and lead-time reduction in order to support growth and competitiveness. It involves continuous improvement of the processes and relationships of employees through proven systematic methods, which reduce waste and maximise on customer value. It follows Plan, Do, Check, and Act systematic method. The system achieves low cost productivity, reduce waste, quick response to customer needs and high-quality production (Vlachos, 2015).
Moreover, the Five S's (5S) tools and techniques improves the work place, making it clean, safe, organised and uncluttered thus reducing waste and increase productivity. It builds both mental and physical quality work place (Urick et al., 2018).
The best quality process improvement tool or technique for my project is the 5Ss. This is because it is systematic and aims at making working environment of high quality, improves productivity, makes wastage low, increase employee morale, reduces cost of operation and improves safety (Urick et al., 2018).
Conclusion
In conclusion, tools and techniques for improving quality processes are key in any project. Thought they focus on diverse issues, the 5Ss seems to cover most aspects that increases quality production processes.
References
Pinto, J. L. Q., Matias, J. C. O., Pimentel, C., Azevedo, S. G., & Govindan, K. (2018). Lean M.
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What You're Going to Learn
- How These 4 Leaks Force You To Work Longer And Harder in order to grow your income… improve just one of these and the impact could be life changing.
- How to SHUT DOWN the revolving door of Income Stagnation… you know, where new sales come into your magazine while at the same time existing sponsors exit.
- How to transform your magazine business by fixing the 4 “DON’Ts”...
#1 LEADS Don’t Book
#2 PROSPECTS Don’t Show
#3 PROSPECTS Don’t Buy
#4 CLIENTS Don’t Stay
- How to identify which leak to fix first so you get the biggest bang for your income.
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2. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 1 of 16
Guidance
About this Checklist
The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary
requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the
following benefits:
Ensures the audit is conducted systematically;
Promotes audit planning;
Ensures a consistent audit approach;
Actively supports your organization’s audit process (ISO 9001:2015, Clause 9.2.1);
Provides a repository for notes collected during the audit;
Ensures uniformity in the performance of different auditors;
Provides reference to objective evidence.
This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2015, each required is phrased as a
question. This audit checklist may be used for element compliance audits and for process audits. If you wish to create separate process audit checklists, select
the clauses from the tables below that are relevant to the process and copy and paste the audit questions into a new audit checklist. We suggest that you
retain this audit checklist as your ‘master copy’.
3. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 2 of 16
Audit Scoring Criteria
A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to your organization. The audit’s role is to provide
assurance that key risks to your organization’s objectives are being well controlled.
The audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of any system or processes being audited. The rating
system is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method for scoring each audit finding. At the end of the
audit, you can transfer the findings into an Excel spreadsheet to create charts, summary tables and trend data to paste into your audit report or management
review documentation.
This methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and process audits) that your organization will likely
undertake.
Finding Definition/Impact Action/Mitigation
COMPLIANT
Compliant means adherence with the requirements of the standard and the QMS. The
process is implemented and documented and records exist to verify this.
Continueto monitortrends/indicators.
OFI
A low risk issue that offers an opportunity to improvecurrent practice. Processes may
cumbersomeor overly complex but meet their targets and objectives. Unresolved OFIs may
degrade over time to become non-compliant.
Review and implement actions to improve the process(s).
Monitor trends/indicators to determine if improvement was
achieved.
MINOR N/C
A medium risk, minor non-conformanceresulting in deviation from process practice not
likely to result in the failure of the management system or process that will not result in the
delivery of non-conforming products nor reduce the effectiveness of the QMS.
Investigate root cause(s) and implement corrective action by
next reporting period or next scheduled audit.
MAJOR N/C
A high risk, major non-conformancewhich directly impacts upon customer requirements,
likely to result in the customer receiving non-conforming products or services, or which may
reduce the effectiveness of the QMS.
Implement immediatecontainment action, investigate root
cause(s) and apply corrective action. Re-audit in 4 weeks to
verify correction.
4. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 3 of 16
Process Activity Map
PROCESS NAME/DESCRIPTION:
What steps are involved in the process?
What happens at each step in the process?
What documents and records are generated?
Is the process implemented in accordance with
procedures, instructions or plans?
Are controls applied as described?
PROCESS INPUTS:
What triggers the process?
What inputs are required?
Where do the inputs come from?
Are they received in a timely manner?
Are they fit for purpose?
PROCESS OUPUTS:
What is the product produced by this process?
Are product measures in place to ensure that
product meets requirements?
How are processes measured?
Are product and process measures achieved?
What feedback is received from customers?
EQUIPMENT & FACILITIES:
What equipment and resources are required?
Is equipment suitable and properly maintained?
Is the work environment maintained?
Is there evidence of appropriate maintenance of
all equipment used by this process?
INSTRUCTIONS & PROCEDURES:
Review the documents that describe and control
the process. Review all the important steps and
activities of the process being audited. This info
must be documented within the QMS. Evaluate
how effectively the process flows through the
steps. Do you see roadblocks or issues?
SUPPORT PROCESSES:
As you audit, you will see how it connects and
interacts with other processes. Interactions with
other processes are always important. As you
audit the, you will see how it connects and
interacts with other processes. Audit the relevant
links to related processes and support processes.
KEY PERFORMANCE INDICATORS:
Review metrics and performance with Managers,
Supervisors and operators. They should know
how things are running, objectives, customer
issues, problem areas. If they do not, the
requirements were not met. Is there evidence that
quality objectives and targets affected by this
process are being achieved?
PERSONNEL:
Review employee skill lists for the process. Are
there lists of skills for each position? Do they
show enough detail? This is often a finding,
where lists are generic with inadequate detail.
Training is a key process of any system. Are
there particular skills you want to evaluate?
CONTROL PROCESSES:
How is the process defined and who is
responsible? How are customer requirements
defined? What specifications apply defined?
What objectives and targets apply process?
What controls/check points are there? What
acceptance criteria exist?
5. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 4 of 16
Process Audit Checklist
Process Definition
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
1 Is the process defined and documented?
2
Is the process owner identified? (Process map,
procedure or work instruction, etc.)
3
Is there evidence that process inputs are accurately
defined and understood by all employees involved?
4
Is there evidence that process activities are accurately
defined and understood by all employees involved?
5
Is there evidence that process outputs are accurately
defined and understood by all employees involved?
6 Are inputs defined and prioritized based on risk?
6. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 5 of 16
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
7
Have procedures, instructions, and forms been
established as needed to control the process?
8
Are procedures, instructions and forms used in
controlling the process readily available?
9
Do procedures, instructions and forms accurately
reflect the practices? (Note: Requires the auditor review
and observation!)
10
Are there adequate plans in place to achieve the
objectives?
11
Is relevant customer feedback available? (Feedback
from subsequent processes)
12 Are documents understood by process participants?
7. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 6 of 16
Process Resources
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
13
Is there evidence of management commitment,
involvement and allocation of resources?
14
How many people participate in the process, is this
adequate to achieve process requirements?
15
Are participants adequately trained to carry out roles,
responsibilities, and authorities?
16
Is equipment (e.g. manufacturing, measuring &
monitoring equipment; transport/logistics;
hardware/software; PPE; etc.) adequate for its intended
use?
17
Is equipment identified to allow participants to
determine its readiness for safe use prior to and during
the operation?
18
Are process owners accountable for the performance
and compliance of their processes?
8. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 7 of 16
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
19 Are employees satisfied with their work area?
20 Is the work area clean and safe?
21 Is there adequate equipment/tools/IT support?
22
Are employees motivated and encouraged to make
suggestions for process improvement?
23
Are all employees aware of the organizational
objectives and the current status of these
measurements?
24
Are all employees aware of who their customers are
and whether they are satisfied?
25
Are employees aware of the process metrics which
their activities can affect?
9. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 8 of 16
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
26
Are they aware of the current data analysis related to
these metrics and the plans in place to achieve them?
10. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 9 of 16
Process Execution
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
27
Is the observed process activity consistent with
approved plans and procedures?
28
Is the process flow constructed to avoid unnecessary
movement of materials and personnel?
29
Are redundant and non-value adding activities
minimized?
30 Is material usage maximized to avoid waste?
31
Is waste material effectively removed and segregated
from the process?
32
Are unused materials returned to the correct location
in conditions suitable to allow re-use?
33
Are process outputs passed on to subsequent
processes only when all planned process activities are
completed?
11. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 10 of 16
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
34
Is there evidence of continuity between the various
support processes?
35
Do the interfaces between the departments operate
smoothly?
36
Does product information flow freely between the
support processes?
37
Is there evidence for the reduction in measurement
system and process variation?
12. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 11 of 16
Process Monitoring
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
38
Is the process monitored, measured, analyzed and
improved?
39
Are monitoring activities carried out according to
approved plans and procedures?
40
Is process monitoring compared against standards to
determine the current status of the process?
41
Is process status communicated to appropriate
members of the process team?
42
Are records of process monitoring maintained
according to approved procedures?
43
Have key performance indicators (KPI) been
established to allow the effectiveness of the process to
be evaluated?
44 Are KPI consistent with quality and business objectives?
13. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 12 of 16
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
45 Are KPI consistent with customer requirements?
46
Are KPI reviewed and communicated to the process
team, as appropriate, by process leaders?
47
Is the process measured for effectiveness and
efficiency?
48
When a process is not performing, is there evidence of
data analysis to determine the root cause?
49
When a process is not performing, is there evidence
that the cause(s) are dealt with in accordance with
procedure?
50
Are records of process monitoring reviewed regularly
to determine opportunities for corrective and
preventive action?
14. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 13 of 16
Process Improvement
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
51
Is the performance of the process reviewed at an
appropriate frequency by top management?
52
Are process improvement objectives aligned with
organizational objectives, e.g. the business plan?
53 Is there evidence of an effective PDCA cycle?
54
Can the process owner demonstrate how PDCA applies
to their process?
55
Can the process owner to show examples of
improvements driven by their PDCA cycle?
56
Can employees demonstrate areas of previous
continual improvement?
57
Are records of process upsets and actions taken
reviewed to determine the need for
corrective/preventive action?
15. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 14 of 16
Ref Audit Question
Audit Findings
(Score ‘1’ per box)
Audit Evidence
Opportunities for
Improvement (OFI)
COMPLIANT
OFI
MINOR
N/C
MAJOR
N/C
Provide reference to documented
information to justify the finding
Provide suggestions for process
improvement
58
Where corrective/preventive actions have been
implemented, have the action(s) taken been
demonstrated as effective?
59
Where opportunities for improvement have been
implemented, have the action(s) taken been
demonstrated as effective?
60
Are all process participants encouraged to be involved
in identifying improvements?
16. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 15 of 16
Findings Summary
Non-conformance
No. ISO/Specification Ref. Summary Root Cause NCR No. Rectification Date
Corrective Action
No. ISO/Specification Ref. Summary Root Cause CAR No. Rectification Date
Opportunities for Improvement
No. ISO/Specification Ref. Summary Root Cause PAR No. Implementation Date
17. Insert yourcompany’s name orlogo.
ISO 9001:2015 Process Audit Checklist
System & Process Compliance Auditing
Document Ref: Page 16 of 16
Observations, Comments & Notes