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Sample Internal Audit Report For QMS

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100% found this document useful (1 vote)
2K views34 pages

Sample Internal Audit Report For QMS

Sample-Internal-Audit-Report-for-QMS

Uploaded by

Travis Mann
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 34

‘Sample Internal Audit

Report’ for QMS


AGAINST
ISO 9001:2015

BUSINESS EXCELLENCE CONSULTANCY


SAMPLE “Internal Audit Report” for Quality Management Systems

Table of Contents
1. Report Preparation and Approval ...................................................................................................... 3
2. Audit Information ............................................................................................................................... 3
3. Audit Objectives and Criteria ............................................................................................................. 3
4. Audit plan ........................................................................................................................................... 4
5. Methodology and Scope of the Audit ................................................................................................ 4
6. Limitations of Audit and Confidentiality of the Information ............................................................. 4
7. Non Conformity Criteria ..................................................................................................................... 4
8. Audit Report Summary ....................................................................................................................... 5
9. Positive Points .................................................................................................................................... 6
10. Evidence of compliance and/or non compliance ............................................................................... 6

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1. Report Preparation and Approval

Name Designation Signature

Prepared By

Reviewed by

Approved by

2. Audit Information

Management Systems Quality Management Systems

Audit Criteria ISO 9001:2015, Industry Best Practices

Audit Type Internal

Audit Date 14-15 July, 2022

Report Distribution  Management Representative,


 Head of departments/ Process owners
 Top management
 Auditor(s)

Audit Team

Audit duration 02 Auditor Days

3. Audit Objectives and Criteria


The objectives and criterial of the audit are
 Determination of extent of conformity of organization’s documented quality
management systems against ISO 9001:2015; applicable legal requirements and
industry best practices,
 Evaluation of efficiency and effectiveness of aforesaid quality management systems in
meeting its specified objectives, and
 Identification of areas for improvement in order to add value to these systems.

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4. Audit plan

Sr # Process Time
Day 1
1. Opening Meeting 9:00
2. Top management 9:30 AM - 1030 AM
3. HR 1030 AM - 0100 PM

Lunch & Prayer Break

4. QC 2:00 PM – 3.00 PM

5. Sales & Marketing 3:00 PM – 4:40 PM

Day 2

6. Work Shop 9:30 AM – 10:15 AM

7. Stores 10:15 AM – 11:15 AM

8. Operations 11:30 AM – 12:30 PM

Lunch & Prayer Break

9. Purchase 12:30 PM – 1:00 PM

10. operations 1:00 PM – 2:00 PM

11. Closing Meeting 3:00 PM

5. Methodology and Scope of the Audit


The scope of ‘Audit’ is all the departments, facilities, and employees.
The methodology is as under:
1. Review of documents and records,
2. Interviews and discussions with Management and selected staff, and
3. A sample based inspection of equipment; operations; activities; facilities and locations
throughout the premises.

6. Limitations of Audit and Confidentiality of the Information


4. This ‘Audit’ is based on sampling and therefore, nonconformities may still exist; and
5. This report and its contents should be treated as “Confidential” except with the prior
written consent of the top management of the company.

7. Non Conformity Criteria


Major Non-conformance
 Non-compliance to any legal requirement;
 The absence or total breakdown of a system to meet the requirements;
 Repeated minor non-conformances in the same area;
 Any non-conformance that relates to a high risk activity; and
 Non-implementation of agreed ‘Action Plan’ to address a minor non-conformance.

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Minor Non-conformance
 Partial implementation of the system; and
 Partial non-fulfilment of any documentation requirement.
Observation
An observation describes the situation wherein there is a potential of deviating from the System
Suggestion
It’s a recommendation with regards to the best practices
Note: The process owner is recommended to do the “Cost & Benefits” analysis for an Observation
and Suggestion; so, if the benefits overweigh, the Corrective Action should be taken and vice versa.

8. Audit Report Summary


A detailed onsite audit was conducted with the audit findings detailed below against each of the
clauses of ISO 9001:2015. The non-conformances are categorized as major, minor, observation and
suggestion.
Sample based documents and records reviewed and verified.
There is a quality documentation established and documented against the latest version of ISO
9001:2015.
The MR, department Heads and other management and staff are in general are competent,
courteous, committed, willing to listen to the alternate opinion, and passionate for learning.
The GM is committed to allocate necessary resources for effective documentation,
implementation, maintenance and continual improvement of the Quality Management Systems in
order for total compliance with statutory, regulatory requirements, and Industry Best Practices.
It is recommended that GM should continue its support in the same spirit through personal
involvement e.g. participation in Management Review Meetings, QMS Committee Meetings, and
through communicating the importance of compliance with the quality policy.
The following are the areas where the Management need to focus through department Heads:
1) It is recommended to review further and hence revise process flow diagrams (PFD) e.g.
process owners & pertinent records and monitoring i.e. quality control checks (QC)
requirements;
2) It is recommended to reconsider RACI matrix for operations department.
3) Organizational chart should be controlled and available in all the departments
4) More risks and opportunities should be included to the existing ones and the actions to
address them, determined accordingly
5) The Review of objectives and targets should be documented
6) It is recommended to upgrade welfare facilities e.g. washrooms, rest rooms for drivers and
dining facilities etc.
7) It’s recommended to control documentation with regards to preparation, review & approval
authorities
8) Its recommended to identify the performance parameters, monitored & measured (data
collection), analyzed (e.g. putting in graphical form) for trends, evaluated against the previous
data or bench marks
9) The SoPs at the department level should be controlled and approved by the relevant
authorities
10) It is recommended to document the Escalation Matrix/Plan (suggestion, not heard by, not
agreeing on performance appraisal outcome, any dispute etc.) that includes authorities and
response time, at minimum.
11) There are 2 supplier lists, these should be consolidated in one and controlled e.g. approval of

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the relevant authority


12) It is recommended to conduct management review meeting more frequently; however with
shorter agenda so that the full agenda is covered during the year (as explained to MR)

9. Positive Points
These include, but not limited to the following:
1) The top management is committed & willing to allocate resources of all kinds
2) Friendly work environment
3) The Management Representative and other Managers and Staff are courteous, well mannered,
polite, competent, open minded, co-operative and willing to learn and improve
4) 01 window operation with staff and management in the open plan office, with waiting areas, to
enhance Customer Satisfaction, Communication & Coordination for HR activities (in process).
5) Effective standard operating procedures
6) JD include HSE responsibilities, separately

10. Evidence of compliance and/or non compliance

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clause # QMS Requirements Auditee(s) Reference1 Remarks


4.4 Quality Management System and its processes
 The following have been identified as the key processes:
 Human Resources
 Quality Control
Have the processes of the organization been  Sales & Marketing
identified?
 Workshop
 Inputs and Outputs
 MR  Operations
 Sequence and interaction
 QC  Purchase
 Criteria, method and performance indicators It is recommended to add
 Sales & Marketing  Health & Safety and Environment
 Resources needed more information in PFD e.g.
 HR  Process Flow Diagrams (PFDs) developed for the
 Defined responsibility and authority for all process owner & pertinent
4.4  Workshop aforementioned processes, ref. doc # ABC-QMS-P.15, records and monitoring (QC)
personnel.
 Purchase heading 9, Related documents requirements [Sug.]
 Risks and Opportunities
 Operations  RACI Matrix developed for the mentioned processes, doc #
 Method for monitoring and change to ensure ABC-QMS-P.15, heading 9, related documents, page 2
intended results
 Criteria, methodology, monitoring requirement are
 Opportunities for improvement of the defined in the relevant policies, procedures and associated
processes documents specific to each department separately with
controlled access to ensure confidentiality and protection
 Risks and opportunities and the actions to address these
have been identified for the processes referred to above
Has the organization defined Defined in the relevant policies, procedures and associated
 Needed documented information to support the documents, for each department separately with controlled
MR, QC, Sale & Marketing, access to ensure confidentiality and protection
operation of its processes?
HR, Workshop, Purchase,
4.4  Documented information to be retained as Operations
evidence that the processes are being carried out
as planned?
5 Leadership

1
To internal documentation including manual, policies, system element procedures, standard operating procedures & associated templates for records, minutes of discussion with management; interviewing
of staff and observation of facilities
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clause # QMS Requirements Auditee(s) Reference1 Remarks


Has GM demonstrated leadership by
 Taking accountability of the process?
 Establishing the Quality Policy and Objectives?
 Communicating the Policy?
 Quality policy sent through email to participants in group
 Ensuring QMS Requirements are integrated into the
(05/07/2022)
processes?
 Quality objectives (minimum 1 for each department) is set
 Making available adequate resources? GM and MR
5.1.1 on yearly basis, with quarterly review, approved by GM
 Communicating QMS effectiveness?
 For each objective, Action Plan is documented
 Ensuring achievement of results?
 Engaging/directing/supporting process effectiveness?
 Promoting continual improvement?
 Supporting other management roles within the
organization to do the same?
Can GM demonstrate evidence of commitment to the
development, implementation and improvement of the
effectiveness of the quality management system by:
 Communicating to the organization the importance of
meeting customer requirements? Yes; Sales and operations departments collect data on
 Establishing the quality policy?
MR
5.1.1 customer satisfaction
 Ensuring that quality objectives are
established?
 Conducting management reviews?
 Ensuring the availability of resources?
5.1.2 Customer Focus
Has GM demonstrated leadership by
 Identifying customer requirements?
MR Yes, the evidence to be provided in the following sections of
 Identifying regulatory requirements?
5.1.2 this report
 Identifying statutory requirements?
 Risks and Opportunities determined and

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addressed?
 Focus to consistently provide
products/services that meet customer
requirements?
 Enhancing customer satisfaction?
5.2 Quality Policy
Has GM established a quality policy that
 Is appropriate to the organization?
 Allows for review of process indicators and
objectives?
 Includes a commitment to satisfy applicable Yes, refer to Quality Manual, doc # ABC-QMS-QM-01, Section
GM and MR
5.2.1 requirements? C4, Rev # 01, page # 24
 Includes a commitment to continual improvement?
 Is communicated and understood throughout the
organization
 Is reviewed for continuing suitability?
Are the quality objectives measurable and consistent with Yes
5.2.1 GM and MR
the quality policy?
Is the quality policy Yes, refer to Quality Manual, doc # ABC-QMS-QM-01, Section
 Documented? C4, Rev # 01, page # 24, Signed by GM and displayed on
GM and MR Notice boards
5.2.2  Communicated and understood?
 Available to relevant interested parties?
5.3 Organizational roles, responsibilities and authorities

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Has GM defined  JDs for head of department
 Responsibility and authority for all personnel QC, QC Supervisor should
affecting quality? be developed [Obs.]
 RACI Matrix developed process wise with PFDs, ref. doc #
 Ensuring that the processes are effective and  Organizational Chart ( Doc
ABC-QMS-P.15, heading # 9, related document
delivering their intended results? # is missing)
 Job descriptions [JDs] reviewed for the following
 Reporting on the performance of the QMS and HR, QC, Stores  Organizational chart
5.3  QC Assistant & QC Inspector should be available to all
opportunities?
 For all the positions on the organogram in HR, etc. [Obs.]
 Ensuring Customer Focus throughout the
organization?  Sr. Executive - Client relationship
 Maintaining the integrity of QMS when changes
are implemented?
6 Planning for the Quality Management System

Has the organization considered risks and opportunities  Risk register is not
noted in 4.1 and 4.2 and have assurances that QMS accessible for HR which an
 Can achieve its intended results?
issue in regards to the
GM, MR, HR, HSE, QC,
Risks & opportunities register documented, department control of document
 Mitigate Risk by prevention or reduction of W/shop, Sales, Stores,
6.1.1 wise, doc # ABC-QMS-P.15, Rev # 01, and associated record distribution [Obs.]
undesired effects? Purchase
 Identify more risks &
 Enhance desirable effects?
opportunities for all the
 Achieve improvements? processes [Sug.]
Does the organization plan Action plan, as of June for Operations: outcome is 77.1%  The review of objectives
MR, HR, HSE, QC, and targets is not
 Actions needed to address risks and opportunities.
W/shop, Sales, Stores, documented in purchase
6.1.2  Integrate actions into its QMS processes?
Operations and Purchase [Obs.]
 Evaluate the effectiveness of actions?
Has the organization established Quality  100 % compliance of quality objectives with regulatory &
objectives that are: requirement, Action plan, reviewed for QC Division
MR, HR, HSE, QC,  The review should be
 Consistent with the Quality Policy?  A total of 9 quality objective set by Sales and Marketing,
W/shop, Sales, Stores, documented [Obs.]
6.2.1  Are measurable?  Quality Objectives for HR in the following categories
Purchase reviewed:
 Considered applicable requirements?
 Relevant? 1) Training,
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 Monitored? 2) Timeline, reporting & analytics,
 Communicated? 3) Cost Saving,
 Updated? 4) Recruitment,
5) Compensation/Rewards & recognition,
6) Performance appraisal, improvement plan and
organization structure
7) Total 20 objectives are set.
 01 Quality Objective developed [Air changing pit] for 2018,
reviewed quarterly
 01 objective by store division for year 2018, action plan
reviewed
 01 objective is set by purchase division for year 2018,
action plan reviewed.
Has the organization planned how to achieve its quality
objectives by
 Identifying what has to be done? MR, HR, HSE, QC,
 Identifying the needed resources?
Yes, Action pan to achieve the targets and objective is
W/shop, Sales, Stores, developed
6.2.2
 Identifying the responsibility for achievement? Operations, Purchase
 Due date for achievement?
 Evaluation of the results?
For changes to the QMS, has the organization proceeded
in a planned and systemic manner by
 Identifying the changes and their consequence?
 The integrity of the QMS? MR Yes, through third party (mention the name)
6.3
 Availability of resources?
 Allocation or reallocation of responsibilities and
authorities?
7 Support

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Has the organization determined the needed resources
while considering
GM & MR Yes
7.1.1  Limitations of internal resources?
 What has to be obtained from external providers?
7.1.2 People
Yes, reviewed as follows
 Enough internal resources e.g. in QC, there are 8
Are adequate human resources in place to ensure Inspectors with 2 in backup and 5 cleaners,
7.1.2 compliance with the customer and applicable regulatory GM & MR, QC
 For store: 1 Supervisor, 01 store keeper, Assistant store
and statutory requirements?
keeper, working in shift (24/7)
 12 people in Operations
7.1.3 Infrastructure
Has the organization identified the infrastructure needed
for effective operation of the QMS, , including It is recommended to upgrade
 Maintenance of equipment? welfare facilities e.g.
GM and MR
7.1.3  Buildings and associated utilities? Washrooms, rest rooms and
 Transportation? dining facilities [Sug.]
 Information and Communication Technology?
7.1.4 Environment for the operation of processes
How will it be demonstrated that the organization HR, HSE, QC,
determines and manages the work environment needed to W/shop, Sales, Stores,
7.1.4
achieve conformity to product and service requirements? Operations, Purchase
7.1.5 Monitoring and measuring resources
Has the organization determined the monitoring and Yes
measurement to be undertaken, and the monitoring and
7.1.5 QC
measurement resources needed to provide evidence of
conformity to determined requirements?

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Are suitable monitoring and measuring resources
available to ensure valid and reliable results, including
 Ensuring suitable resources?
 Resources are maintained to ensure their
continued fitness for their purpose?
QC
7.1.5  Maintaining documented information as evidence
of fitness of the monitoring and measuring
resources?
 Determining suitability of the specific type of
monitoring and measurement activities?
7.1.5 Have all monitoring and measuring activities determined? QC
Are monitoring and measuring resources suitability
maintained?
What documented information is maintained as evidence
of fitness for the monitoring and measurement  Monitoring and measuring resources are enough; 07 QC
resources? inspectors with Tablet and Cameras.
 Is measuring equipment calibrated or verified, or both,  The QC report goes online every 48 hours
at specified intervals or prior to use against traceable
international or national measurement standards? (If
7.1.5 international or national measurement standards are QC
not available, the basis for calibration or verification
shall be defined)
 Identified in order to determine its calibration status?
 Safeguarded from adjustments that would invalidate
the measurement result?
 Protected from damage and deterioration during
handling, maintenance and storage?
How will it be demonstrated that:
 The validity of previous measuring results are assessed
7.1.5 QC
by the organization when equipment is found not to
conform to requirements?
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 Appropriate action is taken on the equipment and any
affected product?

7.1.6 Organizational Knowledge


 All the relevant information is documented and controlled
that includes, but not limited to the following
MR, HR, HSE, QC,  Process flow diagrams [PFD’s]
What evidence is available to ensure that the Organization  Risks & opportunities register,
7.1.6 has determined the knowledge necessary for effective W/shop, Sales & marketing,
operation of its processes? Stores, Operations,  Standard operating procedures and policies
Purchase  Corrective action plans and associated records
 Workshop SOP; doc # FOD-FMS-SOP-“D” services, Test,
trail, experiment & research proposal.
 The necessary knowledge for the operation of the various
processes determined, maintained, and made available.
 For marketing, this includes the following
 Data Base
 Ongoing tenders and follow up clients
 Contract expiry, renewal details
Is the knowledge necessary for the operation of the MR, HR, HSE, QC,
 Potential clients, not approved yet
various processes determined, maintained, and made W/shop, Sales, Stores,
7.1.6 available, if needed? Operations, Purchase  Policies, Procedures, associated documents and
records
 Historical data e.g. objectives and targets
 Corrective actions taken
 Reports for lost contracts
 Store Standard policies & procedure, ref # G2l/HM/12/M-
16, approved by senior vice president.
7.2 Competence
Has the necessary competence for personnel performing  reviewed for Senior Executive - Client relationship, Rev #  Organogram not controlled
7.2 HR, Sale and Marketing
work affecting conformity to product requirements been 01 for workshop [Obs.]
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determined?  Upon Appraisal, if expected outcome is less than,  JD for meter section in
Appropriate documented information for education, explanation can be called; the other things include charge not available [Obs.]
training, skills and experience are maintained. improvement plan and warning letter as a last resort  JDs for assistant store
 Minimum competencies are in documented but in HR keeper, not approved &
department controlled [Obs.]
 Annual performance
evaluation Form should be
synchronized with
minimum competencies
 It is recommended to
document the escalation
matrix plan (e.g.
suggestion, not heard,
disagreement, on outcome
of appraisal, dispute etc.)
with the timeline [Sug].
Where applicable, is the Training provided or other actions Outcome of performance appraisal become the input of
7.2 taken evaluated for effectiveness in meeting the necessary HR training need analysis (TNA)
competence?
Are Personnel aware of the relevance and importance of
7.2 their activities and how they contribute to the achievement HR Yes, interviewing of staff
of the quality objectives?
Are documented information maintained to demonstrate Performance appraisal on annual basis, the overall score,
7.2 competency achievements through education, training, HR strengths and weaknesses are communicated with the
skills and experience? employees; signed by Employee & the Appraiser
7.3 Awareness
Are methods in place to ensure understanding of the
following by all affected personnel:
MR Yes; Internally by MR and externally by consultant e.g.
 The quality policy?
7.3 awareness training, etc.
 Relevant Quality Objectives?
 Contributions to the effectiveness of the quality

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management system?
 Benefits of improved quality performance?
 Implications of not conforming to the quality
management system requirements?
7.4 Communication
Have the following been addressed for all internal and
external communication channels?
 Subject of Communication?
 When to communicate?
Yes, Communication plan is in place, doc # ABC-QMS-P.05-
MR
7.4 F.01
 With whom?
 How?
 Who?
Yes, these include distributing
 Internal audit report to all department heads,
Is Leadership able to demonstrate how they ensure that  discussing outstanding issues with regards to setting
appropriate communication processes are established and achieving quality objectives
7.4 within the organization and that communication takes MR
place regarding the effectiveness of the quality  management review meeting minutes,
management system?  training and awareness sessions with regards to
quality
 display of quality policy
7.5 Documented Information

Does the organization’s quality management system  Departmental procedures and other associated  It is recommended to
include documents (Level 3) are sent to departmental heads control distribution
through email concerning preparation,
 Documented information required by ISO MR, HR, HSE, QC,
 The documents are controlled online, with access to review & approval
9001:2015? W/shop, Sales, Stores,
7.5.1 Document Controller for contracts, these can be retrieved authority [Sug.]
 Documented information determined by the operations, Purchase
through making search for “name”, “date range”, “doc #”,  Master List of documents
organization to be necessary for the effectiveness
“client name” etc. & master list of files for
of the quality management system?
operations not available

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[Obs]

Are all documented information


 Mater list of documents for HR, doc # ABC-HR/QP 001,
 Properly identified (e.g. title, date, author or
MR, HR, HSE, QC, issue 1, include policies, procedures and associated
reference)?
W/shop, Sales, Stores, records, are viewable by all in HR
7.5.2  In defined format – language, software version,
Operations, Purchase  Documents in soft & hard copy, put in folder ( different
graphics, and media.
categories),
 Reviewed and approved for adequacy?
Are all documented information controlled to ensure MR, HR, HSE, QC,  Only the latest version of all documents is made available.
 Its suitability and availability? W/shop, Sales, Stores,  The obsolete ones are retrieved and placed in the
7.5.3.1
 Adequately protected from use or improper use? Operations, Purchase ARCHIVED folder.
Have the following issues addressed for control of
Documented Information;
 Distribution, control, access, retrieval and use?
MR, HR, HSE, QC,
 Storage and preservation, including legibility?  All document include title, doc #, revision status
W/shop, Sales, Stores,
7.5.3.2  Control of changes (version control)?  The retention period is 3 years, unless otherwise stated.
Operations, Purchase
 Retention and disposition?
 Identification and control of documents of external
origin?
8 Operation
Are adequate actions in place to ensure effective planning,
implementation and control of the processes, including, Plan for target customers through:
the methods needed to ensure  SWOT Analysis,
MR, HR, HSE, QC,
 Adequate identification of requirements for  PEST analysis,
products and services? W/shop, Sales, Stores,
8.1  Competitive Landscape,
Operations, Purchase
 Establishment of criteria for products and services?  Market shares, and
 Determination of needed resources?  Seasonality (Market), etc.
 Implementation of the processes in accordance
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with the noted criteria?
 Retention of documented information to show
process effectiveness, and to demonstrate
conformity of products and services to
requirements?
How are the consequences of unintended changes
controlled, and how are actions take to mitigate their  MR
8.1
adverse effects?
8.2 Determination of requirements for products and services
The process is as follows
 Through phone/email, arranging a meeting (if required):
 If by phone, write the requirements including details &
request to send an email,
 Understand the requirement,
 If it’s tender, call for a meeting between Sales, Finance,
Is there a process in place for communicating with
HSE, Operations, and Training & HR department heads,
customers in relation to:
 Sales receive price from Procurement,
 Information related to products and services?
 Information & additional statement & other by sales (if
 Handling of enquiries, contracts, including
needed),
changes? Sales
8.2.1  Send to Finance for costing & rates, Schedules of rate by
 Obtaining customer views and perceptions,
Finance and final quotation send by Sales,
including customer complaints?
 Head of Sale department will sign the quotation and send
 Handling customer supplied property?
to client by Sale Executive
 Requirements of actions for contingencies?
 Follow up through Email/Phone after 2 or 3 days,
 L.P.O,
 Follow up with operations for status of delivery of
vehicles,
 Mobilization from operations, and
 Agreement (upon mobilization).

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Have the processes been implemented for
 Identification of product requirements,
including applicable statutory and regulatory
requirements? Sales
8.2.2
 Ability to meet the defined requirements and
substantiate the claims for the products or
services?
Driver report to concern department/section, upon work
How are the following requirements determined? order the vehicle is sent to workshop where the Foreman
 Customer specified requirements including confirm the problem, write down the problem via vehicle
delivery and post-delivery. checklist, job card # 11654, the technician complete the job
and foreman test the vehicle finally.
 Requirements not stated by the customer but
necessary for specified or intended use when
8.2.3 Sales
known.
 Statutory and regulatory requirements
applicable to the product.
 Any additional requirements considered
necessary by the organization.
Is there a process in place to
 Review requirements specified by the
customer?
 Consider requirements not stated by the
customer, but necessary?
 Identify the applicable statutory and regulatory
8.2.3 Sales Refer to 8.2.1
requirements for the products or services?
 Handle order changes?
 Review of customer orders prior to order
acceptance?
Also, are documented information maintained as a result
of the review and handling of change orders.
Are Requirements related to the product reviewed Sales, Purchase Refer to 8.2.1
prior to the commitment to supply a product to the
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8.2.3 customer?
Does the review activity ensure:
 Product requirements are defined?
 Contract or order requirements differing from those
Sales Refer to 8.2.1
8.2.3 previously expressed are resolved?
 The organization’s ability to meet defined
requirements?
How will it be demonstrated that the organization
confirms customer requirements when no documented Sales Through Email always
8.2.3 statement of requirement is provided by the customer?
How will the relevant documented information amended,
8.2.4 and persons made aware of the changes, when the Sales
requirements are changed?
8.3 Design and development of products and services
Is evidence available that the organization plans and
controls the design and development of products and
8.3.2 N/A
services, considering the nature, duration and complexity
of the design activities?
Is the following determined during design and
development planning?
 The design and development stages
 The review, verification and validation appropriate to N/A
8.3.2
each design and development stage.
 The responsibilities and authorities for design and
development.
Are the interfaces between different groups involved in
design and development managed to ensure effective
N/A
8.3.2 communication and clear assignment of responsibility,
including involvement of customer and/or user groups?

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Are documented information maintained to
8.3.2 demonstrate that the design and development N/A
requirements have been met?
Are inputs relating to product requirements determined
and documented information maintained relating to:
 Functional and performance requirements?
 Applicable statutory and regulatory requirements?
8.3.3  Applicable information from previous similar designs? N/A
 Other requirements essential for design and
development?
 Level of control by customers and other relevant
interested parties.
What evidence is available to indicate that
 Design and development inputs are reviewed for
adequacy? N/A
8.3.3
 Requirements are complete, unambiguous and not in
conflict with each other?
8.3.4 Design and development controls
Are controls in place to ensure
 The results to be achieved are clearly defined?
 Design and Development reviews are planned and
conducted?
8.3.4 N/A
 Verification activities are conducted to ensure all
inputs are met?
 Validation is conducted to ensure suitability for the
intended use?
Is verification performed to ensure that design and
8.3.4 development outputs have satisfied the design and N/A
development input requirements?

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Is design and development validation conducted to ensure
that the resulting product is capable of fulfilling the
8.3.4 N/A
requirements for the specified or known intended use or
application?
Are controls in place to ensure
 Input requirements have been met?
 Outputs are adequate for the subsequent
processes of the provision of products and
services?
8.3.5 N/A
 Identification of monitoring and
measuring requirements, and the
acceptance criteria?
 Designed products are fit for intended purpose
and their safe and proper use?
Are documented information maintained for the design
8.3.5 N/A
and development activities?
8.3.6
Are design and development changes:
 Controlled during, and after, the design and
development process?
 Identified?
 Reviewed?
 Verified and validated as appropriate? N/A
8.3.6
 Evaluated for effect on constituent parts and
delivered products?
 Approved before implementation?
 Considered to have no adverse impact on conformity
to requirements
Are documented information on results of changes and
N/A
any necessary actions maintained?
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8.3.6
8.4 Purchasing
What processes exist to ensure that externally provided
Verification and confirmation of Deliverables with regards to
8.4.1 processes, products and services conform to specified Purchase
quality and quantity as per the Agreement by the End User
purchase requirements?
Are the requirements in 8.4.2 applied to all suppliers who
 Provide products for incorporation in the products
8.4.1  Provide products directly to the customers Purchase There are no such products or services procured
 Provide full or partial outsourced process to the
organization.
Are external providers evaluated and selected,
monitored for performance and re-evaluated based Prequalification record for Delta Digital System, reviewed
8.4.1 Purchase
upon their ability to supply product in accordance with
the organization requirements?
 List of suppliers should be
controlled with regards to
approval & its
Are documented information of the results of supplier identification [Obs.]
8.4.1 evaluations and any necessary actions arising from Purchase
 There are 2 suppliers lists,
evaluations maintained?
these should be
consolidated into one
[Obs.]
8.4.2 Type and extent of control
Does the external provider monitoring process take
into consideration:
 The type and extent of controls to be applied?
 The potential impact of the externally provided Purchase yes
8.4.2
processes, products and services on the ability to
meet applicable statutory and regulatory
requirements?
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 The perceived effectiveness of the controls applied
by the external provider?

Have necessary verification processes been implemented Yes


to ensure the externally provided processes, products
Purchase
8.4.2 and services do not adversely affect the organization’s
ability to meet customer requirements?
Are controls of outsourced processes and Yes
functions remain within the scope of the Purchase
8.4.2
organization’s quality management system?
Are documented information maintained as a result of Yes
8.4.2 evaluation, monitoring and re-evaluation of external Purchase
providers?
Have inspection or other activities necessary for
ensuring that purchased product meets specified
8.4.2 Purchase Yes, in the scope of work in the inquiry, LPO etc.
purchase requirements been established and
implemented?
8.4.3 Information for external providers
Does the organization ensure communication to external
providers concerning:
 Products and services to be provided or provided on
behalf of organization?
 Approval of products and services, methods, processes
or equipment?
8.4.3 Purchase These are specified and verified at the prequalification stage
 Competence of personnel, including needed
qualification?
 Interactions with the organization’s quality
management system?
 Control and monitoring of the external provider’s
performance?

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 Notification of verification activities to be conducted by
the organization at the external provider’s premises?

Is the adequacy of specified purchase requirements


Purchase Yes, signed by purchasing officer
8.4.3 ensured prior to their communication to the supplier?

8.5 Production and Service provision

8.5.1 Control of production and service provision

 W/shop,  Yes, the PFDs have been developed for the key processes
Are production and service operations carried out under
8.5.1  Mass Transit,  The policies, SoPs and associated documents are approved
controlled conditions?
 Taxi & Limousine by GM

What evidence is available to demonstrate that


controlled conditions include the following, as
applicable?
 The availability of information that describes the  Procedure for QC is documented, doc # ABC-QMS-OCP.09,
characteristics of the product. Rev # 01 There is lack in control of
 The availability of the required documented  The preventative maintenance is with the reference to services in operations
information.  QC operational & maintenance manuals, using the checklist department as many drivers
8.5.1  The use of suitable equipment.  W/shop, (Vehicle inspection) were seen, for their
 The availability and use of monitoring and  operations  Monitoring is based on judgment (normally), through issues/concerns, and not
measurement resources. unique # (job card) being attended properly
 Characteristics of services are outlined in scope of work in [Minor NC]
 The implementation of monitoring and
measurement. the agreement
 The implementation of release, delivery and post-
delivery activities.
 The competency requirements or qualification of
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personnel.
 The implementation of products and services release,
delivery and post-delivery activities.
Can it be demonstrated that measurement and
monitoring of the product is carried out at various stages  W/shop,
8.5.1
of the product realization process in accordance with  operations
planned arrangements?
through customer complaint and satisfaction
Are production and service processes validated, and
periodically revalidated, where the resulting output  W/shop,
8.5.1
cannot be verified by subsequent monitoring or  operations
measurement?
8.5.2 Identification and traceability

Are process outputs identified, as appropriate, by  Purchase


 The software makes sure the unique # ing of transactions
8.5.2 suitable means throughout the product/service  W/shop,
 Though unique order #
realization process?  operations
 Purchase
Is product status identified with respect to measuring and  W/shop,
8.5.2 Yes, the incoming product is identified by order #
monitoring requirements throughout product realization?  Mass Transit,
 Taxi & Limousine
Is traceability a specified requirement? If so, is unique  W/shop,
identification of the product outputs controlled and Yes, the incoming product have order #, so it can traced back
 Mass Transit,
8.5.2 documented information maintained to ensure adequate to the supplier &/manufacturer
traceability?  Taxi & Limousine

8.5.3 Property belonging to customers or external providers  


Is customer property provided for the use or The process is as follows:
incorporation into the product under the control or use  W/shop,  If lost some valuable, make a call to the regulatory body,
of the organization? If so, does a process exist which
8.5.3 ensures that care is provided for customer or external  Operations the concerned company to ask the driver, if found,
provider property? handover to customer and get signed

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Is the organization reporting to the customer or  If not complained but found, take photo & upload
external provider, when their property is incorrectly  W/shop, completed form and send to regulatory body.
8.5.3 used, lost, damaged or otherwise found to be  Operations  If driver finds, but lies, cross checking by regulatory body is
unsuitable for use? possible
How will it be demonstrated that customer
 W/shop,
8.5.3 property is:
 Operations
Identified? Verified? Protected? Safeguarded?
Is lost, damaged, or unsuitable product reported to the  W/shop,
8.5.3
customer?  Operations
8.5.4 Preservation
How will it be demonstrated that product, and constituent
parts of the product, are preserved during internal
Stores
8.5.4 processing and delivery to the intended destination in
order to maintain conformity to requirements?
As applicable, are product preservation methods Online inventory management system
established, as appropriate, for:  Enough storage arrangements
 Identification?  Re order process ( for minimum inventory]
8.5.4  Handling? Stores
 Packaging?
 Storage?
 Protection?
8.5.5 Post-delivery activities
Is the organization meeting requirements for post-
8.5.5 MR, RAC
delivery activities?
With respect to post-delivery activities, are the
following considered? The maintenance & inspection with reference to agreement
 The risks associated MR, RAC,
8.5.5
 The nature, use and intended lifetime of the
products and services
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 Customer feedback
 Statutory and regulatory requirements
8.5.6 Control of changes
Are documented information maintained describing the
results of the review of the changes, the personnel MR Control of change procedure and associated records
8.5.6
authorizing the change, and the necessary actions?
8.6 Release of products and services
Are planned arrangements in place to ensure
8.6 achievement of the product and service MR, Purchase Yes
requirements?
Are documented information maintained as
8.6 evidence of conformity with the acceptance MR, Purchase Yes
criteria?
Are controls in place to ensure that release of product and
delivery of service to the customer do not proceed until all
8.6 planned arrangements are satisfactorily completed? Do MR, Purchase Yes
documented information identify the person authorizing
the release?
8.7 Control of nonconforming outputs
Are products and services that do not conform to the
8.7 requirements, identified and controlled to prevent their QC
unintended use or delivery?
 The meter will be frozen and identification of driver/car is
Do the dispositions include any of the following? noted
 Correction  Any non-conforming product/service is reported, and
 Segregation, containment corrective action request is generated
8.7 QC
 Informing the customer  The non-conforming vehicle is sent to workshop & driver is
 Obtaining authorization for use “as-is”, asked to do needful
continuation or acceptance under concession.
8.7 Are documented information maintained as evidence of QC
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conformity with the acceptance criteria?
Are corrected nonconforming products and services
QC
8.7 verified for compliance after rework?
9 Performance Evaluation
Yes; Monitoring includes;
Has the organization identified  Objectives & targets
 What has to be monitored  Customer satisfaction,
 The methods for monitoring, measurement,  Department wise KPIs,
MR
9.1.1 analysis, evaluation
 Customer complaints, and
 When the monitoring to be performed
 # of accidents
 When the results to be analyzed.

Is documented information maintained to ensure that


the monitoring and measurement activities are
MR Yes
9.1.1 implemented in accordance with the above
requirements?
Does this evaluation include review of the quality
performance data to ensure effectiveness of the quality MR Yes
9.1.1
management system?
9.1.2 Customer Satisfaction
Is information relating to customer perception to Yes It is recommended to use
9.1.2 whether the organization has fulfilled customer MR date to calculate overall
requirements monitored? satisfaction & for a particular
period of time & than
Is information obtained related to customer views and Yes
analyses & evaluate [Sug.]
9.1.2 opinions of the organization and its products and MR
services?
Is the method for obtaining and using the customer
9.1.2 MR Yes, through third party survey
satisfaction information determined?
9.1.3 Analysis and evaluation
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 The analysis & evaluation
Does the organization analyze and evaluate the data on the performance of
9.1.3 MR, Purchase Yes
arising from monitoring and measurement activities? external suppliers should
be conducted [Obs.]
Is the organization using the sources of data to  W/shop performance
 Demonstrate conformity of products and services parameter should
to requirements? identified, data collected
 Lost and found, # of complaints, cases open, customer (monitored) & analyzed
 Assess and enhance customer satisfaction?
follow ups, handover to person, handover to police, [Obs.]
 Ensure conformity of effectiveness of the quality handover to charity, disposed by stores  Recommended to identify
management system? MR, HR, HSE, QC, W/shop,  Vehicles washed for a specified period performance indicator data
 Demonstrate that planning has been successfully Sales, Stores, Operations
9.1.3  Vehicle inspected collected (monitoring) &
implemented? and Purchase
 regulatory violation ( total fine, company fine, driver fine, analyzed and evaluated
 Assess the performance of processes? [Sug.]
company black points, driver black points)
 Assess the performance of external providers?  Recommended to analyze
 # of accidents, Evaluation by HSE
 Determine the need or opportunities for the data that is gathered
improvement within the quality management over time and evaluated
system? [Sug.]
Are the results of the above analysis provided as input Yes
9.1.3 MR
to management review?
9.2 Internal Audits
Does the internal quality audit activity determine
whether the quality management system:
 Conforms to planned arrangements?
Yes, In the procedure, doc # ABC-QMS-P.02, Rev # 01,
9.2.1  Conforms to ISO 9001:2015? MR
Internal audit by 3rd Party
 Conforms to quality management system
requirements established by the organization?
 Is effectively implemented and maintained?

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Is evidence available to confirm that internal audits are Yes, these are as follows;
conducted at planned intervals based upon:  Criteria: 9001:2015
 The status and importance of the processes and  Scope: MR, Purchase, HR, Sales & Marketing, Operations,
9.2.2 areas to be audited? MR Store, Workshop
 The results of previous audits?  Frequency: Annual
 Customer feedback?  Method: review of documents and records, discussion
 Changes impacting the organization? with top & middle management, interviewing of staff,
observation of practices
Have audit criteria, scope, frequency and methods been  Audit conducted on 14 & 15 July 2022 with 03 major NCs
9.2.2 MR
defined? and 15 minor NCs
Is evidence available to confirm that internal auditors
9.2.2 do not audit their own work, and are objective and MR The audit has been conducted by the third party Auditor,
impartial of the audit process?
Does the management responsible for the area being
audited ensure that any necessary corrections and
corrective actions are taken without undue delay to Yes, it’s the department Heads who take the corrective
9.2.2 MR
eliminate detected action with support from the GM, if needed
Nonconformities and their causes?
Are documented information maintained as evidence of
9.2.2 the implementation of the audit program and the audit MR The Audit Plan and Audit Report are available
results?
9.3 Management Review
It is recommended to conduct
Does GM review the quality management system at
The management review meeting to be conducted after the MRM on monthly basis;
9.3.1 planned intervals to ensure its continuing suitability, MR
internal audit however with shorter agenda
adequacy and effectiveness?
(as explained to MR) [Sug.]
Does management review evaluate the need for changes The quality objectives are set at department level by the
9.3.1 to the quality management system, including the quality MR department Heads in liaison with the other management &
policy and quality objectives? staff and reviewed & approved by the GM
9.3.1 Is documented information maintained as the result of MR The minutes of last year dated august 03/08/2017, reviewed
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management reviews?
Do the inputs to management review include information
on the following (including quality indicators (if any):
 Results of audits
 Customer Satisfaction
 Nonconformities and Corrective Actions
 Monitoring and measurement results
 Issues concerning external providers and other
9.3.2 MR yes
relevant interested parties
 Adequacy of resources
 Process performance and conformity of products
and services
 Effectiveness of actions taken to address risks and
opportunities.
 Performance of external suppliers.
Do the outputs from management review include
decisions and actions related to:
 Improvement of the effectiveness of the quality
9.3.3 management system and its processes? MR yes
 Improvement of product related to customer
requirements.
 Resource needs.
Are documented information maintained as evidence of
9.3.3 MR yes
management reviews?
Does management review evaluate the need for changes
9.3.3 to the quality management system, including the quality MR yes
policy and quality objectives?
10.1 Improvement
Is the organization selecting opportunities for MR, HR, HSE, QC, W/shop,  The organization trying to bring about improvement

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10.1 improvement and implementing necessary actions to Sales, Stores, Operations through setting and achieving qualify objectives, setting
meet customer requirements? and Purchase and monitoring KPIs, effectively managing internal &
external audits, effectively conducting management
review meetings, through analysis and evaluation of data,
benchmarking and effective corrective action etc.
 Meeting with Client by sales and operations & listening to
Is the organization taking actions to prevent their concerns
nonconformities, improve products and services, and MR  Training Programme for drivers
10.1
improve the overall quality management system results?  Driver performance monitoring through the in-house
software
10.2 Nonconformity and corrective action
In the presence of a nonconformity, does the
organization
 React to the nonconformity by taking actions  Yes, upon detection of a nonconformity e.g through
to control and correct it, and dealing with its internal audit, external audit, customer complaint,
consequences? MR, HR, QC, W/shop, regulatory concern, decided by GM, or D/Head, an
 Evaluate the need for action to eliminate the Sales, Stores, Mass Transit, effective corrective action process is initiated till the
10.2 cause? closeout of it through verifying it effectively.
Taxi & Limousine, Purchase
 Implement any action needed?  Ref: ABC-QMS-P.03, Rev # 01, nonconformance and
 Review the effective of any corrective action? corrective action and associated forms
 Make change to the quality management
system?
In the presence of a nonconformity, does the
MR, HR, QC, W/shop, Sales,
organization react to the nonconformity by taking actions
Stores, Operations, yes
10.2 to control and correct it, and dealing with its
Purchase
consequences?
MR, HR, QC, W/shop, Sales,
Are actions taken appropriate to the effects, or potential
10.2 Stores, Operations, yes
effects of the nonconformity?
Purchase
10.2 Is action taken to eliminate the causes of MR, HR, QC, W/shop, Sales, yes

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nonconformities in order to prevent recurrence? Stores, Operations,
Purchase
Is documented information maintained to show the
MR, HR, QC, W/shop, Sales,
nature of the nonconformity and any subsequent
Stores, Operations, Yes
10.2 actions taken, and the results of any corrective action
Purchase
taken?
10.3 Continual Improvement
Is the organization continually improving the MR, HR, QC, W/shop, Sales,
10.3 suitability, adequacy and effectiveness of the quality Stores, Operations, Purchase
management system?
Are the outputs of analysis and evaluation, and the outputs MR, HR, QC, W/shop, Sales,
from the management review process used to identify the Stores, Operations, Purchase
areas of underperformances? Refer 10.1
Are specialized tools and methodologies used for MR, HR, QC, W/shop, Sales,
10.3 investigation of the causes of underperformance? Stores, Operations, Purchase

How is it demonstrated that the effectiveness of the MR, HR, QC, W/shop, Sales,
quality management system is being continually Stores, Operations, Purchase
improved?

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