DP 456

ISO 9001
REQUIREMENTS
OVERVIEW
WHAT IS ISO
9001:2015?
Creating, implementing and maintaining
Quality Management Systems (QMS) is an important
documentary requirement for any company. It
formalizes the procedures and policies that promote the
quality of products and services that a company
provides.

One way to do this is to follow the ISO standard and

gain ISO 9001:2015 certification.
 WHAT ARE
THE ISO 9001
REQUIREMEN
DOCUMENTS AND
TS?
RECORDS
1. Monitoring and measuring equipment calibration records
2. Records of training, skills, experience and qualifications
3. Product/service requirements review records
4. Record about design and development outputs review
5. Record about design and development inputs
6. Records of design and development controls
7. Records of design and development outputs
8. Design and development changes records
 WHAT ARE
THE ISO 9001
REQUIREMEN
9. Characteristics of product to be produced and

TS?
service to be provided
10. Records about customer property
11. Production/service provision change control
records
12. Record of conformity of product/service with
acceptance criteria
13. Record of nonconforming outputs
14. Monitoring measurement results
15. Internal audit program
16. Results of internal audits
17. Results of the management review
18. Results of corrective actions
1. Procedure for determining context of the organization and
WHAT ARE
interested parties
2. Procedure for addressing risks and opportunities
THE ISO 9001
3. Procedure for competence, training and awareness
4. Procedure of equipment maintenance and measuring
REQUIREMEN
NON-MANDATORY
equipment REQUIREMENTS —TS?
BUT
5. Procedure for document and record control OFTEN INCLUDED
6. Sales procedure
7. Procedure for design and development
8. Procedure for production and service provision
9. Warehousing procedure
10.Procedure for management of nonconformities and
corrective actions
11.Procedure for monitoring customer satisfaction
12.Procedure for internal audit
13.Procedure for management review
 PLAN
WHAT ARE THE
P
• 1 Scope
• 2 Normative references

ISO 9001
• 3 Terms and Definitions
• 4 Context of the organization
• 5 Leadership
• 6 Planning

REQUIREMENT
D
DO All the ISO 9001 requirements are set out by ISO in
ten clauses.
S?
• 7 Support
• 8 Operation

C
CHECK
• 9 Performance evaluation

A
ACT
• 10 Improvement
Fundamentals of
Auditing
What is
Auditing?
• Auditing is a systematic process of
objectively obtaining and evaluating
audit evidence.

• Aims to assess the fairness and

reliability of financial statements.

• Provides assurance to users of those

statements.
Importance of
Auditing
• Ensures accuracy and reliability of
financial information

• Helps in detecting and preventing

fraud and errors

• Provides assurance to stakeholders

• Facilitates decision-making
Types of Audits

External Audit Internal Audit Forensic Audit

External Audit

• Conducted by independent auditors

outside of the organization

• Aimed at providing assurance to

external stakeholders, such as
investors, creditors, and regulators

• Reports findings and opinions in the

form of audited financial statements
Internal Audit

• Conducted by internal auditors

employed by the organization

• Focuses on evaluating internal

controls, risk management, and
operational efficiency

• Helps management improve processes

and achieve organizational objectives
Forensic Audit

• Investigative audit focused on

uncovering fraud, embezzlement, or
financial misconduct

• Requires specialized skills in forensic

accounting and investigative
techniques

• Often conducted in response to

suspicions or allegations of
wrongdoing
Auditing
Process
1.Planing 2.Risk
Assessment

3.Evidence Gathering 4.Reporting

Auditing
Process
1.Planing • Understand the organization's business
and industry

• Assess risks and develop an audit plan

• Determine audit scope and objectives

Auditing
Process
2.Risk • Identify potential risks and areas of
Assessment material misstatement

• Evaluate internal controls and control

environment

• Determine appropriate audit

procedures
Auditing
Process
3.Evidence Gathering • Perform audit procedures to obtain
sufficient and appropriate evidence

• Use a combination of techniques such

as inspection, observation, inquiry, and
analytical procedures

• Document findings and conclusions

Auditing
Process
2.Reporting • Communicate audit findings and
opinions to stakeholders

• Issue audit reports in accordance with

auditing standards

• Include recommendations for

improvement, if applicable
 Ethical
Considerations
Independence
• Auditors must maintain
independence from the
organization being audited
• Avoid conflicts of interest
or bias that could impair
objectivity
• Independence enhances
credibility and integrity of
audit opinions
Professional Skepticism Confidentiality
• Approach audits with a • Safeguard confidential
questioning mindset and information obtained during
critical evaluation of the audit process
evidence • Respect privacy rights of
• Remain vigilant for individuals and
potential fraud or organizations
misstatements • Only disclose information
• Exercise professional as required by law or
judgment based on facts professional standards
and circumstances
Thank You
DP 436

Edrick Godwin Santos