INTRODUCTION TO ISO 9001:2015

ISO 9001:2015

Awareness Of
ISO 9001 : 2008
untuk :

PT. RSUP INDUSTRY

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

Introduction to ISO 9001:2015

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

I.Objectives
II.Instructions
III.Issues Affecting the External Auditor
IV.Audit Preparation and Planning Issues
V.Defining the Internal Audit Process
VI.Self assessment

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

1. Objectives

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

Objectives:
Understand ISO 9001:2015 issues affecting external
auditor.
Understand audit preparation and planning issues.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

2. Intructions

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

Intructions
There are important details and comments voiced over in this course.
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The course is interactive and not necessarily linear, but all pages can be
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The course is deemed completed once the last training page is reached.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Enhanced Auditor Role
ISO 9001:2015 places greater emphasis on the role and
importance of the auditor.
The auditor will need to understand much better the context of the
organizations he will audit.
The auditor will need to acquire more business processes insight.
The auditor will require a careful preparation and additional time or
operational efficiencies.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Audit Objectives Have not Changed
A QMS audit is a tool to provide information both to management
of the audited organization and the Certification Body on whether
the QMS:
Conforms to the requirements of the Standard.
Conforms to the organization’s own requirements.
Is effectively implemented and maintained.

So that each can take the necessary actions.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

The Auditing Principles Have not Changed
1. Integrity
The foundation of professionalism.
2. Fair Presentation
The obligation to report truthfully and accurately.
3. Due Professional Care
The application of diligence and judgment in auditing.
4. Confidentiality
Security of information.

5. Independence
The basis for impartiality of the audit and objectivity of the audit
conclusions.
6. Evidence-based Approach
The rational method for reaching reliable audit conclusions in a systematic
audit process.
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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

So, What has Changed?
New structure.
New approaches.
New and revised terms.
New requirements.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

So, What has Changed?
The external auditor will need to:
Understand the new standard’s approach and requirements.
Acquire a better knowledge of the organization’s business
processes.
Review and update his audit methods and skills.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
New Structure
ISO 9001:2008 > 8 clauses.

ISO 9001:2015 > 10 clauses.

Sequence follows PDCA cycle.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
Context of the Organization
Internal and external issues?
Which affect the ability to achieve intended results?

Considered in planning processes and the QMS?

Monitored and reviewed?

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
Needs and Expectations of Interested
Parties
Process to identify relevant interested
parties?
Needs and expectations of relevant
interested parties?
Considered in QMS planning?

Monitored and reviewed periodically?

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
Leadership Requirements
Top management with “hands-on” approach?

Which requirements can be delegated and which cannot?

Objectives and goals aligned to business strategies?

Support to relevant management roles to demonstrate leadership?

Communication of importance of conformance to requirements?

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
Risk-based Thinking
Risks and opportunities
Methodology for identification?
Planned approach for addressing?
Integrated into QMS processes?
Actions effective and proportionate?
Actions recorded?

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
External Providers
Consideration of potential impact of outsourced processes,
products and services on meeting customer and regulatory
requirements?
Controls to ensure outsourced processes, products and
services do not adversely affect ability to deliver conforming
products and services?

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
Organizational Knowledge
Necessary knowledge identified?
Communicated as necessary?
Maintained and protected?
Assessed prior to changes to the QMS?

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
Performance Evaluation
Emphasis on evaluation of data, not just analysis.

Monitoring of quality performance and effectiveness

Information for management review to include use of trends

and indicators.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

3. Issues Affecting the External Auditor

Key Changes in the New Standard
Documented Information
No required documented procedures.

Control of documented information still required.

Technical upskill could be necessary for auditors.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

4. Audit Preparation and Planning Issues

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

4. Audit Preparation and Planning Issues

Preparing for a Process-based Audit
Read all relevant information at your disposal:
From the organization web site.
From sector web site.
From previous audit reports.
Establish initial contact with the relevant process owners:
To confirm availability of relevant information about their
processes.
Perform a document review:
To confirm availability of required and necessary documents.
Prepare the audit plan:
Using a process approach.
Prepare work documents:
Process matrix.
Checklists.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

5. Defining the Internal Audit Process

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

5. Defining the Internal Audit Process

Understand Relevant Processes
Establish initial contact with the process
owner.
Confirm availability of relevant process
information:
Value adding activities.
Resources, Personnel.
Methods, documentation.
Monitoring and measurements.
Performance indicators .
Determine availability of process risk analysis.
Determine feasibility of the audit.

Documented Information
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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

5. Defining the Internal Audit Process

Asses Availability of Documented Information
Perform a document review.
To confirm availability of required and necessary
documented information such as:
Procedures.
Work instructions.
Legal and regulatory requirements.
Contracts.
Records.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

5. Defining the Internal Audit Process

Preparing the Audit Plan
Prepare the audit plan with a process approach. Example
Necessary information to include:
Audit objective, scope, criteria and auditors.
Processes to be audited, sequence and
time.
Opening and closing meetings.
Applying clauses of the standard.

No change with current practice in

certification audits 28
 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

5. Defining the Internal Audit Process

Deciding on the Auditing Sequence
Two ways to decide on the auditing
sequence*:
From ISO 9001 requirements down to
the QMS, to verify conformance.
From the QMS requirements up to the
ISO 9001 requirements, to verify both
conformance and performance.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

5. Defining the Internal Audit Process

Preparing for a Process Audit
To prepare for a process audit you need:
Good knowledge and understanding of
the new Standard.
Adequate general knowledge of the type
of process.
Good understanding of the process
relevant interrelations.
Good understanding of the organization
and its context.

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

6. Self Assessment

Now it's time to practice!

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 INTRODUCTION TO ISO 9001:2015
ISO 9001:2015

Thank You…..

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