ISO 9001:2015

Requirements
Overview

Purpose of presentation:
To Provide a summary of notable changes from ISO
9001:2008 to ISO 9001:2015

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ISO 9001:2015 Overview Training Plan

1. What is ISO 9001?

2. Why this revision?
3. Risk-Based Thinking
4. Context of the Organization (New Requirement)
5. Leadership
6. Planning (New Requirements)
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
11. How to implement ISO 9001:2015
12. Q & A

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1. What is ISO 9001:2015?

ISO 9001:2015 is an international

standard for implementing a
quality management system

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1. What is ISO 9001:2015?

1.2 The Revised Quality Principles

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1. What is ISO 9001:2015?

1.3 High Level Structure

ISO Standard Requirements
Clause 1 - Scope
Clause 2 - Normative references
Clause 3 - Terms and definitions
Clause 4 - Context of the organization
Clause 5 - Leadership
Clause 6 - Planning
Clause 7 - Support
Clause 8 - Operation
Clause 9 - Performance evaluation
Clause 10 - Improvement
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1. What is ISO 9001:2015?

1.4 High-Level Structure Comparison

ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative Reference 2. Normative Reference
3. Terms and Definitions 3. Terms and Definitions
4. Quality Management Systems 4. Context of the organisation
5. Management Responsibility 5.Leadership
6. Planning
6. Resource Management 7. Support
7. Product Realisation 8. Operation
8. Measurement, Analysis and 9. Performance Evaluation
Improvement 10. Improvement
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2.1 Beneficial Changes to ISO 9001

a) Enhanced leadership involvement in the

management system
b) Risk-based thinking
c) Simplified language, common structure and
terms
d) Aligning QMS policy and objectives with the
strategy of the organization
e) Both ISO 9001 and ISO 14001 revised standards
followed the new outline
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2.2 Beneficial Changes to ISO 9001…PDCA

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3. Risk-Based Thinking

3.1 Risk in ISO 9001:2015

a) Key purposes of a quality management system is to

act as a preventive tool.
b) Consequently, this International Standard does not
have a separate clause or sub clause on preventive
action.
c) The concept of preventive action is expressed
through the use of risk-based thinking in
formulating quality management system
requirements.

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3. Risk-Based Thinking

Risk-Based Thinking Is Not New

Something You Already Do

Is Continuous

Ensures Greater Knowledge

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Increases Reaching Goal

Reduces Poor Results

Makes Prevention a Habit

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4. Context of the Organization

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4.1 Understand the Organization and its Contents

4
Context of Determine what the relevant external and
organization
internal issues are for your organization, and
4.1
Understanding that are relevant to its strategic direction
the organization
and its context

4.2
Understanding
needs and
expectations
Interested parties

4.3
Determine the
scope of QMS

4.4
QMS and its
processes

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4.1 – Understanding-Organization-Context

Internal Factors May Include

Overall Management
Compensation Strategy

Employee Business
Satisfaction Continuity

Work
Environment

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4.1 – Understanding-Organization-Context

External Factors May Include

Society
External
Suppliers
Environment

Internal
Environment
Customers Government

Financial Competitors

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 4.2 Understanding needs and expectations Interested
parties
4
Context of Identify the relevant interested parties and
organization
their relevant requirements
4.1
Understanding
the organization
and its context

4.2
Understanding
needs and Employee/
expectations Stakeholder
Interested parties
Interested
4.3 Customers Parties
Determine the
scope of QMS Government

4.4
QMS and its
processes

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 4
Context of
organization
4.3 Determine the scope of QMS
4.1
Understanding  The products and services covered.
the organization
and its context
 Justification for any case where a
4.2 requirement cannot be applied (exclusion)
Understanding
needs and
expectations
Interested parties
4.4 QMS and its Processes
4.3
Determine the
scope of QMS
 Retain documented information necessary to
have confidence that the processes are being
4.4
QMS and its carried out as planned.
processes

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4.4 - QMS and its Processes

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4.4 – Manufacturing Process Map

Quality Objectives For The Manufacturing Process

OBJECTIVE ACTUAL GOAL ACTION

PPM 25 50 Continue to Monitor

Machine Up 82 % 95% Increase PM, have spare parts

Time available, staffing

Parts Per 235 215 Continue to Monitor

Hour
Cost of $496 <$500 per Continue to Monitor/consider risk
Rework month

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Significant Changes

a) Determine organization context and their potential

effects on the organization and have a plan to take
actions to address these risks and opportunities (e.g.
SWOT, PEST, etc.).
b) More emphasis on having a plan to achieve the quality
objectives,
c) Determine the needs and opportunities for change to
maintain and improve the performance of the quality
management system,

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5. Leadership

Human
Resource

Work
Infrastructure
Environment

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 5.1 Leadership

5
Leadership Leadership is required to ensure:
 Take accountability for the effectiveness of
5.1.1
Leadership and
the quality management system (QMS).
commitment

5.1.2
 Promote the use of the process approach
Policy and risk-based thinking,
5.3
Organizational  Engage, direct and support persons to
roles,
responsibilities and
authorities
contribute to the effectiveness of the QMS,

 Promotion of improvement

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Significant Changes

a) More emphasis on leadership and its role in

establishment of quality policy and objectives aligned
with the strategic direction of the organisation.
b) Promoting, engaging , and supporting improvement,
innovation and leadership
c) Top management shall be accountable for the
effectiveness of the quality management system
d) Term “Management Representative” has been
removed, however the tasks remain.

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6. Planning

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 6. Planning

6
Planning

 This clause requires the determination of

6.1
Actions to risks and opportunities which need to be
address risks
and addressed,
opportunities

6.2  Actions to be taken and evaluation of the

Objectives and
planning effectiveness of these actions, (e.g. SWOT,
6.3
FMEA, etc.),
Planning of
changes
 Changes to the QMS should be carried
out in a planned manner,
 To enable organizations to adapt to
changing environments or circumstances
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6.1 Actions to address risks and opportunities

Addressing Risks/Opportunities

Determine Risks
Manage QMS
and
Change
Opportunities
per sections 4.1
and 4.2

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Establish Actions to 30

Quality Address
Objectives Risks

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6.1 Actions to address risks and opportunities

Why Use Risk Based Thanking ?

• Build a strong knowledge base

• Establish a proactive culture of

improvement

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• Assure consistency of quality

• Improve customer confidence and

satisfaction.

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6.1 Actions to address risks and opportunities

Identify The Analyze & Plan Actions Take Action Check Learn &
Risks Prioritize to address Effectiveness Improve

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Risk Management

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 6.1 Actions to address risks and opportunities

3.2 ISO 9001:2015 Risk Requirements

Use FMEA to Initiate Risk-Based Thinking
a) There is no requirement for formal methods for risk
management,

b) Organizations can decide whether or not to develop

a more extensive risk management methodology,

c) The concept of “risk” in the context of the

international standards relates to the uncertainty in
achieving these objectives

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 Significant Changes

a) Determine Risks and opportunities and have a plan to

take actions to address these risks and opportunities
(e.g. FMEA, etc.).

b) Determine the needs and opportunities for change to

maintain, and
c) Identifying risks and opportunities and reviewing the
potential consequences of change.

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7. Support

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 7. Support
7
Support

7.1 Resources
There should be adequate resources to ensure
7.1.2 People effectiveness of the QMS providers, such as
7.1.3 Infrastructure people or monitoring and measuring resources,
7.1.4 Environment for
the operation of
Organizational knowledge required to ensure
processes
the processes provide conforming products
7.1.5 Monitoring and and services,
measuring resources
Communication.
7.1.6 Organizational
knowledge
Relevant persons doing work under the
7.2 Competence organization’s control need to have awareness,
7.3 Awareness

7.4 Communication

7.5 Documented
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Significant Changes

7.3. Knowledge

• Competence remains, but knowledge is a

new requirement
• Determine the knowledge necessary for the
operation of the QMS and its processes.
• Quality manual have been enhanced and
made more flexible to allow for the use of
documented information needed for the
quality management system.

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8. Operation

PDCA

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 8. Operation
8 Operation

8.1 Operational  Requirement for establishing criteria for

planning and control processes.
8.2 Requirements  Customer communications; customer property,
for products and
services and contingency actions.

8.3 Control of
 Involvement of customers and users as part of
externally provided p design planning to be considered,
8.4 Control of  Control for externally provided processes,
externally provided products and service.
 The release of products and services is now part
8.5 Production and
service provision of the operational requirements.

8.6 Release of
 Control of nonconforming output is considers the
products and options to apply correction and corrective action.
services

8.7 Control of
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Significant Changes

8.4 Control of External Provision of Goods and

Services
• Term “Purchasing” is replaced by “Outsourcing” and
“external provision”
• The type and extent of control shall be dependent upon
the risks identified and the potential impacts,

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9. Performance Evaluation

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 9. Performance evaluation
9
Performance
evaluation
 Requirement for planning is identifying what
9.1
Monitoring, needs monitoring and measuring, and the
measurement,
analysis and
methods to be used.
evaluation

9.1.1  Requirements for customer satisfaction results

General
as inputs to management review.
9.1.2
Customer satisfaction  Requirements for analysis and evaluation when
using results as inputs to management review,
9.1.3
Analysis and
evaluation
 Effective implementation of planning and
9.2
Internal audit
actions to address risks and opportunities are
new requirements in this clause.
9.3
Management review

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Significant Changes

9.1. Monitoring, measurement, analysis and evaluation

The organisation shall take into consideration the determined
risks and opportunities

9.2. Internal Audit

The audit programme(s) shall take into consideration the
quality objectives, the importance of the processes
concerned, the related risks, and the results of previous
audits;

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10. Improvement

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 10 Improvement

10  Addresses more comprehensive

Improvement
opportunities for improvement; not only
10.1
continual improvement
General

 Addresses improvement of products and

10.2 Nonconformity
and corrective action
services and future needs and expectations

10.3 Continual
improvement
 Emphasis is now on improving processes to
prevent nonconformities and improving
products and services

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Significant Changes

10. Improvement
• Clarify the difference between
“Correction” and “Corrective action”
• Remove term “preventive action”, but
Preventive Action concepts are deployed
throughout the Standard (eg. New clauses 4.1
and 6.1)

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11 Summary
1) Determining the organizational context enables a
more effective implementation of the quality
management system,
2) Alignment with strategic direction,
3) Integration of the QMS into organization’s business
processes,
4) Determining risks and opportunities increase the
effectiveness of the organization’s QMS,
5) Organizational knowledge introduced to ensure the
organization acquires and maintains the necessary
knowledge,
6) Communication expanded to include external
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12 How to implement ISO 9001

1. Set up the ISO 9001 Group / Committee

Traditionally a committee of all the managers from
every department of the company
Grouped together to analyze processes, come up
with better solutions and documents / procedures

2. Write a Quality Policy and Objectives

A mission statements of the company’s commitment
to the QMS and signed off by top management

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12 How to implement ISO 9001

3. Define Business Scope and Risk Analysis

Define scope of management system for
certification,
A statements of the company’s commitment
toward business risk.

4. Create Company Context & Procedures

Create company context and procedures needs to
be compiled of all the company’s processes and
contain the best practices

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12 How to implement ISO 9001

5. Implementation of QMS
Started to used the company’s procedures in daily
operations and allow staffs to give opinion,
Training subordinates during implementation.

6. Fine Tune Quality Procedures and Records

During implementation fine tune the quality
procedures / SOPs and records where needed.
Plan internal quality audit after this step

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12 How to implement ISO 9001

7. Conduct Internal Audit

A company’s procedures are checked and allows
for refinement and correction of errors
Competent auditing firm / internal audit team is
required so all problems can be resolved.

8. Conduct Management Review

Management must conduct management review
with all the head of department or managers to
review the QMS status
Management Representative prepared minute of
meeting

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12 How to implement ISO 9001

9. Get Certified
Find an internationally 3rd. Party certification auditor
to certify the company
Announce certification to clients after this step

10. After Certified

Head of department must continue to follow the
procedures or SOP and use the records as stated in
procedures or SOP
Continue to improve the QMS (quality management
system)

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