PELATIHAN INTEGRASI ISO (9001-2015 &

14001-2015 DAN IMPLEMANTASI ISPO

• AGUNG SETYO NUGROHO

Sertifikasi Profesi :
1. AK3U
2. Auditor ISPO
3. Auditor SMK3
4. Lead Auditor Course ISO 9001-2015 (IRCA)
5. Lead Auditor Course ISO 14001-2015 (IRCA)
6. Auditor ISCC
MODULE 1:
Quality Management Systems
ISO Fact

ISO is an independent, non-governmental

membership organization and the
world's largest developer of voluntary
International Standards.
ISO is a worldwide federation of national
standards bodies (ISO member bodies)

ISO is an international standard that direct & control the

organization to achieve their goal or target, that released by
International Organization for Standardization
 ISO Fact ❖International Organization for
❖Standardization
Based in Switzerland
Made up of over 170
National Standards Bodies(“NSB’s”)
Almost 20,000 standards in the ISO
portfolio
All standards are based on
INTERNATIONAL CONSENSUS

❖❖
ISO standards are usually developed by its Technical Commit
tees (“TC’s”) and Sub-committees (“SC’s”)

ISO/TC176/SC2 (Quality Systems) is responsible for ISO

9001
 Quiz

The following statements relate to ISO, except

a An independent, non-governmental membership

organization
b Direct and Control the Organization

c Release the ISO certificate.

d A worldwide federation of national standards bodies

e International Organization for Standardization

Quality Management Systems

• Definition of Quality
• Benefits
• Scope of a QMS
ISO 9001

Philip B. Crosby (1979 ) The quality is conformance

with the requirements
Joseph M. Juran(1993 ) , is the quality of the suitability of the use of
products to meet customer needs and satisfaction.

ISO 9000:2015 Quality is degree to which a set of inherent characteristics of an

object fulfils requirements
35
36
 Compliance vs. Conformity

Compliance
“Act in accordance with another’s requirements, requests, rules or
wishes and in terms of obligations”

Conformity
“Follow or adhere to something”

So what is the role of the auditor in relation to

compliance and conformity?

Activity 1:
Legal Compliance vs. Conformity

In your syndicate group review the list of requirements

and determine if:

• Requirement relates to a statutory requirement

OR

• Requirement is a conformance requirement

ISO 9001 Fact

ISO 9001 specifies requirements for a Quality Management

System.

ISO 9001 is an international standard that direct & control the

organization regardng the Quality Aspect.

➢➢ needs to demonstrate its ability to consistently provide product

that meets with :
✓✓customer requirement
✓✓applicable statutory and regulatory requirements
 41

ISO Fact
❖ ISO 9001 are among ISO's most well known standards ever

❖ It is implemented by more than a million organizations in so

me 175 countries.

❖ All requirements of ISO 9001 are generic and are intended

to be applicable to all organizations, regardless of type, siz
e and product provided.
China

Germany

Italy

India
Italy

USA
Number of certificate Growth
 Quiz

The following statements related with Definition of

Quality management ….

a Meet with customer requirement

b Customer Satisfaction

c Meet with statutory and regulatory

d Improve the productivity

f A & C.
MODULE 2:
Quality Management Concepts
Quality Management Principles

1. Customer Focus

2. Leadership

3. Engagement of People

4. Process Approach

5. Evidence based Decision Making

6. Improvement

7. Relationship Management
 Revision of Quality Management Principles

ISO 9001:2008 ISO 9001:2015

1. Costumer Focus 1. Customer Focus

2. Leadership
2. Leadership
3. Involvement People 3. Engagement of people

4. Process Approach
4. Process approach

5. System approach to management 5. Improvement

6. Continual improvement 6. Evidence – based decision making

7. Factual approach to decision making 7. Relationship management

8. Mutually beneficial supplier relationships

 Revision of Quality Management Principles

ISO 9001:2008 ISO 9001:2015

Involvement People Engagement People

The revised principle still describes the involvement of people at all levels.
It is essential for the organization that all people are competent, empowered
and engaged in delivering value
 Revision of Quality Management Principles

ISO 9001:2008 ISO 9001:2015

Process approach Process approach
System approach to
management

Consistent and predictable RESULT are

achieved more effectively and efficientl
y when activities are understood and
managed as interrelated processes that
function as a coherent system

PROCESS
 Sistimatika Proses

Requirements Risk
Resources
including including
Legislation People

Objectives Controls

PROCESS
Products Products
Services INPUT (S) Interrelated and Interacting OUTPUT(S) Services
Information Activities Information
 Revision of Quality Management Principles

ISO 9001:2008 ISO 9001:2015

Continual Improvement Improvement

Improvement can also arise as a result of periodic breakthroughs,

reactive change or as a result of re organization.
Thus, the title of this is now “Improvement”
 Revision of Quality Management Principles

ISO 9001:2008 ISO 9001:2015

Factual approach to Evidence – based
decision making decision making

The revised principle still addresses decisions that are based on the
analysis of data and information

It states that evidence-based analysis leads to decisions with greater

objectivity and confidence.
 Revision of Quality Management Principles

ISO 9001:2008 ISO 9001:2015

Mutually beneficial supplier Relationship management
relationships

For sustained success,

organizations manage their
relationships with interested parties,
such as suppliers, distributor, etc

This principle has expanded from supplier relationship to relations with

interested parties.

For example, the ISO 9001:2015, clause 4.2,

identifies possible
interested parties as direct customers, end users, suppliers,
distributors, retailers, and regulators.
 Quiz

There are the revision on Quality Management

Principles in ISO 9001 :2015, except

a Relationship Management

b Improvement

c Customer Focus.

d Decision making base on evidence

 Quiz

All employees in Organization must competent &

empowered in delivering values. It meet with the
Quality Management Princeiples….

a Leadership.

b Process Approach

c Customer Focus

d Engagement People,
 Plan Do Check Act (PDCA) Cycle

Figure 2 Source: ISO 9001 –

Introduction 0.3.2
Group Discussion: Plan Do Check Act (PDCA) Cycle

• In your groups identify a minimum of two activities from

within your own respective organisations that fit under
each of the headings
– Plan:

• Defined the SCOPE (Sample)

• Describe the Quality Policy (Sample)
– Do

– Check

– Act
CLAUSES BY PDCA FLOW
 Implementation ISO 9001:2015 by PDCA

4.1 Define Context 4.2 Need & expectation

ACT of Organization of Interest party PLAN
4.3 Determine Scope

10.3 Continual Improvement 4.4 QMS & Process Identification

Determine 5.1 Leadership & Commitment

10.2 Nonconformity & Corrective Goal
Action 5.2 Establish & communicate Policy

10.1 Select opportunity for 5.3 Rules, Responsibility & Authorities

improvement
6.1 Address Risk & opportunities
Determine Metho d of reaching
9.3 Management Review goal
6.2 Establish Quality Objective & Planning to achive them

9.2 Internal Audit 6.3 Planning of change

9.1 Monitoring, Measurement, 7.1 Provide Resources

Analysis & Evaluation
7.2 Competence, 7.3 awareness & 7.4 communication

CHECK 8. Operation Control 7.5 Documented Information

DO