ISO 9001:2015

Requirements Awareness &

Transition Training

Presented By:

PUBLIC TRAINING
January 24-25, 2018
By
FRANKLIN SAMUEL PALILINGAN
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Training Agenda

Day One
 Registration
 Introduction
 Brief Overview
 Risk Base Thinking
 QMS Requirement

Day Two (Risk Register and Internal Audit)

 Making Risk Register
 Internal audit
 Planning
 Preparation
 Performing the audit
 Reporting
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 Introduction

• Pre-course questionnaire
• Quality system principles
• An n ex SL
• High level structure
• Process approach, PDCA, Risk based thinking
• Issues, Interested parties
• Knowledge management

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Changing of ISO 9001 standard

• Standar ISO ditinjau setiap lima tahun sekali untuk

memastikan standard tersebut tetap up-to-date dan
sesuai dengan kebutuhan market.
• Respon terhadap tren terbaru dan akan selaras dengan
system management lainnya seperti ISO 14001.
• Munculnya permintaan untuk penggunaan bahasa yang
umum serta selaras dengan standard-standard lain.
• Mempertimbangkan manajemen risiko untuk mencapai
tujuan organisasi

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 Course Objective

• An understanding of quality terminology (pemahaman

atas terminologi mutu)
• An understanding of the requirements of ISO
9001:2015 (pemahaman atas persyaratan standard ISO
9001:2015)
• An understanding of the requirements regarding
internal auditing (pemahaman atas persyaratan proses
audit)

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Basic Concepts & Definitions

• A world wide federation of national standards bodies (federasi

badan standarisasi)
• Derived from the Greek words “iso”, meaning “equal” (berasal
dari kata Yunani “iso”, yang berarti “sama / sepadan”)
• Established in 1947 (berdiri tahun 1947)
• Management System: ISO 9001, ISO 14001, ISO / TS 16949
(produknya yang termasuk kategori sistem manajemen)

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 ISO Terminology on Products

• Telephone & banking cards

• Paper Size
• Symbols for automobile controls
• ISO international codes for country names, currency
and languages
• Universal system of measurement known as SI
(Systeme International d’unites )
• Safety of wire ropes
• ISO metric screw threads
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ISO 9000 Family

• ISO 9000 series (seri / kelompok ISO 9000)

– ISO 9000:2005, quality management system – foundation &
vocabulary (prinsip dasar dan peristilahan)
– ISO 9001:2015, quality management system – requirement
(persyaratan standard)
– ISO 9002:2016, quality management systems – guidelines for
performance improvement (petunjuk peningkatan kinerja sistem)

• ISO 19011:2011, guidelines for auditing quality &

environmental systems (petunjuk pelaksanaan audit sistem mutu
dan lingkungan)

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 Changing History

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OVERVIEW OF CHANGES

ISO 9001:2008 ISO 9001: 2015

Product Products and Services
Stakeholder Interested Parties
Exclusion N/A
Management Representative N/A (it is now part of leadership roles)
Documents, Records Documented Information
Preventive Action Risk-based Thinking and Improvement
Monitoring and Measuring Equipment Monitoring and Measuring Resources

Purchased Product Externally Provided Products and Services

Supplier, Producer, Distributor, Provider (Internal or External)

Vendor, Contractor

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 Changes

1. Risk-based thinking by determining issues and interested

parties expectation
2. Emphasis on Achieving Value for the organisation and its
customers
3. Emphasis on understanding and control of Risk to the
organisation
4. No formal requirement for a Management Representative
5. No formal requirement for Preventive Action
6. Enhanced Leadership Requirements
7. No exclusions, only Not Applicable clauses

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Basic Core Concepts

• The Process Approach – the System Level view of

linkages, interfaces and process interactions

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 Basic Core Concepts

• PDCA

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Basic Core Concepts

• Applies the Plan-Do-Check-Action (PDCA) cycle

with an overall focus on Risk-based Thinking
– Plan : Establish System & Process Objectives
– Do : Implement & Perform Processes
– Check : Monitor, Measure, Verify, Validate, Report
– Act : Make changes to the plan
• PDCA is applied to all processes and the QMS as a
whole
• PDCA cycle can be used to consider opportunities
as well as risks
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 Basic Core Concepts

• Risk Based Thinking

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RISK-BASED THINKING

• Requirement for ISO 9001:2015 certification

• Risk-based Thinking and Improvement – replace
Preventive Action in ISO 9001:2008
• Organizations must plan and implement actions to
address risks and opportunities.
• Those actions must be proportionate to the potential
impact of the risks or opportunities

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 RISK

• Risk - the positive or negative effect of

uncertainty
– Negative Risk = Threat
– Positive Risk = Opportunity
• Uncertainty - created due to the lack of
meaningful information related to the knowledge
or understanding of an event
• Organization must consider both positive &
negative risks, and the treatment of both, e.g.
reducing exposure of negative risk or exploiting
the effects of positive risk
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RISK-BASED THINKING

• Planned / implemented actions to address

risks and opportunities pertaining to
undesired outputs or outcomes, e.g.
– Negative Risk should be mitigated to acceptable
level
– Positive Risk should be exploited
• Risk Treatment – the proactive management
of risk using countermeasure and controls

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 RISK LIKELIHOOD & CONSEQUENCE

• Risk is often expressed as a combination of

Likelihood and Consequence
• Likelihood : The probability of an event occurring or
recurring
• Consequence : The possible impact/severity of an
event characterized as effect or influence

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RISK MANAGEMENT STRATEGY

An effective risk management strategy involves

proactive and iterative :
1. Risk Identification
2. Risk Ranking
3. Risk Treatment
4. Risk Monitoring
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 RISK IDENTIFICATION & RANKING

Risk Identification – determine the factors that could

cause a process or the entire QMS to deviate from the
planned results. Usually using a risk-register, risk-log or
other computer-software etc, to record the risks

Risk Ranking/Rating – place the risks in order based on

frequency, likelihood, severity, impact on objectives,
monetary consequences, loss of customers, legal
exposure, impact on interested parties or other criteria
develop by the organization

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RISK MONITORING

• Periodically reviewing identified risks

• Identifying new risks (internal / external)
• Ensuring proper execution of planned risk treatment
• Evaluating effectiveness of actions taken
• Reviewing with interested parties

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 Risk-based approach

Organisations are required to understand its context (Clause

4.1), Interested Parties (Clause 4.2) and determine the risks
and opportunities that need to be addressed (Clause 6.1)

There is no separate clause or sub-clause titled “preventive

action”

The concept of preventive action is expressed through a

risk-based approach to formulating QMS requirements.
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High Level Structure

ISO 9001:2015 adopts the high-level structure and

terminology of Annex-SL

High Level Structure - identical and common terms and

definitions for use in all Management System
Standards:

Purpose to enhance the consistency and alignment of

different management system standard
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 Common Structure

Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

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Applicability

No specific reference to “exclusions” when determining

applicability of requirements to the organisation’s QMS

An organisation will need to review the applicability of

requirements due to the size of the organisation, the
management model it adopts, the range of activities
and the nature of the risks and opportunities it
encounters.

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 ISO 9001:2015

Quality Management Systems – Introduction and

requirements.

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Introduction

0.1 General
0.2 Quality management principles
0.3 Process approach
0.4 Relationship with other MSS

• introduces the rationale for the Standard

• more formally structured.

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 0.1 General

Adoption of a quality management system is a STRATEGIC

DECISION for an organization that can help to improve its
overall performance
Potential benefits are:
- Ability to be consistent in providing product and services
- Opportunities to enhance customer satisfaction
- Able to address risk and opportunities
- demonstrate conformity to QMS requirements

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0.2 Quality management principles

ISO 9001:2008 was based on eight quality management

principles whereas the ISO 9001:2015 refers to just seven

The principle of “a systems approach to management” has

been dropped

The last principle is now called “Relationship management”

instead of “Mutually beneficial supplier relationships”.

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 Quality Management Principles

1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence-based Decision Making
7. Relationship Management.

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7 PRINSIP MANAJEMEN MUTU

ISO 9001:2015

Fokus pada
pelanggan

Hubungan antar Kepemimpinan

manajemen

Pengambilan Keterlibatan
Keputusan 7 Prinsip Manaj. Karyawan
Berdasar Fakta Mutu

Pendekatan
Peningkatan Proses

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 0.3 Process Approach

Understand and manage interrelated processes as a system

Enables consistent and predictable results

PDCA cycle is fundamental

Introduces risk based thinking

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0.4 Relationship with other management system

standard

Now a framework to improve alignment among all

International Standards for management systems

Better facilitates integration with other Management

System Standard

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 Section 1 - Scope

Consistently provide products and services to meet

requirements and enhance customer satisfaction

All requirements are intended to be applicable to all

organisations, regardless of type, size and products /
services provided

Removal of exclusions.
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Section 2 – Normative references

ISO 9000:2015, Quality management systems –

Fundamentals and vocabulary

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 Section 3 – Terms and Definitions

1. document – information and the medium on which it is

contained
2. documented information - information required to be
controlled and maintained by an organisation and the
medium on which it is contained
3. procedure – specified way to carry out an activity or a
process (can be documented or not)
4. record – document stating results achieved or providing
evidence of activities performed.

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Section 3 – Terms and Definitions

5. improvement – activity to enhance performance

6. objective – result to be achieved
7. nonconformity – non-fulfilment of a requirement
8. correction – action to eliminate a detected nonconformity
9. corrective action – action to eliminate the cause of a nonconformity and
prevent recurrence
10. preventive action – action to eliminate the cause of a potential
nonconformity or other undesirable situation
11. verification – confirmation that specified requirements have been
fulfilled
12. validation – confirmation that requirements for a specified intended use
or application have been fulfilled.
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 Section 3 – Terms and Definitions

13. product – output of an organisation that can be produced without any

transaction taking place between the organisation and the customer
14. service – output of an organisation with at least one activity necessarily
performed between the organisation and the customer
13. performance - measurable results
14. risk - effect (positive or negative) of uncertainty
15. outsource - to make an arrangement where an external
organisation performs part of an organisation’s function or
process - Note: An external organisation is outside the scope of
the management system although the outsourced function or
process is within the scope.

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Section 3 – Terms and Definitions

16. top management – person or group of people who directs and

controls an organisation at the highest level
17. QMS consultant – advisor on QMS realisation – can assist in
realising parts of a QMS
18. interested party – person or organisation that can have an affect,
be affected by, or perceive itself to be affected by a decision or
activity
19. competence – ability to apply knowledge and skills to achieve
intended results
20. infrastructure – facilities, equipment & services
21. work environment - conditions under which work is performed.

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Section 4 – Context of the Organisation

4.1 Understanding the

• this is a new clause and
organisation and its context
provides a key insight into
4.2 Understanding the needs the organisation
and expectations of interested
parties What constitutes the
4.3 Determining the scope of organisation’s quality
the quality management management system.
system
4.4 Quality management
system and its processes
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Section 4 – Context of the Organisation

4.1 Understanding the organisation and its context

The organization shall determine external and internal issues that are
relevant to its purpose and its strategic directions and that affect its ability to
achieve the intended results of its quality management system

The organization shall monitor and review information about the external and
internal issues

Considerations: Vision, Mission, Policies, Objectives, Strategies,

Infrastructures, Legal, Technological, Competition, Culture, Location,
Organizational Knowledge and Performance

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Section 4 – Context of the organisation

4.2 Understanding the needs and expectations of

interested parties

Organization shall determine

a. The interested parties that are relevant to the quality management
system
b. The requirements of these interested parties that are relevant to the
quality management system

Organization shall monitor and review information about these interested

parties and their requirements

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Section 4 – Context of the organisation

4.3 Determining the scope of the quality management

system
• establish scope by determining boundaries and
applicability of the QMS to consider external/internal
issues, requirements of interested parties and the
organisation’s products and services
• scope must be documented and available, justify any
clauses of ISO 9001 that is not applicable
• any not-applicable clauses must not effect conformity of
products/services and customer satisfaction.
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 Section 4 – Context of the organisation

4.4 Quality management system and its processes

• must establish, implement, maintain and continually
improve the QMS
• interaction of processes required
• assign responsibilities and authorities for processes
• retain documented information to evidence the
processes when needed
• documented procedures are required when needed
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Section 5 – Leadership

5.1 Leadership and • top management to now have

commitment a greater involvement in the
QMS
5.2 Policy
5.3 Organisational roles, What is required by top
responsibilities and management.
authorities

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 Section 5 - Leadership

5.1 Leadership and commitment

• must take accountability for the QMS’ effectiveness
• ensure Quality Policy and quality objectives are established
• ensure QMS is integrated into business processes
• ensure resources are available; communicate importance of effective QMS and
conformance
• ensure QMS achieves intended results
• promote improvement
• support other management to demonstrate leadership.
• top management must ensure: customer and regulatory requirements are met,
risks and opportunities are determined and addressed and focused on
enhancing customer satisfaction.
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Section 5 – Leadership

5.2 Policy
• must be documented
• must be available internally and to interested
parties.

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 Section 5 – Leadership

5.3 Organisational roles, responsibilities and

authorities
• ensures responsibilities and authorities for relevant
roles are assigned, communicated and understood
• no formal requirement for specific management
representative

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Section 6 – Planning

6.1 Actions to address risks • introduces risk based approach

and opportunities to planning
6.2 Quality objectives and • addresses risks, opportunities
planning to achieve them and quality objectives

6.3 Planning of changes

How quality planning is
achieved.

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 Section 6 – Planning

6.1 Actions to address risks and opportunities

When planning for the quality management system, the organization shall
consider the issues referred to in 4.1 and the requirement referred to in 4.2
and determine the risks and opportunities that need to be addressed

Considerations: Context of the Organization (4.1), Needs/Expectations of

Interested Parties (4.2), QMS Objectives, Processes and Controls, Resources,
Improvement Needs, Customers, Organizational Changes, Product/Service
Requirements, External Providers, Audit Results, Analysis and Evaluation
Results

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Section 6 – Planning

6.2 Quality objectives and planning to achieve them

• quality objectives need to be established at relevant functions, levels and
processes, these objectives should be:
─ consistent with the Quality Policy, measurable and take into account
applicable requirements
─ relevant to conformity of products and services, and the enhancement of
customer satisfaction
─ monitored, communicated and updated as appropriate

Quality Objectives should be SMART

Specific, Measurable, Achievable, Realistic, Timely
• must determine what, how, who, when, etc
• quality objectives must be documented.
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 Section 6 – Planning

6.3 Planning of changes

• where change is needed, it needs to be carried out in
a planned and systemic manner
• must ensure integrity of QMS.

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Section 7 - Support

7.1 Resources • newly constructed clause

7.2 Competence • much of what was in 2008
Version Clauses 4,5 & 6
7.3 Awareness
The support required to meet the
7.4 Communication
organisation’s goals.
7.5 Documented information

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 Section 7 - Support

7.1 Resources
7.1.1 General
• must provide resources for the implementation and
maintenance of the QMS
• must consider constraints of existing resources and
what may be provided from external providers.

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Section 7 - Support

7.1 Resources
7.1.2 People
• must determine and provide people necessary for
effective information of QMS and operations /control
of processes.

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 Section 7 - Support

7.1 Resources
7.1.3 Infrastructure
• same as for ISO 9001:2008 Clause 6.3.
Infrastructure can include:
a. Buildings and associate utilities
b. Equipment include IT Infrastructure
c. Transportation
d. Communication technology

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Section 7 - Support

7.1 Resources
7.1.4 Environment for the operation of processes
• same as ISO 9001:2008 Clause 6.4
Suitable environment can be combination of human
and physical factor

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 Section 7 - Support

7.1.5 Monitoring and Measuring Resources

7.1.5.1 General
• determine resources needed to ensure valid and reliable monitoring and
measuring results
• resources must be suitable for the activity and maintained as fit for purpose
• evidence of fit for purpose must be retained
• other requirements for measuring equipment unchanged.
• 7.1.5.2 Measurement Traceability
• Calibrated or verified
• Identified to determined their status
• Safeguards from adjustments and damage

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Section 7 - Support

7.1 Resources
7.1.6 Organisational knowledge
• new clause required to determine, maintain and
make available the knowledge necessary for the
operation of its processes and to achieve conformity
of products and services
• particular knowledge required for changing need and
trends.

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 7.1.6 Organisational Knowledge

• organisational knowledge can include information such as

intellectual property and lessons learned

• may consider:

─ internal sources (eg learning from failures and successful

projects, capturing undocumented knowledge and expert
experience)

─ external sources (eg standards, training, conferences, knowledge

from customers or providers).

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Organisational Knowledge

Organisational knowledge (Clause 7.1.6) addresses the need to

determine and maintain the knowledge obtained by the
organisation and its personnel, to ensure that it can achieve
conformity of products and services

The process for considering and controlling knowledge needs to

take account the organisation’s context, its size and complexity,
the risks and opportunities it needs to address and the need for
accessibility of knowledge

The balance between knowledge held by competent people and

knowledge made available by other means is at the
discretion/policy of the organisation.
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 Section 7 - Support

7.2 Competence
• very similar to ISO 9001:2008 Clause 6.2.2
• - determine necessary competence of person
• - ensure person are competent in education, training or
experience
• - take action to acquire competence and evaluate
effectiveness
• - retain documented information

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Section 7 - Support

7.3 Awareness
• specific clause for awareness
• must be aware of
• - Quality Policy
• - Objectives
• - contribution to effective QMS
• - implication of not conforming with QMS.
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 Section 7 - Support

7.4 Communication
• much expanded clause for communication
• must determine what will be communicated internally and
externally about the QMS
• - what
• - when
• - to whom
• - how and by whom.
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Section 7 - Support

7.5 Documented information

• QMS needs documented information required by the
Standard and as determined by the organisation
• The extent of documented information can differ from one
organisation to another due to its size, activities, processes,
products and services, complexity of processes and their
interactions, and the competence of people.
• Combines ISO 9001:2008 Clauses 4.2.3 (documentation) and
4.2.4 (records).
• documented information requires: identification and
description, review and approval.

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 Section 7 - Support

• a common clause of “Documented Information” has

been adopted
• the terms “documented procedure” and “record”
have both been replaced throughout the
requirements by “documented information”
• documented procedures (e.g. to define, control or
support a process) are now expressed as a
requirement to maintain documented information
• records are now expressed as a requirement to
retain documented information.
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Section 8 - Operation

8.1 Operational planning and control • covers many of the

8.2 Requirements for products and Product Realisation
services requirements contained
in Clause 7 of the 2008
8.3 Design and development of products
version
and services
8.4 Control of externally provided
processes, products and services The heart of the
management system
8.5 Production and service provision (the business).
8.6 Release of products and services
8.7 Control of nonconforming outputs
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 Section 8 - Operation

8.1 Operational planning and control

• similar to ISO 9001:2008 Clause 7.1
• must plan, implement and control processes needed
to meet requirements for the provision of products
and services
• must control planned changes and review
unintended changes
• any outsourced processes must be controlled.
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Section 8 - Operation

8.2 Requirements for products and services

8.2.1 Customer communication
• same as ISO9001:2008 Clause 7.2.3

• includes communicating with customers about handling and

controlling their property, establishing contingency requirements,
when relevant.

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 Section 8 - Operation

8.2.2 Determining the requirements for products and services

• same as ISO 9001:2008 Clause 7.2.1

• plus the organisation must meet the claims of products or services

it offers.

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Section 8 - Operation

8.2.3 Review of requirements for products and services

• combines ISO 9001:2008 Clauses 7.2.1 and 7.2.2

• documented information required on results of the review and any

new requirements.

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 Section 8 - Operation

8.3 Design and development of products and services

• where the detailed requirements of the organisation’s
products and services are not already established or not
defined by the customer or by other interested parties, the
organisation shall establish, implement and maintain a design
and development process;
• a significantly increased focus on the role the customer has in
all stages of the design process
• the need for documented information to confirm
appropriateness of all stages is also clearly stated
• any changes made to design inputs and design outputs during
the design and development must be clearly identified.
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Section 8 - Operation

8.4 Control of externally provided processes, products and

services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
• changes are mainly terminology and revised wording, i.e.
suppliers become ‘external providers!
• much as before, each stage of the purchasing process,
including evaluation, selection, performance monitoring and
re-evaluation remains a key requirement
• there is a significant increase in the steps needed to control
external provision.
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 Control of externally provided processes,
products and services

Control of externally provided products and services (Clause 8.4)

addresses all forms of external provision, whether by:
– purchasing from a supplier
– an arrangement with an associate company
– the outsourcing of processes and functions of the
organisation, or by any other means

Now required to take a risk-based approach to determine the

type and extent of controls appropriate to external providers and
externally provided products and services.
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Section 8 - Operation

8.5 Production and service provision

8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
• reference to ‘changes and post delivery activities’ have been strengthened.
• new clause for post-delivery activities
• specific clause for control of changes to ensure continuing conformity
• documented information must be retained describing the review of changes and
any action arising.

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 Section 8 - Operation

8.6 Release of products and services

• must verify that product and service requirements have
been meet and evidence of conformity retained
• release to customer does not proceed until the planned
verification of conformity has been satisfactorily
completed, unless otherwise approved by a relevant
authority and by the customer
• documented information to provide traceability to the
person(s) authorising release for delivery to the
customer.
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Section 8 - Operation

8.7 Control of nonconforming outputs

• similar to ISO 9001:2008 Clause 8.3
• documented information required describing
nonconformity, actions taken, any concessions and
authority for taking action.

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 Section 9 – Performance Evaluation

9.1 Monitoring, Determining what is to be

measurement, analysis and
evaluation
9.2 Internal audit
9.3 Management review
monitored, measured, analysed
and evaluated will enable the
organisation to determine ‘if the
management system suitable,
adequate and effective ?’

How performance of the QMS

is evaluated.

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Section 9 – Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

• what needs to be monitored and measured,
• the methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results
• when the monitoring and measuring is to be performed
• retain appropriate documented information as evidence
of the results.
• information resulting from monitoring and measuring
appropriate data should be analysed and evaluated
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 Section 9 – Performance Evaluation

9.2 Internal audit

• same as ISO 9001:2008 Clause 8.2.2
• at planned intervals
• evidence of internal audits and results must be
documented.

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Section 9 – Performance Evaluation

9.3 Management review

• similar to ISO 9001:2008 Clause 5.6
• at planned intervals
• clearer agenda items (inputs)
• evidence of management review results must be
documented.

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 Section 10 - Improvement

10.1 General • QMS must continually improve

10.2 Nonconformity and • nonconformities must be

corrective action identified and reacted to
• corrective action must be
10.3 Continual improvement considered
Continual improvement remains
a core focus of the QMS.

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Section 10 – Improvement

10.1 General
• opportunities for improvement must be determined

• action must be taken to meet customer requirements and enhance

customer satisfaction:

▫ improve products and service

▫ correcting, preventing or reducing undesired effects

▫ improve performance and effectiveness of the QMS

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 Section 10 - Improvement

10.2 Nonconformity and corrective action

• nonconformities (including complaints) must be reacted to
and applicable action taken
• root cause analysis must be considered based on its
significance
• effectiveness of corrective action must be reviewed
• change QMS if required
• evidence of action taken from nonconformities must be
documented
• evidence of results of corrective action must be documented.
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Section 10 – Improvement

10.3 Continual improvement

• organisations must continually improve the
suitability, adequacy and effectiveness of the QMS
• must consider results of analysis and evaluation, and
outputs from management review.

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End of Day
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