NLU-05-ISO-9001-2015-2018

History of ISO

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• IOS : The International Organization for
Standardization
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IOS : ISOS (equally) -> ISO
Establishment: 14 Oct, 1946 (2489)
25 countries had a meeting at London
General assembly: Geneva, Switzerland
Members > 137 countries
TISI: Thai Industrial Standards Institute

Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

History of ISO
• Responsibility:

– Support & development for trade/ service standard
– Development & collaboration of Science & Technology, economic
– Consumer policy

• International Standard in 1987

– QMS : Quality Management System
– Guideline from BS 5750 (UK)
– ISO 9000 series
– Revise every 5 years
Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

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History of ISO
• 1st Revision in 1994
– ISO 9000-1994

• 2nd Revision in 2000
– ISO 9001-2000

• 3rd Revision in 2005

– ISO 22000: 2005 (FSMS)
– GMP/HACCP + ISO 9001

• 4th Revision in 2008

– ISO 9001-2008 (Nov., 2008)

• 5th Revision in 2015

– ISO 9001-2015 (Sep., 2015)

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ISO 9001-2000, 2008

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• Quality Management System, QMS (Not product
standard)
• International standard
• Can be use in all businesses
• Involvement of people in organization
• Requirements of quality standard
• Continual improvement / flexible
• System approach to management

ISO 9001-2000/2008 (requirements)
1.Scope
2.Normative0Reference
3.Terms0and0Definition
4.Quality0Management0System
5.Management0Responsibility
6.Resource0management
7.Product0realization
8.Measurement,0analysis0and0improvement

Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

ISO 9001-2000/2008 (requirements)
1. Scope

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4.10General0requirements

1.10General
1.20Application

4.20Documentation0requirements
4.2.10General

2.0Normative0References

4.2.20Quality0Manual

J

4.2.30Control0of0document

ISO$9000:2005,$Quality$management$systems$– Fundamentals$and$
vocabulary

4.2.40Control0of0records

3.0Terms0and0Definitions
? “Products”$can$also$mean$“Service”

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5.10Management0commitment
5.20Customer0focus
5.30Quality0policy
5.40Planning

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6.10Provision0of0resources
6.20Human0resources
6.2.10General

5.4.10Quality0objectives
5.4.20QMS0planning

6.2.20Competence,0training0and0awareness

6.30Infrastructure

5.50Responsibility,0authority0and0communication
5.5.10Responsibility0and0authority
5.5.20Management0representative
5.5.30Internal0communication

6.40Work0environment

5.60Management0review
5.6.10General
5.6.20Review0input
5.6.30Review0output

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7.10Planning0of0product0realization
7.20CustomerJrelated0processes

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7.40Purchasing
7.4.10Purchasing0process

7.2.10Determination0of0requirements0related0to0the0product
7.2.20Review0of0requirements0related0to0the0product

7.2.30Customer0communication

7.30Design0and0development
7.3.10Design0and0development0planning
7.3.20Design0and0development0inputs
7.3.30Design0and0development0outputs
7.3.40Design0and0development0review
7.3.50Design0and0development0verification
7.3.60Design0and0development0validation
7.3.70Control0of0design0and0development0changes
Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

7.4.20Purchasing0information
7.4.30Verification0of0purchased0product

7.50Production0and0service0provision
7.5.10Control0of0production0and0service0provision
7.5.20Validation0of0processes0for0production0and0service0
provision0
7.5.30Identification0and0traceability
7.5.40Customer0property
7.5.50Preservation0of0product

7.60Control0of0monitoring0and0measuring0equipment
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8.10General

(4)0Continual0
improvement0of0QMS

8.20Monitoring0and0measurement
8.2.10Customer0satisfaction

Customers

8.2.30Monitoring0and0measurement0of0processes
8.2.40Monitoring0and0measurement0of0product

8.30Control0of0nonconforming0product
8.40Analysis0of0data

Management0
responsibility0(5)
Resource0
Management(6)

8.50Improvement
Requirements

8.5.10Continual0improvement
8.5.20Corrective0action

Input

Measurement,0
analysis0and0
improvement0(8)

Product0
realization0(7)

Output

Customers

8.2.20Internal0audit

Satisfaction

8.5.30Preventive0action
Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

Implementation Step of ISO 9001

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1. Steering committee/QMR
2. Evaluating quality system of organization
3. Determining of Quality Policy
4. Training for management & staff
5. Preparing Quality Manual
6. Implementation and practice

7. Internal Audit
8. Quality improvement and correction
9. Pre-audit
10. External Audit
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ISO 9001: 2015

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4. The introduction of a requirement to understand the “Context of
the Organization” as well as the expectations of interested
parties, as it impacts on the objective of the system which is to
achieve customer satisfaction.
5. Leadership includes most of the existing “management
responsibility” requirements.
6. Greater emphasis on “Planning”, which focuses on the
identification of risks and opportunities as they impact on the
scope of the system. This removes the need for preventive
action as defined in the 2008 version, but includes
strengthened requirements for the management of change and
risk management.

HLS = High Level Structure
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7. “Support” includes most of the requirements of the previous
clause 6 – resource management but includes a new
requirement to manage “organizational knowledge”.

TERMINOLOGY
ISO 9001:62008

ISO 9001:62015

Products

Products0and0services

8. “Operations” replaces the previous Product realization clause 7
but contains most of the previous requirements. The intention is
to make it more relevant to the service sector.

Documentation,0Records

Documented0information

Work0environment

Environment for0the0operation0of0
processes

9. “Performance evaluation” replaces the previous clause 8 and
withdraws the need for preventive action which has now been
subsumed into clause 6 Planning.

Purchased0product

Externally provided0products0and0services

Supplier

External0provider

Monitoring0and measuring0equipment

Monitoring0and measuring0resources

Management0representative

Not used

Exclusion

Not0used

10.Increases the focus on “Improvement” and includes nonconformities and corrective action previously in clause 8
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ISO 9001: 2015 Concepts
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PDCA model
Process approach concept
Risk Base Thinking
Annex SL- Standardised High Level Structure (HLS)
Starting0point

Source0of0
Inputs

Inputs

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Risk Base Approach - PDCA

End0point

Activities

Outputs

Receivers0of0
Outputs

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ผศ.ดร.สุทัศน์ สุระวัง

ผศ.ดร.สุทัศน์ สุระวัง

PDCA in High Level Structure (HLS)

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ผศ.ดร.สุทัศน์ สุระวัง


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• ISO 9001 requirements encourage organizations to use
more external focus in a broader risk-based approach to
Quality Management
• Adoption of the Annex SL framework will help with

alignment and integration of other management system
standards
• Gives grater flexibility to individual organization’s QMS
structure and content

ผศ.ดร.สุทัศน์ สุระวัง

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ISO 9001-2015
• In this International Standard, the following verbal forms
are used:
• “shall” indicates a requirement;
• “should” indicates a recommendation;
• “may” indicates a permission;
• “can” indicates a possibility or a capability

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Annex SL- Framework
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning

7. Supporting
8. Operation
9. Performance evaluation
10. Improvement
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1.
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3.
4.

5 Leadership
5.1 Leadership and commitment

Scope
Normative reference
Terms and definition

5.1.1 Leadership and commitment for the QMS
5.1.2 Customer focus

Context of the organization

4.1
4.2
4.3
4.4

Understanding the organization and its context
Understanding the needs and expectations of interested parties
Determining the scope of the quality management system
Quality management system and its processes

5.2 Quality policy
5.3 Organizational roles, responsibilities and authorities

6. Planning for the quality management system

6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes

5 Leadership
5.1 Leadership and commitment

5.1.1 Leadership and commitment for the quality management system
5.1.2 Customer focus

5.2 Quality policy

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7. Support

8. Operation

7.1 Resources

7.2
7.3
7.4
7.5

7.1.1
7.1.2
7.1.3
7.1.4
7.1.5
7.1.6

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8.1 Operational planning and control

General
People
Infrastructure
Environment for the operation of processes
Monitoring and measuring resources
Organizational knowledge

8.2 Requirements for products and services

8.2.1 Customer communication
8.2.2 Determination of requirements related to products and services
8.2.3 Review of requirements related to the products and services

Competence
Awareness
Communication
Documented information

7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented Information
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8.3 Design and development of goods and services
8.3.1
8.3.2
8.3.3
8.3.4
8.3.5
8.3.6

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8.5 Production and service provision

General
Design and development planning
Design and development inputs
Design and development controls
Design and development outputs
Design and development changes

8.5.1
8.5.2
8.5.3
8.5.4
8.5.5
8.5.6

8.4 Control of externally provided products and services

Control of production and service provision
Identification and traceability
Property belonging to customers or external providers
Preservation
Post-delivery activities

Control of changes

8.6 Release of products and services

8.4.1 General

8.4.2 Type and extent of control of external provision
8.4.3 Information for external providers

8.7 Control of nonconforming process outputs, products and services

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Annex SL- ISO 9001: 2015

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9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation

9.2 Internal audit
9.3 Management review

10. Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual Improvement
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ISO 9001:2015 Model

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Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

ISO Terminology
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ISO Terminology

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QMS (Quality Managent System)
FSMS (Food Safety Management System)
QMR (Quality Management Representative)
PRP (pre-requisite program)
OPRP (Operational Pre-requisite Program)
Quality Policy
Quality manual / Procedure / Work instruction (WI)/ SD
Validation (การยืนยัน หรือรับรองสภาพความใช้ได้)
Verification (การทวนสอบ)
Mornitoring (การเฝ้าระวัง หรือ การตรวจติดตาม)
Calibration (การสอบเทียบ)
Audit (Internal audit / External audit / third party audit)
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Recall (การเรียกคืนสินค้า)
Withdrawal (การถอดถอนสินค้า)

Correction (การแก้ไข)
Corrective action (การปฏิบัตกิ ารแก้ไข)
Certification Body (CB)
Accreditation Body (AB)
CAR (Corrective Action Request)
DAR (Document Action Request)
Outsource (ผู้รับจ้างภายนอก- part of production process)
Subcontactor (ผู้รับเหมาช่วง-services)
OEM (Original Equipment Manufacturer)
CSR (Corporate Social Responsibility)
Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001

Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001