NLU-05-ISO-9001-2015-2018

Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001• Quality Management System, QMS Not product standard • International standard • Can be use in all businesses • Involvement of people in o

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

History of ISO

• IOS : The International Organization for Standardization

• 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

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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

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History of ISO

• 1 st Revision in 1994

– ISO 9000-1994

• 2 nd Revision in 2000

– ISO 9001-2000

• 3 rd Revision in 2005

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

• 4 th Revision in 2008

– ISO 9001-2008 (Nov., 2008)

• 5 th Revision in 2015

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

• 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

1.Scope 2.Normative0Reference 3.Terms0and0Definition 4.Quality0Management0System 5.Management0Responsibility 6.Resource0management 7.Product0realization 8.Measurement,0analysis0and0improvement

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ISO 9001-2000/2008 (requirements)

1 Scope

1.10General

1.20Application

2.0Normative0References

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

vocabulary

3.0Terms0and0Definitions

? “Products”$can$also$mean$“Service”

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4.10General0requirements 4.20Documentation0requirements

4.2.10General 4.2.20Quality0Manual 4.2.30Control0of0document 4.2.40Control0of0records

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5.10Management0commitment

5.20Customer0focus

5.30Quality0policy

5.40Planning

5.4.10Quality0objectives

5.4.20QMS0planning

5.50Responsibility,0authority0and0communication

5.5.10Responsibility0and0authority

5.5.20Management0representative

5.5.30Internal0communication

5.60Management0review

5.6.10General

5.6.20Review0input

6.10Provision0of0resources 6.20Human0resources

6.2.10General 6.2.20Competence,0training0and0awareness

6.30Infrastructure 6.40Work0environment

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7.10Planning0of0product0realization

7.20CustomerJrelated0processes

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

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7.40Purchasing

7.4.10Purchasing0process 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

8.20Monitoring0and0measurement

8.2.10Customer0satisfaction

8.2.20Internal0audit

8.2.30Monitoring0and0measurement0of0processes

8.2.40Monitoring0and0measurement0of0product

8.30Control0of0nonconforming0product

8.40Analysis0of0data

8.50Improvement

8.5.10Continual0improvement

8.5.20Corrective0action

8.5.30Preventive0action

Management0 responsibility0(5)

Product0 realization0(7)

Resource0 Management(6)

Measurement,0 analysis0and0 improvement0(8)

(4)0Continual0 improvement0of0QMS

Requirements

Satisfaction

Output Input

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Implementation Step of ISO 9001

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

ISO 9001: 2015

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HLS = High Level Structure

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.

7 “Support” includes most of the requirements of the previous

clause 6 – resource management but includes a new

requirement to manage “organizational knowledge”.

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.

9 “Performance evaluation” replaces the previous clause 8 and

withdraws the need for preventive action which has now been

subsumed into clause 6 Planning.

10.Increases the focus on “Improvement” and includes

non-conformities and corrective action previously in clause 8

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TERMINOLOGY

Documentation,0Records Documented0information Work0environment Environment for0the0operation0of0 processes Purchased0product Externally provided0products0and0services

Monitoring0and measuring0equipment Monitoring0and measuring0resources Management0representative Not used

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• PDCA model

• Process approach concept

• Risk Base Thinking

• Annex SL- Standardised High Level Structure (HLS)

Activities Outputs

Source0of0

Starting0point End0point

ผศ.ดร.สุทัศน์ สุระวัง

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PDCA in High Level Structure (HLS)

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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

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

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1 Scope

2 Normative reference

3 Terms and definition

4 Context of the organization

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

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

5 Leadership

5.1 Leadership and commitment

5.1.1 Leadership and commitment for the QMS 5.1.2 Customer focus

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

7 Support

7.1 Resources

7.1.1 General

7.1.2 People

7.1.3 Infrastructure

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring resources

7.1.6 Organizational knowledge

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information

7.5.1 General

7.5.2 Creating and updating

7.5.3 Control of documented Information

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8 Operation

8.1 Operational planning and control 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

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8.3 Design and development of goods and services

8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

8.3.6 Design and development changes

8.4 Control of externally provided 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

8.5 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

8.6 Release of products and services 8.7 Control of nonconforming process outputs, products and services

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

Annex SL- ISO 9001: 2015

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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)

ISO Terminology

• Recall (การเรียกคืนสินค้า)

• Withdrawal (การถอดถอนสินค้า)

• Correction (การแก้ไข)

• Corrective action (การปฏิบัติการแก้ไข)

• 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)

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