หลายท่านคงทราบกันดีแล้วว่า หัวใจสำคัญของการทำระบบบริหารคุณภาพให้ประสบผลสำเร็จนั้น
มาจาก หลักบริหารระบบคุณภาพทั้ง 8 ประการ หรือ QMS ISO 9001 Eight Management Principles นั่นเอง
เรามาทำความรู้จักกับหลักฯ ทั้ง 8 ประการกันเลยดีกว่าครับ
1. Customer Focus : การมุ่งเน้นที่ลูกค้า
2. Leadership : ความเป็นผู้นำ
3. Involvement of People : การมีส่วนร่วมของบุคลากร
4. Process Approach : การบริหารเชิงกระบวนการ
5. Systems Approach to Management : การบริหารที่เป็นระบบ
6. Continual Improvement : การปรับปรุงอย่างต่อเนื่อง
7. Factual Approach to Decision Making : การตัดสินใจบนพื้นฐานความเป็นจริง
8. Mutually Beneficial Supplier Relationships : ความสัมพันธ์กับผู้ขายเพื่อประโยชน์ร่วมกัน
Monday, June 28, 2010
ใครว่าการทำระบบ ISO เป็นเรื่องยาก
หลายคนคิดว่าการทำระบบบริหารคุณภาพ(ISO9001:2008) นั้นเป็นเรื่องที่ที่ยุ่งยาก
ที่จริงแล้วหากเราพิจารณาให้ดีจะพบว่า การทำระบบบริหารคุณภาพในสมัยนี้เป็นเรื่องที่ไม่ยุ่งยากอย่างที่คิด
ทำไมถึงพูดเช่นนั้น...หากท่านลองพิจารณาดูจากหลายๆประเด็นท่านจะพบว่ามันไม่ยากอย่างที่คิดจริงๆ
ประการแรก...ปัจจุบันนี้มีบริษัทที่ปรึกษาเกิดขึ้นอย่างมากมาย มากจนเราเองไม่รู้จะเลือกที่ไหนดี
ประการที่สอง...มีการจัดการอบรมในหัวข้อที่เกี่ยวข้องอย่างแพร่หลาย ทั้งจากบริษัทที่ปรึกษา สถาบันอบรมต่างๆ รวมถึงจากบริษัทที่ให้การรับรองเองด้วย
ประการที่สาม...บุคลากรในองค์กรมีความรู้ความสามารถเพิ่มมากขึ้น เนื่องจากมีสื่อต่างๆให้เรียนรู้อีกมากมาย เช่น บทความจากหนังสือ และเว็ปไซต์ต่างๆ
และที่สำคัญ...เรามีการรวมกลุ่มเพื่อแลกเปลี่ยนข้อมูล ความรู้และข่าวสารต่างๆ กันมากขึ้น (ชมรมนักบริหารระบบคุณภาพก็เช่นกัน) Quality Management Assocation:QMA
ที่จริงแล้วหากเราพิจารณาให้ดีจะพบว่า การทำระบบบริหารคุณภาพในสมัยนี้เป็นเรื่องที่ไม่ยุ่งยากอย่างที่คิด
ทำไมถึงพูดเช่นนั้น...หากท่านลองพิจารณาดูจากหลายๆประเด็นท่านจะพบว่ามันไม่ยากอย่างที่คิดจริงๆ
ประการแรก...ปัจจุบันนี้มีบริษัทที่ปรึกษาเกิดขึ้นอย่างมากมาย มากจนเราเองไม่รู้จะเลือกที่ไหนดี
ประการที่สอง...มีการจัดการอบรมในหัวข้อที่เกี่ยวข้องอย่างแพร่หลาย ทั้งจากบริษัทที่ปรึกษา สถาบันอบรมต่างๆ รวมถึงจากบริษัทที่ให้การรับรองเองด้วย
ประการที่สาม...บุคลากรในองค์กรมีความรู้ความสามารถเพิ่มมากขึ้น เนื่องจากมีสื่อต่างๆให้เรียนรู้อีกมากมาย เช่น บทความจากหนังสือ และเว็ปไซต์ต่างๆ
และที่สำคัญ...เรามีการรวมกลุ่มเพื่อแลกเปลี่ยนข้อมูล ความรู้และข่าวสารต่างๆ กันมากขึ้น (ชมรมนักบริหารระบบคุณภาพก็เช่นกัน) Quality Management Assocation:QMA
Saturday, June 26, 2010
ISO 9001:2008 Requirements
INTERNATIONAL STANDARD ISO 9001Forth Edition 2008-11-15
INTERNATIONAL STANDARD ISO9001:2008
1.Scope
2.Normative reference
3.Terms and definitions
4.Quality management system
5.Management responsibility
6.Resource management
7.Product realization
8.Measurement, analysis and improvement
-------------------------------------------------------
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization:
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only applies to
a)product intended for, or required by, customer,,
b)any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements
2 Normative reference
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005 Quality management systems – Fundamentals and vocabulary.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall:
a) determine the processes needed for the quality management system, and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure where applicable, and analyze these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced shall be defined within the quality management system.
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.
NOTE 2 An “outsource process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced can be influenced by factors such as
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the application of 7.4
4. 2 Documentation requirements
4. 2. 1 General
The quality management system documentation shall include:
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes,
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4. 2. 2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
4. 2. 3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at point of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4. 2. 4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records shall remain legible, readily identifiable and retrievable.
INTERNATIONAL STANDARD ISO9001:2008
1.Scope
2.Normative reference
3.Terms and definitions
4.Quality management system
5.Management responsibility
6.Resource management
7.Product realization
8.Measurement, analysis and improvement
-------------------------------------------------------
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization:
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
NOTE 1 In this International Standard, the term “product” only applies to
a)product intended for, or required by, customer,,
b)any intended output resulting from the product realization processes.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements
2 Normative reference
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005 Quality management systems – Fundamentals and vocabulary.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization shall:
a) determine the processes needed for the quality management system, and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure where applicable, and analyze these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced shall be defined within the quality management system.
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.
NOTE 2 An “outsource process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced can be influenced by factors such as
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
b) the degree to which the control for the process is shared,
c) the capability of achieving the necessary control through the application of 7.4
4. 2 Documentation requirements
4. 2. 1 General
The quality management system documentation shall include:
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes,
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4. 2. 2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
4. 2. 3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at point of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
4. 2. 4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records shall remain legible, readily identifiable and retrievable.
Friday, June 25, 2010
Job vacant in Pinthong Industrial Estate
Post date 19-Jul-2010
Position:-
1. Accounting Officer
2. BOI Officer
3. Program Administrator
4. QA Engineer
5. Supervisor Production
6. Production Engineer
7. QA operator
8. Production operator
All position contact to Khun Arpaporn
Tel.: 038-348-380-1 Ext.104
Position:-
1. Accounting Officer
2. BOI Officer
3. Program Administrator
4. QA Engineer
5. Supervisor Production
6. Production Engineer
7. QA operator
8. Production operator
All position contact to Khun Arpaporn
Tel.: 038-348-380-1 Ext.104
Thursday, June 24, 2010
ISO 9001:2008 What is Change?
เปรียบเทียบข้อกำหนด ISO 9001:2008 และ ISO 9001:2000
หมายเหตุ
ตัวเอียง คือ คำเดิมที่ถูกเปลี่ยนไป
ตัวหนา คือ คำใหม่ที่ถูกนำมาใช้แทนที่
(คำในวงเล็บ) คือ คำที่เพิ่มมา
ข้อกำหนดที่ 4.1 Bullet a)
a) identify determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
a) ระบุ กำหนด กระบวนการต่างๆ ที่จำเป็นสำหรับระบบบริหารคุณภาพและการนำไปใช้ทั่วทั้งองค์กร(ดู 1.2)
ในข้อ a) มีคำว่า determine แทนคำว่า identify
ข้อกำหนดที่ 4.1 Bullet e)
monitor, measure (where applicable), and analyze these processes, and
e) เฝ้าติดตาม ตรวจวัด (ที่มีการประยุกต์ใช้) และวิเคราะห์ กระบวนการเหล่านี้
หมายเหตุ
ตัวเอียง คือ คำเดิมที่ถูกเปลี่ยนไป
ตัวหนา คือ คำใหม่ที่ถูกนำมาใช้แทนที่
(คำในวงเล็บ) คือ คำที่เพิ่มมา
ข้อกำหนดที่ 4.1 Bullet a)
a) identify determine the processes needed for the quality management system and their application throughout the organization (see 1.2),
a) ระบุ กำหนด กระบวนการต่างๆ ที่จำเป็นสำหรับระบบบริหารคุณภาพและการนำไปใช้ทั่วทั้งองค์กร(ดู 1.2)
ในข้อ a) มีคำว่า determine แทนคำว่า identify
ข้อกำหนดที่ 4.1 Bullet e)
monitor, measure (where applicable), and analyze these processes, and
e) เฝ้าติดตาม ตรวจวัด (ที่มีการประยุกต์ใช้) และวิเคราะห์ กระบวนการเหล่านี้
Tuesday, June 22, 2010
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