ISO 9001:2000 Standard Requirement

ISO 9001:2000Standard Requirement

Interpretation

Summarized of Standard Requirement

1 Scope1.1 General ( 1.0 )1.2 Application ( 1.0 ) 2 Normative reference

3 Term and definitions

4 Quality management system 4.1 General requirements ( 4.2.1 )4.2 Documentation requirements ( 4.2.1, 4.2.2, 4.5, 4.16 )

Summarized Standard Requirement ( cont’)

5 Management responsibility

5.1Management commitment ( 4.1.1)5.2 Customer focus ( 4.3.2 )5.3 Quality Policy ( 4.1.1 )5.4 Planning ( 4.1.1, 4.2.3 )5.5 Responsibility, authority and

communication ( 4.1.2.1, 4.1.2.3 )5.6 Management review ( 4.1.3 ).

6 Resource management 6.1 Provision of resources ( 4.1.2.2 )

6.2 Human resources ( 4.1.2.2, 4.18 )

6.3 Infrastructure ( 4.9 )

6.4 Work environment ( 4.9 )

7 Product Realization7.1 Planning of product realization ( 4.2.3, 4.10.1)7.2 Customer-related processes ( 4.3.2 - 4.3.4, 4.4.4 )7.3 Design and development ( 4.4.2 - 4.4.9 )7.4 Purchasing (4.6.2-4.6.4, 4.10.2)7.5 Production and service provision ( 4.7, 4.8, 4.9, 4.10.5, 4.12, 4.15.2- 4.15.6, 4.19 )7.6 Control of monitoring and measuring devices (4.11)

8 Measurement, analysis and improvement

8.1 General ( 4.10.1, 4.20 )8.2 Monitoring and Measurement

(4.10.2- 4.10.5,4.17,4.20 )8.3 Control of Nonconforming

product ( 4.13 )8.4 Analysis of Data ( 4.20 )8.5 Improvement ( 4.1.3, 4.14 )

10. Scope 11. “ General “

Organization are required

a) Consistently provide product meet with customer and applicable regulatory requirements.b) Enhance customer satisfaction through the effective application of the system continuous improvement.

12 “ Application ” Generic and applicable to all organizations. Can be exclusion due to the nature of an organization and its products Exclusion are allowed only clause No. 7.3 : Design and Development. There was no effected to Organization ‘s ability and there responsibility.

Example “DEF Filling Company” Soft Drink manufacturer under affiliate agreement, license , specification and quality controlled by Mother Company aboard. It therefore, all product are produced under these specification only. This company establish the QMS and request to excluded clause 7.3 ( Design and Development) because of the filling circumstance was not covers these activity . This request are accepted, The QM of this company will clearly define and available to the public.

3.0 Terms and Definitions •Supplier•Organization•Customer

ISO 9001:1994 = Subcon – Supplier - Customer

ใช้�คำ��จำ��กัดคำว�มต�มที่��กั��หนดไว�ใน ISO 8402

Supplie

r Organiz

ation

Custom

er

CompaCompanyny

4.0 QMS

4.1 General Requirement

a) Identify the process needed for QMS , the application throughout the organization (out sources)• Some indirect affected to the quality and customer satisfaction need to be covered e.g.“ Site safety process” “ Customer visit process” “ Staff recruitment process ”

General Requirement ( cont’)b) Determine the sequence and

interaction of these processc) Determine the criteria and

method needed to operation and

control of process are effective.

d) Resources available and adequate to support these process

e) Process Monitoring, Measurement and Analysis

f) Implement action , plan for achievement and continuous

improvement

Product Realization Process Marketing & Sales

Design& Develop.

Purchasing

Customers Satisfaction

Production Process Identification& Trace.

Customer Property Preservation of product

Control of measuring equip.

Customers Requirements

Measurement Analysis

Improvement• ManagementResponsibility

•Resource Management

ProductInformation

42. “ข้�อกำ��หนดระบบเอกำส�ร” (Documentation requirements)4.2.1 General: The component of quality

document: a) Documented statements of a

quality policy and Quality Objectives;

b) a quality Manual c) d ocumented procedures required by International Standard

d) system document need by the organization ( plan, operation and process control)

e) records required by International Standard

ISO 9001 : 1994 - Clause 4.2.2

Documented Procedure4.2.3 Control of Documents4.2.4 Control of Quality Records8.2.2 Internal audit8.3 Control of non-conforming product8.5.2 Corrective action8.5.3 Preventive action

Document required by International Standard Quality policy,Quality Objectives,Quality Manual

Document should be established.Process map,Organization chart, Internal communication, Production SchedulesApproved supplier listsQuality plan

Record required by International Standard 5.6.1 Management review 6.2.2 (e) Education, Training, Skill and Experience 7.1 (d) Evidence that the realization processes and resulting

product fulfill requirements 7.2.2 Results of the review of requirements relating to the

product and actions arising from the review 7.3.2 Design and development input 7.3.4 Results of design and development review and any.. 7.3.5 Results of design and development verification and. 7.3.6 Results of design and development validation and… 7.3.7 Results of the review of design and development

change and any… 7.4.1 Result of supplier evaluations and action arising….

7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output..

7.5.3 The unique identification of the product, where… 7.5.4 Customer property that is lost , damaged or …. 7.6 (a) the basic used for calibration and verification.. 7.6 Validity of the previous measuring results when the.. 7.6 Result of calibration and verification of measuring .. 8.2.2 Internal audit results 8.2.4 Evidence of conformity with the acceptance criteria

and indicate the person(s) authorizing release of product 8.3 Nature of the product nonconformity and any… 8.5.2 (e) Result of corrective action 8.5.3 (d) Result of preventive action

Documents will be related with the organization and circumstance as:

Size of organization system complicationskill of operator

4.2.2 Quality ManualThe organization shall establish the Quality Manual covers a) Scope of QMS , Detail and Justification for an exclusion

b) documented procedures , clause reference

c) Describe the interaction between the processes of QMS

Note. 423. . and 424. . equal 45 , 4.16 ISO 9001:1994

5.0 Management responsibility 51. “ ManagementCommitment”

Top management shall provide the evidence of its commitment to develop, implement QMS and continual improvement bya) Communicating to the organization as customer statuary are regulatory requirementb) Establish the quality policy

c) Ensure the quality objectives are establishedd) Conduction the Management Reviewe) Ensure the available of resources

ISO 9001 : 1994 - clause 411

52. “Customer focus ”

Top management shall ensure that customer requirement are determined and met with the aim of enhancing the customer satisfaction

ISO 9001 : 1994 - clause 4.3.2

53 “Quality policy ” a) appropriate with the

purpose of the organizationb) commitment to comply with the related requirementscontinuous improve the QMS effectiveness c) provide a frame work for establish and review the quality objectivesd) communicated and understood within organization e) review for the continuing suitabilityISO 9001 : 1994 - clause 411. .

54. Planning541. . “ Quality Objective ”shall be establishedcovers relevance functions

and level within organizationmeasurable consistent with the quality

policy

ISO 9001 : 1994 - ข้�อกั��หนด 411. .

542. . “Quality management system Planning ” a) QMS is carried out and meet the requirement and quality objectiveb) maintained the integrity when changed the the QMS

ISO 9001 : 1994 - ข้�อกั��หนด 423. .

Quality policyQuality

ObjectiveProcess

Management

PolicyDeployment

customer focus company targets

ExampleQuality Policy (JK-company) “Produced the good quality products and reduce the production defected to ensure that only the good quality of products are submitted to the customer with consistent on the continuous improvement . ”

- Quality Objective 1 ( Production Division ) Reduce the % defect rate of SYD Olympic 001 not more than 5 % within 2003.ISO 9001 : 1994 - ข้�อกั��หนด 411

421. .

5.5 “ Responsibility, authority and communication”

551. . Responsibility and authority are defined and communicated within an organization5.5.2 Management representative appointment and defined the role of responsibilities

IIIIIIII IIIIIIIIIIIII 553 the appropriate internal communication system shall be established regarding of the QMS system.

Example SDY Olympic 001 product are rejected from the customer during August 2002 volumes = 1000

0 pcs. or about 100, 000 2,000,000 Baht. the defection detail are classified under the root cause as follow: crack ( green) , rupture ( blue) and wrong color

0

10

20

30

40

50

60

อ�กำ�รเส�ย

ฉี�กำข้�ดส�มี�ตำ��น�รอยข้�ดข้�วน

56 “Management Review ” Emphasis on the agenda (input) and the result ( out put ) of management meeting

Input a) results of audit b) Customer feedbackc) Process performance and product conformityd) Status of corrective and preventive actionse) Follow up action from the previous management review f ) Change that could affect the QMS g) Recommendation for improvement

Review Output : a) The effectiveness of QMS Improvement and its process b) Product improvement related to customer requirementsc) Resources need

ISO 9001 : 1994 – clause 413

applicable education/ คว�มีร��กำ�รศึ�กำษ� training/ กำ�รฝึ กำอบรมี skills/ ทั"กำษะกำ�รทั��ง�น experience/ ประสบกำ�รณ์&กำ�รทั��ง�น

Personnel performing work affecting product quality shall be competent on the basis of /

พน"กำง�นทั�(ปฏิ�บ"ตำ�ง�นทั�(มี�ผลกำระทับตำ�อค,ณ์ภ�พจะตำ�องมี�คว�มีส�มี�รถเหมี�ะสมี อย��บนพ01นฐ�นข้อง

6.2.1 General / ทั"(วไป6.2.1 General / ทั"(วไป6.2 Human resources/ ทัร"พย�กำรบ,คคล

The organisation shall/ องค&กำรจะตำ�อง determine the necessary competence/ พ�จ�รณ์�/กำ��หนดค,ณ์สมีบ"ตำ�ทั�(เหมี�ะสมี provide training or other actions/ จ"ดกำ�รฝึ กำอบรมีหร0อกำ�จกำรรมีอ0(น evaluate the effectiveness/

ประเมี�นประส�ทัธิ�ภ�พ

6.2.2 Competence, awareness and training/

คว�มีส�มี�รถในกำ�รปฏิ�บ"ตำ�ง�น และกำ�รฝึ กำอบรมี (1)



• ensure that employees are aware of the relevance and importance of their activities and how they contribute to the achievement of quality / / มี"(นใจว��พน"กำง�นมี�คว�มีตำระหน"กำกำ"บส�(งทั�(เกำ�(ยวข้�องและ คว�มีส��ค"ญข้องกำ�รทั��ง�นทั�(จะบรรล,ว"ตำถ,ประสงค&

• maintain records/ ร"กำษ�บ"นทั�กำ





building, workspace and associated facilities/ สถ�นทั�(ทั��ง�นและส�ธิ�รณ์�ปโภคทั�(เกำ�(ยวข้�อง process equipment/ อ,ปกำรณ์&ในกำระบวนกำ�ร supporting services/ บร�กำ�รสน"บสน,นอ0(น ๆ

Infrastructure needed to achieve product conformity shall be identified, provided and maintained, including/ ระบบส�ธิ�รณ์�ปโภคทั�(จะมี�คว�มีจ��เป:นในกำ�รทั��ให�ผล�ตำภ"ณ์ฑ์&สอดคล�องกำ"บข้�อกำ��หนด จ"ดทั��และบ��ร,งร"กำษ�รวมีถ�ง

6.3 Infrastructure/ ส�ธิ�รณ์�ปโภค6.3 Infrastructure/ ส�ธิ�รณ์�ปโภค

The organisation shall identify and manage the work environment needed to achieve conformity of product /จะตำ�องกำ��หนดและบร�ห�รสภ�พแวดล�อมีในกำ�รทั��ง�นเพ0(อบรรล,ถ�งคว�มีสอดคล�องข้องผล�ตำภ"ณ์ฑ์&

6.4 Work environment/ สภ�วะแวดล�อมีในกำ�รทั��ง�น

6.4 Work environment/ สภ�วะแวดล�อมีในกำ�รทั��ง�น

• Planning the realisation processes shall be/

กำ�รว�งแผนกำระบวนกำ�รจะตำ�อง• consistent with the other requirements/

ครอบคล,มีสอดคล�องกำ"บข้�อกำ��หนด อ0(น• documented in a suitable form/

จ"ดทั��เป:นเอกำส�รอย��ในร�ปแบบอย��งเหมี�ะสมี

Product realisation is that sequence of processes and sub-processes required to achieve the product/ ค0อกำ�รจ"ดข้"1นตำอนกำ�รทั��ง�นข้องกำระบวนกำ�รและกำระบวนกำ�รย�อยทั�(จ��เป:นเพ0(อให�บรรล,ตำ�มีข้�อกำ��หนดผล�ตำภ"ณ์ฑ์&

7.1 Planning of product realization/

กำ�รว�งแผนเพ0(อให�ผล�ตำภ"ณ์ฑ์&บรรล,ผล (1)



7. Product realization/ กำ�รทั��ให�ผล�ตำภ"ณ์ฑ์&บรรล,ผล

7. Product realization/ กำ�รทั��ให�ผล�ตำภ"ณ์ฑ์&บรรล,ผล

The following shall be determined, as appropriate/

จะตำ�องกำ��หนดส�(งตำ��ง ๆ ด"งน�1อย��งเหมี�ะสมี • quality objectives and requirements/

เป<�หมี�ยค,ณ์ภ�พและข้�อกำ��หนด• the need to establish processes, documentation and provide resources specific to the product/

คว�มีตำ�องกำ�รในกำ�รจ"ดตำ"1งกำระบวนกำ�ร, เอกำส�รและทัร"พย�กำร ส��หร"บกำ�รผล�ตำภ"ณ์ฑ์&• verification, validation, monitoring, inspection and test, and its criteria/ กำ��หนดกำ�รทัวนสอบ, ย0นย"น, เฝึ<�

ตำ�ดตำ�มี และตำรวจสอบ, ทัดสอบพร�อมีทั"1งกำ��หนดในกำ�ร

ยอมีร"บ• necessary records/ บ"นทั�กำทั�(จ��เป:น





Planning of Product

realizationInput

CustomerRequirement• Product specificationincluding(Pro ductStandard)• PackingSpecification• Order Quantity• Deliverydate• Services( D elivery, Post Delivery )

- 7201Activities ( ref. PM .“ Customer Related Process”)

1) Review requirement before Submission of tender, Acceptance of contract/order,Acceptance of Change

2 ) Product requirement are defined 3) Contract/order requirements differing

are resolved. 4) Has ability to meet the defined

requirements 5) Records of review are maintained

6) No documented requirements, requirements are confirmed.

7) ....

product requirements specified by the customer/ ข้�อกำ��หนดข้องผล�ตำภ"ณ์ฑ์&จ�กำล�กำค�� statutory and regulatory requirements/ กำ�รตำกำลงเกำ�(ยวกำ"บผล�ตำภ"ณ์ฑ์&รวมีถ�งข้�อกำ��หนดและกำฎหมี�ยตำ��ง ๆ additional requirements/ ข้�อกำ��หนดเพ�(มีเตำ�มีอ0(น ๆ

7.2.1 Determination of the customer requirements include:

7.2.1 Determination of the customer requirements include:

7.2 Customer-related process/กำระบวนกำ�รทั�(เกำ�(ยวข้�องกำ"บล�กำค��

7.2 Customer-related process/กำระบวนกำ�รทั�(เกำ�(ยวข้�องกำ"บล�กำค��

product requirements/ ข้�อกำ��หนดเกำ�(ยวกำ"บผล�ตำภ"ณ์ฑ์& && resolution of differences/ จ"ดกำ�รแกำ�ป>ญห�กำ"บส�(งทั�(แตำกำตำ��ง ข้�อกำ��หนด ability to meet defined requirements/ ส�มี�รถทั�(จะบรรล, ตำ�มีข้�อกำ��หนดทั�(กำ��หนดข้�1น

Prior committing to supply product, the organisation

shall review/ กำ�อนทั�(จะตำกำลงทั�(จะส�งมีอบผล�ตำภ"ณ์ฑ์&องค&กำรจะตำ�องทับทัวน

7.2.2 Review of requirements related to the

productกำ�รทับทัวนข้�อกำ��หนดข้องผล�ตำภ"ณ์ฑ์& (1)7.2.2 Review of requirements related to the

productกำ�รทับทัวนข้�อกำ��หนดข้องผล�ตำภ"ณ์ฑ์& (1)

the results of the review shall be recorded/ จะตำ�องบ"นทั�กำผลกำ�รทับทัวน where product requirements are changed, the relevant

documentation shall be amended/ กำรณ์�ทั�(ข้�อกำ��หนดข้อง ผล�ตำภ"ณ์ฑ์&มี�กำ�รเปล�(ยนแปลงจะตำ�องด��เน�นกำ�รเปล�(ยนแปลงเอกำส�รตำ��งๆ ทั�(เกำ�(ยวข้�อง relevant personnel shall be made aware of the

changed requirements/ บ,คล�กำรทั�(เกำ�(ยวข้�องจะตำ�อง ทัร�บและระมี"ดระว"งกำ"บข้�อกำ��หนดทั�(เปล�(ยนแปลง

7.2.2 Review of requirements related to the

productกำ�รทับทัวนข้�อกำ��หนดข้องผล�ตำภ"ณ์ฑ์& (2)7.2.2 Review of requirements related to the

productกำ�รทับทัวนข้�อกำ��หนดข้องผล�ตำภ"ณ์ฑ์& (2)

These to include/ ข้�อกำ��หนดรวมีถ�ง product information/ ข้�อมี�ลเกำ�(ยวกำ"บผล�ตำภ"ณ์ฑ์& enquiries, contracts or order handling, and amendments/ ข้�อเสนอร"บเข้�� ส"ญญ�หร0อค��ส"(งซื้01อและ กำ�รแกำ�ไข้กำ�รร"บ customer feedback, including customer complaints/ กำ�รตำอบสนองข้องล�กำค��รวมีถ�งรวมีถ�ง ค��ร�องเร�ยนข้องล�กำค��

Arrangements for communication to customers shall be identified and implemented/ จะตำ�องกำ��หนดและด��เน�นระบบกำ�รจ"ดกำ�รส0(อส�รกำ"บล�กำค��

7.2.3 Customer communication/

กำ�รส0(อส�รกำ"บล�กำค��7.2.3 Customer communication/

กำ�รส0(อส�รกำ"บล�กำค��

7.3.1 Design and development planning


The design and development planning, the organization shall determine/ ในกำ�รว�งแผนกำ�รออกำแบบและพ"ฒน�องค&กำรจะตำ�อง ค��น�งถ�ง• the design and development stages/ ข้"1นตำอนข้องกำ�ร

ออกำแบบและพ"ฒน�• the review, verification and validation that are appropriate to each design and development stage/ กำ��หนดข้"1นตำอน ข้องกำ�รทับทัวน, ทัวนสอบ และย0นย"นผลทั�(หมี�ะสมี

7.3 Design and development/

กำ�รออกำแบบและพ"ฒน�7.3 Design and development/

กำ�รออกำแบบและพ"ฒน�


กำ�รว�งแผนกำ�รออกำแบบและพ"ฒน� (2)


กำ�รว�งแผนกำ�รออกำแบบและพ"ฒน� (2)

• the responsibilities and authorities for design and development/ กำ��หนดอ��น�จหน��ทั�(ในกำ�รออกำแบบและพ"ฒน�• the interfaces between different groups involved in design and development/ กำ�รประส�นง�นระหว��งกำล,�มี

ตำ��ง ๆ ทั�(เกำ�(ยวข้�อง• planning output shall be updated/ กำ�รปร"บแผนให�ทั"นสมี"ย

Inputs shall include/ ข้�อมี�ลรวมีถ�ง functional and performance requirements/ ข้�อกำ��หนดกำ�รทั��ง�นและ คว�มีส�มี�รถข้องผล�ตำภ"ณ์ฑ์& statutory and regulatory requirements/ ข้�อกำ��หนดและข้�อบ"งค"บทั�(เกำ�(ยวข้�อง information derived from similar previous designs/ ข้�อมี�ลจ�กำกำ�รออกำแบบทั�(ทั��กำ�อนหน��ทั�(คล��ยคล�งกำ"น other requirements/ ข้�อกำ��หนดอ0(น ๆ

7.3.2 Design and development inputs/

ข้�อมี�ลกำ�รออกำแบบและพ"ฒน�7.3.2 Design and development inputs/

ข้�อมี�ลกำ�รออกำแบบและพ"ฒน�

7.3.3 Design and development outputs/

ผลข้องกำ�รออกำแบบและพ"ฒน�7.3.3 Design and development outputs/

ผลข้องกำ�รออกำแบบและพ"ฒน�• provided in a form that enables verification and approve

prior release/ อย��ในร�ปแบบทั�(ส�มี�รถทัวนสอบได� และอน,มี"ตำ�กำ�อนน��ไปใช้�• meet the input requirements for design and development/

สอดคล�องกำ"บข้�อกำ��หนด• provide appropriate information for purchasing, production and for service provision/

ให�ข้�อมี�ลส��หร"บกำ�รจ"ดซื้01อ, ผล�ตำหร0อบร�กำ�ร• contain or reference product acceptance criteria/

มี�อย,�หร0ออ��งอ�งถ�งเกำณ์ฑ์&ยอมีร"บ• specify the characteristics of the product that are essential for its safe and proper use/

กำ��หนดถ�งค,ณ์สมีบ"ตำ�ในแง�คว�มีปลอดภ"ยและกำ�รใช้�ง�น

evaluate the ability to meet requirements/ ทัดลองคว�มีส�มี�รถในกำ�รบรรล,ตำ�มีข้�อกำ��หนดอย��งครบถ�วน identify problems and propose actions/ ระบ,ป>ญห�และกำ�รด��เน�นกำ�ร participants shall include representatives of functions

concerned/ ประกำอบด�วยตำ"วแทันข้องฝึB�ยทั�(เกำ�(ยวข้�อง records/ บ"นทั�กำ

7.3.4 Design and development reviews/

กำ�รทับทัวนกำ�รออกำแบบและกำ�รพ"ฒน�7.3.4 Design and development reviews/

กำ�รทับทัวนกำ�รออกำแบบและกำ�รพ"ฒน�

7.3.5 Design and development verification/

กำ�รทับทัวนกำ�รออกำแบบและกำ�รพ"ฒน�7.3.5 Design and development verification/

กำ�รทับทัวนกำ�รออกำแบบและกำ�รพ"ฒน�• ensure that the outputs have satisfied the input requirements/

มี"(นใจว��ผลล"พธิ&น"1นสอดคล�องกำ"บข้�อมี�ลในเบ01องตำ�น• records / บ"นทั�กำ

ensure that the products is capable of fulfilling the requirements/ มี"(นใจว��ผล�ตำภ"ณ์ฑ์&มี�ค,ณ์สมีบ"ตำ�สอดคล�องกำ"บ คว�มีตำ�องกำ�ร where practical validation to be completed prior to

the delivery or implementation of the product/ กำ�รทัวนสอบย0นย"นจะตำ�องเสรCจส�1นกำ�อนกำ�รส�งมีอบหร0อกำ�รใช้� ผล�ตำภ"ณ์ฑ์& (ในบ�งกำรณ์�) records / บ"นทั�กำ

7.3.6 Design and/or development validation/ กำ�รทัวนสอบย0นย"นกำ�รออกำแบบและหร0อ

กำ�รพ"ฒน�

7.3.6 Design and/or development validation/ กำ�รทัวนสอบย0นย"นกำ�รออกำแบบและหร0อ

กำ�รพ"ฒน�

changes shall be identical and records maintained/ ช้�1บ�งกำ�รเปล�(ยนแปลงและเกำCบร"กำษ�บ"นทั�กำ verify and validate changes as appropriate/ ทัวนสอบและ ย0นย"นกำ�รเปล�(ยนแปลง และอน,ตำ�ใหมี�กำ�อนกำ�รน��ไปใช้� evaluation of changes to include the effect of changes

on constituent parts and delivered products/ ทั��กำ�ร ประเมี�นกำ�รเปล�(ยนแปลงรวมีถ�งผลกำระทับจ�กำกำ�รเปล�(ยนแปลงตำ�อส�วน ประกำอบตำ��ง ๆ และผล�ตำภ"ณ์ฑ์&ทั�(ส�งมีอบไปแล�ว records/ บ"นทั�กำ

7.3.7 Control of design and development changes/ กำ�รควบค,มีกำ�รเปล�(ยนแปลงกำ�รออกำแบบและ

พ"ฒน�ผล�ตำภ"ณ์ฑ์&

7.3.7 Control of design and development changes/ กำ�รควบค,มีกำ�รเปล�(ยนแปลงกำ�รออกำแบบและ

พ"ฒน�ผล�ตำภ"ณ์ฑ์&

7.4 Purchasing

7.4.1 Purchasing process• ensure that purchased product conforms to specified

purchase requirements/ มี"(นใจว��ผล�ตำภ"ณ์ฑ์&น"1นสอดคล�อง กำ"บคว�มี

ตำ�องกำ�ร• evaluate and select suppliers based on their ability to meet requirements/ ประเมี�นและค"ดเล0อกำผ��ข้�ยบนพ01นฐ�นข้องกำ�ร ตำอบสนองตำ�อคว�มีตำ�องกำ�ร• criteria for selection, evaluation and re-evaluation shall be established/ กำ��หนดเกำณ์ฑ์&กำ�รค"ดเล0อกำและประเมี�น

7.4.2 Purchasing information / ข้�อมี�ลกำ�รจ"ดซื้01อPurchasing information shall describe • requirements for approval of product, procedures, processes and equipment/ กำ�รอน,มี"ตำ�ผล�ตำภ"ณ์ฑ์&, กำระบวนกำ�รหร0ออ,ปกำรณ์&• requirements for qualification of personnel/ ค,ณ์สมีบ"ตำ�ข้องบ,คล�กำร• quality management system requirements/ ข้�อกำ��หนดข้องระบบค,ณ์ภ�พ

7.5.3 Identification and traceability/

กำ�รช้�1บ�งและกำ�รสอบกำล"บได�• identify the product by suitable means throughout

product realization/ ช้�1บ�งตำลอดกำระบวนกำ�ร• identify the product status with respect to monitoring

and measurement requirement/

ช้�1บ�งสถ�นะข้องกำ�รเฝึ<�ตำ�ดตำ�มี และตำรวจสอบ• control and record the unique identification of the

product for traceability purpose/

ควบค,มีและทั�กำกำ�รช้�1บ�งเฉีพ�ะตำ"วเพ0(อกำ�รสอบกำล"บ

7.5.5 Preservation of product/

ถนอมีร"กำษ�ผล�ตำภ"ณ์ฑ์&• preserve the conformity of product and constituent of a product/ ถนอมีร"กำษ�สภ�พข้องผล�ตำภ"ณ์ฑ์& และส�วนประกำอบข้องผล�ตำ ภ"ณ์ฑ์&• include identification, handling, packaging, storage and protection/

รวมีถ�งกำ�รช้�1บ�ง, เคล0(อนย��ย, บรรจ,, จ"ดเกำCบและปกำป<อง

The organisation shall identify/ องค&กำรจะตำ�องระบ,ถ�ง measurements that need to be made and/ กำ�รว"ดทั�(จ��เป:นทั�(ตำ�องใช้� monitoring devices required to assure conformity of

product to specified requirements/ เคร0(องมี0อกำ�รตำรวจตำ�ดตำ�มี ทั�(ใช้�ส��หร"บประกำ"นค,ณ์ภ�พคว�มีสอดคล�องข้องผล�ตำภ"ณ์ฑ์&ตำ�มีข้�อกำ��หนด

Monitoring devices to be used and controlled to ensure that measurement capability is consistent with measurement requirements/ เคร0(องมี0อตำรวจว"ดตำ�ดตำ�มีผลทั�(ใช้�และควบค,มีจะตำ�องถ�กำมี"(นใจว��คว�มีส�มี�รถในกำ�รว"ดสอดคล�องกำ"บข้�อกำ��หนดทั�(กำ��หนดไว�

7.6 Control of measuring and monitoring

devices / กำ�รควบค,มีเคร0(องว"ด และเฝึ<�ตำ�ดตำ�มี (1)

7.6 Control of measuring and monitoring

devices / กำ�รควบค,มีเคร0(องว"ด และเฝึ<�ตำ�ดตำ�มี (1)

Monitoring devices, where applicable shall be/ จะตำ�อง calibrated and adjusted periodically or prior to use/ ได�ร"บกำ�รสอบเทั�ยบปร"บตำ�มีระยะเวล�กำ��หนดหร0อกำ�อนใช้� traceable to international or national standards/

สอบกำล"บได�ถ�งมี�ตำรฐ�นระด"บช้�ตำ�หร0อน�น�ช้�ตำ� identify the calibrations status/ ช้�1บ�งสถ�นะข้องกำ�รสอบเทั�ยบ safeguarded from invalid adjustments/ ป<องกำ"นจ�กำกำ�รปร"บเทั�ยบโดยไมี�ถ�กำตำ�อง

7.6 Control of measuring and monitoring devices/

กำ�รควบค,มีเคร0(องมี0อว"ดและตำรวจเฝึ<�ตำ�ดตำ�มี (2)


กำ�รควบค,มีเคร0(องมี0อว"ดและตำรวจเฝึ<�ตำ�ดตำ�มี (2)

protected from damage and deterioration/ ป<องกำ"นกำ�รเส�ยห�ยและเส0(อมีสภ�พ take action when the equipment is found not to conform to requirements/

ด��เน�นกำ�รเมี0(อเคร0(องมี0อ/อ,ปกำรณ์&ไมี�เป:นไปตำ�มีข้�อกำ��หนด results recorded/ บ"นทั�กำผล


กำ�รควบค,มีเคร0(องมี0อว"ดและเฝึ<�ตำ�ดตำ�มี (3)7.6 Control of measuring and monitoring devices/

กำ�รควบค,มีเคร0(องมี0อว"ดและเฝึ<�ตำ�ดตำ�มี (3)

Management audit performed by company on its own systems to determine effectiveness

To assessperformanceneedsstrong pointsfailings

May be performed by external party

8.2.2 Internal Audit

Authority & Responsibility

Auditor Training & Selection

Audit programs

Requirements for Additional Audits

Procedures Planning

Preparation

Performance

Reporting & Follow-up

Results to Senior Management

Records

Internal Audit Protocols

Auditor Training Aspects based ? Audit Skills ?

Audit program Comprehensive ? Minimum Frequency ? Changeable ? Activity “Significance” ?

Audit Planning & Preparation Impartiality/objectivity ? System-based checklist ?

Audit Results Complete Record ? Show effective training ?

Findings Classification ? Demonstrate effective training ? Allow Corrective Actions? Timely ?

Audit reports Adequate for Management

Review ?

External Review of Internal Audit

8.2.3 Monitoring and measurement of process/

เฝึ<�ตำ�ดตำ�มีและว"ดผลกำระบวนกำ�ร• apply suitable methods for monitoring and measurement of the processes/

กำ��หนดว�ธิ�ในกำ�รเฝึ<�ตำ�ดตำ�มีและว"ดผลกำระบวนกำ�ร• demonstrate the ability of the processes to achieve planned results/

แสดงให�เหCนถ�งคว�มีส�มี�รถทั�(จะทั��ให�ได�ตำ�มีผลทั�(ว�งแผนไว�• when results are not achieved, correction and preventive

action shall be taken/ เมี0(อไมี�ประสบผลจะตำ�องแกำ�ไข้และป<องกำ"น

8.2.4 Monitoring and measurement of product/

เฝึ<�ตำ�ดตำ�มีและว"ดผลผล�ตำภ"ณ์ฑ์&

• monitor and measure the characteristics of the product to verify that product requirements are fulfilled/

ทั��ให�ข้"1นตำอนทั�(เหมี�ะสมีเฝึ<�ตำ�ดตำ�มีและว"ดค,ณ์ล"กำษณ์ะข้องผล�ตำภ"ณ์ฑ์& ตำ�มีข้�อกำ��หนด• evidence shall be maintained/ หล"กำฐ�นตำ�องเกำCบร"กำษ�ไว�

Deal with nonconforming product by the following / ด��เน�นกำ�รด"งน�1• taking action to eliminate the detected nonconformity/

ด��เน�นกำ�รเพ0(อกำ��จ"ดคว�มีไมี�เป:นไปตำ�มีข้�อกำ��หนด• authorizing its use, release or acceptance under concession/ น��ไปใช้�ในกำรณ์�พ�เศึษ• taking action to preclude its original intended use or application/ ด��เน�นกำ�รเพ0(อป<องกำ"นกำ�รน��ไปใช้�• records of the nature of non conformities and any subsequent actions taken/ บ"นทั�กำประเภทัช้น�ดข้องผล�ตำภ"ณ์ฑ์&ทั�( ไมี�เป:นไปตำ�มีข้�อกำ��หนดรวมีทั"1งกำ�รด��เน�นกำ�ร

8.3 Control of nonconforming product/

กำ�รควบค,มีผล�ตำภ"ณ์ฑ์&ทั�(ไมี�เป:นไปตำ�มีข้�อกำ��หนด

the suitability and effectiveness of the QMS/ คว�มีมี�ประส�ทัธิ�ภ�พและคว�มีเหมี�ะสมีข้องระบบบร�ห�รค,ณ์ภ�พ to identify improvements that can be made/ เพ0(อช้�1บ�งกำ�รปร"บปร,งทั�(ส�มี�รถทั��ได� to provide information on/ เพ0(อให�มี�ข้�อมี�ลในเร0(อง

- customer satisfaction and/or dissatisfaction/ คว�มีพ�งพอใจและไมี�พ�งพอใจข้องล�กำค�� - conformance to customer requirements/ คว�มีสอดคล�องกำ"บข้�อกำ��หนดข้องล�กำค��

- characteristics of processes, product and trends/ ค,ณ์สมีบ"ตำ�ข้องกำระบวนกำ�รผล�ตำภ"ณ์ฑ์&และแนวโน�มี

- suppliers/ ผ��ส�งมีอบตำ��ง ๆ

Appropriate data shall be collected and analysed to

determine:/ ตำ�องรวบรวมีข้�อมี�ลอย��งเพ�ยงพอและว�เคร�ะห&เพ0(อห�

8.4 Analysis of data/ กำ�รว�เคร�ะห&ข้�อมี�ล8.4 Analysis of data/ กำ�รว�เคร�ะห&ข้�อมี�ล

8.5 Improvement

8.5.1 “Continual Improvement”

Policy Quality Objective Monitoring Results Data Analysis Corrective and Preventive action Management Review

QMS

Improvement

8.5.2 Corrective action/ ปฏิ�บ"ตำ�กำ�รแกำ�ไข้ 8.5.2 Corrective action/ ปฏิ�บ"ตำ�กำ�รแกำ�ไข้

• take action to eliminate the cause of non conformities in order to prevent recurrence/ ด��เน�นกำ�รเพ0(อกำ��จ"ดส�เหตำ,ข้องป>ญห�และป<องกำ"นกำ�รเกำ�ดซื้�1�• documented procedure shall be established/ จ"ดทั��เอกำส�รว�ธิ�กำ�ร• determining the causes of non conformities/ว�เคร�ะห&ส�เหตำ,• evaluating the need for action/ พ�จ�รณ์�คว�มีจ��เป:นในกำ�รด��เน�นกำ�ร• records of the results of action taken/ บ"นทั�กำผลข้องกำ�รด��เน�นมี�ตำรกำ�ร• reviewing corrective action taken/ ทับทัวนมี�ตำรกำ�ร

8.5.3 Preventive action/ ปฏิ�บ"ตำ�กำ�รป<องกำ"น 8.5.3 Preventive action/ ปฏิ�บ"ตำ�กำ�รป<องกำ"น

• determine action to eliminate the causes of potential non conformities in order to prevent their occurrence/ ด��เน�นกำ�รเพ0(อกำ��จ"ดส�เหตำ,ข้องป>ญห�ทั�(มี�ศึ"กำยภ�พเพ0(อป<องกำ"นกำ�รเกำ�ดซื้�1�• documented procedure shall be established/ จ"ดทั��เอกำส�รว�ธิ�กำ�ร • determining potential non conformities and their causes/ กำ��หนดป>ญห�ทั�(มี�ศึ"กำยภ�พและส�เหตำ,• evaluating the need for action/ พ�จ�รณ์�คว�มีจ��เป:นในกำ�รด��เน�นกำ�ร• records of the results of action taken/ บ"นทั�กำผลข้องกำ�รด��เน�นมี�ตำรกำ�ร

ISO 9001:2000 Standard Requirement

Documents

Transcript of ISO 9001:2000 Standard Requirement