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ISO 9001:2000

ISO 9001 is a management system ensuring that all processes through which a product or service       passes

till the stage of being presented to the customer regardless of its type are managed within the quality

principles and their sustainability is guaranteed.

 

To be able to survive in the current world order will be realized with providing of the product and service

appropriate to the customer needs and expectations in all sectors. One of the most preferred and common

ways of this is also the application of ISO 9001 quality management system covering all stages as starting

from the design stage till the marketing, production/service presentation and after sales services and aiming

at continuous development.

 

ISO 9001 Certificate

ISO 9001Certificate is a standard defining the efficient quality management system. When the institution

meets the conditions of this standard, it can get ISO 9001 certificate.The usage of the ISO 9001 Certificate;

the ISO 9001 Certificate is requested by many customers. This certificate can provide  market advantage to

you alone. However, this benefit is short term as also previously mentioned.ISO 9001 gains your institution

a continuous betterment mechanism and discipline other than the market advantage. However the getting of

the certificate does not mean that you achieve perfectness. In an institution having ISO 9001 certificate, every

problem is considered as a betterment opportunity. The important issue in the solution of the problem

is to ensure that it wil  not be repeated once again.

 

ISO 9001:2008

ISO 9000: is the whole of standards guiding the organizations in the establishment and development of the quality management system oriented for the increasing of the customer satisfaction and being published by ISO.

ISO 9001: is a standard in which the conditions required to be applied during the establishment of the Quality Management Systems are defined and which is subject to the certification inspection. It is the name of the certificate given.

ISO 9001:2008: ISO 9000 Standard is reviewed one in every 5 year by ISO and it is re-published by making the required revisions in the direction of the opinions and needs of the implementers. The number of 2000 is the version date that shows that this revision was made and published in the year of 2008 (ISO 9001:2008 version).

 

 

History of ISO 9001:2000

In today’s world, the developments encountered in the issues such as industry, technology etc. have pushed the communities to the cutthroat competition and to an economic race in which new developments are encountered in every passing day. To be able to survive in the competition environment and these stunning developments can be realized with the providing of the production of the goods and service appropriate to the customer needs and expectations in all sectors. This can only be possible with the application of the Quality Management System covering all stages as starting from    the purchasing stage till the marketing, design, production, quality control and after-sales services in the institutions.

ISO is the abbreviation of "International Organization for Standardization" and symbolizes the quality management standard that the International Organization for Standardization forms.

ISO 9000 Quality System Standards in the issue of the Quality Management System have become an international standard and guideline attracting the highest interest and finding implementation area as of the date at which it was published in the year of 1987.

ISO 9000 Quality Standards Series display how an effective management system will be established and documented and sustained.

ISO 9000 Certificate mentions that the product and services of the related institution are revealed as a result of a management understanding administrated and conducted in accordance with an internationally accepted management system and therefore it mentions the assurance that the continuity of the product and service quality of the institution can be ensured.

ISO 9001Certificate is a standard defining the efficient quality management system. When the institution meets the conditions of this standard, it can get ISO 9001 certificate.

The usage of the ISO 9001 Certificate; the ISO 9001 Certificate is requested by many customers. This certificate can provide market advantage to you alone. However, this benefit is short term as also previously mentioned.

ISO 9001 gains your institution a continuous betterment mechanism and discipline other than the market advantage. However, the getting of the certificate does not mean that you achieve perfectness. In an institution having ISO 9001 certificate, every problem is considered as a betterment opportunity. The important issue in the solution of the problem is to ensure that it will not be repeated once again.

 

Quality terms

QUALITY: It is degree of meeting the conditions by the current and existing characteristics. (ISO 9000:2000)

QUALITY POLICY: It is the expression formulated officially by the senior management regarding the quality and showing the orientation of the company and its total objectives.

QUALITY MANAGEMENT: They are activities coordinated for the management and control of an organization.

QUALITY OBJECTIVES: Things that are requested or aimed related to the quality
the quality objectives must be SMART.
S: Specified
M: Measurable
A: Achievable
R: Real
T: Timing

QUALITY PLANNING: It is a part of the quality management focused on the issues of the operational process required for the determination of the quality objectives and the meeting of these objectives and the procurement of the related resources.

QUALITY CONTROL: It is a part of the quality management focused on the meeting of the quality conditions.

QUALITY ASSURANCE: It is a part of the quality management focused on giving assurance that the quality conditions are met.

BETTERMENT: It is a part of the quality management focused on the increasing of the ability of the institution to meet the quality conditions.

WORKING ENVIRONMENT: The conditions of the environment in which the work is realized.

INSPECTION CRITERION: Policy, procedure and requirements determined as reference.

PRODUCT: A result of the process
Four General Product Category:
Hardware
Software
Services
Processed Materials or the combination of all of these.

CONDITIONS: Needs and expectations which are expected, generally requested or legal. The product can be related to the system or customer. The conditions determined are the ones made written. The conditions can have been revealed by the different sources.

CORRECTIVE ACTIVITY: Activity made for eliminating the main reason of a noncompliance determined and made for preventing its repetition.

PREVENTIVE ACTIVITY: Activity made for eliminating the main reason of a potential noncompliance (which has not appeared yet).

NON-STANDARD PERMISSION: Giving exit permission to the products which do not comply with the conditions.

RELEASING: Permission given for continuing of the process with the following stage

REVIEWING: Activities realized for the determination of the compliance and efficiency of the issues formed for realizing the targets determined.

VERIFICATION: The operation of confirmation based on the objective evidences showing the conditions determined are met.

VALIDATION: Confirmation of the fact that the requirements oriented for the requested objective and application are met as a result of the evaluation of the real evidences.

REAL EVIDENCE: Information or data showing that a thing is found and real.

NONCOMPLIANCE: Not obeying to the requirements

PROCESS: A series of activities which are related or interactive with each other and transforming the inputs to the outputs

 

ISO 9001:2000 Standard Articles

 

1.  CONTENT

2.  REFERRED STANDARDS

3.  TERMS AND DEFINITIONS

4.  QUALITY MANAGEMENT SYSTEM
      4.1  GENERAL CONDITIONS
      4.2  DOCUMENTATION CONDITIONS

5.  MANAGEMENT RESPONSIBILITY
      5.1  MANAGEMENT’S COMMITMENT
      5.2  CUSTOMER ORIENTATION
      5.3  QUALITY POLICY
      5.4  PLANNING
      5.5  RESPONSIBILITY, AUTHORITY AND COMMUNICATION
      5.6  REVIEWING BY THE MANAGEMENT

6.  RESOURCE MANAGEMENT
      6.1  PROVIDING OF THE RESOURCES
      6.2  HUMAN RESOURCES
      6.3  INFRASTRUCTURE
      6.4  WORKING ENVIRONMENT

7.  PRODUCT REALIZATION
      7.1  PLANNING OF THE PRODUCT REALIZATION
      7.2  PROCESSES RELATED TO THE CUSTOMER
      7.3  DESIGN AND DEVELOPMENT
      7.4  PURCHASING
      7.5  PROVIDING OF THE PRODUCTION AND SERVICE
      7.6  CONTROL OF THE MONITORING AND MEASURING DEVICES

8.  MEASUREMENT, ANALYSIS AND BETTERMENT
      8.1  GENERAL
      8.2  MONITORING AND MEASUREMENT
      8.3  CONTROL OF NON-COMPLIANT PRODUCT
      8.4  DATA ANALYSIS
      8.5  BETTERMENT

 

Benefits of ISO 9001:

1.        It provides national and international competitive advantage.

2.        It increases economy, efficiency and profitability.

3.        It strengthens communication.

4.        It strengthens the corporate image.

5.        It provides product/service reliability.

6.        It promotes customer oriented working.

7.        It increases the motivation of the workers.

8.        It increases the productivity of the processes with the process approach.

9.        It makes the continuous betterment in the processes as organizational culture with the corrective and preventive activities.

10.     It provides the prevention of the economic and other losses arising from the quality problems.

11.     It decreases the costs.

12.     It ensures the easy acceptance of the institution by the customer in the export and internal market.

13.     It provides the traceability and inspection easiness.

14.     It helps the determination of the betterment areas.

15.     It can be applied to every size of institutions and institutions in every sector.

 

 

 

 
Innovations coming with ISO 9008:

 

The expression of “work environment, environmental changes and risks arising from the environment” has been added. The expression of “legal and regulatory conditions applied for the product” has been included.

In the 0.2 third paragraph, the expression of “result requested in the product” has been added.

The expression of 0.3 “applicable legal and regulatory conditions” has been included.

The reference made to 0.4 ISO 14001:1996 has been changed as ISO 14001:2004.

In the 1.1 articles a and b, the word mentioned as regulatory has been changed as statutory and regulatory in ISO 9001:2008. However, both words can be interpreted as the legal requirements. To note 1, the expression of “the purchased or intermediate product is included” has been added to the product definition. As note 2, the expression of “the legal and regulatory conditions are defined as the legal conditions” has been included.

In 1.2 the expression of “in case one or some articles of this standard is not applied due to the structure of the product or institution , this situation will be called as exclusion” has been included.(However, the exclusion has been constrained only with the 7th article again) The word mentioned as regulatory has been changed as statutory and regulatory. However, both words can be interpreted as legal requirements.
The reference made to 2 ISO 9001:2000 has been changed as  ISO 9001:2005.
The 3 Supplier– institution – customer explanation has been removed.

In the 4.1 article a, instead of "defining", the "determining" has been used, however there will not be any changes in the application. The expression of “the controls that will be realized for the external sourced processes should be defined within the quality management system” has been changed as "the type and content of the controls that will be realized for the external sourced processes should be defined within the quality management system", however it is thought that it will not bring any changes in the application. As note 2, the expression of “The external sourced processes needed within the quality management system of the institution are determined, however the external sourced processes are realized by an institution selected from outside.” has been added. As note 3, “The factors affecting the control to be applied to be external sourced processes have been mentioned.”

In the 4.2.1 article d, the expression of "the documents that it needs" has been changed as "the documents and records that it needs". The article e has been removed. The expression of a document to note 1 can meet the requirement of one or more procedures. A procedure difficult to be documented can be defined with more than one document has been added.

To the expression of "external sourced documents" available in the 4.2.3 article f, the expression of "the external sourced documents required for the planning and application of the quality management system" has been added.

In the 4.2.4 first sentence, the change has been made, but there has not been any change in the meaning. The expression of “The records should be established for proving of the compliance of KYS to the conditions and their efficient applications.” has been included.

In 5.5.2, the expression of “a member from the management” has been changed as “a member from the organization”, therefore it has been given permission that a member from the organization can be Management Representative.

The expression of 6.2.1 “product quality” has been changed as "requirements for the product compliance", however it is thought that there will not any changes in the implementation. As note, the expression of "the requirements as the product compliance can directly or indirectly affected from the personnel taking charge in the quality management system" has been added.

The article heading of 6.2.2 “competence, consciousness and training” has been changed as “competence, training and consciousness”. The expression of "it should provide training or the precautions should be taken for meeting such needs" taking place in the article b has been changed as "it should provide the training to show the required competence when being able to be applied or it should take the other precautions to meet such needs", however it is thought that it will not bring any changes in the implementation. In the article c, the expression of “it should evaluate the efficiency of the precautions taken” has been changed as “the required competence should be provided”, it is expected that the trainings should be evaluated via the providing of the required competence.

To the 6.3 article c “the information systems” have been included.

As note to 6.4, the expression of “the working environment is related to the physical, environmental and other factors (for example, noise, temperature, humidity, light or weather condition) " has been included.

To 7.1 article c, the expression of “measurement” has been included.

In 7.2.1 article c, the expression of “related” has been changed as "applicable". In the article d, the expression of “determining” has been changed with the expression of "deemed as required". As note, the expression of “It covers the agreement conditions including after shipment activities, activities under guarantee, maintenance activities and complementary services such as recycling or disposal." has been added.

In 7.3.1 as note, the expression of “the reviewing, verification and validation of the design and development have different objectives. These can be managed and recorded separately or it can be managed collectively for the organization and product.” has been included.

In 7.3.3, the word of “providing” has been removed, the word of “allowing” has been changed with "appropriate", however it is thought that there will not be any changes in the implementation. As note, the expression of "the information for providing product and service should include details for the protection of the product." has been included.

In 7.5.1 article d, the word of “device” has been changed with the word of “equipment”.

The sentence in the 7.5.2 first paragraph has been rearranged and there is not any change in the implementation.

In the 7.5.3, the requirement of being certain of the examination and experiment situation during the product realization has been included.

In 7.5.4, the sentence related to the records has been rearranged, but there is no change in the meaning and implementation. To the note section, the "personnel data" have been included.

In 7.5.5 first sentence, the expression of "product compliance" has been changed as "the requirements should be protected for the compliance", in the second sentence, the expression of "as it has been applied" has been added, however there is not any change in the meaning and application.

In 7.6, the word of “device” has been changed as the word of "equipment". The reference to the article 7.2.1 has been removed. In the article a, the expression of "the calibrated or verified" has been changed as "calibrated and/or verified or both". In the article a, the reference to article 4.2.4 has been made. In the article c, the expression of "it should be defined in a way that will allow the determination of the calibration situation" has been changed as "it should have the definition that will determine the calibration situation", however, there is not any change in the implementation. In the note section, the references of ISO 10012-1 and ISO 10012-2 have been removed.

In 8.1 article a, the  expression of “product” has been changed as the “product requirements”.

In 8.2.1 as note, the expression of “the monitoring of the customer perception can include the source inputs such as customer satisfaction questionnaire, customer data related to the delivered product quality, user opinion questionnaire, lost work analysis, congratulation, guarantee demands, vendor reports” has been included and the opinion has been given for the measurement of the customer satisfaction.

In 8.2.2, the sentence related to the documented procedure has been changed, however there has not been any changes in the meaning and implementation. The expression of “required corrections” has been changed as "corrective activities". The reference made to  “ISO 10011-1, ISO 10011-2 and ISO 10011-3 “ in the note section has been changed as “ISO 19011”

In 8.2.4 first paragraph, the expression of "the acceptance criteria which are device should be provided for the compliance" has been moved to the end of the first paragraph and the expression of "customer" has been added to the third paragraph and also, the arrangements which are oriented for clarification and which do not change the implementation and meaning have been made.

In 8.3, the arrangements not changing the meaning have been made in the sentences. The expression of "'in case it can be realized" has been added to the expression of "the institution should deal with the noncompliant product with one or more of the following ways". In the last paragraph, the expression of "if the product which is not compliant is determined after the shipment or the starting of the usage, the institution will implement activity according to its effects or potential effects." has been made as article d.

 

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