ISO 9001:2008 changes

Some new points in ISO 9001:2008

On 14th January 2008, International Standard Organization officially published ISO 9001:2008 standards, which is the latest version of Quality Management System applied in 175 countries all over the World.

ISO 9001:2008 remains the same in structure with little change in accordance with ISO 9001:2000. It includes the following sections:
Standard structure

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

However, in content, there are some new points as below:

1. Identify in the quality system approach and method of controlling external processes;

2. Clearer details on the control of external processes;

3. Change in document structure in quality management; the importance of files increases in equal to procedures;

4. Emphasis on analysis and improvement of processes;

5. Clearer representation of procedures; one procedure may involve many processes or many procedures represent a process;


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ISO 9001 questions

Auditors may use the following method to ask questions in an ISO 9001 internal audit. Following are some tips that need consideration:

1. Remember that the audited individuals are not recruited to answer the auditor’s questions

They are paid to do their jobs. Therefore, they are not likely to tell you exactly what you expect to hear, but instead, they will describe their own working processes in their understanding and experience which shows that they are qualified for the jobs.

2. Ask open-ended questions instead of close-ended questions

Let the audited employees explain their own performance. One will be more likely to give the most sufficient response if he or she is not subjectively suggested of the answer by the auditors.

3. Ask the audited employees how their jobs are performed

An auditor will not only want to know which tasks were done but also how correctly they were done in conformity with procedures. A non-conformance report will help the auditor know the wrong actions, but the audit may also be good to help identify which the root cause to wrong actions is.

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ISO 9001 quality policy

ABC Corporation strives to become the leading company in XYZ market in the areas of manufacturing engineering and construction services in the following commitments:

• ABC Company is ready to meet satisfactorily all the requirements of the customer contract has been signed as well as statutory requirements and regulatory.

• Applying scientific advances and new technologies in production and installation to:
– Ensure quality of mechanical products and construction services.
– Optimization of costs to achieve a competitive price.
Transactions and convenient delivery.


Continue reading at: ISO 9001 history

ISO 9001 quality manual

An ISO 9001 quality manual must follow structure of ISO 9001 standard. So that you can ref more information for ISO 9001 quality manual at table of contents as follows:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus

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ISO 9001 implementation

Steps to apply ISO 9001:2000

a professional support organization with the knowledge, skills and business experience will help a lot in advance to shorten the time of certification, to help businesses track and avoid the negative effects due process operation of the waste and inefficiency

ISO 9001:2000 applies to an organization will be conducted in 9 steps:

Step 1:
Learn the criteria and determine the scope of application. Leaders need to understand the meaning of ISO 9000 in organizational development and orientation activities, identify goals and specific conditions apply

Step 2:
Project steering ISO 9000. The application of ISO 9000 is a big project, so it needs a steering committee of ISO 9000 in the enterprise, including leaders and representatives of the departments represented in the scope of ISO 9000. The representative should be appointed leader instead of quality leadership in directing the application of ISO 9000 management system and responsible leadership on quality activities.

Step 3:
Assessment of business situation compared with the standard requirements. Should review the activity-oriented process, to consider any applicable requirements and meet the current level of activity in the enterprise. This assessment as the basis for determining the activities to change or supplement so that the implementation plan details

Step 4:
System design and establish the quality system documents. The documentation must be built and completed to meet the requirements of standards and operating requirements of the business including:
- Quality Manual
- The processes and procedures related
- The work instructions, rules and regulations necessary

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ISO 9001 history

ISO 9001 History
Overview

ISO 9001 Quality Management System, as know as ISO 9001, is one of ISO 9000 standards. This system sets up requirements for organizations those design, develop, manufacture, assemble or supply any kind of product or service and want to apply that system to improve their product and service quality.
ISO 9000

ISO 9000 Standards include many standards, in which the main standard is ISO 9001: Quality Management System which sets up requirements that organizations have to meet with their quality system. Besides, there are additional and guide standards which are:

1. ISO 9000: Terms and Definitions

2. ISO 9004: Guidelines for Performance of Management System Assessment

3. ISO 19011: Guidelines on principles of auditing a management system
ISO 9001 Versions

4. ISO 9001:1987 – Quality Systems
Quality management – quality management models in design/implementation, manufacturing, installment and technical service


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ISO 9001 certification bodies

ISO 9001:2008 requirements are available at ISO 9001 standard such as:

1. ISO 9001 GENERAL

1.1. Index and revision status
1.2. Purpose and scope
1.3. Exclusions

2. COMPANY BACKGROUND

2.1. Company background and history
2.2. Activities

3. DEFINITIONS AND CONVENTIONS

3.1. Definitions and conventions
3.2. Abbreviations

4. QUALITY MANAGEMENT SYSTEM

4.1. General requirements
4.2. Documentation and records

5. MANAGEMENT RESPONSIBILITY

5.1. Management commitment
5.2. Customer focus
5.3. Quality policy
5.4. Quality system planning
5.5. Organization and communication
5.6. Management review


Continue reading at: ISO 9001 2008 requirements