Monday, November 22, 2010

ISO 9001 auditor

Who is ISO 9001 Auditor?

Internal Audit is a mandatory requirement according to ISO 9001 Standards.

An ISO 9001 Auditor must participate in a training course about internal audit and must be certified with auditor certificate by authorized training organization.

There are two kinds of auditor:

1. Normal Auditor; and

2. Lead Auditor
Basic Content of a training course on ISO 9001 Internal Audit


A training course about ISO 9001 will help participants understand the basic principles and necessary practical skills to perform an internal audit and make an effective report on the implementation and maintenance of quality management system in an organization.

1. General Introduction to Quality and quality management;

2. Introduction to 8 principles in quality management;

3. Introduction to and explanation of ISO 9001:2008 Standards;

Continue reading at: ISO 9001 auditor

Sunday, November 21, 2010

ISO 9001 audit report

ISO 9001 Audit Report

Audit Report isn’t necessary to be long but must be general and objective on the current condition of the audited organization. The report must address good practices that should be recognized, visible risks and identified problems.

An audit report should involve the following contents:

1. The Date of the Audit

When was the Audit performed? This is a proof that the audit has been performed according to a planned schedule. If the managers want to know about the use of personnel for the audit or timeline of the audit, it is good to mention them in the Audit. All of these will help answer the question “How much time and money have been spent on internal audit activity?”

2. Audited areas

This is very important, especially when the organization has got many operation offices.

3. Applied Standards

When performing an audit on a third party, audit standards to be applied should be those on quality management system such as ISO 9001, ISO 14001, etc. In internal audit, auditing standards are often a list of documents relating to the audited activities such as procedure, guidance, or forms, etc.

Continue reading at: ISO 9001 audit report

Saturday, November 20, 2010

ISO 9001 2008 requirements

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

Continue reading at: ISO 9001 2008 requirements

Friday, November 19, 2010

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;


Continue reading at: ISO 9001 quality manual

Thursday, November 18, 2010

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.

Continue reading at: ISO 9001 implementation

Wednesday, November 17, 2010

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

Tuesday, November 16, 2010

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

Continue reading at: ISO 9001 certification bodies

Monday, November 15, 2010

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

Continue reading at: ISO 9001 auditor

Sunday, November 14, 2010

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


Continue reading at: ISO 9001 audit report

Saturday, November 13, 2010

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

Monday, October 25, 2010

ISO 9001 in Education and Training

While usually associated with manufacturing and service activities, ISO 9001 should be considered equally as effective as a management system for education and training programs. If we consider the desired outcome (learning), education and training is just another form of service; the product is the knowledge, skill and/or ability that is achieved by the program attendees. As with other services, the delivery of education and training incorporates the processes of design, development, verification, validation, delivery, subsequent correction and ongoing improvement. Therefore, when we try to apply the requirements of ISO 9001 to education and training activities, we find that it aligns exceptionally well with generally accepted practices.

A fundamental objective of any quality management system is to ensure that customer needs are met. In order to define these needs as they relate to education and training, we must first define the primary customer of this service - the program attendee. I've used the term "primary customer" in this discussion, as numerous ancillary customers may also be involved, including the parents of the attendee, the state which provides funding to the institution, and possibly even the country in which the activity is performed (as skill development contributes to the national economy). In the case of corporate training, we must also consider the needs of the individual's employer, the industry they serve, as well as regulatory bodies or other interested parties. The list of potential customers can be as varied as the number of offerings that are available; identification of both primary and ancillary customers is a critical part of the initial needs assessment process, and is essential to the overall success of any education or training effort.

Once the above customers have been defined, their needs must be translated into terms that can be understood by the organization, and that can be further developed to serve as a measurement of an individual's competency. Typically, these needs are reflected through the establishment of learning outcome statements, commonly referred to as learning objectives. Upon completion of specific portion of a program (or upon the completion of the program as a whole), the participant should be able to demonstrate a defined level of mastery of the course content, or be able to demonstrate the ability to perform a specific task or activity. To determine if these needs are satisfied, the participants performance throughout this entire process is monitored, and at defined intervals, the individual's ability to meet a defined learning objective is measured against an established set of criteria (be it quizzes, examinations, demonstrations or other evaluation methods). Once the criteria established for competency is met, the objective is considered to be achieved. This process then continues until all established objectives have been met for the program, at which point a certificate or other form of recognition is awarded.

When considering what would be required to properly design, develop and document such a system to meet the requirements of ISO 9001, we find that there is very little difference between the approach needed to develop a system for this application, in comparison to approaches commonly used to develop systems which address manufacturing activities and other services. Proper design should begin with a review of the key processes used by the institution or organization, their ability to meet the customer needs established above and their overall degree of compliance with the requirements of the ISO 9001 standard.

System documentation required by the ISO 9001 standard, including a quality manual, and the six "system" procedures required by the ISO 9001 standard - the control of documents, the control of records, internal audits, the control of nonconformances, corrective action and preventative action all have a place in this system (as do the 19 types of records addressed in the ISO 9001 standard); they are just as relevant in this application as they are with their counterparts in other industries. Additional documentation, addressing the various activities performed by the organization will also be needed, as necessary to address the critical nature of the activities performed, as well as to ensure the customer needs defined above are met.

While the ISO 9001 standard does allow for an organization to take exclusion to the requirements found in Clause 7, there are relatively few instances where such exclusion would be justified. Typical education and training activities encompass Design and Development (instructional design), Purchasing (materials and services) Validation of Processes (pilot programs and peer reviews), Customer property (information) and even the Control of Measurement and Monitoring Devices (quizzes and examinations). While the specific processes used may vary between different organizations and offerings, almost every clause of ISO 9001 could conceivably apply.


Source: http://ezinearticles.com/

Saturday, October 23, 2010

ISO 9001 Training

Implementing ISO 9001 in any organization first requires the development of the necessary knowledge, skills and understanding to enable the practical application of the standard. At this stage organizations often seek the help of a consultant but this is often unnecessary since the required understanding can easily be sought for free.

The ISO 9001 training section provided by ISO 9001 Checklist is intended to give any business a knowledgeable foundation that ensures their quality management system is highly robust. It could save you 0000's in consultancy fees.

The Concept behind ISO 9001 Training

ISO 9001 training is a unique internet browser based tutorial solution that provides expert practical guidance for businesses wishing to interpret ISO 9000 fundamentals to help better understand and implement the requirements of ISO 9001:2008. It could help your business to get the most out of your quality management system, and it's free to use!

The ISO 9001 training section represents a body of knowledge which explains the requirements of the standard in plain English coupled with practical guidance and interpretation. The online ISO 9001 training section divides the standard into four sections that follow the Plan, Do, Check and Act cycle. The page menu then subdivides each section into Principles, Base Clauses and Requirements for easy comparison. Each stage of the cycle then relates each clause of ISO 9001:2008 to the key concepts that lie at the heart of quality management.

How does it Work?

Simple, it encourages the use of the PDCA cycle as a means to implement your quality management system by prompting the user to:

PLAN your quality system's high level processes, define your quality policy and establish your quality objectives in accordance with the expected output. Consider; how will the quality management system be documented, what resources will be needed, who will have responsibility for what and how will the effectiveness of the system be evaluated and communicated.

DO carry out day-to-day activities by performing the necessary processes in accordance with any planned arrangements. Gather performance information by undertaking audits and other measurements as planned.

CHECK the results and analyse the information gathered through various measurements and monitoring activities to determine whether the quality management system has achieved what it set out to do.

ACT by using the results from internal audits, preventive actions and management reviews to ensure the continual improvement of your quality management system; continual improvement should be the organization's permanent objective.

What Happens after Implementation?

You need to choose a registrar. The registrar is a third party certification auditor who will assess your quality management system and issue a certificate if it meets the requirements of ISO 9001:2008. In choosing a registrar you should consider their industry experience, geographic coverage, price and service level offered. The key is to find a registrar who can meet your requirements. For further information regarding national accredited certification bodies, please visit UKAS.

Pre-assessment by your registrar normally takes place about 6 weeks before registration. The purpose of the pre-assessment audit is to identify areas where you may not be operating in accordance with the standard. This allows you to correct any deficiencies before registration.

Prior to registration, you should arrange an initial assessment with your registrar. At this point the registrar will review your quality management system (by interviewing staff, observing activities and checking records) to decide whether you should be recommended for registration.

Summary

Once you have achieved certification, you can begin to communicate your success and promote your business. To maintain registration, you need must be able to demonstrate that your quality management system continually improves.


Source: http://ezinearticles.com/

Tuesday, October 19, 2010

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