ISO 9001 Standard / ISO 9001 Standards – ISO 9000 Standard / ISO 9000 Standards Certification & Implementation

The International Organization for Standardization, ISO, is a non-governmental agency that publishes and develops standards for the public and private sectors. From mechanical engineering and technology to agriculture, the ISO 9000 Standards establishes benchmarks and guidelines for quality products and services. ISO 9001 quality standards are a highly regarded and internationally recognized set of standards that are used in businesses, nonprofit groups and government organizations.

Since 1947, the ISO has published more than 17,500 standards. Many of these standards are specific for a product or process. In 1979, the ISO established the quality management and quality assurance committee. This committee established international quality management guidelines. The first guidelines published in 1986 were referred to as ISO 8402. These standards were updated and replaced with the ISO 9000 family of quality management systems standards. The latest round of quality standards fall under the ISO 9001:2008 title.

ISO quality standards include technical requirements, customer service levels, continual improvement requirements and documentation of key systems and processes. Quality is assured through strict process monitoring, checking for defects and routine internal and external reviews. Conformance with the rules and regulations of the ISO standards results in a company being publicly labeled as ISO 9001 certified or ISO 9001 registered.

Companies and organizations that adopt ISO quality standards increase their visibility as a quality-focused company. The public recognition as an ISO 9001 certified company could lead to increased access to contracts, especially for the government and to higher prestige in an industry. For some businesses, ISO 9001 certification is seen as a competitive advantage, while in other industries compliance is a requirement for continued operation.

The ISO claims that implementation of ISO standards increases a company’s return on investment, increases market share and profits and improves operational results. Societal benefits are improved health and safety, corporate compliance with legal requirements and reduced environmental impact.

The ISO quality standards and audits confirm compliance with the processes and business framework for a company to produce quality goods and services. Audits and reviews do not certify the actual products or services provided by a company, only the business methodology and quality systems that are designed to ensure quality. It is also a misconception that the ISO standards for quality only apply to manufacturing and physical goods. The ISO standardsare also applicable to the service industry.

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Industrialization has completely gone under a drastic change with the growling levels of development. With the advancement in technology, there is huge competition between major players. Thus, to stand up with such high competition and developments, all sectors must produce apt services and products according to the needs of the consumers.

This could be just that the quality management system intends continual development in the company beginning from the purchasing department, design, marketing, production, and various other departments in order to provide the best of services and products, which is harmless to both the consumers as well as the environment.

To maintain the quality standards, one needs to get International Organization for Standards (ISO) that symbolizes the quality management standard at international standards. For every company, which deals in facilitating any type of services and goods, it is very important to get certified from ISO 9001:2008.

ISO 9000 is a group of standards for the quality management system and is managed or administered by the certification and accreditation bodies. Few of the requirements in the ISO 9001, one of the standards from the group or family of ISO 9000 include:

A set of methods, which covers all the main and essential processes in the industry
Monitoring each and every process to make sure that it is effective
Maintaining adequate records
Checking all outputs for any kind of defects with corrective and appropriate action where required
Regularly reviewing individual procedures and quality system as well for its effectiveness
Last but not the least, facilitating continual improvement

An organization or company, which has been autonomously certified and audited to be in conformity with the ISO 9001:2008, might publicly state that it is certified with International Organization for Standards 9001:2008 or ISO 9001:2008 registered. Nevertheless, certification with ISO 9001:2008 standards does not ensure conformity and thus the quality of end services and products, to a certain extent certifies that reliable and dependable business procedures are being applied.

Besides, to get the ISO 9001:2008 certifications, one is required to accomplish various obligations of quality control. Few of the vital clauses that must be put up to avail the ISO 9001:2008 include knowledge, range, expressions, identifications, resource management, conscientiousness, analysis, product recognition and measurement. To avail the international standards for organization 9001 certificates, one can easily get them from several certificate providers.

The providers provide the certificate once they have carefully analyzed the production and various other production departments that include quality control standards. In addition, ISO 9001:2008 is offered only when the parent company is pleased and convinced with the output. Hence, for those individuals or businesses that are looking forward to seek ISO 9001:2008 certificates, they must make sure that they fulfill all the required industrial norms.

The practice of ISO 9001:2008 for successful operation and improved customer contentment shows the way to retention of the services and goods for a longer period. With the application of ISO 9001:2008, one can also experience decreased audits and improved marketing. ISO 9001:2008 assists in endorsing international deals, revenue that directs to worker enthusiasm and self-esteem inoculation of types.

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In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

Why is ISO 9001:2008 Certification Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9001:2008 to do business.

Consider the facts (source MORI/SGS-ICS) that with ISO 9001 certification:

• 83% realized improved management control
• 82% realized improved customer satisfaction
• 62% said it improved the ability to win work
• 61% stated a more motivated workforce
• 60% realized improved productivity
• 60% saw reduced waste
• 52% stated it improved marketing
• 50% had reduced costs
• 49% realized increased market share

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

ISO 9001:2008 Draft Changes

0.1 Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It’s also clarified that these requirements are restricted to those applicable to the product.

0.4 There is a comment that state that the new standard is made due consideration to ISO 14001:2004.

1.1 &1.2  Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.

After so many years of auditions the long last debate had been settled. Statutory legal requirements and statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.

2Normative reference – the ISO 9000 is now replaced by ISO 9000:2005.

3The explanations about what is a customer and what is an organization and what is a supplier had been removed.

4.1 Clause a – The word “determine” is replacing the “identify”

A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products.

4.2.1 Slight change of words but when you examine the change you realize the meaning is the same.

Note 2 was changed – a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document.

It’s about time. A lot of headaches are vowed to be save. If your audit was one of the old school and demanded everything by the book – now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the requirements.

4.2.3 A clarification that external documentation is considered while it is part of the quality management system.

5.1 Clause a – the word “statutory” had been added.

5.5.2 An addition for a requirement that the management representative would be a member of the organization’s management.

That addition puts all external consultants at risk – you can no longer be the

management representative. That sets a whole new line of form and documentations for you to develop in order that the external consultants would be considered as a management representative.

6.2.2Clause b –”provide training or take other actions to satisfy these needs” changed to “where applicable training needs to be provided to achieve the necessary competence”

Clause c – you must ensure that the training is with competence rather than if it was an effective training.

It all goes back to defining .You defined what is necessary now you must provide it nothing is new.

On one hand it is an improvement. The training must be reviewed before. But I think it’s not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before.

6.3 Clause c – information systems are included.

6.4 A new note: noise, humidity, temperatures are part of a working environment.

7.1 Clause c – measurement had been added to the activities.

7.2.1

Clause a – change of words – not of the meaning.

Clause c – the word ‘applicable’ replaces ‘related’.

Clause d – change of words – not of meaning.

A note has been added to explain what is the meaning of “post delivery activities”.

7.3.1 A note had been added clarifying that design review, verification and

validation are separated processes but they might be conducted together.

7.3.3

A change of words.

A note had been added clarifying what is included in “preservation of product”.

7.5.3 A requirement added specifying that product traceability must be included throughout the product realization.

That actually means that the product must be identified not only on the shelves after or between, but also throughout the realization process. Is pacticable? Only time will tell…

7.5.4

A change of words in the requirement to inform the customer of any problem

regarding his property.

The note had been amended that also personal data is included as customer’s

property.

7.5.5

A change of words:

from “conformity of” to “in order to maintain conformity to requirements”.

7.6

A change of words: from “devices” to “equipment”.

The reference to paragraph 7.2.1 had been removed.

Clause c – from “be identified to enable the”

to ” identification to enable their”.

Changes in the notes:

Note 1 – the reference to ISO 100012-2 had been removed.

Note 3 – explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.

That means that from now on a computers that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done.

8.2.1

A note had been added to suggest some means of conducting customer satisfaction evaluation.

8.2.2

Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken.

The reference to the ISO 10011 is changed to ISO 19011.

8.2.3

A change of words:

“to ensure conformity of the product” had been removed.

A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.

8.2.4

A change of word:

“maintain evidence of conformity with acceptance criteria” had been removed but it is still a requirement.

8.3

An addition Clause d – specify how to deal with a nonconforming product that was discovered after delivery – but actually there nothing new only that they moved it to a new clause.