ISO 9001:2008 Standards Check List

1. ISO 9001 General Requirements Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of ISO 9001?
 2. General Documentation Requirements Does the quality management system documentation include documented procedures and records required ensuring effective operation and control of its processes?
 3. Quality Manual Has a quality manual been established and maintained that includes:
 4. Control of Documents Are documents required for the quality management system controlled?
 5. Control of Records Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?
 6. Management Commitment How has top management demonstrated commitment to the development and improvement of the quality management system?
 7. Quality Policy Organization has top management ensured that the quality policy:
 8. System Planning 1. Quality Objectives a. What are the quality objectives that have been established at relevant functions and levels within the organization?
 9. Responsibility, authority and Communication Responsibility, authority and Communication Audit Checklist 1. Responsibility and authority
 10. Resource Management Resource Management Audit Checklist 1. Provision of resources
 11. Planning of Product/Service Realization Planning of Product/Service Realization Audit Checklist Is planning of the realization processes consistent with the other requirements of the organization’s quality management system?
 12. Management Review Management Review Audit Checklist 1. General checklist a) Does the top management review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? 13. Product review Determination of Requirements Related to the Product (7.2.1)
 14. Design and Development Planning and Design and Development Inputs What is the design and development planning methodology described in the design procedure?
 15. Design and Development Outputs Audit Are the outputs of the design and/or development process documented in a manner that enables verification against the design and/or development inputs?
 16. Design and Development Review Audit Are systematic reviews of design and/or development conducted at suitable stages?
 17. Design and/or Development Verification Is design and/or development verification performed to ensure the output meets the design and/or development inputs?
 18. Design and/or Development Validation Is design and/or development validation performed to confirm that resulting product is capable of meeting the requirements for the intended use?
 19. Control of Design and Development Changes Are design and/or development changes identified, documented, and controlled?
 20. Purchasing Process Does the organization control its purchasing processes to ensure purchased product conforms to requirements?
 21. Purchasing Information Do purchasing documents contain information describing the product to be purchased?
 22. Verification of Purchased Product Have the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented?
 23. Control of Production and Service Are the production and service provision planned and carried out under controlled conditions including:
 24. Validation of Processes for Production and Service Provision Have processes where deficiencies may become apparent only after the product is in use or the service has been delivered been validated checklist.
Read more on ISO 9001:2008 Standard at http://www.iso9001store.com

Training In ISO 9001 Standards

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 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.

The ISO 9001 Standards Training DVD can be obtained at http://www.iso9001store.com

Why is ISO 9001:2008 Certification Important?

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

Improve your performance management with new version of ISO 9001

A quality management system enables you to manage your business processes effectively:

it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.

The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.

There are three main objectives to the new standard:

Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)

Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)

There are no new requirements in the new standard:

The title, scope, and structure of the standard are unchanged

The process approach is confirmed

Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon

Preservation of the quality management principles included in ISO 9000:2000

There are five main areas to note. The relevant sections of the standard are noted in brackets.

1. A reinforcement of the notion of product conformity

2. Compatibility with other standards is evolving

3. A better understanding of outsourced processes

4. An editorial clarification of some requirements – for instance;

A reinforcement of the notion of product conformity2.3.4.

An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving

• (6.4) work environment, including an explanatory note on work environment giving examples,

to help meet product conformity requirements

• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond

satisfaction surveys to include other channels such as customer feedback5.

• (Introduction) the notion of risk

• (5.5.2) appointment of a management représentative

• (6.2.2) assessing the effectiveness of achieving compétence

• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?

Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total more
than 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.

They also serve in a number of countries as the technical basis for environmental regulations.

ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.

This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.

This national consensus is derived from a process of consultation with interested parties.

From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.