Benefits Of Obtaining ISO 9000 Certification

Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.

Internal benefits to the company include:

• improved customer focus and process orientation within the company;

• improved management commitment and decision-making;

• better working conditions for employees;

• increased motivation of employees;

• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,

• continual improvement of the quality management system.

The following external benefits are generated:

• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;

• an improved image of the company;

• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;

• more confidence that the company’s products meet relevant regulatory

requirements;

• better objective evidence to defend product liability charges if such are brought by customers.

Refer http://www.iso9001-standard.us for more information.

Implementing A Quality Management System

An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:

1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.

At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).

2. Obtain information about the ISO 9000 family

The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.

Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;

3. Appoint a consultant, if necessary

If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.

Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.

4. Awareness and training

Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.

The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.

5. Gap analysis

Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.

6. Product realization processes

Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.

The processes covered by this clause include:

• Customer-related processes

• Design and development

• Purchasing

• Production and service provision

• Control of measuring and monitoring devices

Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.

7. Staffing

Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.

8. Planning a time frame

Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and

7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.

9. Draft a Quality Manual

In your Quality Manual;

• Include how the QMS applies to the products, processes, locations and departments of the organization;

• Exclude any requirement with justification for doing so as decided in step 6

above;

• Refer to or include documented procedures for QMS;

• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and

• Draft the quality policy and quality objectives for the organization.

The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.

The effective date of implementation should also be decided.

10. Carry out internal audits

During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.

11. Apply for certification

On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.

12. Conduct periodic evaluations

After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.

ISO 9001 Standards Requirements – Design and Development

Design and Development Planning
Plan and control the product design and development. This planning must determine the:
Stages of design and development
Appropriate review, verification, and validation activities for each stage
Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.

Design and Development Inputs
Determine product requirement inputs and maintain records. The inputs must include:
Functional and performance requirements
Applicable statutory and regulatory requirements
Applicable information derived from similar designs
Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.

Design and Development Outputs
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
Meet design and development input requirements
Provide information for purchasing, production, and service
Contain or reference product acceptance criteria
Define essential characteristics for safe and proper use
Be approved before their release

Design and Development Review
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
Evaluate the ability of the results to meet requirements
Identify problems and propose any necessary actions
The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

Design and Development Verification
Perform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.

Design and Development Validation
Perform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.

Control of Design and Development Changes
Identify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.

Organizations preparing to implement a QMS For ISO 9001

For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.
For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:
- Identifying the processes necessary for the effective implementation of the quality management system
- understanding the interactions between these processes.
- documenting the processes to the extent necessary to assure their effective operation and control. (It may be
appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)
These processes include the management, resource, product realization and measurement processes that are relevant
to the effective operation of the QMS.
Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes.

Outsourced Processes In ISO 9001 Standards

One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.
An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.
The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.
The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:
• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).
• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

ISO  9001 2008  was created with a view to specifying the requirements for a quality management system especially where an organization or firm needs to demonstrate its capacity to provide customers with durable products and appropriate regulatory and statutory requirements. ISO  9001 2008  and ISO  9001 2008  draft also helps enhance customer satisfaction by ensuring effective application of a system including various processes that promote continual development and assurance of product conformity for the customer. All requirements of ISO  9001 2008  are usually generic in nature and are intended to be applied in various organizations regardless of the type of product that they produce. The formal international standards and technical reports that govern ISO  9001 2008  are contained in ISO 9000 standards. The same applies to various web based documents and technical specifications that regulate ISO  9001 2008  (FAQ).

Information on quality assurance of ISO  9001 2008  can be found at the Quality Information Center. In order to improve the quality of a business process output through identifying and removing defects and to enhance ISO  9001 2008 , the six sigma was created for organizations and businesses. The business management strategy that seeks to promote ISO  9001 2008  uses various sets of quality management methods that are all aimed at creating unique infrastructure within organizations known as black belts. This in turn helps enhance quality control and quality management especially for ISO 9001 and ISO  9001 2008 . One way through which an organization can enhance ISO  9001 2008  is by adopting methods such as process control. A process control is a discipline that deals with mechanisms, architectures and algorithms for regulating the output of a particular process. It helps the ISO 9001 standards to be upheld.

ISO 9000 helps ensure quality improvement. Organizations that have ISO certification, which meet ISO 9001 standards such as ISO 9001, ISO  9001 2008  and ISO 14000 have the ability of ensuring that services and products that they produce achieve standards of quality that are widely recognized in all parts of the world. Other regulations and requirements that govern ISO  9001 2008  are set out in 14001 ISO. ISO 14001 is basically an internationally recognized standards especially for environmental management systems that are to be implemented in an organization or business. The International Standards Organization released the standards in order to cater for ISO  9001 2008 . It also helps organizations to promote ISO  9001 2008  requirements and to minimize the negative effects of their ISO  9001… operations.

Various training institutes offer ISO training particularly for ISO  9001 2008  standards. This also helps promote ISO quality and ISO audit systems. ISO 17799 and ISO 17025 are intended to be the launch pad for individuals and organizations that are seeking help with international standards including ISO  9001 2008 . ISO 9001 is particularly helpful for promoting 9001 quality that meets ISO 9000 standards. One program that helps in the successful carrying out of an audit 9001 ISO system can be found in an ISO manual. Most organizations are now carrying out a transition to standard 9001 management standards. ISO 9002 is a Quality Managed Standard that is published by the International Organization for Standardization to uphold ISO  9001 2008  standards. In order to uphold ISO control especially for ISO  9001 2008 , various organizations undergo certification 9001 and ISO 9001 training.

Growing scrutiny toward industry’s effects on the environment has made conformance with ISO 14001:2004 – a voluntary, internationally recognized Environmental Management Systems (EMS) standard – more important than ever. As more companies pursue ISO 14001 certification to demonstrate environmental commitment to their customers, shareholders and government agencies, many are discovering the benefits of partnering with Intertek. As one of the first accredited certification bodies, Intertek offers expertise, experience and know-how that no one else can deliver.

Your certified EMS can help you reap the benefits of: Improved overall performance Your ISO 14001 certified EMS can help make your business more efficient and productive. Lower energy and raw materials use, reductions in waste and pollution, and mitigated risks of accidents and emergency situations translate into greater profitability and productivity. Expanded market access Your company’s environmental credibility and commitment to quality are established from day one.

It will take less time to demonstrate the effectiveness of your EMS and earn your prospective customers’ trust and confidence, and you’ll enjoy access to markets you might not otherwise penetrate. Improved corporate image Your certification demonstrates your company’s commitment to environmental responsibility, fostering improved relationships with the community, shareholders, and governmental and environmental organizations.

Enhanced competitiveness While helping you to operate more efficiently and profitably, your ISO 14001 certified EMS can instill additional confidence in shareholders, investors, insurers and your customers – making your business the clear choice in a highly competitive market. Plus, you can maximize your human and financial resources by using your existing Quality Management System (QMS) as a basis for your EMS, taking advantage of the synergies between ISO 9001 and ISO 14001.

Who was involved in determining aspects?

Were air emissions, posshible ground and surface water contamintation, landfill issues, use of natural resources, raw materials and energy considered as well as community issues such as noise, traffic and odor?

Are current, planned and modified activities considered? Look for potential aspects that have not been taken into consideration and ask why they were not considered. How are significant environmental aspects determined?

Does the decision making process take into consideration the amount of control and influence the organization has over its aspects? Look for procedures.

How/when are aspects reviewed and maintained; changes to processes, changes to regulations, introduction of new raw materials?

Does the documentation reflect this change?

Legal and other requirements – Has the organization established, implemented and do they maintain a procedure(s) to identify and have access to the applicable legal requirements and other requirements to which the organization subscribes, related to its environmental aspects and determined how these requirements apply to its environmental aspects?

What is the procedure regarding this requirement? How does the organization know what regulations and requirements they may be subject to? Do they subscribe to industry newsletters or websites? Do they have a third party environmental service monitor regulations for them and alert them as to any changes?

Is there a list of applicable rules and regulations?

Who is responsible for keeping this information updated and current?

Does the list include any voluntary standards?

How does the organization ensure it is complying with these regulations?

Speak with people in the organization to determine if they are aware of any regulations.

Did the organization consider national, international, state and local rules and regulations?

Does the organization have any agreements with public authorities, or with customers?

Do they subscribe to any voluntary guidelines or industry practices such as Responsible Care?

What process does the organization have for reviewing requirements to make sure they are current in the face of changing processes and business requirements?

Do regulations include such things as Federal Title V or Synthetic Minor, State Emissions Inventory and Permit Fee Program, Regulated Toxic Air Pollutants ENV-A 1400, SARA Title III Toxic chemical releases, SARA Title II Tier II report, Federal EPA clean water act, National Pollution Discharge Elimination systems (NPDES) and Storm water program permit?.

Check the organization’s objective and targets to determine if requirements are included. Was the selection of significant aspects based partially on applicable legal requirements and other requirements?

Objectives, targets and programs – Are the objectives and targets measurable, where practical, and consistent with the environmental policy, including the co mmitments to prevention of pollution, to compliance with applicable legal requirements and with other requirements to which the organization subscribes, and to continual improvement?

How does the organization develop objectives and targets? Who is responsible for developing them? What types of things were taken into consideration during development? Were reducing the creation of waste, reducing the release of specific elements to the air, reducing ground water contamination, reducing use of raw materials by reducing rework and scrap, taken into consideration? Was promoting awareness within

the organization and the surrounding community considered?

Do the objectives and targets reflect the vision of the EMS policy? Are they consistent with the policy?

Do they include commitments to the prevention of pollution and compliance with applicable rules, requirements and

regulations?

Have measurable targets been defined? If not, why not?

Are targets both short and long term?

What factors does the organization consider in setting objectives and targets? How are significant impacts considered? Are legal and other requirements, available technology, financial, operational and business requirements considered? Were interested parties involved in the development of objectives? If so, how?

How were objectives developed? Who participated in their development?

Has the organization established, implemented and does it maintain a program(s) for achieving its objectives and targets, including designation of responsibility for achieving objectives and targets at each relevant function and level of the organization and the means and time-frame by which they are to be achieved?

What plans have been developed to achieve objectives and targets? Do plans include responsibility for achieving the objectives and targets? Do plans reflect objectives and targets at lower levels of the organization? Does the plan include its own targets and timelines for reaching them?

Look at plans. Is there one for every objective and target? What happens when something doesn’t go

according to plan? Is corrective action taken?

How is management kept informed of the progress towards the targets?

How are employees informed of the progress towards the targets?

Look for graphs, information in newsletters, meeting minutes, and posters.

How does the organization plan to achieve objectives and targets?

Have responsibilities been defined?

Have time lines been defined?

How is progress monitored? Is it measurable?

Migration To ISO 9001:2008
The International Accreditation Forum (IAF) and the International Organization for
Standardization (ISO) have agreed on an implementation plan to ensure a smooth transition of
accredited certification to ISO 9001:2008, the latest version of the world’s most widely used
standard for quality management systems (QMS). The details of the plan are given in the joint
communiqué by the two organizations which appears below.
Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that it
is maintained at the state of the art and a decision taken to confirm, withdraw or revise the
document.
ISO 9001:2008, which is due to be published before the end of the year, will replace the year
2000 version of the standard which is implemented by both business and public sector
organizations in 170 countries. Although certification is not a requirement of the standard, the
QMS of about one million organizations have been audited and certified by independent
certification bodies (also known in some countries as registration bodies) to ISO 9001:2000.
ISO 9001 certification is frequently used in both private and public sectors to increase
confidence in the products and services provided by certified organizations, between partners
in business-to-business relations, in the selection of suppliers in supply chains and in the right
to tender for procurement contracts.
ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing and
certification. These services are performed independently of ISO by certification bodies. ISO
does not control such bodies, but does develop voluntary International Standards to
encourage good practice in their activities on a worldwide basis. For example, ISO/IEC
17021:2006 specifies the requirements for bodies providing auditing and certification of
management systems.
Certification bodies that wish to provide further confidence in their services may apply to be
“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC
17011:2004 specifies the requirements for carrying out such accreditation. IAF is an
international association whose membership includes the national accreditation bodies of 49
economies.
ISO technical committee ISO/TC 176, Quality management and quality assurance, which is
responsible for the ISO 9000 family of standards, is preparing a number of support documents
explaining what the differences are between ISO 9001:2008 and the year 2000 version, why
and what they mean for users. Once approved, these documents will be posted on the ISO
Web site – probably in October 2008.

ISO (International Organization for Standardization) and the IAF (International Accreditation
Forum) have agreed an implementation plan to ensure a smooth migration of accredited
certification to ISO 9001:2008, after consultation with international groupings representing
quality system or auditor certification bodies, and industry users of ISO 9001 certification
services.
ISO 9001:2008 does not contain any new requirements
They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008
only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight
years of experience of implementing the standard world wide with about one million
certificates issued in 170 countries to date. It also introduces changes intended to improve
consistency with ISO14001:2004
The agreed implementation plan in relation to accredited certification is therefore the
following:
Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO
9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued
after official publication of ISO 9001:2008 (which should take place before the end of 2008)
and after a routine surveillance or recertification audit against ISO 9001:2008.
Validity of certifications to ISO 9001:2000
One year after publication of ISO 9001:2008 all accredited certifications issued (new
certifications or recertifications) shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued
to ISO 9001:2000 shall not be valid.