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

Step by step

The solution devised by registrar auditing teams was to adopt a practice known as process auditing. For those who don’t know, process auditing is a standardized approach to reviewing  an activity by dividing it into basic components of:

1. Inputs

2. Process steps

3. Outputs

Every activity in an ISO-certified company can be analyzed using this methodology. In order to  better evaluate how well the company had implemented its QMS, registrars also added  standard questions to the audit, asking for knowledge and demonstrations of  process/performance improvement goals for each area of the company. With this approach,  companies became more aware that process improvement wasn’t simply a shop-operations practice; it was everyone’s responsibility. So for the first time, a company’s support activities such as sales, purchasing, engineering and personnel were required to show how they were  working to improve customer satisfaction as well.

ISO 9001:2008 was approved for implementation at the beginning of 2009. For the casual reader, the changes might seem hard to discern. And for the most part, the changes are  only intended to clarify and improve language. However, there is an important change in the wording of the introduction that encourages organizations to consider and use the process approach as a way to improve customer satisfaction and increase value.

From a practical standpoint, what this means is that companies currently using the process approach to auditing should talk to their registrar before making any changes to their QMS. One additional activity that needs to be carried out now that the new standards have been issued is to review all documentation for correct terminology. Failure to upgrade the term ISO 9001:2000 to ISO 9001:2008 might seem like a small thing. But it can become a sticking point if registrars spot it too often.

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ISO 9001 is a quality management system (QMS) created and maintained by the International Organization for Standardization (ISO), the largest developer of international standards in the world. QMS systems are meant to provide organizations with a formal framework for process improvements and quality standards. The system provides a set of procedures that covers all key processes to ensure they are effective. It also provides a methodology for record-keeping, checking for defects and continuous improvement and maintenance of these functions.

- Provide resources needed to support process operations, monitoring and the management review process.

- Transform and maintain physical workspaces, equipment, hardware, software, utilities and support services needed to meet requirements.

- Develop a system to review transportation (if any), communication and information services for sharing data relating to ISO 9001 standards.

- Provide adequate training for management reviewers (MRs) and internal auditors. They should have the right experience, education and skills needed to ensure that competence requirements are being met.

- Keep a record of the review process. This includes corrective and preventive action procedures.

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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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ISO 14000 is primarily concerned with Environmental Management. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

Improving the environmental performance of corporations is one way of limiting environmental damage. Environmental management systems (EMS’s), such as ISO 14001, provide a framework for organizations that wish to effectively manage their environmental affairs. Implementing an EMS that conforms to the ISO 14001 standard may help businesses integrate environmental values into their operations.

An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.

The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by the members of the ISO, while others are in different stages of preparation.

ISO 14000 is a group of standards covering the following areas:
•Environmental Management Systems (14001,14002, 14004)
•Environmental Auditing (14010, 14011, 14012)
•Evaluation of Environmental Performance (14031)
•Environmental Labeling (14020, 14021, 14022, 14023, 14024, 14025)
•Life-Cycle Assessment (14040, 14041,14042, 14043)

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ISO 9001 is a quality management system (QMS) created and maintained by the International Organization for Standardization (ISO), the largest developer of international standards in the world. QMS systems are meant to provide organizations with a formal framework for process improvements and quality standards. The system provides a set of procedures that covers all key processes to ensure they are effective. It also provides a methodology for record-keeping, checking for defects and continuous improvement and maintenance of these functions.

- Provide resources needed to support process operations, monitoring and the management review process.

- Transform and maintain physical workspaces, equipment, hardware, software, utilities and support services needed to meet requirements.

- Develop a system to review transportation (if any), communication and information services for sharing data relating to ISO 9001 standards.

- Provide adequate training for management reviewers (MRs) and internal auditors. They should have the right experience, education and skills needed to ensure that competence requirements are being met.

- Keep a record of the review process. This includes corrective and preventive action procedures.

Kindly go to http://www.e-wia.com for more information.

Companies dream of achieving success and recognition in their respective fields. That is why a lot of companies aim for certification of their management systems. Certification often gives companies an edge in their field, and the needed push for consumers to select their product or service.  While this article covers the basics of getting ISO 9000 certification, you can learn much more about how to get this certification and how it benefits your business by taking relevantcourses in business management.  If you don’t have time to attend a traditional school, consider online universities - they’re convenient and cost-effective!

ISO 9000 is a certification body that assesses a company’s quality management system against set standards. If a certain company passes their criteria, ISO grantsthem a certification that they have passed internationally recognized ISO standards. ISO 9000 is divided into 3 levels: ISO 9001, ISO 9002, and ISO 9003.

How do you go about acquiring this type of certification? Here are some steps to guide you in organizing an ISO 9000 certification.

Study the quality of your management systems. Preparation for an ISO certification with an evaluation of your own company’s management systems, procedures and standards. It is important to tap people from within the company to first make a realistic evaluation of the quality of management, procedures, and service that your business is offering.

Compare these with the ISO standards. Once you have completed your own evaluation, the next step is comparing it to the standards set by ISO 9000, according to the level you may want to apply for. It is crucial that your company takes important notice of the different things that need to be addressed in their system, may it be management procedures, regulations, or company practices.

Make the necessary adjustments. Upon recognizing the needed adjustments, then take the necessary actions to align your management systems and procedures to agree with the standards set by the ISO. Have these steps implemented and practiced, so that the changes can be adapted to gradually.

Have your quality management system evaluated. Once the needed changes have been realized, then it is time to request an outside audit by the registrar of the ISO certification body. An audit of your management systems will begin, and once approved, then you are certified to have met ISO’s requirements. ISO will then give you the certification, once they have approved the quality of your management system.

It’s also important to note that a company may opt not to get certification from ISO, but still use this standard to their advantage. Instead of requesting a certification from ISO, the company or business may form an ISO compliant management system and simply market your company as compliant with the ISO 9000 standard of choice.

High quality standards and procedures are key for any business or company. They promote a culture of excellence and hard work. And in return, this practice can improve company performance and sales. ISO accreditation will affirm the quality for which you want your company to be known.  You can also keep company standards high by regularly taking continuing education courses in business.

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Accreditation and certification is important for businesses these days and proving a competency can be important to gaining future contracts or orders. Some firms will only work with suppliers that are able to indicate they have a level of competency in certain areas and the best way to show this is through recognized training and accreditation. One such training program is the ISO 9001training program, which sets out to ensure quality management is taking place.

As well as the training course, the ISO 9001 training programcan provide great assistance in continually implementing the methods and lessons developed through the course. Every firm should be able to provide a policy manual with regards to the audit process and the management system. In addition to this, a procedures manual should be created in order to inform every employee of what they should be doing in the workplace.

If further instructions are needed, it may be of benefit to gain additional assistance in creating working instructions for the ISO 9001 training program. One of the most importantaspects of implementing ISO 9001 training is to ensure that a proper management structure is in place that can hopefully improve over time. There is no doubt that the business world is a very fluid place and changes occur all the time. Having a correct structure in place makes it easier to deal with changes, hopefully improving the long-term implementation and management of any system.

A major issue for any firm, especially in the current economic climate, relates to waste management and ISO 9001 training can help a firm with regards to this. Reducing waste will lower expenditure and is something that all companies should make consideration towards in their management systems.  Improving the waste management system is likely to lead to an increase in gross revenue, which again is something that every firm should be aiming for.

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Whether an organization is implementing ISO 9001:2008 or just improving their quality management system, they will undoubtedly need to review and analyse their current systems and processes in order to identify gaps in compliance. Gap analysis requires that organizations review their existing processes, procedures and documentation, etc. The framework for this review technique is often provided in the format of an ISO 9001 audit checklist which many organizations and auditors consider to be an indispensable tool that actively supports the audit process.

The Advantages of the ISO 9001 Audit Checklist

Regular internal audits are carried out to ensure compliance is maintained and the ISO 9001 audit checklist comes in handy for this purpose. This is just one of many tools that are available from the auditors’ toolbox that help ensure the audit addresses the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:

- Ensures the audit is conducted systematically
- Promotes audit planning
- Ensures a consistent audit approach
- Actively supports the organization’s audit process
- Serves as an aide memoire
- Provides a repository for notes collected during the audit process
- Ensures uniformity in the performance of different auditors
- Provides objective evidence

Structuring the Audit Checklist

One of the simplest methods of structuring the ISO 9001 audit checklist is by taking the applicable requirements from an organizational policies, procedures and of course, from the standard itself, and turning each requirement into a question. Be sure to include the requirements as well.

Add a section for comments, add check boxes for compliant or non-compliant and you can even add a column to note objective evidence and to provide an audit trial. Each element of the audit process should have customized checklists to serve as documentation outputs from the audit process itself.

This type of approach is primarily utilised by external auditors, including registration and certification body auditors, but the technique can equally be applied by any organization actively seeking to enhance their audit process.

Adding Value to the Checklist

Organizations should assess the potential value that the ISO 9001 audit checklist can bring in helping their audit process to develop. It’s worth remembering that a good checklist is no substitute for an enquiring mind and a good questioning technique.

If an internal auditor uses the checklist to ask narrowly focused questions then little benefit will be derived from the audit. If, on the other hand, the auditors conduct detailed preparation of the requirements of the process they intend to cover during the audit; the checklist then becomes an invaluable output for recording and communicating that preparation work.

Using the ISO 9001 audit checklist should not restrict the scope of audit activities, since that scope may change as a result of information actually collected during the audit. The key to unlocking the checklist’s value is the willingness of the organization to use it as a guide rather than being a slave to it.

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