ISO 9001 Standard - ISO 9001 Standards

ISO 9001 Standard - ISO 9001 Standards

ISO 9001 Standards Audit Checklist

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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What Is ISO 14000 Environmental Management System

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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Management Review IN ISO 9001 Standard

One of the most important factors in determining the success of an ISO 9001 implementation is management commitment and management understanding of what makes a good quality systems. Our turnkey Quality Management System (QMS) gives you everything you need to educate your entire company from top to bottom.

Management review is one of the key elements to building a sustainable quality system. To do this, management must be committed. This means that the management must do more than just say they are committed, they must allocate the resources to make sure that the company can continuously improve quality. Most quality systems fail from the top down! That is why external auditor almost always review the management review documentation every audit. External ISO 9001 auditors look for this commitment by evaluating the management review records. Management reviews should focus on both the quality of the products and the quality of the QMS. In general, it is very simple to maintain compliance of the management review portion of the standard. It can be done with a simple notebook that is maintained as a quality record. The Management review procedure includes a list of documentation that should be included in management review meeting. Management reviews should be done a least once per year and auditors like to see them quarterly.

Under ISO 9001, executive management has defined responsibilities. Although most of the work required to implement and maintain ISO certification is done below the executive level, ISO requires involve of personnel at the top of the organization.

It is the leader of an organization that set the goals and objectives for the quality of the company. It is also the leader that assigns resources (responsibility and authority) throughout the organization. Because of this, the leaders must be kept aware of the status of the quality system and product/service quality so they make good decision.
Much of how the company accomplishes these tasks is covered in the quality manual. Here are the 8 areas that should be address in the quality system to assure compliance to the ISO standard.

Top Management must:

Show A Commitment To The Customer

This requirement includes maintain records showing their commitment to the a customer focus, the quality system and the continuous improvement system. The use of a customer survey program is an excellent way to meet the ISO requirements for a customer focus. It is also an excellent way to keep in touch with your customers.

Make Quality Important

This includes communicating to the organization the importance of meeting the customer regulatory, legal needs as well as their produce or service needs (customer focus). Training and posting quality information around the building can do this.

Establish A Quality Policy

This should include a concise quality statement in conjunction with quality goals and a quality manual. The policy verbiage should include a commitment to continuous improvement. This information must be communicated to and understood by the entire organization.

Establish, Monitor And Update Quality objectives

These objectives should be measurable and should be relevant to all levels of the company. I recommend that they be publicly posted where everyone can see them and their status may also be posted.

Assign Resources

Ensure that resources are available to achieve the quality goals. This is the area where many companies do not meet the requirements but it is very hard to audit this general statement. Resources should be identified and planned. Planning includes manuals, procedure, work instructions and quality plans.

Assign Responsibility And Authority

Ensure that responsibilities and authorities are assigned and communicated to individuals. Responsibilities can be assigned as part of the personnel records ( see training summary sheet). Having authority means that the individual must be empowered to make changes.

Designate A Management Representative

This person will report the QMS status at periodic management reviews and promote awareness of the importance of meeting the customers needs. This is usually the quality, engineering or production manager.

Conduct Periodic Management Reviews

Management review meetings should include inputs from audits, customer feedback, process performance analysis, preventive and corrective actions system, follow-up from previous management meetings and areas for improvement. The output from the management reviews should include resource assignments, action targeting improvement of the products, processes and QMS.

The records for the management review are frequently audited so I recommend keeping a organized notebook with tabs for each management review. The creation of a check sheet (listing all the reports to be shown to top management) will make this periodic task simple to maintain. The check sheet can also be used to keep track of attendance and log feedback that is generated during the meeting.

Corrective and Preventive Actions In ISO 9001 Standard

Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and external sources be entered into the engineering change request system. This can include customer survey results, customer complaints, nonconforming material data, field failure data, work-in-process testing results, internal audit results, external audit results and suggestions from personnel. The inputs are then entered into the Engineering Change Request System. This system is used to queue workload for the engineering and quality problem solvers. The engineering manager or quality manager then reviews this bulk of requests for prioritization. The highest priority issues are assigned to personnel who create an engineering change order to correct the problem. Some engineering change requests will be denied and the denial will be justified in the ECR system before the item is closed. Other requests will generate an Engineering Change Order that includes an assignment to a project manager. The engineering change order will include complete details on how to correct the problem and when the change will take effect. This system is a closed loop system that will continuously improve quality. The status of the ECR and ECO systems should be used as input for the management review meetings.

The process of managing this data usually requires a database since priorities change on a daily basis and the amount of input can be very large, even at small companies. A database is also advised since the system can be used to generate automated reports that are used in the management reviews. Without constant supervision, engineering requests and change orders can pile up and start dragging down the company.

Corrective and preventive actions are listed separately in the standard to drive home the point that you can not have successful company that only corrects problems, you must prevent problems.

Corrective and preventive actions also go hand-in-hand with the requirement for continuous improvement. If the company is analyzing their mistakes, anticipating future mistakes and continuously improving, The quality of the product and services at the company will eventually be GREAT. The corrective and preventive actions system is the most critical element for an efficient quality system. Corrective and preventive actions are made using Engineering Change Requests (ECR) and Engineering Change Orders (ECO).

Any quality problem or suggestion should generate an ECR. This is the queue for engineering. If the engineering/quality manager decides that an action is required, then an ECO is created and assigned to someone with the resources to correct and prevent future problems.

ECOs should be generated by negative customer feedback, negative trend in product performance, observed areas for improvement, upgrades to documentation, or any other continuous improvement activities. Engineering change orders are the lifeblood of the organization and they must always be flowing to keep the organization strong and growing.

With this in mind, it is critical that the engineering change order system quick, simple and effective. I highly recommend the use of a database for managing ECRs and ECOs. This will give you a searchable history of changes to your products and is the best tool for continuous improvement.

About ISO 14001:2004 Standards

The ISO 14001 aims to reduce the environmental carbon footprints that many businesses leave behind today because of not taking the right steps to be environmental sustainable. This standard promotes the decrease in the waste of necessary business resources and also reduces the pollution that can sometimes be a by product of a business.

About ISO 14001

The most updated version of the ISO 14001 was released in the year 2004 by the International Organisation of Standardization (ISO), which was attended by members from all the committees from around the world. In order for a company to be awarded the ISO 14001 standard certificate, an external auditor has to audit the company by an audit body that has been accredited by an accreditation body. The certification auditors are required to be accredited by the International Registrar of Certification Auditor and the certification body has to be accredited by the Registrar Accreditation Board in the USA or by the National Accreditation Board in Ireland.

The structure of ISO 14001 is very much like the ISO 9000, which is management standard, so these two standards can be implemented side by side to achieve the best results. As a part of the ISO 14000family, which deals with different aspects of environmental issues, ISO 14001:2004 and ISO 14002 deal with environmental management system (EMS). ISO 14001 gives the requirements for the

EMS and ISO 14002 gives the basic guidelines for EMS.

Environmental Management System with ISO 14001:2004

The EMS, as per the requirements of the ISO 14001, enables the company, may it be of any size, location and income to:

• It helps the company improve its environmental strategy and this positively affects their environmental performance.
• It helps in identifying and controlling the environmental impact that the activities, services or products of the company might have.
• And it helps in carrying out a systematic approach to set environmental targets and objectives, to achieve these and also to demonstrate that they have been achieved.

How does it work?

ISO 14001 does not specify or chalk out a definite level that each business has to reach. If the performance was determined, then it would have to be done for every specific business. But that is not how it works and has a very different approach, like:

• The ISO has various standards dealing with environmental issues. ISO 14001 deals with a framework provided for a strategic and holistic approach to the businesses environmental policy, actions and plans.
• It gives the general requirements for the EMS.
• This also states the reference to the communication requirements for the communication of the environmental management issues between the company, stakeholders, the public and the regulators.
• As these standards are not company specific, any and every business can undertake them as long as they are dedicated to the continued and improved environmental performance and they have a commitment to comply with the set norms.

ISO 9001 Equipment Maintenance Procedure

The purpose of this procedure is to regulate the planning and inspecting maintenance of equipments and machines while implementing process of production industry. The maintenance is to minimize and prevent from unexpected incidents caused by machines influencing the plan and schedule of production.

This procedures include steps as follows:

1. Need of equipment maintenance:

Due to the fact is that maintenance of machines and equipments is very important to the implementation of production industry, so the need of machines maintenance is set up to eliminate and prevent from unexpected incidents by machines and equipments that may affect to the plan and progress of production.

2. Making list of equipments

All machines and equipments that are working are conforming to requirements of production. The maintenance will coordinate with other Heads of departments (HODs) to make a list of each equipment for checking, preparing to replace, or repairing to submit to Technical department for approval.

3. Making a schedule of investigation:

Based on the machines and equipments that are using and depending the capacities and purposes of specialized equipments, the maintenance will make a schedule of investigation accordingly identifying the machines that serve requirements of practical products and give schedule of maintenance periodically or regularly maintained according to frequency of using.

4. Implementation of Investigation:

Based on plan of investigation, the maintenance department will investigate machines and equipment and record clearly:

o The duration of time used
o The duration of time maintained previously
o Trouble shootings earlier.
o Status of machines and equipments.
o Need repairing, replacing or maintenance.

5. Making schedule of maintenance:

After investigation and examination, the maintenance department will review the frequency of using of each machine so as to make a schedule of specific maintenance for each kind of machine and equipment.

o After identifying purpose and the importance of each machine in production, the maintenance department will make a schedule of maintenance for each of equipment as regulated by designers.

6. Material estimate:

Once having schedule of maintenance or repair, the maintenance will inspect to identify the causes leading trouble shootings, make a material estimate request to supply accessories of the equipment that need repairing at definite time. At the same time, there will be supervision and inspection from Head of department where machines or equipments are used.

7. Implementation:

Once having made material estimate and provided, Maintenance Department carry out repair based on the plan of maintenance and approval for repair. After the maintenance is finished, the maintenance will coordinate with the using department to make a report of inspection and evaluating quality of equipment and machines to put into operation and stating clearly about status of equipments that are replaced.

8. Updating files:

When finishing maintenance and repair, the maintenance Dept. will file each of machine whose accessories are repaired and for how long they can work as well as make a file for each machine.

More information on ISO 9001, kindly go to ISO 9001