ISO 14001 Environment Management System

ISO 9001 Standard - ISO 9001 Standards

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ISO 9001 Standard - ISO 9001 Standards

Management Review IN ISO 9001 Standard

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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

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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) andEngineering 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

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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.

What Should Be Documented In Quality Management System?

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What Should Be Documented In Quality Management System?

General Description of ISO14001 Standards

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General Description of ISO14001 Standards

ISO14001 Standards requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.

Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.

The preparatory review and definition of the organization’s environmental effects is not part of aISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in

the past (i.e. contamination of land).

The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.

The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management Systemprovides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.

As with ISO 9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.

In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.

ISO 9001 Standards Check List

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ISO 9001:2008 include these checklists as follows:

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?

25. Identification and Traceability
Is the product identified by suitable means throughout product realization?

26. Customer Property
How does the organization exercise care with customer property while it is under the
organization’s control or being used by the organization?

27. Preservation of Product
Is conformity of product preserved during internal processing and delivery to the intended destination?

28. Audit Checklist of Control of Measuring and Monitoring Devices
Has the organization determined the monitoring and measurement to be undertaken and the monitoring and measurement devices needed to provide evidence of conformity of product to determined requirements?

29. Customer Satisfaction
Are measurement and monitoring activities needed to assure conformity and achieve improvement been identified and included in the product quality plan?

30. Internal Audit Checklist
Are periodic internal quality audits conducted to determine whether the quality management system has been effectively implemented and maintained?

31. Monitoring and Measurement of Processes
Are suitable methods applied for monitoring and where applicable, measurement of the quality management system processes necessary to meet customer requirements?

32. Monitoring and Measurement of Product
Are product characteristics monitored and measured to verify that product requirements are met?

33. Control of Nonconforming Product Checklist
Is nonconforming product identified and controlled to prevent unintended use or delivery?

34. Analysis of Data
Is appropriate data determined, collected and analyzed to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can
be made?

35. Corrective Action
How is corrective action taken to eliminate the cause of nonconformities in order to prevent recurrence?

36 Continual Improvement
Are processes necessary for the continual Improvement of the quality management system planned and managed?

37. Preventive Action
Has the organization determined actions to eliminate the causes of potential nonconformities in order to prevent occurrence?

These checklists also called ISO 9000 audit checklist.

ISO 9001 Standards Document control procedures

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ISO 9001 Standards Document control procedures
The ISO 9001 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9001 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

Integrating Management Systems Within The ISO 9001 Standards

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Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8?700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO 9000 Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430?000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000?, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)

Integrating Management Systems Within The ISO 9001 Standards

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Aligning At ISO 9001 Standard Requirements

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In conformity with the explanations of international series of standards elaborated in the 2008 year, the

implementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be done

in every kind of organization, indifferent of its field of activity , size or number of personnel. This means that

SMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to their

limited resources. The success of this action depends on more elements, mainly, the following ones:

· Strong commitment and decision of top management;

· Adopting an organization structure accordingly both with business plan of SME, and with the

requirements and guides of standards from quality management field, too.

This means that SME (sector in continuously development in Romania starting from 1990) can align to

these requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources.

The success of this demarche depends on several elements, mainly, the following:

· The decision and the strong commitment of the top management ;

· Adopting an organizational structure according to the business plan of SMEs, but also with the
requirements and the directions of the norm/standards in the quality management field.

· Accurate planning of the implementation project of a quality management system

· Allocation of the m a t erial, financial and human resources necessary for developing and

maintaining of the system;

· Suitable training of the personnel of the organization for the documentation and implementation of the system, but also for its supervising;

· Maintaining of an efficient communication and collaboration with business partners, first, with the

suppliers and the clients of SMEs, but also with other interested parts, including their own

personnel;

And one more remark: the success of a quality management system in a SME depends on endowment degree and on technological level of the equipments and working and controlling installation of the processes.

In conformity with the explanations of international series of standards elaborated in the 2000 year, theimplementation of QMS having the requires of ISO 9001 standard on basis (included in this series) can be donein every kind of organization, indifferent of its field of activity , size or number of personnel. This means thatSMEs can also align at these requires. Practically, this thing is not so easy accessible to all SMEs, due to theirlimited resources. The success of this action depends on more elements, mainly, the following ones:· Strong commitment and decision of top management;· Adopting an organization structure accordingly both with business plan of SME, and with therequirements and guides of standards from quality management field, too.This means that SME (sector in continuously development in Romania starting from 1990) can align tothese requirements. Practical, this is not easy to aces by all SMEs, because of their limited resources. Thesuccess of this demarche depends on several elements, mainly, the following:· The decision and the strong commitment of the top management ;· Adopting an organizational structure according to the business plan of SMEs, but also with therequirements and the directions of the norm/standards in the quality management field.· Accurate planning of the implementation project of a quality management system· Allocation of the m a t erial, financial and human resources necessary for developing andmaintaining of the system;· Suitable training of the personnel of the organization for the documentation and implementation ofthe system, but also for its supervising;· Maintaining of an efficient communication and collaboration with business partners, first, with thesuppliers and the clients of SMEs, but also with other interested parts, including their ownpersonnel;And one more remark: the success of a quality management system in a SME depends on endowmentdegree and on technological level of the equipments and working and controlling installation of the processes.

A transparent quality management system, well conceived and applied, with adequate trained and motivated personnel, will be efficient and if technological level of endowments (working, supervising, measuring and monitoring equipments of the processes and product, working environment and infrastructure) will be comparable with the level of endowment of the top firms in the same activity area, as of the organization we refer to.

So, adopting a quality management system based on the requirements of the ISO 9001 standard is a strategic decision of the top management of an organization, much more for the management of SME that first of all has to analyse very well all the necessary resources, to put in balance both the necessary costs of the implementation and sustaining in function of a quality management system and the benefits brought, then to decide advisedly. Developing a quality management system gives both direct benefits and a contribution at the cost and risk management, being important not only for organization but also for the satisfaction of its clients and other interested parts.

The decision of designing and implementation of a quality management system in SME is influenced by proposed objectives, by the demand of the market, by products and services offered, as well as by objectives tendency of developing and the continuously improving of the performances of the processes of any organization.

A quality management system contains two essential elements. First, the most critical, refers to human resources and the other necessary resources for constant delivery of the adequate products and services to the client. Second refers to the existence of “documented quality management system” that is, usually, defined by documented policies, objectives, plans, processes, procedures and fabrication standards. The documented quality management system has to reflect the planning and carrying on the activities, made by SME. Both for the audit reported to the ISO 9001 standard’s requirements but also for improving activities, will need to generate adequate registrations to document the effective performance and to demonstrate the concordance.

Top management of SME has to be aware that the implementation of a quality management system according to this standard has to be approached as a project, to which are assigned resources and which has to be managed by a defined schedule.

First step is represented by defining the objectives of the schedule with an accent on those that will bring benefits for SME. For each objective must be defined the way in which will be measured his achievement, as well as the reference level. Schedule must also establish:

· An identification, documentation and continue improving system of SME’s processes;

· Stages that must be carried out for achieving the objectives regarding to the quality of the product and for long-term improving of a quality management system of SME;

After establishing the objectives, the next decision of the top management of SME refers to the type of approaching that will appeal to [3].

There are two ways of approaching:

a) to design the whole quality management system and then to be implemented;

b) to evaluate the processes and to appeal to improving techniques to build the system step by step, starting from existing elements.

The advantage of designing the whole quality management system is represented by obtaining a distinct structure, the main disadvantage being the tendency of a theoretical approach, separated from the realities and practices of SMEs. The performances of the personnel can also suffer because of the necessity to apply simultaneous a great number of new procedures.

The essential advantage of step by step approach is that if through evaluation of processes are determined both the adequate practices and the less acceptable, the efforts can be focused on those areas that ensure a maximum benefit. This approach has the disadvantage of the tendency to achieve a quality management system that is not so well structured and so is more difficult to understand and to apply by the personnel of SME.

The optimum approach represents a combination of the two variants. So, initially it is good to be established a general structure of the quality management system and then to be established frame models for documentation of the processes. Implementation activities will have in view identification and solving the problems and then the improving key processes of SME.

Indifferent the approaching way, top management of SME can decide if the conceiving and implementation project of the quality management system will be carried out through internal forces, or will be carried out external appealing to a specialised advising. In case they appeal to an advising firm, must exist an abiding collaboration between the two firm and a well tuned up contract to which will be affixed a plain schedule, with responsibilities and achievement terms.

Designing and implementation project of the quality management system cannot ensure solving all the problems. Changing the culture of an organization takes time and patience. Project must be accomplished through a well defined series of phases, with well established terms and with objectives that can be reached.

Active Implication Of The Implementation Of Quality Management System

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Successful implementation of a quality management system is conditioned by implication of the top management of SME. ISO 9001 gives a special importance of the commitment of the top management obviously defining its role in the quality management system. It is underlined the promoting the leadership principle in practice as a base for operational the others principles of the quality management system.

The commitment and active implication of the top management are essential for developing, implementation and maintaining an efficient and efficacy quality system management, having as a final purpose ensuring an increasing clients’ satisfaction.

To achieve such a desideratum, top management must consider the following actions:

· defining the visions, policies and strategic objectives of SME;

· direct participation of the management to improving projects;

· obtaining the feedback regarding efficiency and efficacy of the processes of making the products;

· developing an environment that encourages the involving of the personnel;

· ensuring the necessary resources for achieving the objectives.

Top management defines the methods of the performances of SME to determine the stage of achievement the objectives.

These methods must allow the evaluation:

· financial performances of SME;

· performances of the processes of SME;

· client’s satisfaction, personnel’s and other interested parts’ satisfaction;

· other success factors identified by management.

Information that results from such evaluations are used as incoming elements for the analysis done by management for continue improving of the quality management system, that must ensure the base for improving

the performances of SME.

In this way, top management can demonstrate its commitment through:

· understanding the necessities and present expectations and client’s perspective;

· promoting policies and objectives for increasing the awareness and implication of the personnel in SME;

· adopting the principle of continue improving as a base principle for the processes of SME.

· Rigorous planning of all processes of SME and to operate the changes;

· ensuring an adequate background to satisfy the requirements of the interested parts.

Top management has to involve directly in identification the processes of fabrication the products because these are directly tied by SME’s success. Also, a special attention must be paid on identification of those reliance processes that affects either the efficacy and efficiency of the processes of fabrication of the products of SME, or the necessities and expectations of the interested parts.

The management of SMEs should ensure that the processes are carried out as an efficacious and efficient net. For this it should be analyzed and got at its best the interaction of all processes. In this purpose it must consider the following aspects:

· ensuring the sequence and interaction between processes are in that way designed so they allow getting the desired results;

· ensuring that incoming and outgoing elements are obvious defined and are kept under control;

· monitoring the incoming and outgoing elements to check if the processes are correlated and carried out efficacious and efficient;

· identification and administrate the risks and to turn to account the opportunities of improving

performances;

· doing the analysis of the information for continuously improving of the processes;

· designating the responsible of the processes;

· ensuring that every process is managed so that it allows the achievement of the established objectives;

· defining the necessities and expectations of the interested parts.

Top management can present proves regarding its commitment for developing and implementation of the quality management system as well as for continuously improving of its efficacy through:

· communication of the importance of satisfaction of the clients’ requirements in SME, as well as legal requirements;

· defining the policy and objectives regarding the quality;

· managing the analysis of the quality management system;

· ensuring the necessary resources for the achievement of the objectives.

One of the main tasks that top management has to accomplish refers to defining the policy in the quality field. There is no form of standard presentation, but the policy must be in such way formulated so it ensure:

· getting client’s satisfaction as a main goal;

· clarifying the way in which it is ensured the quality of the products and services of SME;

· explicit commitment of the management regarding continue improving of the quality;

· assuming by the management the responsibility regarding the achievement of the objectives regarding quality.

Policy will be implemented through the objectives regarding the quality, that should be measurable. The more participation of the top management is more direct and more visible, the more the necessary period will be shorter for establishing and implementation of the quality system management, on one hand because of the availability of the resources and on the other hand because of a less bureaucratic approach that top management of SME has in this case.

When it is decided the implementation of a quality management system or it is approved an improving schedule of this, it is vital to exist an obvious understanding of the estimated duration and necessary resources from the management. Often, the initiatives regarding the quality management system fail because of this commitment is missing, especially from the top management.

Introduction To ISO 14001 Standards

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An environmental policy should reflect the vision, intentions, philosophy, values, and beliefs of the organization with respect to the environment. Top management should put a great deal of thought and imagination into developing and crafting the policy, since it will become the code of conduct by which the organization lives and operates. The policy should be practical and inspirational, providing a framework and a compass for business and technical decisions and actions, and at the same time motivate and encourage all personnel in the organization to achieve excellence in environmental performance.

The ISO 14001 Standard specifies several requirements for the development, content, intent, and implementation of an environmental policy:

1. Top management is responsible and accountable for defining the organization’s environmental policy. They must, as a minimum, carefully review, approve, and commit to abiding by an environmental policy that has been developed for their consideration.

2. The policy must completely cover the organization’s (i.e., facility’s) range of operations, including where appropriate, raw material acquisition, transportation, packaging, and shipping of product,as well as all on-site operations that may impact the environment.

3. The policy must contain three core commitments that are ISO 14001 absolute requirements:

(i) A commitment to continual improvement of the EMS and environmental performance.
(ii) A commitment to the prevention of pollution (i.e., this means taking all reasonable steps to eliminate, or at least minimize, pollution).
(iii) A commitment to comply with relevant environmental legislation and regulations, and with other requirements to which the organization subscribes. This means the organization commits to meet local, regional, and national legislated environmental standards.

4. The policy must give direction and a framework for progress through new environmental objectives and targets that will be set during the course of implementing and maintaining the EMS.

5. The policy must be documented, and it must be implemented through the day-to-day functioning of the EMS.

6. The policy must be maintained, meaning kept up to date and relevant to current operations and conditions.

7. The policy must be communicated to all employees. This implies active, intentional efforts by the organization, led by top management, to ensure all employees know about, understand, and apply the principles, ideas, and commitments in the policy.

8. The policy must be made available to the public, i.e., it must be accessible to all members of the public who wish to see it.

In addition to the essential requirements for an environmental policy, other considerations that may be incorporated into the policy include:

Principles of sustainable development, resource renewal, and preservation • of biological diversity

A commitment to use the most effective pollution abatement technology and • equipment, consistent with economic viability of the business (i.e., BEAT – Best Economically Achievable Technology)

Use of environmental performance indicators to quantitatively monitor • progress

Life cycle thinking – consideration of ‘cradle to grave’ impacts of a • product, which would require the organization to assess cumulative environmental impacts from all stages, from design of the product; acquisition of raw materials; processing to finished product; packaging; shipment; end-use; and ultimate re-use, recycle, or disposal.

For all components of this element of the Standard to be brought to fruition, it is essential that there is clear allocation of responsibilities for developing, approving, communicating, disseminating, implementing, maintaining, and when necessary, revising the environmental policy.

Although environmental policy is the first element of ISO 14001, it may be prudent for an organization to defer finalization of the wording of their policy until work has been done to identify the scope of environmental impacts from the operation, and other planning and preliminary preparation for the EMS has been done. This will help to ensure the policy is authentic and appropriate for the organization’s purpose.

Please visit http://www.e-wia.com for more information.

Global Warming & ISO 14001 Standards

2011-02-28T05:18:00.002-08:00

Some 180 countries are proceeding toward an expected ratification of the Kyoto Protocol by the end of this year. Of the six gases it will control CO2 is by far the largest contributing nearly 90% of the global warming impact. The primary source of CO2 is the burning of fossil fuels. Therefore the focus on energy will continue to increase.

Throughout the world different methods are being used to encourage reduced energy use. Japan has enacted the Energy Conservation Law in 1999 mandating huge efficiency improvements by 2004 for nearly all air conditioning products. The U.S. has revised ASHRAE Standard 90.1 for buildings to raise the minimum COP level for centrifugal chillers from the current value of 5.2 to 6.1 effective in October 2001. DOE and Green Seal have revised their recommended efficiency levels to an even higher level of 6.27.

Some countries use laws. Others use codes and standards. An increasing number of countries are using environmental costing which increases the price of energy thereby increasing the financial attractiveness of high efficiency products. European countries have been using such “carbon taxes” for more than a decade. However a rapidly growing trend in developing countries is the reduction of subsidies to energy industries “so prices more accurately reflect environmental impacts” according to OECD’s Environmental Strategy for the First Decade of the 21st Century.

China has shown leadership by reducing subsidies to the coal industry from $24.5 billion in 1990 to $10 billion in 1996 resulting in 7% emissions reduction while seeing a solid economic growth of 36%! China is now moving aggressively into environmental costing with the just announced (1/13/2002) 5-year environmental plan that commits 700 billion yuan ($84 billion) to help protect the environment. The government will provide the fist 65 billion yuan to initiate the project but will apply the “polluter pays” principle for the rest. The “environmental protection authorities will collect funds from the pollution-producing companies”. The impact on the price of energy is not known at this time. However it is clear that the addition of environmental costing will increase energy prices. According to a European Research Commission Report of July 2001 “The cost of producing electricity from coal or oil would double if costs such as damage to the environment and health were taken into account”.

The global movement to high efficiency is accelerating just like the rate of temperature increase. But this is not all that is changing. This second environmental threat of global warming is making it clear that we need to give combined consideration to ozone depletion and global warming. But more important is the need to focus on the real issue which is the total environmental impact not address each individual environmental threat in isolation. This includes the concept of environmental risk exposure, which recognizes that there are other environmental threats that are less well understood today. However, there are “no regrets” decisions we can make today (such as minimum refrigerant charge, minimum atmospheric life refrigerants, etc.) to minimize these risks.

Combined consideration would place more emphasis on reducing the use of CFCs, which are still being produced in developing countries until 2010 in accordance with the Montreal Protocol. Little attention is being given the large contribution to global warming from CFCs. Actions which cause confusion and delay the phaseout of CFCs cause increased environmental damage rather than lessening the environmental impact.

The other rapidly changing factor in the HVAC industry is the shift to becoming a hermetic industry, where refrigerant is contained throughout the life of a chiller and recycled for further use when the chiller is replaced. This simple understanding that “if it doesn’t get into the environment it does no harm” is a powerful argument, which will lead to the continued use of the most efficient refrigerants in such closed hermetic applications as chillers. In just 15 years annual refrigerants emissions from chillers have been reduced from 25% to well below 1% today. This defines a whole different world than that which existed when the Montreal Protocol was crafted some 15 years ago.

But perhaps the most important change coming to our industry is the realization that there are no new or “perfect” refrigerants waiting to be discovered. There are eight elements that can be combined for use in a vapor compression cycle. All feasible combinations of these eight have been evaluated. The reality is “what we have now is all there is”.

This recognition is why we are now seeing a shift from the search for a perfect refrigerant to a search for the right refrigerant(s) for the right application. Said another way, the highest efficiency refrigerants for the lowest emissions applications. Many in our industry call this “Responsible Use”.

It is not difficult to become a believer in global warming. According to the U.S. National Climatic Data Center 2001 was the second warmest year on record and it was the 23rd consecutive year of above normal temperatures. Perhaps most troubling is the fact that the rate of temperature increase is accelerating. Add to this the data just released from insurer Munich Re stating that deaths from natural disasters were more than double in 2001 versus 2000 and insured losses were up more than 50%.UNEP estimates that the extra economic costs of disasters attributable to global warming are running at more than $300 billion annually.
Some 180 countries are proceeding toward an expected ratification of the Kyoto Protocol by the end of this year. Of the six gases it will control CO2 is by far the largest contributing nearly 90% of the global warming impact. The primary source of CO2 is the burning of fossil fuels. Therefore the focus on energy will continue to increase.
Throughout the world different methods are being used to encourage reduced energy use. Japan has enacted the Energy Conservation Law in 1999 mandating huge efficiency improvements by 2004 for nearly all air conditioning products. The U.S. has revised ASHRAE Standard 90.1 for buildings to raise the minimum COP level for centrifugal chillers from the current value of 5.2 to 6.1 effective in October 2001. DOE and Green Seal have revised their recommended efficiency levels to an even higher level of 6.27.
Some countries use laws. Others use codes and standards. An increasing number of countries are using environmental costing which increases the price of energy thereby increasing the financial attractiveness of high efficiency products. European countries have been using such “carbon taxes” for more than a decade. However a rapidly growing trend in developing countries is the reduction of subsidies to energy industries “so prices more accurately reflect environmental impacts” according to OECD’s Environmental Strategy for the First Decade of the 21st Century.
China has shown leadership by reducing subsidies to the coal industry from $24.5 billion in 1990 to $10 billion in 1996 resulting in 7% emissions reduction while seeing a solid economic growth of 36%! China is now moving aggressively into environmental costing with the just announced (1/13/2002) 5-year environmental plan that commits 700 billion yuan ($84 billion) to help protect the environment. The government will provide the fist 65 billion yuan to initiate the project but will apply the “polluter pays” principle for the rest. The “environmental protection authorities will collect funds from the pollution-producing companies”. The impact on the price of energy is not known at this time. However it is clear that the addition of environmental costing will increase energy prices. According to a European Research Commission Report of July 2001 “The cost of producing electricity from coal or oil would double if costs such as damage to the environment and health were taken into account”.
The global movement to high efficiency is accelerating just like the rate of temperature increase. But this is not all that is changing. This second environmental threat of global warming is making it clear that we need to give combined consideration to ozone depletion and global warming. But more important is the need to focus on the real issue which is the total environmental impact not address each individual environmental threat in isolation. This includes the concept of environmental risk exposure, which recognizes that there are other environmental threats that are less well understood today. However, there are “no regrets” decisions we can make today (such as minimum refrigerant charge, minimum atmospheric life refrigerants, etc.) to minimize these risks.
Combined consideration would place more emphasis on reducing the use of CFCs, which are still being produced in developing countries until 2010 in accordance with the Montreal Protocol. Little attention is being given the large contribution to global warming from CFCs. Actions which cause confusion and delay the phaseout of CFCs cause increased environmental damage rather than lessening the environmental impact.
The other rapidly changing factor in the HVAC industry is the shift to becoming a hermetic industry, where refrigerant is contained throughout the life of a chiller and recycled for further use when the chiller is replaced. This simple understanding that “if it doesn’t get into the environment it does no harm” is a powerful argument, which will lead to the continued use of the most efficient refrigerants in such closed hermetic applications as chillers. In just 15 years annual refrigerants emissions from chillers have been reduced from 25% to well below 1% today. This defines a whole different world than that which existed when the Montreal Protocol was crafted some 15 years ago.
But perhaps the most important change coming to our industry is the realization that there are no new or “perfect” refrigerants waiting to be discovered. There are eight elements that can be combined for use in a vapor compression cycle. All feasible combinations of these eight have been evaluated. The reality is “what we have now is all there is”.
This recognition is why we are now seeing a shift from the search for a perfect refrigerant to a search for the right refrigerant(s) for the right application. Said another way, the highest efficiency refrigerants for the lowest emissions applications. Many in our industry call this “Responsible Use”.

Demographers now project that, in the near future, more people are going to live in cities than in rural areas, and this will be the first time in the history of the world that this has been the case. As a result, while there are many different levels of society and business where global warming needs to be dealt with, cities are going to take an ever expanding role. It’s easy for local governments to pass the buck to state, provincial, or national governments, but this isn’t a sustainable practice. If we’re going to successfully fend off the apocalyptic-scale global warming that many scientists now predict, cities are going to have to take the lead. As a start, here are some basic things that municipal governments can do.

Green roofs: If you fly over any major metropolitan area, you’ll likely see a few patches of green where there are parks or tree-lined streets, but for the most part you will see nothing but bare rooftops dominating the landscape. When you think about it, that’s a lot of space that is simply going to waste. In the city of the future, we’re going to increasingly put all this excess space to use for green purposes. There are a few things we can do up there, including:

• Having solar and wind power stations on roof tops can help make buildings and cities in general cleaner and more energy efficient.

• Rooftop gardens can help residents grow their own produce rather than having to buy from energy-inefficient sources.

• Rooftop trees and greenhouses help balance out deforestation while cleansing smog-filled urban atmospheres.

Expanded public transit: When it comes to moving people around, the private automobile is the most energy-inefficient vehicle ever created. Things like buses and trains are not without emissions, but they have a much lower pollution-per-person ratio. Many cities throughout the developed world are decades behind in this respect and need to catch up fast in order to do their part. We need more rail-based transit systems, and many cities would do well to expand their bus networks.

Pedestrian and bicycle infrastructure: In many cities, it’s a sad state of affairs for pedestrians. If you want to travel on foot, you too often have to deal with landscapes that make walking very difficult, not to mention the culture of motorists who drive fast and aggressively and are not used to sharing the road. For a more sustainable future, we need more pedestrian-friendly landscapes, and it also doesn’t hurt to encourage people to take their bicycles.

Better recycling programs: We have come a long way in the realm of recycling, but too many cities are still stuck in the 90s with their recycling technology. We now have the ability to recycle a much broader spectrum of materials, including plastic bags and soiled containers, but many cities haven’t taken the steps necessary to implement these technologies. This investment, which is relatively small in the big picture, can have hugely positive effects in the long run.

Fuel-efficient fleets: Most cities rely on large fleets of vehicles to provide their basic services. From buses, to sanitary trucks, to road maintenance equipment, all of these vehicles can be made more efficient with new technology. Of course, it costs a lot of money to replace these vehicles, but all vehicles do need to be replaced with newer models sooner or later, and cities should use these opportunities to make their investments more efficient, rather than purchasing the same old polluting vehicles.

As individuals, each of us can contribute to the solution. As a start, we can choose to drive vehicles that are more fuel-efficient. We can plant more trees. We can recycle where practicable. We can take stock of our energy consumption practices and try to reduce them by some factor.

But, what steps can your organization take to help? The answers are varied, depending upon the size of the organization and the related environmental aspects and impacts. But no matter how simple or complex the business, each can benefit from the implementation of a management system based onISO 14001:2004. This international standard has as its focus the prevention of pollution, accomplished by a teamwork approach to identifying those aspects of the organization’s processes that have the potential for harming the environment and the development of ways to reduce or prevent this harm. In the process, many organizations have found ways to reduce costs by elimination of scrap, changes to their waste disposal processes or reduced use of natural resources. It is the application of the system approach that has proven to be successful. And, once the system is in place, it is logical and beneficial to have that system certified and registered. This provides added assurance that the management system remains effective and also provides public recognition to numerous stakeholders that your organization is committed to the prevention of pollution.

Go to http://www.iso9001store.com for more information on ISO 14001 Standards.

Training In ISO 9001 Standards

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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

The Difference Between Compliance Auditing and Systems Auditing In ISO 14001

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Often however, there is confusion between regulatory compliance auditing and EMS auditing. This is because there are many elements of regulatory compliance that overlap with the EMS. Recall that the criteria in a compliance audit are the applicable regulations, whereas the criteria in an EMS audit would be ISO 14001. But does not ISO 14001 address compliance? The answer is yes, but from a system standpoint, not performance.

In other words, the standard requires that certain procedures exist regarding identification of legal and other requirements, that periodic compliance assessments be performed, that legal requirements be considered in setting objectives and targets, and that there be a commitment to compliance. However, actually being in compliance is a performance issue, and out of the purview of ISO 14001.

Of course, a system that is constantly out of compliance or does not identify and initiate action to correct noncompliances, will eventually fail due to system failure. The subtle, yet important point is that during an EMS audit, identified regulatory noncompliances are relevant only to the extent that they reflect a potential system problem. The finding therefore is not that the site is out of compliance with a given regulation, but that the noncompliance means some EMS element is not conformed to. For example, a regulatory noncompliance can be related to a problem with training, recordkeeping, or monitoring and measurement.

The EMS auditor is not to do a compliance audit as part of the EMS audit. If, as part of the statistical sampling to verify EMS element requirements, the auditor identifies a regulatory noncompliance, he or she treats it as any other evidence.

This point has been difficult to accept, especially in U.S. industry because of our long history of regulatory enforcement. The EMS auditor needs to constantly remember that compliance auditing is being done separately as part of the EMS requirements itself (4.5.1, paragraph 3) and to stay focused on the criteria at hand – ISO 14001 and the site’s EMS. There may be legal requirements regarding noncompliances encountered during the EMS audit, but this should be decided and addressed in the audit plan.

In summary, the goal of the compliance audit is to verify compliance with regulations, whereas the EMS audit’s goal is to verify that the EMS conforms to planned arrangements, including ISO 14001.

The Audit Plan In ISO 14001

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The audit plan is the document that establishes the scope, objectives and criteria, and schedule of the audit. It also goes into specific details on what areas will be audited, when, and by whom.

Other details such as which checklists may be used, how the report is to be formatted and distributed, and how meetings will be conducted can also be included in the plan. In essence, the audit plan reflects the programs, procedures, and methodologies of the EMS audit process, in accordance with element 4.5.4 of ISO 14001. These planning items are usually described in the procedures for element 4.5.4 and do not need to be re-created every time an audit occurs. For example, it can be determined that the entire EMS will be audited once per year, but in four partial events. This schedule then becomes part of the procedure.

The audit scope defines what part of the organization will be audited. Obviously, this should coincide with the scope of the EMS itself, and is usually the site in question. If the full EMS audit is divided in smaller segments conducted throughout the year, then the scope of any given segment is what portion of the organization will be audited at that time. Typically, an organization will create a chart or matrix showing the various divisions of the site or activity and when it will be audited. A typical entry may show the maintenance department being audited in the first quarter and production in the fourth quarter, for example.

Also noted in the audit plan is the audit objective(s). The audit objective describes why an audit is being conducted. Typically the reason is to conform to ISO 14001 4.5.4 requiring that the EMS be periodically evaluated. Another reason is demonstrate conformance to others.

Although EMS audits may appear in their own right to be “good practice”, it is essential that auditors have a clear concept of what the general objectives of such audits are.

The definition of EMS audits highlights the need to confirm conformance with planned arrangements and to ensure that these arrangements are effective and suitable to achieve objectives. ISO 14011 expands this to form a number of general objectives for any type of EMS audit. Audits should be carried out to:

- determine conformance of an auditee’s EMS with the EMS audit criteria

- determine whether the auditee’s EMS has been properly implemented and maintained

- to identify areas of potential improvement in the auditee’s EMS

- assess the ability of the internal management review process to ensure the continuing suitability and effectiveness of the EMS

- evaluate the EMS of an organization where there is a desire to establish a contractual relationship, such as with a potential supplier or a joint-venture partner.

Using this definition and sources such as ISO 14010 and 14011, the following statement of the specific objectives of an internal EMS audit has been developed. Internal audits should be carried out to ensure that:

- The EMS continues to meet the needs of the business

- The necessary documented procedures that exist are practical and satisfy any specified requirements

- The necessary documented procedures are understood and followed by appropriately trained personnel

- Areas of conformity and nonconformity with respect to implementation of the EMS system are identified and corrective action implemented

- The effectiveness of the system in meeting the EMS objectives is determined and that a basis is created for identifying opportunities and initiating actions to improve the EMS system

The above objectives imply that internal audits are concerned with more than just the policing of an established system. If auditors and managers are to remain committed to the implementation of the EMS system, it must also contribute to the process of developing that system and seeking improvements.

Internal auditing must not be carried out in a way that results in the transfer of responsibility from the operating staff to the auditor or auditing organization, i.e., at all times the individual or department must retain and accept responsibility for his or her role in the EMS.

If the internal audit process is not designed and implemented to meet the objectives and to avoid the pitfalls described above, it is unlikely that the top management commitment essential to an effective audit process will be readily forthcoming.

The audit criteria define what the “rules” are. For the sake of this guide, the criteria will be the elements of ISO 14001. A subtle point to note however is that the site’s EMS requirements are also part of the criteria. This means that in addition to responding to the requirements of ISO 14001, the EMS must also respond to “planned arrangements”, or what the organization said it was going to do. In audits, a common response is “the standard does not require such and such detail”. However, if the site’s procedure does require some specific response, then it becomes part of the criteria. In essence, the auditors are verifying the system not only to ISO 14001, but also to what the EMS documentation states.

How the audit is divided and scheduled throughout the time interval is up to the organization and will be a function of minimizing disruption to site operations and resource needs. The only requirement is that the full audit be completed within the frequency established in the procedures under 14001, 4.5.4. One of the requirements regarding frequency is that how often an area is audited be in part a function of prior audit results. This means that the planned frequency may change with time based on what auditors are finding.

How long each audit takes again is a function of resource needs and operations. It is recommended, however, that any individual audit event not be protracted out over long time periods. The longer a task takes, the easier it is to get distracted and lose focus.

Much has been written about how to audit a system if the full audit is not completed in one event. Unlike other audits, including quality audits, where a more segmented approach can be taken, ISO 14001 systems tend to be very sensitive to consistency. For example, the emergency planning process may conform to the standard element 4.4.7 in that a procedure exists; however,

it may not reflect the potential significant impacts identified in element 4.3.1. Had the audit team focused only on element 4.4.7, they would not have noted the apparent nonconformance.

When developing an audit plan, it is wise to consider the three C’s of ISO 14001 EMS auditing:

Conformance, Consistency, and Continual Improvement. Conformance relates to addressing each of the requirements of the standard, i.e., the “shalls”. Consistency relates to how well each procedure or process of the EMS relates to the others. In other words, do objectives and targets reflect the policy commitments? Are personnel trained on the correct legal and other requirements? Finally, Continual Improvement requires that the system lead to improvements in the system itself as well as with environmental performance. A system that has all the prerequisite procedures, but remains static, is not in conformance.

The concepts of consistency and continual improvement are more subtle because they are through-running threads of the standard and not always a definitive statement. The required commitment to continual improvement and the text of the standard itself however do go some way towards reminding the auditor.

With the three C’s in mind, one now sees why it is best to audit all applicable elements of the standard in a given area at one time, rather that tracing any one standard element throughout various areas. For example, during the first quarter audit event, Company X may audit all of ISO 14001 in maintenance. During the second quarter event, all of ISO 14001 will be audited in the production area, and so on. This is in contrast to auditing only a certain element, i.e., corrective action, across several site areas in one audit event.

Now we know what is being audited, when it is being audited, and to what “rules” it is being audited. The remainder of the plan is simply then the logistics of the audit. The logistics include identification of team members, noting if and what checklists will be used, schedule and formats of meeting to name a few. Below is the full list of recommended audit plan elements as described in ISO 14011:

• the audit objectives and scope;

• the audit criteria;

• identification of the auditee’s organizational and functional units to be audited;

• identification of the functions and/or individuals within the auditee’s organization having significant direct responsibilities regarding the auditee’s EMS;

• identification of those elements of the auditee’s EMS that are of high audit priority;

• the procedures for auditing the auditee’s EMS elements as appropriate for the auditee’s organization;

• the working and reporting languages of the audit;

• identification of reference documents;

• the expected time and duration for major audit activities;

• the dates and places where the audit is to be conducted;

• identification of audit team members;

• the schedule of meetings to be held with the auditee’s management;

• confidentiality requirements;

• report content and format, expected date of issue and distribution of the audit report;

• document retention requirements.

If the internal audit is to proceed smoothly, it is helpful for the internal auditor to establish a dialogue prior to the actual audit with the person responsible for the area being audited. This dialogue may be conducted by memo, telephone, or during a formal or informal meeting. The main factor that should influence the auditor’s choice of method for setting up this dialogue should be the organization’s normal style or culture. Irrespective of the method of communication the auditor adopts, the following points should be established:

• The overall duration of the proposed audit

• The starting location and time

• The proposed scope and areas to be covered by the audit

• A timetable for approximate progress of the audit where applicable, e.g., if a number of different departments or geographical areas are to be included in the scope of the audit

• The arrangements for any close out meeting where the findings of the audit can be agreed and corrective action requirements discussed

• The personnel liable to be involved at each stage of the audit

If an auditor does not give sufficient attention to ensuring that clear agreement is reached with respect to the above points, the potential for misunderstandings that can affect the conduct of the audit is greatly increased. However, these initial communications with the personnel of the area being audited not only affect the “tone” of the forthcoming audit, but they can significantly influence the commitment and level of cooperation shown by that area throughout the audit process and for many subsequent audits.

Prior to commencing the audit, but once the plan is prepared, the audit team assignments are made, and working documents are defined. Working documents are those documents such as observation logs and checklists that are used during the audit to collect evidence, but are not necessarily retained as records. In other words, they may be discarded after the audit is complete and the report prepared.

Of these, only the checklist should require an input at this stage from the auditor. However, before compiling a checklist, the auditor must determine if the function and format of the checklist are prescribed by the audit procedure or whether personal preference can be exercised.

The format of the checklist may vary considerably, depending on whether it is intended to act as an aide or as a part of audit records showing the scope and conduct of the audit. The former may consist only of general topics to be covered during the audit, whereas the latter may be an extensive and detailed questionnaire on which details of sampling and answers to the questions are to be recorded.

The need for checklists and the type appropriate will vary according to other experience of the auditors and the culture of the company. It is recommended that for purposes of internal audits, checklists, even if limited, should always be developed. However, standard questionnaire type checklists not prepared by the auditor that must be slavishly followed and completed, should be

avoided. This latter type is likely to result in an unnecessary restriction in the scope of the audit and a stifling of auditor initiative.

Although an auditor should always work within the scope defined for the audit, the working documents must not be designed so that they restrict additional audit activities or investigations that may become necessary as a result of information gained during the audit. There are differences of opinion over whether it is preferable to create the checklist anew or whether a previously developed checklist can be used. Although the former is desirable in principle, it is not always practical in terms of the best use of the resources available. The best compromise is to utilize whatever available checklists are already in existence, but to review these critically

against the relevant documents previously identified. In this way, time can be saved in using them as a foundation without detracting from effectiveness.

The Audit Report In ISO 14001

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Once agreement has been reached, both among the audit team and with the auditee, it is time to prepare the audit report. Note that ISO 14001 does not require a documented audit report. However, it is very difficult to verify that the auditing requirement has been satisfied without a supporting record, which is typically a documented audit report.

The audit report is prepared by the lead auditor, although he or she may have other team members prepare portions. The content of the audit report is determined by the audit plan and the organization’s EMS audit procedures. Having completed the examination phase and evaluated the collected data observations, etc., the assessor is faced with the problem of documenting any deficiencies he or she may have found. There are many different methods of documenting deficiencies, ranging from inclusion in the body of the audit report to producing non-conformance notes or corrective action requests. Irrespective of which method is adopted, the basic principles to be followed are similar. ISO 14001 does not dictate what should be in the report, and ISO 14011 only suggests contents. ISO 14011 indicates that at a minimum, the findings need to be in the report. The findings appear as a statement that the EMS is or is not in conformance with the criteria, and states what the criteria and supporting evidence are for the statement. ISO 14011 also lists other optional items to include such as:

• the identification of the organization audited and of the client;

• the agreed objectives, scope and plan of the audit;

• the agreed criteria, including a list of reference documents against which the audit was conducted;

• the period covered by the audit and the date(s) the audit was conducted;

• the identification of the auditee’s representatives participating in the audit;

• the identification of the audit team members;

• a statement of the confidential nature of the contents;

• the distribution list for the audit report;

• a summary of the audit process including any obstacles encountered;

• audit conclusions such as:

- EMS conformance to the EMS audit criteria;

- whether the system is properly implemented and maintained;

- whether the internal management review process is able to ensure the continuing suitability and effectiveness of the EMS.

The format of such reports can vary considerably and may range from completion of a simple pro-forma to expansive documents describing all aspects of the audit performance and findings. However, irrespective of the style and format, the audit report should cover the key topics already identified as being essential for discussion and presentation at the opening and closing meetings. In constructing the report two specific objectives must be borne in mind.

(1) The report has to provide objective evidence of effective implementation of the audit procedure.

(2) The report has to allow for corrective action to be addressed and that the follow-up requirements can be established and initiated.

Where there are non-conformances, there are various options regarding deficiency reporting. One option is to describe each of the deficiencies identified in the main body of the report along with any supporting evidence, and if requested, corresponding recommendations. Although this may result in a comprehensive report of audit findings, it has the disadvantage that the individual

deficiencies are often difficult to locate, particularly when trying to monitor follow-up actions.

This can be partly overcome by writing separate corrective action requests for this purpose. A useful alternative that is less time consuming is to restrict the description of deficiencies in the body of the report to general summaries only. Details of deficiencies can then be included in non-conformance notes. Ideally, the non-conformance note should also provide space for agreeing corrective actions and recording subsequent monitoring of that corrective action. In this manner, any duplication of effort with respect to audit reporting is minimized, thus producing a more easily managed system. It is important that however non-conformances are handled, it be constant with the EMS correction action process (ISO 14001, Section 4.5.2).

Before considering the steps in preparing the non-conformance note we must be clear about their purpose.

• To convey to the auditee the findings in a clear and accurate manner so that they know what to do next.

• To advise the EMS personnel or other auditors what you have found so that he can follow it up.

• To present a record that can be reviewed remotely from the scene and be understood.

All non-conformance notes must contain certain basic information.

• The physical area being audited.

- Failure to record this often results in great confusion 3 to 6 months later when a follow up visit is carried out to review corrective action implementation.

• The specific clause(s) of the assessment standard(s) against which the non-conformance is issued.

- If the auditor is unable to readily identify the applicable section of the EMS manual or the procedure against which to issue the non-conformance, he must question whether or not he is justified in writing the non-conformance. It is good practice to re-read the

requirements of the relevant system documentation to confirm that these can be interpreted as supporting the non-conformance. If they do not, then the non-conformance cannot be issued.

• The detailed nature of the non-conformance including the specific identity of documents/procedures/material, etc.

Earlier we considered the requirements for recording observations during the assessment and emphasized the need for them to be factual and to contain objective evidence that the system requirements were not being satisfied. Although this appears to be fairly straightforward, in practice this is often not the case. It is not unusual for inexperienced auditors to identify a deficiency only to fail to communicate the findings in a manner that facilitates implementation of the appropriate corrective action. The non-conformance note, while not being over long, must contain sufficient information to enable a person not present during the audit to be able to gauge the seriousness or otherwise of the observation.

The use of descriptive terms such as extensive, several, isolated, etc… is essential to communicate accurately the nature and extent of the deficiency, but care must be taken to ensure that their use does not result in a lack of objectivity; e.g., the term extensive can only be included if there is irrefutable evidence to justify its use. The auditor must also take care to ensure that the description is not only accurate but it is also fair, e.g., a statement that 50% of manifests were incorrectly signed may be accurate but is hardly fair if only two manifests were sampled.

Having documented the nature of the deficiency, some audit systems require the auditor to grade the deficiency or non-conformance, e.g., major and minor. It is not intended to discuss grading systems in detail since there are many potential variations that companies may wish to adopt. Irrespective of what system is being adopted, the auditor must ensure that the grading given and

the text describing the deficiency are completely compatible.

Distribution of the audit report and nature of documentation are decided between the auditor and auditee, although this too is usually addressed in the audit plan. An audit is considered successful when the auditee and client feel that they have useful, constructive feedback that allows them to improve the system.

ISO 9001 Documents Control – Elements and Requirements

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The ISO 9001 standard is caring for us. It cares for us from several angles. One of these cares regards our documentation. The standard requires that we will document by all means.
But it also cares that we won’t get confused and mix up different documents from different sources. Therefore it requires all documents to be controlled. This is not a recommendation but a requirement. You must control your documents. In order to achieve documents control you must maintain a method. This method must be one of the organizations quality procedures and it should be called “Documents Control”. In this procedure you must refer to the next line of issues.

Types of records
At first, you must define what documents this procedure would include. Documents can be working procedures, diagrams, technical specifications, price quotes etc. In order not to “swirl” around too many documents, let’s make it clear. Let’s define what a document is: Communication of information, evidence for correspondence, sharing of any kind of knowledge, approved documents. Someone within the organization must supervise all documents and see that they are suitable for working before they are released.The reason is to prevent any faults where unsuitable documents are being used or information that is classified is handed to wrong bodies. It is required to define for whom it is authorized and when must he approve any document. Who is responsible? The same one who is responsible for the information documented. It must be part of his job description. There are situations that more than one function would be needed to approve one document. It happens when more than one process is documented on one document.

Updated documents
This requirement assures that always the last version is the version in use – and not an older. Therefore you must define a method for maintaining updated version and elimination of older versions. How would one know what is the last version? Usually organizations manage a list of editions and updates for documents. You can manage the document itself. But most important, it is required to indicate the document itself as the last edition. This way, any employee that would use the document, would be sure that he holds the last edition. Of course, don’t forget to document the method.It is also required to define what to do with the old versions that are now not updated. How do you handle them? Are they to be destroyed, archived etc. Managing editions must include: Date of last update, The reason for the update, The function who demanded the update, The function that authorized the update. Although the ISO 9001 standard doesn’t require these requirements specifically, it would help you to achieve its basic requirements. Of course you would use what is suitable for your organization. Today there is a lot of document management softwares. These software, naturally qualify for the standard requirements but it is recommended to review anyone before purchasing.

Availability and distribution of documents
This is an un separated part of the last requirement. Defining the availability and distribution of documents must include the following:User authorization – to which it is authorized to use the document, the location of the document – where must the document be kept before and after use. Most of today’s process management systems (such as ERP or CRM systems) provide documents control relevant to the process they handle. They present the user with a screen (a screen on a computer system is a document like any other document) with defined information to input. Most of these systems also has authorization module installed. But when systems like the ones mentioned do not exist in the organization, it must provide with his employees the relevant updated documents. That means the latest editions. In order to ensure that, the standard require a documented method. How to obtain that? Well, it depends on your organization and his substructures.

Identification of documents
Any document (internal or external) must be identified somehow. Any internal document must have a name, serial number, catalogue number or whatever. Somehow to define it. The ISO 9001 standard requires that you maintain a method to achieve identification. The identification must include the numbering, coding or however you decided to identify it. But it is required to document the method. You must also include location of documents. How one can trace the document. for example customer’s files are scanned to the computer or stored in some closet. The final purpose of all this is to achieve control of the documents – any employee, once he looks at a document or trying to trace a document, would know where to approach: a department, a process, some function or any kind of identification relevant to your organization. If we look again at process management systems, then it is much simpler. Any document in those systems is identified by a number of some kind, produced by the system. The number is given according to some internal method. In this case you must not document this method but mention it in the procedure that these specific documents are managed. In case there are documents that are manually managed you must document the method. All this also applies for external documents. Any documentation that arrives from outside (with presumption that it is a document as defined) is included in the ISO 9001 standard requirement. In this case you must specify what is to do with these documents and where one can trace them in the hour of need. For example, where to file the documents. Again, you define the method according to your organization’s nature.

Documents removal
You must define a method for documents removal for any reason: un updated, out of use, etc. the method must include what is it to do with the document and who is responsible, once it is out of use. For example, removing old documents from the organization’s server for no further use or removing old forms from the offices that no one would use them again. Some of this things sound trivial and they are, but still this is a ISO 9001 standard requirement..

Summary:
The ISO 9001 standard requires that we document all sorts of our documents. It also requires that we would not confuse all kinds of documents from different sources. Therefore we must define a method for documents control. This is not a recommendation but a requirement.
The method must be presented as a documented procedure.
The documented procedure would be called “Documents control”.
You must include a definition of documents within the method – what is a document.
All documents must be approved before use. The purpose is to verify that the documents are suitable for work.
All documents must be updated. You must define a method to ensure the use of updated documents only. The method should include management documents editions and documents indications.
All documents must be identified. The organization must specify a method for documents identification. The purpose is that any employee would know which document he holds or where to trace it.
It is also required to manage availability and distribution of documents. You must verify that the documents that are distributed to the employees are the correct ones.
You must define a method for documents removal. When and why to remove documents and in whose responsibility.