About ISO 14001:2004 Standards

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

About ISO 14001

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

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

EMS and ISO 14002 gives the basic guidelines for EMS.

Environmental Management System with ISO 14001:2004

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

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

How does it work?

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

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

What Should Be Documented In Quality Management System?

What Should Be Documented In Quality Management System?

Clause 4.2.1 in ISO 9000 Standards requires quality management system documentation to include 5 types
of document:
(a) Quality policy and objectives
(b) Quality manual
(c) Documented procedures
(d) Documents needed to ensure the effective planning, operation and control of processes
(e) Records
Other than the requirements in clause 4 for documentation, there are 14 other references requiring documentation. These are as follows:
(a) The output of the planning
(b) The quality manual
(c) A documented procedure for document control
(d) A documented procedure for the identification, storage, retrieval, protection, retention time and disposition of records.
(e) Planning of the realization processes
(f) Inputs relating to product requirements
(g) The outputs of the design and development process
(h) Design and development changes
(i) The results of the review of changes and subsequent follow up actions
(j) A documented procedure for conducting audits that includes the responsibilities and requirements
(k) Evidence of conformity with the acceptance criteria characteristics of the product
(l) A documented procedure for nonconformity control activities
(m)A documented procedure for corrective action
(n) A documented procedure for preventive action
This list is somewhat inadequate for documentation purposes because it does not tell us what types of things we should document or provide criteria to enable us to decide what we need to document. ISO 9000 clause 2.7.2 includes a more useful list of document types that are classified as follows:
(a) Quality manuals
(b) Quality plans
(c) Specifications
(d) Guidelines
(e) Procedures, work instructions and drawings
(f) Records

General Description of ISO14001 Standards

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

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

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

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.)

Aligning At ISO 9001 Standard Requirements

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.