Integrate ISO 14001 with Existing procedures

Much of what an organization must do in an ISO 14001 EMS is probably already being done. No organization can operate without some environmental programs in place. These programs may need modification to comply with the ISO 14001 standard, but they serve as a good starting point to begin construction of an ISO compliant EMS. In fact, a good way to look at your EMS Manual is to view it as a road map. It will tell people where to find programs the organization uses to handle environmental concerns such as: wastewater systems operational manuals, air permit operating requirements, hazardous wastes handling procedures, materials purchasing requirements, and so forth.

A well-conceived ISO 14001 EMS will use existing environmental programs and procedures as a foundation. It will also include the business management practices of the company wherever possible. An example of this would be tying environmental impacts of raw materials purchases into an existing procedure to review raw materials specifications for engineering requirements and consistency. Many firms already have such procedures in place.

Other types of program integration may include integrating cost accounting practices with environmental operational practices. Many organizations cannot actually determine where their environmental dollars go. As a result, they cannot identify opportunities for financial improvement in environmental practices. Without such information, the environmental management of an organization is difficult. If management cannot see any cost benefit in environmental decision making, the managers usually take the least costly option. Activitybased costing allows a more comprehensive understanding of how environmental expenses are accrued by process and product rather than by facility or region. Then process control and product design can be reviewed to see if costs associated with their environmental impacts can be minimized. This is a good example of what ISO 14001 hopes to accomplish–good financial management leading to better environmental control.

Initial Review Of Gap Analysis In ISO 14001

A fundamental concept of the ISO 14001 EMS Standard is continual improvement of environmental performance. Before you can plan for improvement, you must first determine the current state of the organization’s environmental programs.

The initial review or gap analysis is, in itself, a microcosm of a well-organized approach to the entire ISO 14001 EMS development process. Each specification of the standard must be reviewed, including policy, legal requirements, training, objectives and targets, operational control systems, document control, auditing, management review, and corrective action.

The review should take into account the culture, products, marketing strategies, and other specifics of the organization. In all cases, consideration should be given to the full range of operating conditions, including possible incidents and emergency situations that may be encountered.

The ability of suppliers and subcontractors to comply with the Organization’s EMS program and applicable regulatory requirements should also be evaluated. It is strongly recommended that the initial review consider energy use, financial accounting, and information systems so that these issues may be integrated into the EMS program.

To effectively begin the Initial Review, several things must happen. First, Management should issue a company-wide announcement of intent and endorsement. This should include estimates of the time required to complete the Initial Review, and time required to complete the entire project. Second, the project leader should be identified and vested with ample authority for completion of the project.

The Initial Review is a review of all pertinent documents, from which an accurate plan is designed for the EMS Gap Analysis.

All information from the review, including deviation from regulatory requirements and adverse impacts on the environment, should be identified along with policies, programs, procedures, training and work instructions, and operational controls.

A portion of the project team should begin to assemble a registry of appropriate regulations identified during the Initial Review. All pertinent national, state, local and self-subscribed requirements should be assembled. They should be compared with identified environmental impacts.

An Initial Review is also important in ensuring that EMS design is compatible with all current organizational management structures and operations wherever possible. This is especially important where the EMS interfaces with the site’s existing health and safety, accounting, computer systems, purchasing, energy utilization and other management programs. The focus will be to achieve operational efficiencies that ensure environmental improvements and maximize cost reductions.

Initial Review outputs will be:

· An EMS Gap Analysis Design that details where existing environmental management procedures must be further investigated to determine conformance with the Standard.

· A review of the site’s overall environmental management strengths/weaknesses.

· A schedule of events for the Gap Analysis.

The gap analysis allows for a quick but comprehensive assessment of the facility’s existing environmental management practices and procedures, and compares them

with the requirements of the Standard. To perform the Gap Analysis, a standard template tailored for that specific purpose is used. The template is a questionnaire with a three way scoring system, which develops a final rating of the current programs of the site as they compare with the sections of the Standard. The score from this questionnaire and investigative template identifies which areas of the EMS might be enhanced to improve environmental performance and comply with the Standard.

Based on the results of the Gap Analysis, the project schedule and design may require modifications. Modification should precede further systems development. Using the results of the Gap Analysis, the EMS developmental process can now begin.

This may involve modifying existing procedures, adapting other business procedures such as those designed for health and safety, accounting, or risk management to environmental utilization. At certain points, new procedures will be required.

Prior to embarking on EMS development, always remember that the more flexible your EMS is, the easier it will be to implement and the more flexible it will be in the future.

ISO 9000 Standards Certification and Registration

The International Standards Organization is responsible for two major sets of requirements that relate to an overall quality management system to be used by businesses. The ISO 9000 family of standards is the primary set of requirements for most businesses.

Quality management by definition address that the organization does certain things to “fulfill the customer’s quality requirements and applicable regulatory requirements while aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objectives”.
ISO 14000 address the environmental management to minimize harmful effects to the environment. Again, it is a quality management system designed to “achieve continual improvement of its environmental performance.

ISO certification 9000 is the most common. So, let’s take a look at what ISO certification entails and what it means. To become certified, a quality management system must be in place that meets the requirements of the ISO standard. This begins with the business recognizes the requirements and developing a quality system to meet their needs at the same time they meet the requirements.

ISO 9000 certification and ISO 9000 registration are two different entities, though they are often used interchangeably. To achieve ISO certification 9001 , an independent registrar is hired to audit the quality system for thoroughness and compliance to all the standards. When this is accomplished, the business is offered a certificate stating that the quality system conforms to standards within the particular standard.

ISO registration means that the certification has been recorded in its client register. Because most companies have been certified and in turn registered, the terms are offed interchanged in general use. While the term “certification” is the most widely used, “registration” used in North America. Both are completely acceptable, because the business has fulfilled the requirements set forth by ISO.

ISO 9000 Document Management Software System

Today’s manufacturing companies that seek ISO 9001 compliance-(regardless of their motivation to do so) probably don’t find it that difficult to create intelligent documentation. After all, a few days with a good consultant or a quality manager can take care of document creation. The problem lies in the gap between what employees are doing and what employees are supposed to be doing (in terms of adhering to documentation) and the gap between the manner in which processes are being implemented and the manner in which they should be implemented ( in accordance with documentation). In other words, the problem lies in the way processes are strategized and applied and in the way employees commit to standards when compared against existing documentation. How can a company overcome these issues? The answers may be simpler than you think.

Automation is the Answer for ISO Control
If your underlying processes are poorly strategized then an automated document management software system won’t be of much use. However, once the processes have been effectively planned (and applied) a document management software system can speed process-to-process management by leaps and bounds. Companies that automate not only to comply with ISO standards but to generate more revenue by performing less administrative labor save weeks and even years worth of time just by automating their processes and documentation control with a document management software system.

Making Amends
The right document management software system and ISO document control would also allow companies to find deviations and nonconformance events faster and move those events to resolution phases in a small fraction of the time they were originally routed—if they were routed at all. Some ISO 9000 document management software systems may even be combined with a CAPA QMS solution. This is especially valuable when determining the root cause of major to minor deviations.

A Document Management Software System and Employee Training
ISO standards do not require any type of automation but ISO standards lend themselves to automation in a way that’s quite remarkable. Take for instance the following document management requirements from the official ISO 9001 International Standard.

ISO 9001 Section 4.2.3
ISO standards make it clear that ISO 9001 “approved” companies must define (i.e., document) how they will approve documentation, how they will identify documentation changes, how they will update/reapprove revised documentation, how external documentation will be managed and how assurance will be provided that documentation will be available when it is required. 1 And that’s only a shadow of things to come! A document management software system designed for strict compliance can automate the approval of documentation, the identification of document changes, updates and reapproval notifications, external documentation management and high-level document security. Some solutions also integrate training and online exams as well.

How Much Could You Save?
Chances are high that automation will save you thousands, tens of thousands or even hundreds of thousands of dollars annually depending on the size of your company. Just foregoing a typical document routing process (a manual process) can save many employees fruitless trips back and forth from one office to another. Who wouldn’t want to avoid those time consuming searches through 3-ring binders and lost documentation due to employee absence or neglect?

Conclusion
Regulation and control are the future for manufacturing. Gone are the days of free experimentation and a blind eye toward material waste. Today is the day of premeditated design, quality assurance and web-based automation. If your company plans to be, or already is, compliant with ISO 9001 standards why not consider automating those ISO 9001 controls with a document management software system.

Why Is ISO 9001 Standards Important?

Industrialization has completely gone under a drastic change with the growling levels of development. With the advancement in technology, there is huge competition between major players. Thus, to stand up with such high competition and developments, all sectors must produce apt services and products according to the needs of the consumers.

This could be just that the quality management system intends continual development in the company beginning from the purchasing department, design, marketing, production, and various other departments in order to provide the best of services and products, which is harmless to both the consumers as well as the environment.

To maintain the quality standards, one needs to get International Organization for Standards (ISO) that symbolizes the quality management standard at international standards. For every company, which deals in facilitating any type of services and goods, it is very important to get certified from ISO 9001:2008.

ISO 9000 is a group of standards for the quality management system and is managed or administered by the certification and accreditation bodies. Few of the requirements in the ISO 9001, one of the standards from the group or family of ISO 9000 include:

A set of methods, which covers all the main and essential processes in the industry
Monitoring each and every process to make sure that it is effective
Maintaining adequate records
Checking all outputs for any kind of defects with corrective and appropriate action where required
Regularly reviewing individual procedures and quality system as well for its effectiveness
Last but not the least, facilitating continual improvement

An organization or company, which has been autonomously certified and audited to be in conformity with the ISO 9001:2008, might publicly state that it is certified with International Organization for Standards 9001:2008 or ISO 9001:2008 registered. Nevertheless, certification with ISO 9001:2008 standards does not ensure conformity and thus the quality of end services and products, to a certain extent certifies that reliable and dependable business procedures are being applied.

Besides, to get the ISO 9001:2008 certifications, one is required to accomplish various obligations of quality control. Few of the vital clauses that must be put up to avail the ISO 9001:2008 include knowledge, range, expressions, identifications, resource management, conscientiousness, analysis, product recognition and measurement. To avail the international standards for organization 9001 certificates, one can easily get them from several certificate providers.

The providers provide the certificate once they have carefully analyzed the production and various other production departments that include quality control standards. In addition, ISO 9001:2008 is offered only when the parent company is pleased and convinced with the output. Hence, for those individuals or businesses that are looking forward to seek ISO 9001:2008 certificates, they must make sure that they fulfill all the required industrial norms.

The practice of ISO 9001:2008 for successful operation and improved customer contentment shows the way to retention of the services and goods for a longer period. With the application of ISO 9001:2008, one can also experience decreased audits and improved marketing. ISO 9001:2008 assists in endorsing international deals, revenue that directs to worker enthusiasm and self-esteem inoculation of types.

For more information on ISO 9001 Standards, kindly visit http://www.iso9001store.com

Quality Product By ISO 9001 Certification

The International Organization for Standardization (abbreviated to ISO) conducts standards for institutes which are organized in more than 159 countries across the globe. The ISO has its head office in Geneva, Switzerland. In simple terms ISO certification is given to an organization in order to indicate that the organization has good standards and it is working well with its employees and its customers. The International Organization for Standardization is not a Government organization. It acts as a bridge in between the private and the public sector and brings out good standards for many organizations across a variety of industries.

There are many standards that are released by the ISO. One of the standards is the ISO 9001 certification. The reason why an organization may require the ISO 9001 certification is to ensure that the company has a very good quality management system in place and can then confirm this to their customers. Also, if an organization has ISO 9001 certification it can ensure to its suppliers that it is following a good standard regarding it’s quality management system. The main two reasons for going for the ISO 9001 certification are to show how effective a company’s production is as well as helping to give good recognition for other new markets concerning their company standards.

The main aspects of ISO 9001 certification are maintaining good quality of products and also to maintain low cost and high efficiency for the production process. The primary thing that is checked with ISO 9001 certification is to confirm that the quality goals that are set out in the company’s quality management system are met. It is also important that once a company gets its ISO 9001 certification they should be seeking to improve all the time. There should be an increase in productivity as well. The goals of ISO 9001 certification are to increase the efficiency, increase the revenue, establish proper decision making, achieve good supplier relationships and prepare documentation work about the company plans, a regular improvement process should be in place and on the whole a complete customer satisfaction system should be implemented.

The ISO 9001:2008 certifications have a few revised benefits and let us see a few of them in detail. The goals of the ISO 9001 are the same for all year where as a few enhancements will be added for every year. Likewise the ISO 9001:2008 certification’s benefits include cost reduction in the production of goods, greater customer satisfaction, improved product efficiency and improved productivity, reduction in the scrap and waste products. The aim is to prepare a quality product which passes the goals of the quality management system. The ISO 9001 certification itself should result in the reduction of customer claims, a proper delivery to the customer on time, providing great reliability, safety and quality to the products. So on the whole the ISO 9001 certification has many good policies for the organization and they are also ensuring that the quality of the product should be good, efficient and cost effective, with an increase in the productivity.

Kindly visit http://www.iso9001store.com for more information.

The Audit Plan In ISO 14001

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.