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.

ISO 9001 Standard Quality Manual Template

ISO 9001 Standard Quality Manual Template

The quality manual is the necessary cornerstone for any business venturing out on the ISO 9001:2008 accreditation route as it exhibits top management’s determination to managing an useful quality management system. The quality manual is a type of most essential document which provides the right impression to clients, staff, inspectors and all the parties interested in your company, about your company’s efforts to satisfy all their clientele’s needs. People through your company will relate to it whenever they prefer to find the big picture of the system, or exactly what guidelines have been organized. You can save your valuable time and hard earned money with the quality manual template we offer you. If you really compile the quality manual, you will easily comprehend and apply ISO 9001:2008, which is one of the best methods to do so.By reading by the needs one-by-one and assigning each prerequisite a specific document, process or technique that exists within your company, you will get that over half of the demands have already been resolved. Quality manual makes the relation, between the process and the documents, an official one. Format and content Write your quality manual to ensure that it works for you, for your company and also the manner you work, it is totally your selection however generally make sure that it supports your organisation’s targets. The quality manual should not contain any confidential or proprietary information as it should be readily available to third party auditors and customers. You should also ensure that a clear distinction is made between the contents of the quality manual and the procedures. The quality manual identifies the intention of top management for the operation of the quality management system, whilst the operations explain how these kind of purposes are integrated. There are three things that must be included in the quality manual:

1. The probability of the quality management system such as details of the validation of any exclusions

2. For quality management system, the procedures should be standard or should be mentioned in them

3. A explanation of the discussion between the procedures of the quality management system Who will use your Quality Manual and why?

In general, the clients and the prospective customers need it in order to know how your company system meets their requirements. If your quality manual includes two pages, it may not motivate trust that your system is strong enough to be an useful quality management system. Customers and Clients want assurance that you know how to plan, implement, and control the processes that affect their products or service delivery. The third party inspectors will b interested to know how your company meets their standard needs and also if perhaps the quality management system is useful in accomplishing your organization’s targets. Auditors will use the quality manual as a guide to help out discover and also form the purpose facts that they have to find in exhibition of your company’s compliance with the standard. Internal inspectors can review and inspect their own company for their needs rather than referring to standard documents from external sources. Management ought to be able to determine, from the manual, how the numerous processes and also systems have interaction, and at a high level what policies and methods have been established to maintain and control the processes and systems . The quality manual is usually presented to fresh recruits to familiarize themselves with the organization’s quality management system and also the manuals are often used as an in-house training resource. Most importantly, your quality manual ought to not sit on a dirty shelf or be hidden in an obscure position on the computer network; it is an active and powerful document that requires coverage in order for it to grow and also improve. Please click on the links below to learn more about Quality Manual Templates and view some free examples.

Why do organizations implement ISO 9000 systems?

Why do organizations implement ISO 9000 systems?

More often than not, organizations get ISO 9000 because certain customers force them or encourage them to. In many market sectors—electronics, pulp and paper, telecommunications, automobile manufacturing, defense—major customers have mandated ISO 9000 registration to their key suppliers. Similarly, some overseas regulatory bodies mandate ISO 9000 for the makers of qualitysensitive products (such as medical devices).

Many of these major customers impose ISO 9000 systems in place of, or in addition to, specific quality programs, requirements, specifications, and so on that have been in place for many years. The ISO 9000Standard becomes a key part of the relationship between the customer and its suppliers.

ISO 9000 is not, however, meant to replace customer-specific requirements in any market segment. Rather, ISO 9000 is meant to be a floor: a basic set of generic requirements. They are generic enough to apply to virtually all supplier/customer relationships anywhere in the world. It matters not the size of the supplier, the location of the customer, or the nationalities involved.

In some industrial segments, formalized standards have been created, adding to the generic ISO 9000requirements additional clauses that are industry specific. Examples include:

_ Automotive (QS-9000).

_ Aerospace (AS-9000).

_ Telecommunications (TL-9000).

To the extent that ISO 9000 replaces customer-specific quality programs and supporting audit/oversight activities, it can relieve both customers and suppliers of a great deal of redundancy, duplication, and waste of resources. The fundamental requirements are understood, agreed to, and (usually) confirmed by objective third-party audit. This gives customers confidence in the integrity and effectiveness of their supplier’s basic quality practices. The customer and supplier can then invest their energies and resources in agreeing to and working on the specific requirements unique to their relationship.

To some, ISO 9000 sounds like a mandatory, gun-to-your-head, my-way-or-the-highway program. For many suppliers, it is exactly that (“get ISO 9000 or get lost”). For many others, it is perceived that way:

“They’re trying to tell us how to run our businesses.”

But the goal of ISO 9000 is not to strengthen customers’ control over how their suppliers run their businesses. The goal is to give customers confidence in the ability of suppliers to meet their needs, resulting in satisfied customers, and growing and prosperous suppliers.

Admittedly, implementing ISO 9000 does not guarantee this. Like most things, what you get out of it depends on what you put into it. You can implement a compliant ISO 9000 system that is all cost and no benefit and it’s even possible to pass registration audit this way. This happens, usually, when the supplier’s approach is to try to:

_ Squeak by.

_ Do just enough to get registered.

_ Get this thing done without changing how we work.

But suppliers who implement ISO 9000 fully—to the spirit, as well as the letter—can and do achieve real benefits.

Role of Governments in ISO 14001 Standards

Role of Governments in ISO 14001 Standards

Although ISO 14001 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop the
basic capabilities to adopt ISO 14001. There are wo particular areas in which government action would be useful:
(a) providing information on he sectors and markets where ISO 14001 certification s a significant issue and assisting sector rganizations to develop appropriate responses, and
(b) helping to establish a certification framework, ased on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certification
services. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.

Governments should see EMS approaches as part of a broad environmental strategy that includes regulatory systems, appropriate financial incentives, and encouragement of improved industrial performance. Such encouragement can really only be effective where there is cooperation at the government level between the relevant departments, including industry and trade, as well as environment. There is a growing interest in integrating environmental management issues into productivity or competitiveness centers designed to promote SME performance, but little information exists on experience to date.

ISO 9000 Softwares

ISO 9000 Softwares

1. ISO 9000 Software – ISO 9000 Document Control Software

The concept of document control is integral to ISO 9000. Specifically ISO 9001: 2000, requires the establishment of a document control system that stores and manages documents relating to implementing, maintaining, and continually improving a quality management system. Within the context of ISO 9000, a quality system must be documented and quality records must be maintained. Document control helps ensure effective operation and facilitates better decision-making, by providing a vehicle for employees, customers, and partners to access controlled documentation from any location at anytime.

For high-tech companies that adhere to ISO 14000 environmental management standards, document control procedures are equally necessary to help them continuously improve their environmental management system.

The ISO 9000 Document Control Software is developed & designed to control the ISO 9000 Quality Manual, Operating Procedure, Forms & Documents digitally. System will track the all ISO 9000 Documents by ISO Document No. through out the system.

The ISO 9000 Document Control Software Provides:-

Tracking of Documents- Provides secure tracking of all your ISO 9000 Quality Manual, Operating Procedure & Forms & Documents in any format either in Microsoft Word, Excel, PDF or etc.
Efficiency Document Control- It’s uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits.
Revision Control- Tracking of Document revisions, approval & Release Date. Manually Tracking down any revision on the ISO 9000 document activity is difficult . The ISO 9000 Document Control Software will help to keep track the numbers of revision have been carried out, and also maintain the various revision copies of the documents.
Multiple File Location – System will be able to keep track the directories & folder where the original location is saved.
Centralize Of Document Control – Do not worry about the various department is getting the correct edition of the documents, because all documents have been managed by a centralize software. Document reviews are conveniently scheduled and documented.
Security:System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.
2. ISO 9000 Software – ISO 9000 Audit Control Software

The ISO 9000 Audit Control Softwarewere designed to handle all aspects of an internal or external audit programme, from planning audits to the follow-up of corrective actions against deficiencies found.

The Control Software increases the accountability and efficiency of your internal/external audits by developing core processes with clearly defined audit plans, step-by-step procedures, and standardized auditor roles and responsibilities. It will help to put you to the right path toward developing a well-organized ISO9001:2000 internal /external audit system.

The ISO 9000 Audit Control Software Provides:-

Audit Schedule – maintains the audit schedule, checklist preparation and all audit info.
Track Non-Conformance – System will help to track all non-conformances found during the audit, including actions & verification.
Corrective Action Report (CAR) – Update of the corrective action.
Security: System provide User Right Control module which enable System Administrator to define the access right to authorized users and activity allowed.

ISO 14001 – Application to Small and Medium Size Enterprises

ISO 14001 – Application to Small and Medium Size Enterprises

Most of the development and application of EMS has taken place in large companies. The use of such systems in small and medium-size enterprises (SMEs) has been limited—although it is in this segment of industry that some of the largest benefits might be anticipated, because of the difficulty of regulating large numbers of small firms and the potential efficiency improvements that are believed to exist. In practice, however, the characteristics of the typical SME make the adoption of EMS difficult: most SMEs do not have a formal management structure, they lack technically trained personnel, and they are subject to severe short-term pressures on cash flow.

Anecdotal evidence indicates that an EMS cannot be used to drive improved performance in a poorly organized SME. Targeted training in management and quality control can improve overall performance, including its environmental aspects, and can provide a basis for more specific EMS development. Many firms can reap significant benefits from introducing quality management concepts, even where they are not aiming at formal certification. Any steps in this direction should be encouraged.

An EMS, as normally envisaged, builds on existing production and quality management systems. Where such systems are weak or ineffective, as is often the case in enterprises that have poor environmental performance, a better management framework has to be established before focusing on the details of the EMS. The costs of establishing an EMS will therefore obviously depend on the starting point in terms of both management systems and environmental performance.

The ecoefficiency savings can, in some cases, pay for the costs of establishing the EMS, particularly if most of the planning and organizational work is carried out in-house. However, a poor performer will very likely have to invest in production upgrading or pollution control in order to meet environmental requirements, and these costs can be significant.

A full EMS can be complex and can require an appreciable commitment of operational resources.

However, the final system can be reached reasonably through a series of discrete steps, starting from a basic, simple procedure and becoming more comprehensive and sophisticated as capabilities and resources allow. In this way, even a small enterprise can begin to put in place the basic elements of an ISO 14001 system and can develop them at an appropriate pace. Once the basic EMS is in place, it is possible to carry out a gap analysis and to make a balanced judgment on the costs and benefits of seeking certification.

A related issue is the coverage of the EMS. Certification is normally for specific sites or facilities.

A large enterprise may have a number of different sites and production facilities and may choose to seek certification only for a subset of the sites.

Role of Governments In ISO 14001 Standards

Role of Governments In ISO 14001 Standards

Although ISO 14000 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop the basic capabilities to adopt ISO 14000. There are two particular areas in which government action would be useful: (a) providing information on the sectors and markets where ISO 14001 certification is a significant issue and assisting sector organizations to develop appropriate responses, and (b) helping to establish a certification framework, based on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certification services. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.

Governments should see EMS approaches as part of a broad environmental strategy that includes regulatory systems, appropriate financial incentives, and encouragement of improved industrial performance. Such encouragement can really only be effective where there is cooperation at the government level between the relevant departments, including industry and trade, as well as environment. There is a growing interest in integrating environmental management issues into productivity or competitiveness centers designed to promote SME performance, but little information exists on experience to date.