ISO 9001 Standard - ISO 9001 Standards

ISO 9001 Standard - ISO 9001 Standards

ISO 9000 Training DVD

ISO 9000 Training DVD

ISO 9000 Training DVD

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The “Introduction to ISO 9001:2008” DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.

ISO 14001:2004 Training DVD

ISO 14001:2004 Training DVD

ISO 14001:2004 Training DVD

Global warming, ozone depletion, pollution and extinction of numerous species of animals. These are just a few of the environmental issues that the world faces, in the name of development. As responsible corporate citizens, companies can play their part in preserving our natural environment for our next generation by implementing ISO 14001:2004 Standards – Environmental Management System.

So, what is ISO 14001:2004 Standards – Environmental Management System? What is the requirement of the ISO 14001 standards? What is the content of Environmental Management System? What are the steps in implementing ISO 14001:204 Standards – Environmental Management System? You will find the answers in this “ISO 14001:2004 Standards – Environmental Management System” DVD.

The “ISO 14001:2004 Standards – Environmental Management System” DVD will elaborate in details on:

1. Introduction to ISO 14001:2004 Standards – Environmental Management System.
2. The history & origin of the standards.
3. Requirement of ISO 14001:2004 Standards.
4. Contents Of ISO 14001:2004 Standards.
5. ISO 14001:2004 Implementation Steps & Checklist.

No matter how simple or complex the business, each can benefit from the implementation of a management system based on ISO 14001:2004. This international standard has as its focus the prevention of pollution, accomplished by a teamwork approach to identifying those aspects of the organizations processes that have the potential for harming the environment and the development of ways to reduce or prevent this harm.

In the process, many organizations have found ways to reduce costs by elimination of scrap, changes to their waste disposal processes or reduced use of natural resources. It is the application of the system approach that has proven to be successful. And, once the system is in place, it is logical and beneficial to have that system certified and registered. This provides added assurance that the management system remains effective and also provides public recognition to numerous stakeholders that your organization is committed to the prevention of pollution.

ISO 9000 Document Control Procedures

The ISO 9000 Standard 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 standard 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.

Every process is likely to require the use of documents or generate documents

and it is in the process descriptions that you define the documents that need to

be controlled. Any document not referred to in your process descriptions is

therefore, by definition, not essential to the achievement of quality and not

required to be under control. It is not necessary to identify uncontrolled

documents in such cases. If you had no way of tracing documents to a

governing process, a means of separating controlled from uncontrolled may

well be necessary.

The procedures that require the use or preparation of documents should also

specify or invoke the procedures for their control. If the controls are unique to

the document, they should be specified in the procedure that requires the

document. You can produce one or more common procedures that deal with

the controls that apply to all documents. The stages in the process may differ

depending on the type of document and organizations involved in its

preparation, approval, publication and use. One procedure may cater for all the

processes but several may be needed.

The aspects you should cover in your document control procedures, (some

of which are addressed further in this chapter) are as follows

Planning new documents, funding, prior authorization, establishing need

etc.

- Preparation of documents, who prepares them, how they are drafted,

conventions for text, diagrams, forms etc.

- Standards for the format and content of documents, forms and diagrams.

- Document identification conventions.

- Issue notation, draft issues, post approval issues.

- Dating conventions, date of issue, date of approval or date of distribution.

- Document review, who reviews them and what evidence is retained.

- Document approval, who approves them and how approval is denoted.

- Document proving prior to use.

- Printing and publication, who does it and who checks it.

- Distribution of documents, who decides, who does it, who checks it.

- Use of documents, limitations, unauthorized copying and marking.

- Revision of issued documents, requests for revision, who approves the

request, who implements the change.

- Denoting changes, revision marks, reissues, sidelining, underlining.

Amending copies of issued documents, amendment instructions, and

amendment status.

- Indexing documents, listing documents by issue status.

- Document maintenance, keeping them current, periodic review.

- Document accessibility inside and outside normal working hours.

- Document security, unauthorized changes, copying, disposal, computer

viruses, fire and theft.

- Document filing, masters, copies, drafts, and custom binders.

- Document storage, libraries and archive, who controls location, loan

arrangements.

- Document retention and obsolescence.

With electronically stored documentation, the document database may provide

many of the above features and may not need to be separately prescribed in

your procedures. Only the tasks carried out by personnel need to be defined in

your procedures. A help file associated with a document database is as much

a documented procedure as a conventional paper based procedure.

ISO 14001 Standards Audit

SO 14001 sets out a system that can be audited and certified. In many cases, it is the issue of certification that is critical or controversial and is at the heart of the discussion about the trade implications.Certification means that a qualified body (an accredited certifier) has inspected the EMS system that has been put in place and has made a formal declaration that the system is consistent with the requirements of ISO 14001.The standard allows for self-certification, a declaration by an enterprise that it conforms to ISO 14001. There is considerable skepticism as to whether this approach would be widely accepted, especially when certification has legal or commercial consequences. At the same time, obtaining certification can entail significant costs, and there are issues relating to the international acceptanceof national certification that may make it particularly difficult for companies in some countries to achieve credible certification at a reasonable cost. For firms concerned about having certification that carries real credibility, the costs of bringing in international auditors are typically quite high, partly because the number of internationally recognized firms of certifiers is limited at present.2The issue of accreditation of certifiers is becoming increasingly important as the demand increases.Countries that have adopted ISO 14001 as a national standard can accredit qualified companies as certifiers, and this will satisfy national legal or contractual requirements. However, the fundamental purpose of ISO is to achieve consistency internationally. If certificates from certain countries or agencies are not fully accepted or are regarded as second class, the goal will not have been achieved. It is probable that the international marketplace will eventually put areal commercial value on high-quality certificates, but this level of sophistication and discrimination has not yet been achieved. It is essential to the ultimate success of the whole system that there be a mechanism to ensure that certification in any one country has credibility and acceptability elsewhere.The ISO has outlined procedures for accreditation and certification (Guides 61 and 62), and a formal body, QSAR, has been established to operationalize the process. At the same time, a number of established national accreditation bodiesheavily involved in ISO have set up the informal International Accreditation Forum (IAF) to examine mechanisms for achieving international reciprocity through multilateral agreements (MLAs). However, these systems are in the earlystages, and many enterprises continue to use the established international certifiers, even at additional cost, because of lack of confidence in the acceptability of local certifiers.Given the variability in the design of individual EMS and the substantial costs of the ISO 14000 certification process, there is a growing tendency for large companies that are implementing EMS approaches to pause before taking thislast step. After implementing an EMS and confirming that the enterprise is broadly in conformance with ISO 14001, it is becoming routine to carry out a gap analysis to determine exactly what further actions would be required to achievecertification and to examine the benefits and costs of bringing in third-party certifiers.
ISO 14001 Standards Certification

ISO 14001 Standards sets out a system that can be audited and certified. In many cases, it is the issue of certification that is critical or controversial and is at the heart of the discussion about the trade implications.

Certification means that a qualified body (an accredited certifier) has inspected the EMS system that has been put in place and has made a formal declaration that the system is consistent with the requirements of ISO 14001 Standards.

The standard allows for self-certification, a declaration by an enterprise that it conforms to ISO 14001 Standards. There is considerable skepticism as to whether this approach would be widely accepted, especially when certification has legal or commercial consequences. At the same time, obtaining certification can entail significant costs, and there are issues relating to the international acceptance of national certification that may make it particularly difficult for companies in some countries to achieve credible certification at a reasonable cost. For firms concerned about having certification that carries real credibility, the costs of bringing in international auditors are typically quite high, partly because the number of internationally recognized firms of certifiers is limited at present.

The issue of accreditation of certifiers is becoming increasingly important as the demand increases.

ISO 9001 Standards & ISO 14001 Standards

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

-No changes or minimum changes on user documents, including records

-No changes or minimum changes to existing processes of the organization

-No additional training required or minimal training required

-No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

-Provides clarity

-Increases compatibility with ISO 14001.

-Maintains consistency with ISO 9000 family of standards.

-Improves translatability.

ISO 9001 Documents Control – Elements and Requirements

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

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

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

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

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

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

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