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.

Audit Of Electronic Documents In ISO 9001 Standards

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

How To Prepare ISO 9001 Standards Audit Check List

How To Prepare ISO 9001 Standards Audit Check List

There are a few steps to prepare ISO 9001 Standards Check List, namely:

1. Apply the concept of Plan Do Check Act (PDCA). This PDCA concept is applied at the Quality Management System and the process levels.

2. Convert the question to requirement raised by QMR or the QMS Committee which derived from theISO 9001 standards. In this case, several questions can lead to one single requirement.

3. To edit those questions to suit the process that is to be audited. For example, you are going to audit the Purchasing/Procurement Department and you’re sitting down with the Audit Team trying to come up with relevant questions.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise. There is no better way to do that than by developing the audit questions with them.

Preparing ISO 9001 Quality Manual

Preparing ISO 9001 Quality Manual

The standard requires a quality manual to be established and maintained that includes the scope of the quality management system, the documented procedures or reference to them and a description of the sequence and interaction of processes included in the quality management system.

ISO 9001 defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the quality manual be a response to the requirements of ISO 9001. As the top-level document describing the management system it is a system description describing how the organization is managed.

Countless quality manuals produced to satisfy ISO 9001:2008, were no more than 20 sections that paraphrased the requirements of the standard. Such documentation adds no value. They are of no use to managers, staff or auditors. Often thought to be useful to customers, organizations would gain no more confidence from customers than would be obtained from their registration certificate.

A description of the management system is necessary as a means of showing how all the processes are interconnected and how they collectively deliver the business outputs. It has several uses as :

1. a means to communicate the vision, values, mission, policies and objectives of the organization

2. a means of showing how the system has been designed

3. a means of showing linkages between processes

4. a means of showing who does what an aid to training new people

5. a tool in the analysis of potential improvements

6. a means of demonstrating compliance with external standards and regulations

When formulating the policies, objectives and identifying the processes to achieve them, the manual provides a convenient vehicle for containing such information. If left as separate pieces of information, it may be more difficult to see the linkages.

The requirement provides the framework for the quality manual. Its content may therefore include the following:

1 Introduction

(a) Purpose (of the manual)

(b) Scope (of the manual)

(c) Applicability (of the manual)

(d) Definitions (of terms used in the manual)

2 Business overview

(a) Nature of the business/organization – its scope of activity, its products and services

(b) The organization’s interested parties (customers, employees, regulators, shareholders, suppliers, owners etc.)

(c) The context diagram showing the organization relative to its external environment

(d) Vision, values

(e) Mission

3 Organization

(a) Function descriptions

(b) Organization chart

(c) Locations with scope of activity

4 Business processes

(a) The system model showing the key business processes and how they are interconnected

(b) System performance indicators and method of measurement

(c) Business planning process description

(d) Resource management process description

(e) Marketing process description

(f) Product/service generation processes description

(g) Sales process description

(h) Order fulfilment process description

5 Function matrix (Relationship of functions to processes)

6 Location matrix (Relationship of locations to processes)

7 Requirement deployment matrices

(a) ISO 9001 compliance matrix

(b) ISO 14001 compliance matrix

(c) Regulation compliance matrices (FDA, Environment, Health, Safety, CAA etc.)

8 Approvals (List of current product, process and system approvals)

The process descriptions can be contained in separate documents and should cover the topics identified previously (see Documents that ensure effective planning, operation and control of processes ).

As the quality manual contains a description of the management system a more apt title would be a Management System Manual (MSM) or maybe a title reflecting its purpose might be Management System Description (MSD).

In addition a much smaller document could be produced that does respond to the requirements of ISO 9001, ISO 14001, and the regulations of regulatory authorities. Each document would be an exposition produced purely to map your management system onto these external requirements to demonstrate how your system meets these requirements. When a new requirement comes along, you can produce a new exposition rather than attempt to change your system to suit all parties. A model of such relationships is illustrated in Figure 4.10. The process descriptions that emerge from the Management System Manual describe the core business processes and are addressed in Chapter 4 under the heading of Documents that ensure effective operation and control of processes.

Scope Of The Quality Management System

Scope Of The Quality Management System

The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.

Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.

It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.

The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.

It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.

It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.

For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

ISO 9001 Quality Policy

ISO 9001 Quality Policy

The standard requires the quality policy to be appropriate to the purpose of the organization.

The purpose of an organization is quite simply the reason for its existence and as Peter Drucker so eloquently put it there is only one valid definition of business purpose: to create a customer”(Drucker, Peter F., 1977)2 . In ensuring that the quality policy is appropriate to the purpose of the organization, it must be appropriate to the customers the organization desires to create. It is therefore necessary to establish who the customers are, where the customers are, what they buy or wish to receive and what these customers regard as value. As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9001 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to quality policy.

Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’

– thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.

In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the quality policy.

One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision. Omitting the strategy may not ensure uniformity of approach and direction.

The standard requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system.

A commitment to comply with requirements means that the organization should undertake to meet the requirements of all interested parties. This means meeting the requirements of customer, suppliers, employees, investors, owners and society. Customer requirements are those either specified or implied by customers or determined by the organization and these are dealt with in more detail under clauses 5.2 and 7.2.1. The requirements of employees are those covered by legislation such as access, space, environmental conditions, equal opportunities and maternity leave but also the legislation appropriate to minority groups such as the disabled and any agreements made with unions or other representative bodies. Investors have rights also and these will be addressed in the investment agreements. The requirements of society are those obligations resulting from laws, statutes, regulations etc.

An organization accepts such obligations when it is incorporated as a legal entity, when it accepts orders from customers, when it recruits employees, when it chooses to trade in regulated markets and when it chooses to use or process materials that impact the environment.

The effectiveness of the management system is judged by the extent to which it fulfils its purpose. Therefore improving effectiveness means improving the capability of the management system. Changes to the management system that improve its capability i.e its ability to deliver outputs that satisfy all the interested parties, are a certain types of change and not all management system changes will accomplish this. This requirement therefore requires top management to pursue changes that bring about an improvement in performance.

The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008

The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008

Reduce the time and cost of implementing the new specification by acquiring a concise, yet thorough understanding the scope of ISO 14001:2004 and key terms.

Avoid spinning your wheels by learning precisely which modifications and additions to ISO 14001:2004require your attention for compliance with ISO 9001:2008.

Get a quick handle, through hands-on activities, on the environmental aspects of ISO 14001:2004, including how to:
- Develop an environmental policy statement appropriate for your company
- Integrate processes for identifying environmental aspects and impacts
- Identify environmental objectives, set related targets, and establish programs for achieving results
- Integrate environmental responsibilities and authorities into a management system
- Outline an environmental awareness and training program
- Establish environmental metrics and indicators for monitoring performance
- Integrate requirements on non-conformance and corrective and preventive actions into your existing system
- Understand the purpose and scope of the environmental management review
- Integrate document control requirements of ISO 14001:2004 into your current system
- Identify those operations that need to be controlled under EMS and identify emergency operations and contingencies that must be considered as part of EMS

Get off to a running start by learning to use a versatile prioritization matrix to identify and prioritize significant environmental aspects and impacts.

Optimize understanding and retention with the Plexus Learning Model
- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.
- Hands-on insights. Lecturing is minimized so learning is maximized.
- Learn by doing. Connect the lessons learned to your real world by using your current circumstances as examples for activities.

Implementing ISO 9001 Standards

Implementing ISO 9001 standards

If you have your own business and now you are looking for ISO 9001 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9001 Standards developed many quality standards as per different -different business areas.

ISO 9001 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.

For implementing ISO 9001 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards

An ISO consultant performs the various activities and explains the course objectives :

• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship

• describe the purpose of Quality Management Systems and 8 Quality Management Principles

• Interpret the ISO 9001: 2008 in the context of audit

•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems

• Develop understanding of Roles & Responsibilities of Lead Auditors

Hiring a Consultant is a better and easiest way to implement ISO in your organization.

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.

History Of ISO 9001 Standards

History Of ISO 9001 Standards

Pre ISO 9000
During World War II, there were quality problems in many British industries such as munitions, where bombs were exploding in factories during assembly. The solution adopted to address these quality problems required factories to document their manufacturing procedures and to prove by record-keeping that the procedures were being followed. The standard was BS 5750, and it was known as a management standard because it specified not what to manufacture, but how the manufacturing process was to be managed. In 1987, the British Government persuaded the International Organization for Standardization (ISO) to adopt BS 5750 as an international standard. The international standard was named ISO 9000 Standards.

ISO 9000: 1987 Version
ISO 9000:1987 had the same structure as the British Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organisation:
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organisations whose activities included the creation of new products
•ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 Standards but without covering the creation of new products.
•ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (MIL SPECS), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.

Implementing ISO 9000 Quality Management System

Implementation of ISO 9000 affects the entire organization right from the start. If
pursued with total dedication, it results in 'cultural transition' to an atmosphere of
continuous improvement.
The process of implementing ISO 9000 depends on:
􀂃 a. The sophistication of your existing quality program,
􀂃 b. The size of your organization, and
􀂃 c. The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully.
Step 1: Top management commitment
Step 2: Establish implementation team
Step 3. Start ISO 9000 awareness programs
Step 4: Provide Training
Step 5. Conduct initial status survey
Step 6: Create a documented implementation plan
Step 7. Develop quality management system documentation
Step 8: Document control
Step 9. Implementation
Step 10. Internal quality audit
Step 11. Management review
Step 12. Pre-assessment audit
Step 13. Certification and registration
Step 14: Continual Improvement

Assessment to ISO 9000 Standards

Assessment to ISO 9000 Standards
Once all the requirements of ISO 9000 have been met, it is time for an external audit. This should be carried out by a third party, accredited certification body. In the UK, the body should be accredited by UKAS. The chosen certification body will review the quality manuals and procedures. This process involves looking at the companys evaluation of quality and ascertains if targets set for the management program are measurable and achievable. This is followed at a later date by a full on-site audit to ensure that working practices observe the procedures and stated objectives and that appropriate records are kept.
After a successful audit, a certificate of registration to ISO 9000 will be issued. There will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work.

Why Is ISO 9000 Important?

ISO 9000 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal.
ISO 9000 is important because of its international orientation. Currently, ISO 9000 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence.
ISO is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesnt go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9000 is important.

ISO 9000 Standards

ISO 9000 Standards - ISO 9000 Standard Software
The term ISO9000 Standards refers to a set of quality management standards. ISO9000 currently includes three quality standards: ISO 9000:2005, ISO 9001:2000, and ISO 9004:2000. ISO 9001:2000 presents requirements, while ISO 9000:2005 and ISO 9004:2000 present guidelines. All of these are process standards (not product standards).

ISO 9001 Standard 's purpose is to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.

The ISO 9001 Standards apply to all kinds of organizations in all kinds of areas. Some of these areas include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gas, pulp and paper, petrochemicals, publishing, shipping, energy, telecommunications, plastics, metals, research, health care, hospitality, utilities, pest control, aviation, machine tools, food processing, agriculture, government, education, recreation, fabrication, sanitation, software development, consumer products, transportation, design, instrumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on.

Origin Of ISO 9000 Standards

Origin Of ISO 9000 Standards

Why is ISO 9000 Important?

Why is ISO 9000 Important?