ISO 9001 & ISO 14001 Standards

ISO 9001 includes the following standards:
•ISO 9001:2008 Quality management systems Requirements is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfill to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints.
This is the only implementation for which third-party auditors can grant certification. It should be noted that certification is not described as any of the ‘needs’ of an organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 ‘Scope’) but does recognize that it may be used for such a purpose (see ISO 9001:2000 section 0.1 ‘Introduction’).
•ISO 9004:2000 Quality management systems – Guidelines for performance improvements covers continual improvement. This gives you advice on what you could do to enhance a mature system. This document very specifically states that it is not intended as a guide to implementation.
There are many more standards in the ISO 9001, many of them not even carrying “ISO 900x” numbers. For example, some standards in the 10,000 range are considered part of the 9000 group: ISO 10007:1995 discusses Configuration management, which for most organizations is just one element of a complete management system. ISO notes: “The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards … Organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole”.
Note that the previous members of the ISO 9000 series 9002 and 9003 have been integrated into 9001. In most cases, an organization claiming to be “ISO 9000 registered” is referring to ISO 9001.

Who Is ISO 9001 Consultant?

ISO 9001 Consulting has been available ever since the ISO management system standards were initially published in the late 1970’s. As of now, nearly a million business companies internationally have been certified to one or more of several ISO business standards. These include ISO 9001, ISO 14001, AS9100, ISO/TS 16949, etc. The statistics that have been accumulated to date indicate that while many organizations deployed ISO standards using internal know-how, those that used outside ISO 9001 consulting services profited the most in terms of speed of implementation, effectiveness and return on investment.

ISO 9001 Consultancy firms provide a numberof services. Let’s take a look at some of these so that you can determine what collection of services would best suit your company:

How To Interpret The ISO 9001 Standard?

The ISO 9001 quality management system standard can be a hard document to understand. It is written in semi-legal language and specifies requirements in in a very general sense. This is deliberately so, as it is meant to consider just about any type of business activity. Many companies have problems relating it to their specific organizations. An experienced ISO 9001 consultant can show you exactly how to apply the standard to your specific business processes.

ISO 9001 Gap Evaluation

Prior to implementing the ISO standard within your organization, you need to know the gap between your existing business practices and controls relative to ISO 9001. Using ISO 9001 consulting services, you can have an evaluation done of your current management system practices, controls and documentation, to determine to what extent you comply to ISO 9001 requirements. The consultant will give you a detailed audit report listing the gaps in your company, along with their recommendations. This will assist in developing your ISO 9001 project implementation plan to accomplish full compliance.

ISO 9001 Project Planning and Organization

Depending size and complexity of your business, an ISO 9001 implementation project can take as few as 4 months to over 18 months to complete. Your ISO project needs to well-planned in terms of time and resources needed, specific activities to be carried out, who will be responsible for each activity, milestone reviews, authorizations, training, dealing with problems, etc. A good ISO 9001 consultant can be an invaluable resource in assisting a business address with this important activity.

ISO 9001 Business Process Identification and Documentation

ISO 9001 views business processes as the main point of control. These include internal as well as outsourced processes. Quite a few companies have issues differentiationg between processes, departments and functional activities. ISO 9001 consulting experts can assist you identify and effectively document all organizational processes pertaining to your quality management system. These include customer-oriented, management, product realization, resource planning, measurement, support and outsourced processes.

ISO 9001 System Development and Implementation

The main thrust of the ISO 9001 standard is on effective planning, operation and control of thrust all relevant quality management system processes. This is probably the most time-consuming and difficult aspect of any ISO implementation project. Many questions may arise as to what processes must be be controlled, what should be an effective control, how best to communicate and implement it, the inter-process impact, how to set process goals and objectives and what records to keep. Here is where using external ISO 9001 consulting will significantly help in answering these questions, provide focus and speed up implementation.

ISO 9001 Management System Documentation

The latest ISO 9001:2008 standard minimizes the emphasis on documentation and maximizes its attention on effective planning and control. Adequate documentation is however needed for many business processes in order to establish consistent application of effective controls. Some business have either too much or too little documentation. An experienced consultant can help your organization determine where it is needed, how much and how it should be documented.

ISO 9001 Pre-assessment

ISO 9001 Registrars (also referred to as Certification Bodies) conduct their certification audit in two stages. In stage 1, they determine your state of readiness (which includes your planning, documentation and internal review activities) and in stage 2 they evaluate your management system for effective implementation of planned controls, in both cases relative to the ISO 9001 standard. After spending several months of implementation, you feel your company ready for the certification audit, it might be useful to use external consulting to do an assessment to determine if you are truly ready, identify any issues and help you take appropriate corrective action, prior to the Registrar audit.

ISO 9001 Training

ISO 9001 Consultancy services generally provide a number of training alternatives. These include

- ISO 9001 awareness training to employees at all levels

- An executive summary of the ISO standard to senior management

- Process identification, mapping, analysis and improvement

- ISO project management

- ISO documentation and implementation

- Internal audit

- Use of problem-solving tools

Based on the amount of internal expertise inside your organization, you may want to have an external ISO 9001 consulting service provide some or all of this training.

Develop and Maintain your ISO 9001 Internal Audit Program

To be certified and maintain your certification, the ISO 9001 Standard requires your organization to plan and conduct an internal audit program of its quality management system. In these days, some comapnies are short on resources, internal audit expertise and personnel availability outsource the upkeep of their internal audit programs to ISO 9001 consulting firms.

ISO 9001 Continual Improvement Process

The ISO 9001 standard requires your quality management system to be dynamic and work towards continually improving the effectiveness and efficiency of your organization and enhance customer satisfaction. Some ISO 9001 consulting firms have diversified skills and experience in continual improvement strategies and methods. These mayinclude problem-solving, six sigma, lean manufacturing, use of various business software and tools, etc. They can significantly accelerate your pace at gaining further operational efficiency, customer satisfaction and increased business profitability.

With the growing concerns of global warming, many industries are taking recourse to corrective measures so as to reduce the carbon emissions and abide by the government policies that lay stress on quality control measures so as to reduce the harmful gases in the atmosphere. Apart from following government policies, industries try to introduce various measures so as to reduce the pollution and minimize the risk it involves to the lives of workers and consumers.
To avail the highest quality standards, one has to get the ISO 14001:2004 certification from the International Organization for Standardization. It is an international governing body that lays specific standards for quality controls. Given the fact that environment pollution is the biggest menace that can affect the progress of any organization, to avail the best quality standards one has to get the ISO 14001:2004 certification so as to provide clean and safe environment that is not affected from industrial works.
All those who get the ISO 14001:2004 certificate make sure that their industrial practices do not interfere in the environment by emanating any harmful substance in the atmosphere that can lead to hazard.
ISO 14001:2004 is universally known as Environmental Management System (EMS) that is based on specific environmental aspects and policies that are implemented. Basically, ISO 14001:2004 is not based on finished product as it lays emphasis on the procedures that are adopted in the manufacturing and production of the product. According to ISO, ISO 14001:2004 certificates are provided to those industries and organizations that try to reduce pollution.
Those who avail ISO 14001:2004-certificate benefit from reduction of cost from waste management, saving fuel and energy while lowering the cost of distribution. This leads to improved industrial and corporate image amongst customers, regulators and public. ISO 14001:2004 strives for consistent quality control that helps in providing the best industrial support to an organization by helping in the reduction of global warming and pollution.
For all those organizations that are looking forward to reduce pollution, ISO 14001:2004 is a practical tool that helps an industry in managing its energy consumption along with finding an alternative way so as to enhance the productivity along with reducing pollution levels.
In case an industrial unit is not following ISO 14001:2004 guidelines, it will not be able to avail ISO 14001:2004 certification that provides it quality control features. Apart from ISO 14001:2004, ISO offers numerous other certificates that deal with specific standards such as specification for shipping containers, IT software and languages, Iron Ores, country codes, safety labels, graphics, Standard Generalized Markup Languages and numerous other features that make it a useful guideline.
So, in case one is planning to set up an industrial unit or is an existing owner, it is essential to have quality control measures based on ISO 14001:2004. This certificate provides Environmental Management System. An ISO 14001:2004 certificate will help you in reducing the cost of manufacturing and energy consumption. Manage your business solutions with ISO 14001:2004 guidelines and reap benefits of Environmental Management System.

Certification Of ISO 14001

International Organization for Standardization (ISO) is functioning from Geneva in Switzerland as a worldwide federation of national standards organizations. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing corporation in the spheres of intellectual, scientific, technological and economic activity. ISO’s works result in international agreements which are published as international  agreements which are published as international standards.

ISO 9000

Previous version of ISO 9000 (1994) emphasize on documents and document control. But as per new standard the extent of documentation can differ from company to company in a simplified manner.

ISO 9000 system requires records at relevant stages which provide data for continual improvement and can be used for legacy as a data bank.

ISO 14000

ISO 14000, the environmental management system family of standards, was formally published by the International Organization for Standardization (ISO) on September 2, 1996. ISO 14001 is the conformance standard within the ISO 14000 series. After extensive groundwork, the revised version of ISO 14001 was released on 15th of November 2004. ISO 14001:2004 will replace ISO 14001:1996 after a transition period of 18 months, ending on 14th May 2006, and will become the basis for the certification procedure for environmental management. All ISO 14001:1996 certificates will be rendered invalid on 15th May 2006

Since 1996 the ISO 14001 has formed the basis for structuring, implementation, review and further development of environmental management systems. It lays down the applicable demands for organizations of all kinds and sizes as well as for diverse geographical, cultural and social conditions. The overall objective is to promote environmental protection and the prevention of environmental stress in harmony with economic, social and political requirements.

OHSAS 18001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks (OH&S). The importance of managing Occupational Health and Safety is recognized by all interested parties – employers, employees, customers, suppliers, insurers,shareholders, the community, contractors, and regulatory agencies. It enables an organization to control occupational health and safety risks risks and to improve performance.

The Most Common Mistakes Made with ISO 9001
Some very common mistakes often happen when companies try for ISO 9001. Usually they:
Don’t really know what they want from their system
Don’t make the system work for them
Don’t keep it simple
Don’t understand the Standard, let alone how to apply it to what they do
Don’t know or use a ’systems approach’
Don’t get the documentation right (the dreaded ‘quality manual’)
Don’t get their people involved
Don’t actually know what they mean by ‘quality’.
Then there’s the biggest one of all.
They don’t follow their own system.  Is it any wonder?
Perhaps you’ve already looked into getting ISO 9001.  If you’ve read it, you’ll probably agree it doesn’t make great reading.  But it does talk about a ‘quality manual’, so presumably you have to write lots of documents.

The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.

According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.

However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the

existence and functionality the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results. A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:

1. Complete Death: No documentation, no functioning This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product. Relatively few companies will find themselves in this situation.

2. Informally Alive: No documentation, some level of functioning Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” . SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.

3. Formally Death: Some level of documentation, no functioning SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.

4. Formally Alive: Some level of documentation, some level of functioning Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. As illustrated in Figure 2, this situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.