What Should Be Documented In Quality Management System?

What Should Be Documented In Quality Management System?

Clause 4.2.1 in ISO 9000 Standards requires quality management system documentation to include 5 types
of document:
(a) Quality policy and objectives
(b) Quality manual
(c) Documented procedures
(d) Documents needed to ensure the effective planning, operation and control of processes
(e) Records
Other than the requirements in clause 4 for documentation, there are 14 other references requiring documentation. These are as follows:
(a) The output of the planning
(b) The quality manual
(c) A documented procedure for document control
(d) A documented procedure for the identification, storage, retrieval, protection, retention time and disposition of records.
(e) Planning of the realization processes
(f) Inputs relating to product requirements
(g) The outputs of the design and development process
(h) Design and development changes
(i) The results of the review of changes and subsequent follow up actions
(j) A documented procedure for conducting audits that includes the responsibilities and requirements
(k) Evidence of conformity with the acceptance criteria characteristics of the product
(l) A documented procedure for nonconformity control activities
(m)A documented procedure for corrective action
(n) A documented procedure for preventive action
This list is somewhat inadequate for documentation purposes because it does not tell us what types of things we should document or provide criteria to enable us to decide what we need to document. ISO 9000 clause 2.7.2 includes a more useful list of document types that are classified as follows:
(a) Quality manuals
(b) Quality plans
(c) Specifications
(d) Guidelines
(e) Procedures, work instructions and drawings
(f) Records
This list is similar to that in clause 4.2.1 with some notable differences. The
policy and objective could form part of the quality manual and the quality plans, work instructions, guidelines, drawings and specifications could be the documents needed to ensure the effective planning, operation and control of processes.
Obviously the size, type and complexity of the organization and the competency of personnel will have an effect on the depth and breadth of the
documentation but the subject matter other than that which is product, process or customer specific is not dependent on size, type and complexity of the organization etc. There is no single method that will reveal all the things that should be documented but there are several approaches that can be used to reveal the documentation necessary.

ISO 14001 Standard & Environmental Issues

ISO 14001 Standard & Environmental Issues

ISO 14001 is a systematic tool that enables an organization in any market sector to focus on their situation, identify the relevant environmental issues and to lessen their impact to their benefit and the environment. It is part of a global response to the recognition that we are damaging the environment in which we all live. The cause and effect of the foremost world environmental issues, which are all due to mankind, are generally too vast and too intangible for us to grasp and so the slightly cliché expression ‘think global, act local’ is very relevant. Once the EMS is implemented and to become registered to ISO 14001, the external auditor will assess your EMS in two separate stages, on site. The first stage to understand your business activities and determine formal readiness for assessment and the second to check practical compliance with ISO 14001. After registration he will return at regular intervals every year to verify continual improvement and regulatory compliance, against your set objectives and your EMS. The external auditor should be seen as a wise friend, not a policeman. He should certainly explain his findings and assist the company to find ISO 14001 registration is not a cure for all environmental problems but I hope I’ve demonstrated that it is a worthwhile, if not essential business initiative that could enable your management to better manage your business, gain commercial advantage and minimize its environmental impact.

How to Get an ISO 14001 Accreditation

If you are someone who is looking into getting an ISO 14001, then you may be wondering exactly why it is that you have to get this accreditation. First, you have to understand that ISO stands for the International Organisation of Standardisation. This is a series of standards that have been developed with a singular level of guidance for all companies to measure up to. The particular 14001 deals with the requirements that you will need to have in order to measure up to the environmental standards that have been set forth by the ISO.

While you do not necessarily have to get the ISO 14001 accreditation to operate your business, it is something you can do to prove to your clients and customers that you are doing your part to help out with the environment. However, you may be confused on how to go about getting this important accreditation, but it is not as difficult to attain as you might think, and most businesses should be able to get the certification within a year of the application. You should know that they will want to make sure that you have been following some form of environmental standards for at least three months prior to your application. To do this you can write an environmental review of your company’s environmental impact as it is in its current operating state. You will then want to make sure that you provide this information when you send off your initial paperwork to begin the overall process.

In order to help prove that your company is doing its part to be environmentally aware you will have to go through an initial audit once the application has been filled out and filed. After the audit has been completed you will get a list of issues that the auditor feels you need to resolve before you can be certified for the ISO 14001. You will need to work on and correct these issues before the second audit is conducted, and they will give you a time period (usually three to six months) when they will return to check on your progress.

When the second audit occurs they will once again assess the overall business and then they will address the issues that were laid out in the previous audit. If everything goes well then your company will have proven that they are doing what they can to meet the standard set forth in ISO 14001, and they will then receive accreditation. However, this is not the end of the process. Even though you are now recognised as having environmentally conscious policies that are congruent with the international standards, you will have to go through periodic audits every three years to make sure that you are still operating correctly. Not only this, but every three months partial aspects of your company will be analysed to see that they are still working within the standards as well. As long as you remain within the compliance terms you will continue to receive your ISO 14001 certification.

About ISO 14001:2004 Standards

The ISO 14001 aims to reduce the environmental carbon footprints that many businesses leave behind today because of not taking the right steps to be environmental sustainable. This standard promotes the decrease in the waste of necessary business resources and also reduces the pollution that can sometimes be a by product of a business.

About ISO 14001

The most updated version of the ISO 14001 was released in the year 2004 by the International Organisation of Standardization (ISO), which was attended by members from all the committees from around the world. In order for a company to be awarded the ISO 14001 standard certificate, an external auditor has to audit the company by an audit body that has been accredited by an accreditation body. The certification auditors are required to be accredited by the International Registrar of Certification Auditor and the certification body has to be accredited by the Registrar Accreditation Board in the USA or by the National Accreditation Board in Ireland.

The structure of ISO 14001 is very much like the ISO 9000, which is management standard, so these two standards can be implemented side by side to achieve the best results. As a part of the ISO 14000 family, which deals with different aspects of environmental issues, ISO 14001:2004 and ISO 14002 deal with environmental management system (EMS). ISO 14001 gives the requirements for the

EMS and ISO 14002 gives the basic guidelines for EMS.

Environmental Management System with ISO 14001:2004

The EMS, as per the requirements of the ISO 14001, enables the company, may it be of any size, location and income to:

• It helps the company improve its environmental strategy and this positively affects their environmental performance.
• It helps in identifying and controlling the environmental impact that the activities, services or products of the company might have.
• And it helps in carrying out a systematic approach to set environmental targets and objectives, to achieve these and also to demonstrate that they have been achieved.

How does it work?

ISO 14001 does not specify or chalk out a definite level that each business has to reach. If the performance was determined, then it would have to be done for every specific business. But that is not how it works and has a very different approach, like:

• The ISO has various standards dealing with environmental issues. ISO 14001 deals with a framework provided for a strategic and holistic approach to the businesses environmental policy, actions and plans.
• It gives the general requirements for the EMS.
• This also states the reference to the communication requirements for the communication of the environmental management issues between the company, stakeholders, the public and the regulators.
• As these standards are not company specific, any and every business can undertake them as long as they are dedicated to the continued and improved environmental performance and they have a commitment to comply with the set norms.

ISO 14001 Environmental management programmes

ISO 14001 Environmental management programmes

Introduce a series of projects as an environmental management programme to achieve the set targets. Apply normal project management disciplines (eg. assign a project leader, consider their training needs, outline the key stages of the project and dates that will lead to the target achievement).

Gradually apply environmental management programme thinking to such things as the introduction of new products, new or improved processes and other key activities of the business. In particular, ensure existing projects become environmental management projects where there is a significant environmental impact involved, so that the EMS becomes company wide. This is a frequent oversight found during ISO 14001 assessments. The EMS must cover the whole business – like a net thrown over the whole business and for example including such things as engineering and maintenance.

Elements Of ISO 14001 Environmental Management System

Elements Of ISO 14001 Environmental Management System

ISO/DIS 14001 is one of a series of emerging international environmental management standards aimed at promoting
continual improvement in company environmental performance through the adoption and implementation of an environmental management system. The (draft) standard specifies the core elements of an EMS, but contains only those elements that may be objectively audited for certification or self-declaration purposes. A companion guidance standard, ISO/DIS 14004 includes examples, descrïptions and options that aid in the implementation of an EMS and in integrating the EMS into overall management practices. It is not intended for use by certification/registration bodies.

ISO/DIS 14001 defines an overall environmental management system , closely modeled on the ISO 9000 quality systems standard , and covers the following key elements:

· Establishment of an appropriate environmental policy that is documented and communicated to employees and made available to the public, and which includes a commitment to continual improvement and pollution prevention, regulatory compliance and a framework for setting objectives;
· A planning phase that covers the identification of the environmental aspects of the organization’s activities, identification and access to legal requirements, establishment and documentation of objectives and targets consistent with the policy, and establishment of a program for achieving said targets and objectives (including the designation of responsible individuals, necessary means and timeframes);
· Implementation and operation of the EMS including the definition, documentation and communication of roles and responsibilities, provision of appropriate training, assurance of adequate internal and external communication, written management system documentation as well as appropriate document control procedures, documented procedures for operational controls, and documented and communicated emergency response procedures;
· Checking and corrective action procedures, including procedures for regular monitoring and measurement of key characteristics of the operations and activities, procedures for dealing with situations of non-conformity, specific record maintenance procedures and procedures for auditing the performance of the EMS;
· Periodic management reviews of the overall EMS to ensure its suitability, adequacy and effectiveness in light of changing circumstances.

The EMS as outlined in ISO 14001 provides a structured process for the achievement of continual improvement, the rate and extent of which is determined by the organization in light of economic and other circumstances. Although some improvement in environmental performance can be expected due to the adoption of a systematic approach, it should be understood that the EMS is a tool which enables the organization to achieve and systematically control the level of environmental performance that it sets itself. The establishment of an EMS will not, in itself, necessarily result in an immediate reduction of adverse environmental impact. Indeed, care needs to be taken that the mere establishment of an EMS does not lull the organization into a false sense of security. But effectively used, an EMS should enable an organization to improve its environmental performance and avoid or reduce adverse environmental impacts over time.

History Of ISO 14001 Standards

The ISO 14000 series emerged primarily as a result of the Uruguay round of the GATT negotiations and the Rio Summit
on the Environment held in 1992. While GATT concentrates on the need to reduce non-tariff barriers to trade, the Rio
Summit generated a commitment to protection of the environment across the world. The environmental field has
seen a steady growth of national and regional standards.
The British Standards Institution has BS 7750, the Canadian Standards Association has environmental management,
auditing, eco-labeling and other standards, the European Union has all of these plus the eco-management and audit
requlations, and many other countries (e.g. USA, Germany and Japan) have introduced eco-labeling programs.
After the rapid acceptance of ISO 9000, and the increase of environmental standards around the world, ISO assessed
the need for international environmental management standards. They formed the Strategic Advisory Group on the
Environment (SAGE) in 1991, to consider whether such standards could serve to:
· Promote a common approach to environmental
· management similar to quality management
· Enhance organizations’ ability to attain and measure improvements in environmental performance; and
· Facilitate trade and remove trade barriers.

In 1992, SAGE’s recommendations created a new committee, TC 207, for international environmental management standards. The committee, and its subcommittees include representatives from industry, standards organizations, government and environmental organizations from many countries.
ISO 14004 and ISO 14001—were published in September and October 1996, respectively. The ISO 14000 family
consists of standards and guidelines relating to environmental management systems and supporting standards, terminology and specific tools, such as auditing.
Essentially, the standards are concerned with what an organization does to minimize harmful effects on the environment caused by its activities: either during production or disposal, either by pollution or by depleting natural resources.