Organizations preparing to implement a QMS For ISO 9001 Posted by everise | iso 9001 standard | Friday 9 October 2009 4:13 am

For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008,
the following comments may be useful.
For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a
process approach. This includes:
- Identifying the processes necessary for the effective implementation of the quality management system
- understanding the interactions between these processes.
- documenting the processes to the extent necessary to assure their effective operation and control. (It may be
appropriate to document the processes using process maps. It is emphasized, however, that documented process maps
are not a requirement of ISO 9001:2008.)
These processes include the management, resource, product realization and measurement processes that are relevant
to the effective operation of the QMS.
Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality
management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that
drives the processes.

Outsourced Processes In ISO 9001 Standards

Outsourced Processes In ISO 9001 Standards

One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in a quality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.
An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.
The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.
The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:
• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).
• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

Records required by ISO 9001:2008

Records required by ISO 9001:2008

Clause Record required
5.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action

Demonstrating conformity with ISO 9001:2008

Demonstrating conformity with ISO 9001:2008

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

ISO 14001 ENVIRONMENTAL POLICY

The Environmental Policy statement required under ISO 14001 is the keystone upon which the entire environmental management system is constructed. It is not a public relations document that is posted on the conference room wall or handed out to potentially impacted stakeholder groups. The Environmental Policy is the central focus of the environmental management system. It must contain and clearly communicate the following for the organization:
· Mission and core values with respect to the environment, and· Commitments to control and improve environmental performance withrespect to significant environmental aspects of the organization’s products,services and/or activities.
The commitment to control and improve environmental performance with respect to the environment leads to the development of Environmental Objectives and Targets (4.3.3).Once those items have been delineated the rest of the environmental management system is devoted to accomplishing the objectives and targets which fulfil the EnvironmentalPolicy. ISO 14001 requires that a coherent and cogent Environmental Policy be developed and implemented.

ISO 14001 ENVIRONMENTAL MANAGEMENT PROGRAMME

In order to be in conformance with this provision of ISO 14001 an organization must be able to demonstrate four specific points. First, it must demonstrate that it has established management programs for achieving the Environmental Objectives and Targets. Second, it must demonstrate that it has assigned responsibility at each appropriate level of the organization in order to achieve the Environmental Objectives and Targets. Third, the organization must specify the time frames and the mechanisms needed to achieve the Environmental Objectives and Targets. Fourth, under the principle of continual improvement, the organization must modify its environmental management program for “changed” conditions if they occur.
In general a program designed to achieve the desired endpoint must support every objective and subsequent target. Responsibility for management and leadership must also be assigned where it is necessary and appropriate to complete the task. Timeframes should be clearly outlined within the management program. If additional technology, equipment, staffing, etc. are needed to accomplish the tasks, then these “mechanisms” must be supplied. Continual improvement is referenced within this section of ISO 14001 in order to reinforce its importance within the standard.

ISO 14001 ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT

In order to be in conformance with this provision of ISO 14001 an organization must be able to answer the overall question: “How does the organization conduct environmental audits of the EMS?”. In order to answer that question four specific tasks must be addressed under the Management System Audit section of the standard.
First, the organization must develop a program and related procedures that define an audit plan of the environmental management system. In addition the program must define frequency of the audit process. Second, the procedures must specify the methodology of the audit process, including the qualifications of the auditors. Third, the audit reports must be submitted to top management. Fourth, the audit reports must provide recommendations directed at correcting any reported nonconformance that was discovered in the audit process.
The audit process discussed in this section of the standard is directed at internal audits. The standard is silent on the frequency issue. Generally accepted practice with a mature ISO 14001 system is a total audit of the system once a year. In the implementation phase of an environmental management system a more frequent audit process might be appropriate. In addition any part of the environmental management system that has been previously determined to be in nonconformance should be audited with an increased frequency. The methodology of the audit process required by the standard requires two distinct steps:
A. determine whether the environmental management system conforms to the requirements of ISO 14001, andB. that the system has been managed as described in the Environmental Policy statement, the Environmental Objectives and Targets, and the related work descriptions and procedures.
It is critical that an audit report that relates a nonconformance be forwarded to top management promptly. The internal audit staff must be competent with respect to the requirements of ISO 14001.

ISO 14001 ENVIRONMENTAL ASPECTS

The key to a successful registration for conformance with ISO 14001 is to accurately determine the organization’s Environmental Aspects and Impacts, arrive at which are the most significant and therefore require the most attention. Two definitions should be reviewed at this point.
Environmental AspectElement of an organization’s activities, products or services that can interact with the environment.
NOTE — A significant environmental aspect is an environmental aspect that has or can have a significant environmental impact.”
and
Environmental ImpactAny change to the environment, whether adverse or beneficial, wholly or partially resulting from an organization’s activities, products or services.”
There are three distinct requirements contained within this section of ISO 14001.
First, the organization shall identify the environmental aspects of its activities, products and/or services. In other words the organization must understand how it interacts with the environment.
Second, the organization shall identify the specific environmental aspects that can be controlled, and over which it can be expected to have influence.
Third, arrive at a list of significant environmental aspects based upon the individual environmental impact of each environmental aspect. The importance of this third step cannot be underestimated.
The final list of significant environmental aspects will provide the basis for the Environmental Policy statement, and the Environmental Objective(s) and Targets. In other words the list of significant environmental aspects drives the entire content and scope of the operational portion of the environmental management system.

Change In ISO 14001:2004 – Documentation

Change In ISO 14001:2004 – Documentation

This clause has been updated to align it with ISO 19001:2004, but has not changed in intent. The listed EMS documentation now includes:

• the environmental policy,

• objectives and targets,

• a description of the scope of the EMS,

• a description of the main elements of the EMS and their interaction and reference to related documents, documents and records

• required by the standard, • documents and records determined by the organisation as necessary to ensure the effective planning, operation and control of processes that relate to the significant environmental aspects.

Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.

Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.

The revised standard requires documents required by the EMS and the standard to be controlled documents.

Note that “document” is included in the definitions, and includes its supporting medium which can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.

SUMMARY OF CHANGES TO ISO 14001:2004

SUMMARY OF CHANGES TO ISO 14001:2004

ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.

References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.

An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.

Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.

In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.

There are additional paragraphs in the introduction, which generally cover:

• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;

• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;

• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;

• the use of the process approach is promoted in alignment with ISO 9001:2000;

• possible alignment and integration with other management systems is reviewed.

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 14001:2004 require 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.

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- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.
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What is ISO14001 Environmental Management Systems

What is ISO 14001
?ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
The History of ISO 14000
As a number of national standards emerged (BS 7750 being the first), the International Organization for Standardisation (ISO) created a group to investigate how such standards might benefit business and industry. As a result this group recommended that an ISO committee be created to create an international standard.
What is ISO 14001?ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.


· ISO 14004 provides guidance on the development and implementation of environmental management systems
· ISO 14010 provides general principles of environmental auditing (now superseded by ISO 19011)
· ISO 14011 provides specific guidance on audit an environmental management system (now superseded by ISO 19011)
· ISO 14012 provides guidance on qualification criteria for environmental auditors and lead auditors (now superseded by ISO 19011)
· ISO 14013/5 provides audit program review and assessment material.
· ISO 14020+ labeling issues
· ISO 14030+ provides guidance on performance targets and monitoring within an Environmental Management System
· ISO 14040+ covers life cycle issues
Of all these, ISO14001 is not only the most well known, but is the only ISO 14000 standard against which it is currently possible to be certified by an external certification authority.
ISO14000 – Introduction
After the success of the ISO9000 series of quality standards, the International Standards Organization published a comprehensive set of standards for environmental management. This series of standards is designed to cover the whole area of environmental issues for organizations in the global marketplace.
History of Development
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 regulations , and many other countries (e.g. USA, Germany and Japan) have introduced eco-labeling programs.