Disposition of ISO 9001 Records
Disposition in this context means the disposal of records once their useful life
has ended. The requirement should not be confused with that on the retention
of records. Retention times are one thing and disposal procedures quite
another.
The ISO 9001 standard does not specifically require records to be authenticated, certified
or validated other than product verification records in clause 8.2.4. A set of
results without being endorsed with the signature of the person who captured
them or other authentication lacks credibility. Facts that have been obtained by
whatever means should be certified for three reasons:
They provide a means of tracing the result to the originator in the event of
problems.
They indicate that the provider believes them to be correct.
They enable you to verify whether the originator was appropriately
qualified.
They give the results credibility.
If the records are generated by computer and retained in computerized form,
a means needs to be provided for the results to be authenticated. This can be
accomplished through appropriate process controls by installing provisions for
automated data recording or preventing unauthorized access.
Saturday, August 22, 2009
Monday, August 17, 2009
Control of ISO 9000 records
Control Of ISO 9000 Records
The ISO 9000 standard requires records to be established and
maintained to provide evidence of conformity to require-
ments and the effective operation of the quality manage-
ment system.
A record is defined in ISO 9000 as a document stating
results achieved or providing evidence of activities
performed.
Although a record is a document, the document
control requirement of clause 4.2.3 do not apply to
records primarily because records are not issued,
neither do they exhibit revision status simply
because they are results that are factual when
recorded. If the facts change, a new record is usually
created rather than the previous record revised. Even
where a record is revised and new facts added, the
old facts remain identified as to their date. The only reason for revising facts
contained in a record without changing the identity of the record or the date
when they were collected is where the facts were incorrectly recorded. This
subtle difference demands different treatment for documents that are classed
as records to those that are classed as informative. As with other types of
documents, records result from processes and may be used as inputs to other
processes.
Records required by the management system means records used or
generated by the management system. There is therefore no requirement to
produce records solely to satisfy an auditor. The records required are those for
the effective operation of the organization’s processes (see clause 4.1d of ISO
9001). If a record has no useful purpose within the management system there
is no requirement that it be established or maintained.
This does not mean that a record is required to prove conformity with every
single requirement for every product and service. There are those records
required by the standard (see below) that are required for every product and
service where applicable and in all other cases, audit records showing
compliance on a sample of operations would be sufficient.
Compliance with many requirements can be demonstrated by observation,
analysis, interview or examination of documentation. If a result or an activity
is not required to be recorded in order to manage the organization effectively
and satisfy the interested parties, it is not necessary to maintain records of it.
The ISO 9000 standard requires records to be established and
maintained to provide evidence of conformity to require-
ments and the effective operation of the quality manage-
ment system.
A record is defined in ISO 9000 as a document stating
results achieved or providing evidence of activities
performed.
Although a record is a document, the document
control requirement of clause 4.2.3 do not apply to
records primarily because records are not issued,
neither do they exhibit revision status simply
because they are results that are factual when
recorded. If the facts change, a new record is usually
created rather than the previous record revised. Even
where a record is revised and new facts added, the
old facts remain identified as to their date. The only reason for revising facts
contained in a record without changing the identity of the record or the date
when they were collected is where the facts were incorrectly recorded. This
subtle difference demands different treatment for documents that are classed
as records to those that are classed as informative. As with other types of
documents, records result from processes and may be used as inputs to other
processes.
Records required by the management system means records used or
generated by the management system. There is therefore no requirement to
produce records solely to satisfy an auditor. The records required are those for
the effective operation of the organization’s processes (see clause 4.1d of ISO
9001). If a record has no useful purpose within the management system there
is no requirement that it be established or maintained.
This does not mean that a record is required to prove conformity with every
single requirement for every product and service. There are those records
required by the standard (see below) that are required for every product and
service where applicable and in all other cases, audit records showing
compliance on a sample of operations would be sufficient.
Compliance with many requirements can be demonstrated by observation,
analysis, interview or examination of documentation. If a result or an activity
is not required to be recorded in order to manage the organization effectively
and satisfy the interested parties, it is not necessary to maintain records of it.
Tuesday, August 11, 2009
The environment for a healthy business
Growing scrutiny toward industry’s effects on the environment has made conformance with ISO 14001:2004 – a voluntary, internationally recognized Environmental Management Systems (EMS) standard – more important than ever. As more companies pursue ISO 14001 certification to demonstrate environmental commitment to their customers, shareholders and government agencies, many are discovering the benefits of partnering with Intertek. As one of the first accredited certification bodies, Intertek offers expertise, experience and know-how that no one else can deliver.
Your certified EMS can help you reap the benefits of: Improved overall performance Your ISO 14001 certified EMS can help make your business more efficient and productive. Lower energy and raw materials use, reductions in waste and pollution, and mitigated risks of accidents and emergency situations translate into greater profitability and productivity. Expanded market access Your company’s environmental credibility and commitment to quality are established from day one.
It will take less time to demonstrate the effectiveness of your EMS and earn your prospective customers’ trust and confidence, and you’ll enjoy access to markets you might not otherwise penetrate. Improved corporate image Your certification demonstrates your company’s commitment to environmental responsibility, fostering improved relationships with the community, shareholders, and governmental and environmental organizations.
Enhanced competitiveness While helping you to operate more efficiently and profitably, your ISO 14001 certified EMS can instill additional confidence in shareholders, investors, insurers and your customers – making your business the clear choice in a highly competitive market. Plus, you can maximize your human and financial resources by using your existing Quality Management System (QMS) as a basis for your EMS, taking advantage of the synergies between ISO 9001 and ISO 14001.
Your certified EMS can help you reap the benefits of: Improved overall performance Your ISO 14001 certified EMS can help make your business more efficient and productive. Lower energy and raw materials use, reductions in waste and pollution, and mitigated risks of accidents and emergency situations translate into greater profitability and productivity. Expanded market access Your company’s environmental credibility and commitment to quality are established from day one.
It will take less time to demonstrate the effectiveness of your EMS and earn your prospective customers’ trust and confidence, and you’ll enjoy access to markets you might not otherwise penetrate. Improved corporate image Your certification demonstrates your company’s commitment to environmental responsibility, fostering improved relationships with the community, shareholders, and governmental and environmental organizations.
Enhanced competitiveness While helping you to operate more efficiently and profitably, your ISO 14001 certified EMS can instill additional confidence in shareholders, investors, insurers and your customers – making your business the clear choice in a highly competitive market. Plus, you can maximize your human and financial resources by using your existing Quality Management System (QMS) as a basis for your EMS, taking advantage of the synergies between ISO 9001 and ISO 14001.
Origins of the ISO’s Work
The ISO is a federation of non-governmental organizations established in 1947 to develop international standards, improve international communication and collaboration, and facilitate the exchange of goods and services. The federation is currently comprised of close to 100 national standards bodies (member bodies) from countries representing approximately 95 percent of the world’s industrial production.
The headquarters of the ISO secretariat is in Geneva, Switzerland.2 The ISO’s involvement in establishing environmental standardsbegan in 1991 after organizers for the UN Conference on Environment and Development (held in Rio de Janeiro in 1992) asked whether or not ISO would be attending the conference and whether it was involved in any environmental activities. As a result, the ISO established a Strategic Advisory Group on the Environment (SAGE) in 1991 to assess the need for international environmental management standards.3 SAGE recommended that ISO proceed with an environmental standard by 1992 and that a technical committee be established to carry it through. On June 1, 1993, ISO’s Technical Committee 207 (TC 207) held its first plenary meeting.
TC 207 was directed to establish environmental standards in five areas of environmental management:
- environmental management systems; environmental auditing and related
- environmental investigation; environmental labeling; environmental performance evaluation; and life-cycle assessment.
Consequently, TC 207 was divided into five subcommittees (SCs) for each category of standard and one SC to cover the terms and definitions of the standards. In addition, a working group, which reports directly to TC 207, was formed to deal with the environmental aspects in product standards. The five SCs have two or more working groups (WGs) that report to them (unlike the WG on product standards previously mentioned which reports directly to TC 207).
The key factor that has propelled the ISO 14000 series of standards forward throughout the early 1990s is the increase in national environmental standards. Examples of these standards include some two dozen eco-labeling schemes worldwide (see Annex 1), the British Standards Institute’s BS 7750 (Specification for Environmental Management Systems), the Canadian Standards Association’s Z750 (A Guide for a Voluntary Environmental Management System), and the EU EMAS (Eco-Management and Audit Scheme). Other similar environmental management standards have been developed by the French Standards Association, the South African Bureau of Standards and the Spanish Standards Association.
With the proliferation of environmental standards, concerns have been expressed that these standards would fragment international markets and unduly favor the companies of the countries or of the regions where these standards were developed, unless they were developed by authoritative and broadly based international bodies. The ISO was to serve this role.
The headquarters of the ISO secretariat is in Geneva, Switzerland.2 The ISO’s involvement in establishing environmental standardsbegan in 1991 after organizers for the UN Conference on Environment and Development (held in Rio de Janeiro in 1992) asked whether or not ISO would be attending the conference and whether it was involved in any environmental activities. As a result, the ISO established a Strategic Advisory Group on the Environment (SAGE) in 1991 to assess the need for international environmental management standards.3 SAGE recommended that ISO proceed with an environmental standard by 1992 and that a technical committee be established to carry it through. On June 1, 1993, ISO’s Technical Committee 207 (TC 207) held its first plenary meeting.
TC 207 was directed to establish environmental standards in five areas of environmental management:
- environmental management systems; environmental auditing and related
- environmental investigation; environmental labeling; environmental performance evaluation; and life-cycle assessment.
Consequently, TC 207 was divided into five subcommittees (SCs) for each category of standard and one SC to cover the terms and definitions of the standards. In addition, a working group, which reports directly to TC 207, was formed to deal with the environmental aspects in product standards. The five SCs have two or more working groups (WGs) that report to them (unlike the WG on product standards previously mentioned which reports directly to TC 207).
The key factor that has propelled the ISO 14000 series of standards forward throughout the early 1990s is the increase in national environmental standards. Examples of these standards include some two dozen eco-labeling schemes worldwide (see Annex 1), the British Standards Institute’s BS 7750 (Specification for Environmental Management Systems), the Canadian Standards Association’s Z750 (A Guide for a Voluntary Environmental Management System), and the EU EMAS (Eco-Management and Audit Scheme). Other similar environmental management standards have been developed by the French Standards Association, the South African Bureau of Standards and the Spanish Standards Association.
With the proliferation of environmental standards, concerns have been expressed that these standards would fragment international markets and unduly favor the companies of the countries or of the regions where these standards were developed, unless they were developed by authoritative and broadly based international bodies. The ISO was to serve this role.
Tuesday, June 16, 2009
ISO 9000 vs ISO 14001 Standard
ISO 9000 Standard vs ISO 14000 Standard
Both "ISO 9000" and "ISO 14000" are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management system conforms to the standard.
ISO 9000 is primarily concerned with "quality management". In the everyday context, like "beauty", everyone may have his or her idea of what "quality" is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer.
"Quality management" means what the organization does to ensure that its products or
services satisfy the customer's quality requirements and comply with any regulations
applicable to those products or services
ISO 14000 is primarily concerned with "environmental management". In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.
In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental
management.
Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products - at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.
In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer's quality requirements.
In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization's activities on the environment (ISO 14000).
In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.
http://www.iso-consults.com
http://www.e-wia.com
Both "ISO 9000" and "ISO 14000" are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management system conforms to the standard.
ISO 9000 is primarily concerned with "quality management". In the everyday context, like "beauty", everyone may have his or her idea of what "quality" is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer.
"Quality management" means what the organization does to ensure that its products or
services satisfy the customer's quality requirements and comply with any regulations
applicable to those products or services
ISO 14000 is primarily concerned with "environmental management". In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.
In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental
management.
Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products - at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.
In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer's quality requirements.
In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization's activities on the environment (ISO 14000).
In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.
http://www.iso-consults.com
http://www.e-wia.com
Saturday, March 21, 2009
ISO 14001 Template
ISO 14001 Template
The ISO 14001 Template were created to help you to prepare the ISO 14001Quality Manual, ISO 14001 Operating Procedure & ISO 14001 Forms. This ISO 14001 Template contains prewritten Quality Manual, Operating Procedure along with sample forms and checklists included as Microsoft Word & Excel format. It provides sample practical documentation in the proper ISO format required by the latest ISO 14001:2004.
Special Features :
Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.
Professional design and layout.
It is designed to fulfill the ISO 14001 : 2004 requirements. .
Easy to read, easy to understand, and easy to implement.
Easy to audit as it follows the structure of ISO 14001: 2004..
Includes the required Process Flowchart.
The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process.
The ISO 14001 Environmental Management System (EMS) Template are consist of :
a. ISO 14001 EMS Manual Template
The Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative. ISO 14001 Manual Template Consist of:
• Section 1: General EMS Requirement
• Section 2: Environment Policy – Objectives, Targets & Programmes
• Section 3: EMS Planning
• Section 4: Implementation & Operation
• Section 5: Checking & Monitoring
• Section 6: Management Review
b. ISO 14001 Operating Procedure
The ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation.
The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier.
The entire manual follows the structure of ISO 14001 : 2004. ISO 14001 Operating Procedures Consist Of: • Objective & Targets Procedure
• Environmental Management Program Procedure
• Environmental Aspect & Impact Identification & Evaluation Procedure
• Environmental Monitoring & Measuring Procedure
• Legal & Others Requirement & Evaluation Of Compliance Procedure
• Emergency Preparedness & Response Procedure
• Chemical Control Procedure
• Waste Management Procedure
• 5S House Keeping Procedure
c. ISO 14001 Forms
ISO 14001 Forms Consist Of :
• Environmental Non-Conformance Master List
• Environmental Non-Conformance Notice Form
• Environmental Management Program Form
• Environmental Aspect & Impact Identification Form
• Green Environment Internal Audit Master Plan
• Green Environment Plan & Activities Form
• Green Environment Material Purchase Master List
• ISO 14001:2004 Internal Audit Summary Report
• Equipment Monitoring Master List
• Environment Preventive Action Report (PAR) Master List
• Environment Preventive Action Report (PAR) Form.
• Environmental Responsible Form
• EMS Organization Chart.
• Waste Management Schedule Form
• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form
http://www.iso-consults.com
http://www.e-wia.com
http://www.quality-template.com
http://www.iso9001store.com
http://www.iso9000-software.com
The ISO 14001 Template were created to help you to prepare the ISO 14001Quality Manual, ISO 14001 Operating Procedure & ISO 14001 Forms. This ISO 14001 Template contains prewritten Quality Manual, Operating Procedure along with sample forms and checklists included as Microsoft Word & Excel format. It provides sample practical documentation in the proper ISO format required by the latest ISO 14001:2004.
Special Features :
Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.
Professional design and layout.
It is designed to fulfill the ISO 14001 : 2004 requirements. .
Easy to read, easy to understand, and easy to implement.
Easy to audit as it follows the structure of ISO 14001: 2004..
Includes the required Process Flowchart.
The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process.
The ISO 14001 Environmental Management System (EMS) Template are consist of :
a. ISO 14001 EMS Manual Template
The Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative. ISO 14001 Manual Template Consist of:
• Section 1: General EMS Requirement
• Section 2: Environment Policy – Objectives, Targets & Programmes
• Section 3: EMS Planning
• Section 4: Implementation & Operation
• Section 5: Checking & Monitoring
• Section 6: Management Review
b. ISO 14001 Operating Procedure
The ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation.
The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier.
The entire manual follows the structure of ISO 14001 : 2004. ISO 14001 Operating Procedures Consist Of: • Objective & Targets Procedure
• Environmental Management Program Procedure
• Environmental Aspect & Impact Identification & Evaluation Procedure
• Environmental Monitoring & Measuring Procedure
• Legal & Others Requirement & Evaluation Of Compliance Procedure
• Emergency Preparedness & Response Procedure
• Chemical Control Procedure
• Waste Management Procedure
• 5S House Keeping Procedure
c. ISO 14001 Forms
ISO 14001 Forms Consist Of :
• Environmental Non-Conformance Master List
• Environmental Non-Conformance Notice Form
• Environmental Management Program Form
• Environmental Aspect & Impact Identification Form
• Green Environment Internal Audit Master Plan
• Green Environment Plan & Activities Form
• Green Environment Material Purchase Master List
• ISO 14001:2004 Internal Audit Summary Report
• Equipment Monitoring Master List
• Environment Preventive Action Report (PAR) Master List
• Environment Preventive Action Report (PAR) Form.
• Environmental Responsible Form
• EMS Organization Chart.
• Waste Management Schedule Form
• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form
http://www.iso-consults.com
http://www.e-wia.com
http://www.quality-template.com
http://www.iso9001store.com
http://www.iso9000-software.com
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