ISO9001 Quality Management Standard
This standard was last updated in the year 2000 and should have been reviewed last year but this was delayed until 2008.
The main changes in IS9001:2008 are as follows:
Clause 0.2 (Process approach)
Text added to emphasise the importance of processes being capable of
achieving desired outputs
Clause 1.1 (Scope)
Clause 4.1 (General requirements)
Clause 4.2.1 (Documentation)
Clause 4.2.3 (Document control)
Clarification that only external documents relevant to the QMS need to be
Controlled
Clause 4.2.4 (Control of records)
Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management representative)
States that this must be a member of the organisation's own management
Clause 6.2.1 (Human resources)
Clarification that competence requirements are relevant for any personnel who
are involved in the operation of the quality management system
Clause 6.3 (Infrastructure)
Includes information systems as example
Clause 6.4 (Work environment)
Clarifies that this includes conditions under which work is performed and Includes (for example physical, environmental and other factors such as noise,
Temperature, humidity, lighting, or weather)
Clause 7.2.1 (Customer related processes)
Clarifies that post-delivery activities may include:
Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification and validation have
distinct purposes. These may be conducted and recorded separately or in any combination as suitable for the product and the organisation
Clause 7.3.3 (Design & development outputs)
Clarifies that information needed for production and service provision includes
preservation of the product
Clause 7.5.4 (Customer property)
Explains that both intellectual property and personal data should be considered
as customer property
Clause 7.6 (Now called Control of Monitoring and Measuring equipment)
Explanatory notes added regarding the use of computer software:
"Confirmation of the ability of computer software to satisfy the intended
application would typically include its verification and configuration management
to maintain its suitability for use."
Clause 8.2.1 (Customer satisfaction)
Note added to explain that monitoring of customer perception may include input
from sources such as customer satisfaction surveys, customer data on delivered
product quality, user opinion surveys, lost business analysis, compliments, and
dealer reports
Clause 8.2.3 (Monitoring / Measurement of process)
Note added to clarify that when deciding on appropriate methods, the organisation should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.
The changes are so minor and no new requirements have been introduced that little effort will be required by users of the standard to achieve certification to the 2008 standard.
The main changes in IS9001:2008 are as follows:
Clause 0.2 (Process approach)
Text added to emphasise the importance of processes being capable of
achieving desired outputs
Clause 1.1 (Scope)
- Clarification that product also includes intermediate product
- Information regarding statutory, regulatory and legal requirements
Clause 4.1 (General requirements)
- Notes added to explain more about outsourcing
- Types of control that may be applied to outsourced processes
- Relationship to clause 7.4 (Purchasing)
- Clarification that outsourced processes are still responsibility of the organisation and must be included in the quality management system
Clause 4.2.1 (Documentation)
- Clarification that QMS documentation also includes records
- Documents required by the standard may be combined
- ISO 9001 requirements may be covered by more than one documented Procedure
Clause 4.2.3 (Document control)
Clarification that only external documents relevant to the QMS need to be
Controlled
Clause 4.2.4 (Control of records)
Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management representative)
States that this must be a member of the organisation's own management
Clause 6.2.1 (Human resources)
Clarification that competence requirements are relevant for any personnel who
are involved in the operation of the quality management system
Clause 6.3 (Infrastructure)
Includes information systems as example
Clause 6.4 (Work environment)
Clarifies that this includes conditions under which work is performed and Includes (for example physical, environmental and other factors such as noise,
Temperature, humidity, lighting, or weather)
Clause 7.2.1 (Customer related processes)
Clarifies that post-delivery activities may include:
- Actions under warranty provisions
- Contractual obligations such as maintenance services
- Supplementary services such as recycling or final disposal
Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification and validation have
distinct purposes. These may be conducted and recorded separately or in any combination as suitable for the product and the organisation
Clause 7.3.3 (Design & development outputs)
Clarifies that information needed for production and service provision includes
preservation of the product
Clause 7.5.4 (Customer property)
Explains that both intellectual property and personal data should be considered
as customer property
Clause 7.6 (Now called Control of Monitoring and Measuring equipment)
Explanatory notes added regarding the use of computer software:
"Confirmation of the ability of computer software to satisfy the intended
application would typically include its verification and configuration management
to maintain its suitability for use."
Clause 8.2.1 (Customer satisfaction)
Note added to explain that monitoring of customer perception may include input
from sources such as customer satisfaction surveys, customer data on delivered
product quality, user opinion surveys, lost business analysis, compliments, and
dealer reports
Clause 8.2.3 (Monitoring / Measurement of process)
Note added to clarify that when deciding on appropriate methods, the organisation should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.
The changes are so minor and no new requirements have been introduced that little effort will be required by users of the standard to achieve certification to the 2008 standard.
Labels: iso9001, quality management standard
Posted: Tuesday, 18 November 2008
ISO14001 Environmental Management Standard
What is ISO14001?
14001 is an externally assessed scheme where an organisations declared environmental practices are checked against a set of rules; if successful the organisation can use the logo to endorse the environmental management system incorporated in the organisation.
An additional advantage is that cost savings brought about by reductions in gas, electricity and fossil fuels can be significant.
What does ISO14001 cover?
The standard covers the impact on the environment made by the product (or service) from customer's order through order acceptance, design and development if appropriate, planning, production or service delivery and control of calibration devices. Also included is training and the selection of suppliers that are able to meet the organisation's environmental needs, together with controls on energy usage and waste generation.
The activities are those carried out by most 'Green' companies.
Below is the ISO14001 model which is designed to allow for continual improvement through planned and operated policy.
As is the case with ISO9001 (Quality Management Standard) the information gathered from the processes is fed to top management to allow for continual improvement. In this way the organisation is able to make decisions based on fact and so develop and evolve.
The two standards 9001 and 14001 are often integrated into a single management system.
Labels: iso14001, quality management standard
Posted: Monday, 7 April 2008
ISO9001 Quality Management Standard Upgrade - 2008
ISO9001 has been around now since 2000 and it is normal practise for Standards to be reviewed and updated every five years or so. This update is now overdue.
The PDCA model has been retained and one member of then committee said it should stand for 'Please don't change anything' rather than PLAN-DO-CHECK-ACT.
The ISO Committee has proposed that only minor changes should be incorporated into the 2008 update:
Clause 0.2 (Process approach)
Clause 4.2.3 (Document control)
Clause 4.2.4 (Records control)
Clause 5.5.2 (Management rep)
Clause 6.2.1 (Human resources)
Clause 6.3 (Infrastructure
Clause 6.4 (Work environment)
Clause 7.2.1 (Customer related processes)
Clause 7.3.1 (Design & development planning)
Clause 7.3.3(Design & development outputs)
Clause 7.5.4 (Customer property)
Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)
Clause 8.2.1 (Customer satisfaction)
Clause 8.2.3 (Monitoring / Measurement of process)
I must emphasise that these are proposed changes and not 'set in stone'.
The 2008 Standard is expected to be published in November 2008.
The PDCA model has been retained and one member of then committee said it should stand for 'Please don't change anything' rather than PLAN-DO-CHECK-ACT.
The ISO Committee has proposed that only minor changes should be incorporated into the 2008 update:
Clause 0.2 (Process approach)
- Text added to emphasize the importance of processes being capable of achieving desired outputs
Clause 4.2.3 (Document control)
- Clarification that only external documents relevant to the QMS need to be
controlled
Clause 4.2.4 (Records control)
- Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management rep)
- Clarifies that this must be a member of the organization's own management
Clause 6.2.1 (Human resources)
- Clarification that competence requirements are relevant for any personnel who are involved in the operation of the quality management system
Clause 6.3 (Infrastructure
- Includes information systems as example
Clause 6.4 (Work environment)
- Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather
Clause 7.2.1 (Customer related processes)
- Clarifies that post-delivery activities may include:
- Actions under warranty provisions
- Contractual obligations such as maintenance services
- Supplementary services such as recycling or final disposal
Clause 7.3.1 (Design & development planning)
- Clarifies that design and development review, verification and validation have distinct purposes
- These may be conducted and recorded separately or in any combination as suitable for the product and the organization
Clause 7.3.3(Design & development outputs)
- Clarifies that information needed for production and service provision includes preservation of the product
Clause 7.5.4 (Customer property)
- Explains that both intellectual property and personal data should be considered as customer property
Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)
- Explanatory notes added regarding the use of computer software:
"Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use."
Clause 8.2.1 (Customer satisfaction)
- Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports
Clause 8.2.3 (Monitoring / Measurement of process)
- Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.
I must emphasise that these are proposed changes and not 'set in stone'.
The 2008 Standard is expected to be published in November 2008.
Labels: iso9001, quality management standard, Upgrade. 2008
Posted: Saturday, 29 December 2007
Why is ISO 9001 so Successful?
The Quality Management Standard ISO9001 is the worlds most recognisable standard, with approaching 1,000,000 certificates issued in 130 countries this is a truly global standard.
The standard requires an organisation to turn customer requirements into customer satisfaction; something we all aim to do, but those achieving the required level are awarded a certificate of conformance, declaring this fact to the world.
Most organisations claim to be the best, the quickest, the most cost effective, etc, but an endorsement by a third party often carries more weight. This is where ISO9001 scores highly.
ISO, The International Organisation for Standardisation is a non governmental body whose country members are permitted to issue certificates. In this country there are some 268 bodies permitted to issue certificates and are accredited by UKAS, The United Kingdom Accreditation Service. Certificates issued by an accredited body have the distinctive CROWN and TICK logo next to that of the certification body.
There are a number of non-accredited bodies issuing certificates, unfortunately these certificates are recognised only by the issuing authority and are often worthless as a reference. The certificate is usually issued after a very short time frame and is essentially a receipt for monies paid rather than proof of conformance.
Achieve recognition from a UKAS approved body.
The standard requires an organisation to turn customer requirements into customer satisfaction; something we all aim to do, but those achieving the required level are awarded a certificate of conformance, declaring this fact to the world.
Most organisations claim to be the best, the quickest, the most cost effective, etc, but an endorsement by a third party often carries more weight. This is where ISO9001 scores highly.
ISO, The International Organisation for Standardisation is a non governmental body whose country members are permitted to issue certificates. In this country there are some 268 bodies permitted to issue certificates and are accredited by UKAS, The United Kingdom Accreditation Service. Certificates issued by an accredited body have the distinctive CROWN and TICK logo next to that of the certification body.
There are a number of non-accredited bodies issuing certificates, unfortunately these certificates are recognised only by the issuing authority and are often worthless as a reference. The certificate is usually issued after a very short time frame and is essentially a receipt for monies paid rather than proof of conformance.
Achieve recognition from a UKAS approved body.
Labels: iso, iso9001, quality management standard, ukas
Posted: Wednesday, 7 March 2007
1 Comments:
Nice information !
Which documents are required for QMS is it is implemented on I.T /software development industry.
secondly, whether Configuration management department is necessary to establish or just process should be implemented ?
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