It will be fourth edition belonging to the ISO9001 tqm considering that it was first circulated in 1987. The latest edition belonging to the ISO9001 qms, called ISO9001: 2008 Quality Management System Requirements, ended up being officially produced by the International Organization for Standardization 4th quarter 2008.
ISO9001:2008 can be a qms that provides the common set of standards for agencies desperate to produce a QM method (Quality Management System). The ISO9001:2008 qms centers on strengthening an agencies systems operations. It doesn't identify any standards for item or assistance quality. Users normally set product or service and program quality standards. Then again, the expectancy is that an business enterprise with an efficient ISO9001 based Quality Management System will certainly indeed advance their capacity to fulfill consumer, governmental and also regulating standards.
This will be the only Quality Management System qms to which experts claim an business enterprise might obtain formal 3rd party certification. For the reason that standards are generic and not targeted, agencies have flexibility in creating their own Quality Management System to fit their particular business, culture and dangers.
ISO9001 standards complement contractual as well as appropriate governmental and regulating standards. Those implementing a Quality Management System that conforms to ISO9001 ought to make certain that the targeted standards of their shoppers and appropriate governmental and also regulating agencies are attained.
Who Is Liable With regard to Revising Quality Management System Expectations?
The International Organization for Standardization Tech Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) will be accountable for the actual revision progression in collaboration along with consensus amid level of quality and trade specialists nominated by International Organization for Standardization Member bodies, and which represents all interested parties.
Does ISO9001:2008 Have Further Requirements Beyond ISO9001:2000?
This latest (4th) edition of ISO9001 is made up of no brand new standards compared for the (third) year 2000 edition, which it replaces. What it really does is produce clarification for the current standards of ISO9001:2000 based on eight years experience of worldwide implementing within the qms and also features modifies expected to advance reliability while using ecological operations method qms, International Organization for Standardization 14001:2004.
The clarifications and modifies in ISO9001:2008 represent fine-tuning, as opposed to a thorough overhaul. It concentrates on modifies that agencies might make to superior conform while using spirit within the qms without having adding, deleting, or altering its standards. The modifies are minor in nature and deal with such complications as the requirement to explain, produce greater reliability, resolve perceived ambiguities, and advance compatibility with International Organization for Standardization 14001. The numbering method and also the structure within the qms remain unchanged. As a result, the new qms looks a lot like the outdated qms.
International Organization for Standardization has structured the modifies included in this ISO9001:2008 edition into the following categories:
* No modifies or minimum modifies on user docs, which include records
* No modifies or minimum modifies to current Quality Management System processes
* No supplemental training expected or nominal instruction expected
* No effects on latest accreditations
In contrast, the third edition, ISO9001:2000 produced in 2000, represented a major overhaul within the qms, which include new standards and also a sharpened consumer focus, reflecting developments in qm and knowledge gained considering that the distribution within the preliminary version.
Then Why Was It Required To Introduce This Revision? All International Organization for Standardization requirements, currently even more than 17400, are periodically evaluated. To make certain that International Organization for Standardization requirements are maintained at the state within the art, International Organization for Standardization has a rule requiring them to become periodically reviewed and also a choice taken to ensure, withdraw or revise the docs. The review progression ought to be initiated within three many years of publication of a qms. The review considers several factors for example technological evolution, new methods and materials, new quality and safety standards, or concerns of interpretation and application.
The review of ISO9001 resulting with the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176. This committee, which is accountable for the International Organization for Standardization 9000 loved ones, unites expertise from 80 participating countries and 19 international or regional agencies, plus other technical committees.
This review has a variety of inputs that support it:
* A global user questionnaire/survey
* A market Justification Study
* Suggestions arising from the ISO/TC 176 interpretation progression
* Options for increased compatibility with International Organization for Standardization 14001
* The demand for greater clarity, user friendly set up, and improved translation
* Latest trends - checking up on current developments in operations method practices.
How Does The new ISO9001 QMS Influence Existing ISO9001 QM Devices?
As currently registered agencies begin looking at ISO9001:2008, they are going to wonder to what extent the modifies will influence them. To a big extent, the new qms will not result in considerable adjust to current qm programs (Quality Management System).
ISO/TC 176 was careful in not producing adjust for adjust sake. The modifies which have been designed into this edition within the ISO9001 qms include modifies that need to caused a superior understanding across a broader range of product or service kinds, which include program agencies; usage of deliberate wording to reduce the possible for improper user interpretation; and reflect nuances of comparable term principles. Lastly, some within the modifies to targeted clauses were produced based on the 2004 Overseas User Feedback Survey. This study was conducted following the release of of ISO9001:2000 coupled with asked respondents to recognize sections they most wished to see improved.
What's The Conversion Length of time In order to Adhere to This Revision Together with Will My Business enterprise Call for Full Re-Assessment With regard to Accreditation?
Accreditation to ISO9001:2008 is not regarded as upgrading. The foundations for conversion are as follows:
1. The new edition will not call for any targeted reassessment meant for certification. Accreditation Bodies definitely will examine conformity for the new ISO9001:2008 qms during normal surveillance visits and complete reassessment is only going to occur at the time your company's latest certificate expires.
2. International Organization for Standardization and also the IAF have decided that all certificates to ISO9001 need to be transitioned to ISO9001:2008 within two short years of release date, (i.e., by Nov 14, 2010). Your business enterprise can request your Accreditation body to evaluate your Quality Management System to provide a gap analysis to ISO9001:2008 at your subsequent Surveillance examine.
three. One year following publication of ISO9001:2008 (i.e., by November 14, 2009), all accreditation issued (new accreditation and re-certifications) ought to be to ISO9001:2008.
4. Two many years following publication of ISO9001:2008 (i.e., by November 14, 2010), current ISO9001:2000 accreditation will not be legitimate.
5. Businesses with the progression of certification to ISO9001:2000 are recommended to get certification to ISO9001:2008.
This changeover strategy is deemed reasonable, due to the fact that ISO9001:2008 introduces no new standards. So basically, you've a 2 year changeover window starting from 4th quarter 2008, so don't let it rest for the last crucial moment to make the transition.
What Will Take place With the Other Expectations Together with Docs Within the Latest (2000) International Organization for Standardization 9000 Family members?
The four primary requirements within the latest International Organization for Standardization 9000 loved ones are the following:
* International Organization for Standardization 9000:2005 already produced - no major modifies expected for 2009
* ISO9001:2000 to become superseded by ISO9001:2008
* Considerable modifies are planned for International Organization for Standardization 9004 using a planned publication date of late 2009.
* International Organization for Standardization 19011:2002 is currently with the initial stages within the revision progression, using a new version envisioned in 2011.
The other requirements and docs will be reviewed and updated as essential.
How Very much Stands out as the Implementation In the New QMS Going To Cost? One within the goals of ISO/TC 176/SC 2 would be to produce requirements that will reduce any possible charges in execution or changeover. Any supplemental charges might be regarded as being a value adding investment. A main factor with the development of ISO9001:2008 was to limit the impact of modifies and charges on users. So don't flinch at negotiating with your certification / registration body, if they try to increase charges of certification.
What Do Auditors Will need To Know About ISO9001:2008 QMS?/
Auditors, regardless of whether external or internal, need to have the ability to demonstrate their proficiency around the structure, content and vocabulary within the requirements listed below, and also around the underlying QM Principles.
The requirements call for that auditors are able to realize the organization's proceedures and processes and appropriately examine against the standards within the ISO9001 in relation for the organization's objectives. Auditors need to have the ability to demonstrate proficiency in:
* The standards within the ISO9001:2008.
* The concepts and terminology within the International Organization for Standardization 9000:2005.
* The eight QM Principles
* A general understanding of International Organization for Standardization 9004
* Familiarity while using auditing guidance qms International Organization for Standardization 19011.
How Will ISO9001:2008 Relate With the Requirements Of Precise Enterprise Sectors?
ISO9001:2008 continues to be agreeable with current operations programs requirements for targeted organization sectors like ISO/TS 16949, AS 9000/EN 9100 and TL 9000.
Source: http://ezinearticles.com/
Monday, October 25, 2010
Sunday, October 24, 2010
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)
* 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:
o Actions under warranty provisions
o Contractual obligations such as maintenance services
o 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.
Source: http://ezinearticles.com/
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:
o Actions under warranty provisions
o Contractual obligations such as maintenance services
o 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.
Source: http://ezinearticles.com/
Saturday, October 23, 2010
ISO 9001-2008 Vs ISO 9001-2000 - The New Requirements and a Comparison Between Them
Congratulations to all of us quality managers. We have a new standard. ISO 9001: 2008. This is really an exciting moment for quality managers. In order to celebrate this event in a way that only quality managers know how, I prepared here a comparison article between the ISO 9001:2000 and the new born ISO 9001:2008. I also included my comments regarding my experience and my perspective of things.
At the end of it I will summon the new requirements from the new ISO 9001:2008 standard.
Paragraph number 0.1 - Changes here are a statement about whom and where the standard includes any statutory requirements. Statutory requirement (of any kind) has the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.
Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
My comment - Of course. The world is getting greener every day so they must remind you of the ISO 14001 standard. I believe and recommend to any organization that is required to implement the ISO 14001 standard to implement also the ISO 9001 standard. There is a big correlation between the two. They actually support one another. It would be easier for organization to obtain the ISO standard 14001 requirements if it has been already certified for ISO 9001.
Paragraph number 1.1 & 1.2 - Statutory requirements had been referred in relation with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.
My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and regulatory requirements are applicable to the purchasing processes as well. It was always an open area that no one had the exact answer: Does your supplier must follow the law or not? Apparently yes.
Paragraph number 2 - Normative reference - the ISO 9000 is now replaced by ISO 9000:2005.
Paragraph number 3 - The explanations about what is a customer and what is an organization and what is a supplier had been removed.
Paragraph number 4.1 - Clause a - The word "determine" replaces the word "identify". A note had been added stating that a purchased processes are regarded as purchasing products. Another note had been added demanding that these processes would be controlled as well as products.
My comment - When identifying, you are required to search and find something according to the requirement. When determining, the responsibility of the results is in your hands...
It was obvious before.... Sometime they feel a need to state the obvious.
Paragraph number 4.2.1 - Slight change of words, but when you examine the change you realize the meaning remains same.
Note 2 was changed: A single document may include requirements for more than one procedure. Requirements of one procedure may appear in more than one document.
My comment - It's about time. A lot of headaches are vowed to be save. If your auditor was one of the old schools and demanded everything by the book, you had troubles. Now you may document two quality requirements on one document: Job description and trainings, for example. Or you can split one record into two documents. However it is suitable for you as long as you achieve the requirements.
A good example is that it is possible to combine the corrective and the preventive procedures together. As long as you maintain the requirements...
Paragraph number 4.2.3 - Paragraph f - A clarification that external documentation is considered while it is part of the quality management system.
My comment - When an external document is part of your quality management system, it is required to be included under the quality procedures: documents control and records control.
Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An additional requirement that the management representative would be a member of the organization's management.
My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of form and documentations for you to develop in order that the external consultants would be considered as a management representative. All external consultants would have to be creative on this one.
Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting conformity to product requirements"
Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competence"
Clause c - you must ensure that the training is with competence rather than if it was an effective training.
My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new. On one hand it is an improvement. The training must be reviewed before for its competence to the requirements. But we are still on this one. We think: instead of testing your employees if they got anything out of the training you must now review the training itself before or maybe both.... Only time will tell...
Paragraph number 6.3 - Clause c - information systems are included.
My comment - They are totally right!
Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.
My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine the OHSAS 18001 Standard...
Paragraph number 7.1 - Clause c - measurement had been added to the product acceptance activities.
Paragraph number 7.2.1 - Clause a - change of words - not of the meaning.
Clause c - the word 'applicable' replaces 'related'. Change of words - not of the meaning.
Clause d - change of words - not of meaning.
A note had been added to explain the meaning of "post delivery activities".
My comment - I agree with the "post delivery activities" - it wasn't clear enough for our opinion.
Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.
Paragraph number 7.3.3 - A change of words. A note had been added clarifying the inclusion of "preservation of product".
My comment - The preservation of the product is to be included now in the design and the development outputs.
Paragraph number 7.5.3 - A requirement had been added regarding the measurements and test status must be identified throughout the product realization.
My comment - This requirement so far was required in standards such as ISO 13485 Standard for medical devices and the ISO/TS 16949 for the automobile industry. The requirement assures you that the inspection activities are defined maintained and recorded and so is the product's status.
Paragraph number 7.5.4 - A change of words in the requirement to inform the customer of any problem regarding his property.
The note had been amended that also personal data is included as customer's property.
Paragraph number 7.5.5 - A change of words:
"devices" in the title was changed to "equipment"
"conformity of" to "in order to maintain conformity to requirements".
Reference to paragraph 7.1 was removed
Paragraph number 7.6 - A change of words:
from "devices" to "equipment".
The reference to paragraph 7.2.1 had been removed.
Clause c - from "be identified to enable the"
to" identification to enable their".
Changes in the notes:
Note 1 - the reference to ISO 100012-2 had been removed.
Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.
My comment - That means that from now on, a computers that provides any kind of measurements services, is considered as a monitoring and measuring device. And when the computer configuration has been changed - the software is required to be calibrated again.
How can one calibrate a computer? Ask your supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done and present evidences.
Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.
Paragraph number 8.2.2- Requirements for the audit evidence and results had been added.
Requirements for the management responsibility had been added - The management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011.
My comment - As I see it, that means an addition within the Management Responsibility procedure or the Internal audit procedure about management ensuring that preventive and corrective actions would be taken according to the results and decisions of the internal audit and a reference to the validation and verification.
Take a look at the next web site that provides you with prepared solutions for internal audit procedure the9000store.com.
Paragraph number 8.2.3 - A change of words:
"to ensure conformity of the product" had been removed.
A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.
Paragraph number 8.3 - An addition: Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.
So, what are the new requirements of the new standard?
* Statutory requirements are given scale as any other legal or customer's requirements.
* The statutory requirements include the suppliers as well.
* A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality management system.
* You may include two quality processes in one document and split one process into two documents.
* The management representative must be a member of the top management.
* A requirement to ensure that trainings are suitable for the product in advance and not to examine whether the training was effective after it was taken.
* Information system is now officially considered as a substructure.
* Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
* Measuring is considered as one of the activities of product realization. The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
* The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
* Software configuration is a reason for re-calibrating the software.
* The management is now responsible for preventive and corrective actions regarding nonconformities that were revealed during internal audits.
* The organization should determine the type of the monitoring and measuring according to the processes and indicate how this would affect the quality management system.
Summary
Most of the changes made here are really minor and are assistance for understanding open issues. I excepted a bit more of new standard but I am satisfied. The objective was not to create any earth qaukes in the quality industry but to keep update with changes in technology and to update the feedbacks and responses that were gathered over the last years. I am lucky . I already thought that all my articles in our website should be changed...
Itay Abuahv Eng.
Source: http://ezinearticles.com/
At the end of it I will summon the new requirements from the new ISO 9001:2008 standard.
Paragraph number 0.1 - Changes here are a statement about whom and where the standard includes any statutory requirements. Statutory requirement (of any kind) has the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.
Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
My comment - Of course. The world is getting greener every day so they must remind you of the ISO 14001 standard. I believe and recommend to any organization that is required to implement the ISO 14001 standard to implement also the ISO 9001 standard. There is a big correlation between the two. They actually support one another. It would be easier for organization to obtain the ISO standard 14001 requirements if it has been already certified for ISO 9001.
Paragraph number 1.1 & 1.2 - Statutory requirements had been referred in relation with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.
My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and regulatory requirements are applicable to the purchasing processes as well. It was always an open area that no one had the exact answer: Does your supplier must follow the law or not? Apparently yes.
Paragraph number 2 - Normative reference - the ISO 9000 is now replaced by ISO 9000:2005.
Paragraph number 3 - The explanations about what is a customer and what is an organization and what is a supplier had been removed.
Paragraph number 4.1 - Clause a - The word "determine" replaces the word "identify". A note had been added stating that a purchased processes are regarded as purchasing products. Another note had been added demanding that these processes would be controlled as well as products.
My comment - When identifying, you are required to search and find something according to the requirement. When determining, the responsibility of the results is in your hands...
It was obvious before.... Sometime they feel a need to state the obvious.
Paragraph number 4.2.1 - Slight change of words, but when you examine the change you realize the meaning remains same.
Note 2 was changed: A single document may include requirements for more than one procedure. Requirements of one procedure may appear in more than one document.
My comment - It's about time. A lot of headaches are vowed to be save. If your auditor was one of the old schools and demanded everything by the book, you had troubles. Now you may document two quality requirements on one document: Job description and trainings, for example. Or you can split one record into two documents. However it is suitable for you as long as you achieve the requirements.
A good example is that it is possible to combine the corrective and the preventive procedures together. As long as you maintain the requirements...
Paragraph number 4.2.3 - Paragraph f - A clarification that external documentation is considered while it is part of the quality management system.
My comment - When an external document is part of your quality management system, it is required to be included under the quality procedures: documents control and records control.
Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An additional requirement that the management representative would be a member of the organization's management.
My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of form and documentations for you to develop in order that the external consultants would be considered as a management representative. All external consultants would have to be creative on this one.
Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting conformity to product requirements"
Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competence"
Clause c - you must ensure that the training is with competence rather than if it was an effective training.
My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new. On one hand it is an improvement. The training must be reviewed before for its competence to the requirements. But we are still on this one. We think: instead of testing your employees if they got anything out of the training you must now review the training itself before or maybe both.... Only time will tell...
Paragraph number 6.3 - Clause c - information systems are included.
My comment - They are totally right!
Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.
My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine the OHSAS 18001 Standard...
Paragraph number 7.1 - Clause c - measurement had been added to the product acceptance activities.
Paragraph number 7.2.1 - Clause a - change of words - not of the meaning.
Clause c - the word 'applicable' replaces 'related'. Change of words - not of the meaning.
Clause d - change of words - not of meaning.
A note had been added to explain the meaning of "post delivery activities".
My comment - I agree with the "post delivery activities" - it wasn't clear enough for our opinion.
Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.
Paragraph number 7.3.3 - A change of words. A note had been added clarifying the inclusion of "preservation of product".
My comment - The preservation of the product is to be included now in the design and the development outputs.
Paragraph number 7.5.3 - A requirement had been added regarding the measurements and test status must be identified throughout the product realization.
My comment - This requirement so far was required in standards such as ISO 13485 Standard for medical devices and the ISO/TS 16949 for the automobile industry. The requirement assures you that the inspection activities are defined maintained and recorded and so is the product's status.
Paragraph number 7.5.4 - A change of words in the requirement to inform the customer of any problem regarding his property.
The note had been amended that also personal data is included as customer's property.
Paragraph number 7.5.5 - A change of words:
"devices" in the title was changed to "equipment"
"conformity of" to "in order to maintain conformity to requirements".
Reference to paragraph 7.1 was removed
Paragraph number 7.6 - A change of words:
from "devices" to "equipment".
The reference to paragraph 7.2.1 had been removed.
Clause c - from "be identified to enable the"
to" identification to enable their".
Changes in the notes:
Note 1 - the reference to ISO 100012-2 had been removed.
Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.
My comment - That means that from now on, a computers that provides any kind of measurements services, is considered as a monitoring and measuring device. And when the computer configuration has been changed - the software is required to be calibrated again.
How can one calibrate a computer? Ask your supplier or your system administrator. They will know better than anyone. But you would have to prove it has been done and present evidences.
Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.
Paragraph number 8.2.2- Requirements for the audit evidence and results had been added.
Requirements for the management responsibility had been added - The management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011.
My comment - As I see it, that means an addition within the Management Responsibility procedure or the Internal audit procedure about management ensuring that preventive and corrective actions would be taken according to the results and decisions of the internal audit and a reference to the validation and verification.
Take a look at the next web site that provides you with prepared solutions for internal audit procedure the9000store.com.
Paragraph number 8.2.3 - A change of words:
"to ensure conformity of the product" had been removed.
A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.
Paragraph number 8.3 - An addition: Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.
So, what are the new requirements of the new standard?
* Statutory requirements are given scale as any other legal or customer's requirements.
* The statutory requirements include the suppliers as well.
* A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality management system.
* You may include two quality processes in one document and split one process into two documents.
* The management representative must be a member of the top management.
* A requirement to ensure that trainings are suitable for the product in advance and not to examine whether the training was effective after it was taken.
* Information system is now officially considered as a substructure.
* Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
* Measuring is considered as one of the activities of product realization. The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
* The product realization process shall include references to the inspection activities and the status of the product throughout the realization processes.
* Software configuration is a reason for re-calibrating the software.
* The management is now responsible for preventive and corrective actions regarding nonconformities that were revealed during internal audits.
* The organization should determine the type of the monitoring and measuring according to the processes and indicate how this would affect the quality management system.
Summary
Most of the changes made here are really minor and are assistance for understanding open issues. I excepted a bit more of new standard but I am satisfied. The objective was not to create any earth qaukes in the quality industry but to keep update with changes in technology and to update the feedbacks and responses that were gathered over the last years. I am lucky . I already thought that all my articles in our website should be changed...
Itay Abuahv Eng.
Source: http://ezinearticles.com/
Friday, October 22, 2010
Thursday, October 21, 2010
Wednesday, October 20, 2010
Tuesday, October 19, 2010
iso standards 9001 2008
• ISO 9001 2008 Translated into Plain English
6 Sep 2010 ... ISO 9001 2008 is a quality management standard. Use it to establish, upgrade, ... This page summarizes the ISO 9001 2008 standard. ...
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ISO standard plays role in rescue of trapped Chilean miners • Financial guidance for national standards bodies • No more rashes and tears with ISO standard ...
• ISO 9001:2008 - Quality management systems -- Requirements
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6 Sep 2010 ... ISO 9001 2008 is a quality management standard. Use it to establish, upgrade, ... This page summarizes the ISO 9001 2008 standard. ...
• ISO - International Organization for Standardization
ISO standard plays role in rescue of trapped Chilean miners • Financial guidance for national standards bodies • No more rashes and tears with ISO standard ...
• ISO 9001:2008 - Quality management systems -- Requirements
All requirements of ISO 9001:2008 are generic and are intended to be ...
• ISO - ISO 9000 Quality management- ISO 9001:2008
New editions of ISO 9001 and ISO 9004. Advice for users on implementing ISO ...
• ISO - ISO 9000 / ISO 14000
The ISO 9000 and ISO 14000 families are among ISO's best known standards ...
Monday, October 18, 2010
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• TS 16949, ISO 9001, Quality Management, Free Quality Manual ...
Download our Free ISO 9001:2008 Qualiity Manual ... We've held hundreds of courses on ISO and TS (as well as other standards) and while I probably have ...
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Download our Free ISO 9001:2008 Qualiity Manual ... We've held hundreds of courses on ISO and TS (as well as other standards) and while I probably have ...
• ISO 9001 2008 new standard
PUBLICATION OF STANDARD ISO 9001:2008 will be available for purchase from ASQ ... Business-Management, standar free, downloadable iso, download free, doc, ...
• ISO - Publications and e-products - Management standards
This ISO Standards collection on CD includes ISO 9001:2008, the latest edition .... Download. English, CD, 978-92-67-10485-0, free*. ISO 9000 video (NTSC) ...
• New editions of ISO 9001 and ISO 9004 Advice for users on ...
ment of ISO 9001:2008. Organ- izations are free to implement the standard ...
• ISO 9001:2008 QMS Quality Procedures Manual
Based on the latest ISO 9001:2008 Standard, this quality policies and procedures manual simplifies your ISO ... Download Free Sample Policies and Procedures ...
Sunday, October 17, 2010
pdf - iso 9001 2008 standards
• ISO 9001:2008 - Quality management systems -- Requirements
English, PDF (383 kB), CHF 118,00. English, Paper, CHF 118,00 ... Note: This standard is also included in the ISO 9000 Quality management CD-ROM. ... ISO 9001:2008 specifies requirements for a quality management system where an ...
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6 Sep 2010 ... ISO 9001 2008 is a quality management standard. ... Title 20 is 112 pages long and comes in pdf and MS doc file formats. ...
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15 Oct 2008 ... ISO. 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. ...
English, PDF (383 kB), CHF 118,00. English, Paper, CHF 118,00 ... Note: This standard is also included in the ISO 9000 Quality management CD-ROM. ... ISO 9001:2008 specifies requirements for a quality management system where an ...
• ISO - ISO 9000 Quality management - ISO 9000 essentials
The ISO 9001:2008 standard provides a tried and tested framework for taking ...
• ISO 9001:2000 - Quality management systems -- Requirements
International Standards for Business, Government and Society ...
• ISO 9001 2008 Translated into Plain English
6 Sep 2010 ... ISO 9001 2008 is a quality management standard. ... Title 20 is 112 pages long and comes in pdf and MS doc file formats. ...
• Implementation Guidance for ISO 9001:2008.pdf - Implementation ...
15 Oct 2008 ... ISO. 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. ...
Saturday, October 16, 2010
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• ISO 9001 2008 new standard
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From Wikipedia, the free encyclopedia. Jump to: navigation, search ... Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO ...
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2 Nov 2006 ... Can anyone direct me where I can optain a free copy of the ISO 9001:2000 .... Can anybody provide a copy of ISO 9001:2008 standard, anil123, ISO 9001 ...
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27 Apr 2009 ... Use our ISO 9001 2008 Gap Analysis Tool to upgrade your Quality Management System. ... material as often as you wish, free of charge. ... legally authorized to print or produce additional copies, or to copy and paste ...
PUBLICATION OF STANDARD ISO 9001:2008 will be available for purchase from ... doc, online, torrent, norma iso, version, get, free copy, free jpeg, load iso ...
• ISO 9001:2008
A new version of ISO 9001 (ISO 9001:2008), the world's most widely used quality management ... and participants will be given a free copy of the standard ...
• ISO 9000 - Wikipedia, the free encyclopedia
From Wikipedia, the free encyclopedia. Jump to: navigation, search ... Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO ...
• Copy of ISO 9001:2000 Standard
2 Nov 2006 ... Can anyone direct me where I can optain a free copy of the ISO 9001:2000 .... Can anybody provide a copy of ISO 9001:2008 standard, anil123, ISO 9001 ...
• How to Upgrade to the NEW ISO 9001 2008 Standard
27 Apr 2009 ... Use our ISO 9001 2008 Gap Analysis Tool to upgrade your Quality Management System. ... material as often as you wish, free of charge. ... legally authorized to print or produce additional copies, or to copy and paste ...
Friday, October 15, 2010
iso 9001 2008 standard
• ISO 9001 2008 Translated into Plain English
6 Sep 2010 ... ISO 9001 2008 is a quality management standard. Use it to establish, upgrade, ... This page summarizes the ISO 9001 2008 standard. ...
• ISO - International Organization for Standardization
ISO standard plays role in rescue of trapped Chilean miners • Financial guidance for national standards bodies • No more rashes and tears with ISO standard ...
• ISO 9001:2008 - Quality management systems -- Requirements
Note: This standard is also included in the ISO 9000 Quality management CD ...
• ISO - ISO 9000 Quality management- ISO 9001:2008
New editions of ISO 9001 and ISO 9004. Advice for users on implementing ISO ...
• Changes in ISO 9001:2008 Quality Standard
16 Sep 2008 ... Changes in ISO 9001:2008 Quality Standard. A paper written by Larry Whittington describes the changes expected in the ISO 9001:2008 quality ...
6 Sep 2010 ... ISO 9001 2008 is a quality management standard. Use it to establish, upgrade, ... This page summarizes the ISO 9001 2008 standard. ...
• ISO - International Organization for Standardization
ISO standard plays role in rescue of trapped Chilean miners • Financial guidance for national standards bodies • No more rashes and tears with ISO standard ...
• ISO 9001:2008 - Quality management systems -- Requirements
Note: This standard is also included in the ISO 9000 Quality management CD ...
• ISO - ISO 9000 Quality management- ISO 9001:2008
New editions of ISO 9001 and ISO 9004. Advice for users on implementing ISO ...
• Changes in ISO 9001:2008 Quality Standard
16 Sep 2008 ... Changes in ISO 9001:2008 Quality Standard. A paper written by Larry Whittington describes the changes expected in the ISO 9001:2008 quality ...
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