The Upcoming Release of ISO 9001:2008
Any ISO standard goes through several formal steps on its way to final release. ISO 9001:2008 is currently at the DIS ("Draft International Standard") stage, meaning it is nearly complete. The draft of ISO 9001:2008 is now available for public review. The only step left is to finalize the language and then a formal committee vote.
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 is including any statutory requirements and have 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 needed of the ISO 14001 standard to implement also the 9001. There is a big correlation between these two. They actually help one another.
Paragraph number 1 - Statutory requirements had been referred in connection 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 statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.
Paragraph number 2 - Normative reference - the ISO 9000 is now referred to ISO 9000:2005
Paragraph number 3 - Explanation 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" is replacing the "identify". A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products.
My comment - Come on, like it wasn't obvious before....
Paragraph number 4.2.1 - Slight change of words but when you examine the change you realize the meaning is the same. Note2 was changed - a single document may include requirements for more than one procedure and 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 audit was one of the old school and demanded everything by the book - now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the demands.
Paragraph number 4.2.3 - A clarification that external documentation are the ones needed for the quality management system.
Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An addition for a demand 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 forms and documentations for you to develop in order that the external consultants would be considered as a management representative.
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".
My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new.
Clause c - you must ensure that the training is with competence rather than if it was an effective training.
My comment - On one hand it is an improvement. The training must be reviewed before. But I think it's not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before. 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 OHSAS 18001...
Paragraph number 7.1 - Clause c - measurement had been added to the activities.
Paragraph number 7.2.1 - Clause a - change of words - not of the meaning. Clause c- the word 'applicable' replaces 'related'. Clause d - change of words - not of meaning. A note has been added to explain what is the meaning of "post delivery activities".
My comment - I agree with the "post delivery activities" - it wasn't clear enough for my 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 wording. A note had been added clarifying what is included in "preservation of product".
Paragraph number 7.5.3 - A requirement added specifying that product traceability must be included throughout the product realization.
My comment - That actually means that the product must be identifying not only on the shelves but also throughout the realization process.
Paragraph number 7.5.4 - A change of words to 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: from "conformity of" to "in order to maintain conformity to requirements"
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 computer that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone.
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 and also that the management is responsible for ensuring preventive and corrective action to be taken.
The reference to the ISO 10011 is changed to ISO 19011.
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?
Summery
Most of the changes made here are really minor and are assistance to understanding open issues. I excepted more of from the new standard but hey, isn't it enough as it is? The purpose wasn't to make any "earth quakes" 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.
Itay Abuahv Eng.
The author is Itay Abuhav who is external consultant who decided to establish a quality management knowledge center providing articles, news with added values, offering solutions, help and tips regarding to all quality management systems and the ISO 9001 standard. please visit us at http://www.9001quality.com
Article Source: http://EzineArticles.com/?expert=Itay_Abuhav
Zmiany w standardzie BRC
2008-03-03Po wielu konsultacjach i dyskusjach, 4 stycznia 2008r. BRC opublikowało nową, piątą wersję Standardu BRC, "Global Standard for Food Safety". W celu ułatwienia zrozumienia standardu przez firmy i jednostki certyfikujące, wprowadzono szereg szczegółowych wymagań, np. w odniesieniu do kontroli zagrożeń chemicznych, drewna, szkła, zabezpieczenia miejsca pracy, postępowania z incydentami czy wycofywania produktów z rynku.
Standard ten zacznie obowiązywać od 1 lipca 2008r. Oznacza to, że do 30 czerwca 2008r. weryfikacje będą przeprowadzane zgodnie z wymaganiami zawartymi w poprzedniej wersji, "BRC Global Standard - Food".Więcej informacji o standardzie "Global Standard for Food Safety" znajduje się na stronie BRC http://www.brc.org.uk/.
Z początkiem lipca tego roku wszedł nowy standard OHSAS 18001:2007 dotyczący Systemu Zarządzania Bezpieczeństwem i Higieną Pracy.
Zastępuje on obecnie obowiązujący standard OHSAS 18001:1999.
Firmy posiadające certyfikat wydany zgonie ze standardem OHSAS 18001:1999 mają dwa lata na przejście na nowy standard. Z dniem 30 czerwca 2009 certyfikaty ze starym standardem tracą ważność.
Nowy standard różni się od pierwszego wydania między innymi większym naciskiem na elementy związane z "Higieną Pracy", głównie przez mocniejsze ukierunkowanie w stronę ISO 14001:2004, co ma na celu łatwiejszy rozwój zintegrowanych systemów zarządzania.
LRQA zaprasza na szkolenia związane z dostosowaniem Systemu Zarządzania Bezpieczeństwem i Higieną Pracy do wymagań OHSAS 18001:2007.
Fully Networked Car workshop addresses climate change
| he third edition of the Fully Networked Car workshop, organized in partnership by ISO, IEC and ITU on 5-7 March at the Geneva International Motor Show 2008, focused on standards that will facilitate the convergence of information and communication technologies (ICT) in motor vehicles, as well as addressing this year's special theme of climate change. ITU Secretary General, Dr. Hamadoun I. Touré, commented in his presentation at the opening of the workshop: “Today, ICTs are an integral part of keeping vehicles on our roads safe and secure… This merging of technology requires that the World Standard Cooperation partners, ITU, ISO and IEC, take into account each other’s work and co-operate at points of technological interface so that manufacturers can use our standards to deliver a final product to customers that functions as expected.” At the opening session, ISO Secretary-General Alan Bryden stated (see full speech): “This event is the opportunity to underline that innovation and standardization go hand in hand and how ICT support progress in the performance, safety and functionalities of transportation, It also shows how the collaboration between ISO, IEC and ITU optimizes the channeling of world expertise and best practices into globally relevant international standards.” He indicated that ISO has been directly associated with three major, recent meetings of global significance:
Jack Sheldon, on behalf of IEC General Secretary Aharon Amit, declared: “The IEC – and this applies equally to ISO and the ITU – has an ongoing commitment to provide the market with timely and relevant standards. This commitment embraces a vast spectrum of industries, and automobiles are a significant part of the market. This workshop is an opportunity to study who wants what and who needs to work with whom to provide integrated systems for networked cars”. The main purpose of the workshop is to establish a constructive dialogue among market stakeholders and identify how standards help the the motor industry to make vehicles more efficient and safer, with lower impact on the environment. A feature of this year's Fully Networked Car exhibition is the Honda Racing F1 Team’s new Formula-1 “Earthdreams ” car whose design emphasizes environmental features and points towards green automotive technologies of the future. |
Create a free website at Webs.com