Showing posts with label ISO 9000:2008. Show all posts
Showing posts with label ISO 9000:2008. Show all posts

Wednesday, July 24, 2013

ISO 9001:2008 WILL BE UPDATE TO ISO 9001:2015

The ISO’s most pupolar standard – ISO 9001 now is under revision and updating. The survey’s been completed, the drafts discussion was started and the time frames was tentatively proposed; ISO 9001 - is now under revision with the new working title as ‘ISO 9001:2015’.


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Wednesday, September 5, 2012

ISO 9001:2008 Brings More Clarity to QMS Standard

Although the recently released ISO 9001:2008 contains no new requirements compared to the 2000 edition, it does clarify existing requirements of ISO 9001:2000.

Released last November, ISO 9001:2008 is the latest edition of the International Standard used by many automotive companies and other organizations as the framework for their quality management systems (QMS). The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.


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Monday, July 2, 2012

What is ISO 9000 and Should I Care?

The ISO 9000 series of standards

ISO 9000 consists of a series of Quality Management System standards that are designed to facilitate the establishment of business processes aiming to ensure that customer requirements are met or exceeded. They can be applied in any manufacturing industry or service sector.


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Tuesday, September 27, 2011

Free Webinar | ISO 9001:2008 Formal Interpretations

Attend FREE Webinar:

"ISO 9001:2008 Formal Interpretations"

Date: November 8, 2011
Time: 1:00 P.M. ET
Cost: FREE

Webinar topics include:


  • Does sub-clause 4.2.3 a) require that documents required for the QMS be reviewed as well as approved prior to issue?

  • Does Clause 4.2.2 c), require that the manual include a description of the processes, in addition to a "description of the interaction between the processes of the QMS"?

  • Is it a requirement of Clause 5.4.2 to have a document that describes the objectives, timeframe, action, and responsibilities?

  • In our organization, we have a management representative appointed by top management, who works for the company in a managerial capacity. He is not a permanent member of staff, but works full-time on a contract basis. Is it allowable under the standard for such a person to act as the organization's management representative?

  • Does Clause 6.3 require records of the maintenance of infrastructures?

  • Does the word "specify" or "specified" quoted in various clauses require documentation?

  • Does Clause 7.4.3 require records of the verification of purchased product?

  • Is it correct that Clause 7.6 requires only the measuring and monitoring devices utilized by persons responsible for release of the product to be calibrated or verified?

  • Does Clause 7.5.2, Validation of processes for production and service provision, require that any applicable statutory and regulatory requirements must be taken into account?

  • And much more

Register online today!


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Thursday, September 30, 2010

Why is ISO 9000 / ISO 9001:2000 Certification So Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9000 / ISO 9001:2000 to do business.
Consider the facts (source MORI/SGS-ICS) that with ISO certification:
  • 83% realized improved management control
  • 82% realized improved customer satisfaction
  • 62% said it improved the ability to win work
  • 61% stated a more motivated workforce
  • 60% realized improved productivity
  • 60% saw reduced waste
  • 52% stated it improved marketing
  • 50% had reduced costs
  • 49% realized increased market share

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Wednesday, September 29, 2010

RECORDS REQUIRED BY ISO9000

Section

Description

4.2.1 General

Reference to records required by the standard

4.2.3 Control of documents

For records are controlled according to 4.2.4

4.2.4 Control of records

Records are established and maintained to provide evidence of conformity

5.6.1 Management Review – GeneralReview

Management Review records

6.2.2 Competence, Awareness, and Training

Education, training, skills, and experience

7.1 Planning a product realization

Evidence is recorded that the realization processes and resulting product meet requirements

7.2.2 Review of requirements related to the product

Results of the review and actions are rising from the review

7.3.2 Design and development inputs

Inputs relating to product requirements

7.3.4 Design and development review

Results of the reviews and any necessary actions

7.3.5 Design and development verification

Results of the verification and any necessary actions

7.3.6 Design and development of validation

Records of the results of validation and any necessary actions

7.3.7 Control of design and development changes

Results of the review of changes in any necessary actions

7.4.1 Purchasing process

Results of supplier evaluations and any necessary actions are rising from the valuation

7.5.2 Validation of processes for production and service provision

Requirements for records as applicable

7.5.3 Identification and traceability

Where traceability is a requirement, the unique identification of the product

7.5.4 Customer property

Records of customer property that has lost, damaged, or unsuitable for use

7.6 Control of monitoring and measuring devices

  • Where no standards exist, bases used for calibration is recorded
  • Records of the results of calibration and verification are maintained

8.2.2 Internal audit

  • Records of audit results
  • Implied records for reporting verification follow up activities and results

8.2.4 Monitoring and measurement of product

Records indicates the person(s) authorizing the release of the product

8.3 Control of non-conforming product

The nature of nonconformities and any subsequent actions taken, including concessions obtained

8.5.2 Corrective action

Records for corrective action results taken

8.5.3 Preventive action

Records for preventive action results taken


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Sunday, October 25, 2009

Internal Audit Nonconformance/NC is not closed, is it a nonconformity at CB assessment?

Several times ago, I’m find a question that makes me surprised. It’s a question from Peters from Poland at Elsmar.com forum at June 2007.

The question is like this. “Internal Audit Nonconformance/NC is not closed, is it a nonconformity at CB assessment? “ He also explained like this. “These were some minor nonconformity from latest internal audits. Some (only some!) corrective actions began but are not finished and closed. Lead Auditor from CB had doubts that he can accept this. He was not sure it conforms to the requirements. We couldn't find in rules any information about such problem. Do internal audit nonconformities have to be closed before certification audit? Organization began corrective actions but these actions are not closed. Is there any requirement in Rules that this situation is nonconformity in certification audit?”

Several in the cove have answered this question.


Stijloor from North Caroline as the forum moderator’s was response like this. “No not necessarily. The corrective action may have to be monitored for a while to demonstrate its effectiveness before a CAR can be (finally) closed. Your CAR log should show the status of the CAR. Inactions (delays, etc.,) are bad”. He also told, “Now, if the Certification Body's auditor issues nonconformity, then it must be closed within a pre-determined time limit. In other words, a certificate of registration can not be issued unless all NC's have been closed to the satisfaction of the CB”.

Trainerbob from Michigan, USA response like this, “There should be no problem with a third party auditor and a corrective action for an internal audit problem as long there seems to be a reasonable plan in place to eliminate the problem and verify the effectiveness of it. If there is no reasonable plan in place to solve the problem, then the third party auditor would probably have a probably have a problem. As Stiljoor said there is a difference between a corrective action from an Internal Audit and a third party audit. Your third party auditor or his/her organization will have guidelines that they use for the closing of non-conformances found during their audits.

Spartan Kim as Shy poster at Elsmar.com response like this, “I agree with Stijloor and would say the requirement is implied. If an internal audit nonconformance is about a requirement of a standard that is not being done, then that certainly would create a new nonconformance at registration audit time from the registrar. But a departure from an internal, documented process that shows progress in meeting the target completion date (as opposed to no progress for days or weeks) should not create a new nonconformance from a registration audit”.

Sidney Vianna from Long Beach, California response like this, “I don't have my copy of the IATF rules handy, at this moment. So, I can not answer for sure if under the IATF rules that would be a nonconformity or not. But, if this was an ISO 9001 audit, conducted under the requirements of ISO 17021, I would have to ask you further questions. For example, are ALL corrective actions emanating from your internal audit process unresolved/open? If that were the case, how can an external auditor assess the effectiveness of your corrective action process? Further, since results of internal audits and status of corrective actions should be part of your management review, can an external audit assess if your management review activities are done? If we were to assume that a percentage of your corrective actions, originated from your internal audit were "closed" and the external auditor can verify the process is working, I would emphatically agree that there is no requirement mandating all corrective action requests to be closed, prior to the certification audit. However, if NONE of the actions have been closed, verified for implementation and effectiveness, myself as an auditor could not attest that a key process of the QMS, namely the corrective action process, is effectively implemented”.

Howste from Utah response like this, “The Rules are not specifically mentioned what you are talking about. Originally Posted by TS Rules 3rd Edition, the audit team shall record all findings of nonconformity when detected and identify the nonconformities to the client. The identified nonconformities shall not be closed during the audit. If there are still nonconformities present in the system, and the audit team finds them, they must record them. So if a corrective action has been initiated, and correction has taken place, there would be no nonconformity - even if the full corrective action is not complete. If the corrective action has been initiated, and the nonconformity still exists, it must be a nonconformity”.

Arios from Juarez-Chihuahua-Mexico response like this, “Corrective Actions derived from internal audits may still be open provided that the issue does not compromise registration. If for instance you have an internal audit finding and a Corrective Action open because the Management Review meetings have not been performed, then to me is a big issue and I would not take the Corrective Action as a waiver for not meeting a requirement in the management standard.

Raffy from Manila-Philippine response like this, “Hi peters, two years ago we also have the same problem as they are some NC from the internal audits were not closed. This was noted by our CB during our pre-assessment audit and likewise suggests that these items should be immediately addressed by our organization. As regards to the problem, during the certification audit, there also some NC that were not closed and status were not indicated, that's why it was called out against the requirement of the clause 8.2.2 & 8.5.2.1 of ISO/TS16949. Lesson learned, there should be a status of each NC and these should be tracked and monitored. If these are not yet finished and remain Open. Escalation Process must be immediately implemented”.

And I was resuming that stated opinion like this, “I think that is no problem if you have a complete planning about the corrective action. That is including the monitoring of your corrective action progress. And I think that was an excessive finding if that is as a nonconformity. It should be an observation finding not a minor or major finding”.


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