Showing posts with label Quality Management Systems. Show all posts
Showing posts with label Quality Management Systems. Show all posts

Friday, October 9, 2009

ISO 9000 registration or certification

ISO 9000 registration or certification
Registration is documented and objective evidence that an organization’squality system meets the requirements of ISO 9000.
Certification is a term often used interchangeably with registration.
In the context of ISO 9000, they mean the same thing. Registration isthe technically correct term for verification of compliance to standardsof quality systems. Certification usually applies to verification of thequality of products (as opposed to quality systems).
Registration is carried out by independent companies called registrars.These companies are:- Wholly independent.- Accredited by a recognized international accreditation body.- Selected, and paid, by you.
Registration can cover:- The sole location of a single-location organization.- Multiple locations of a multilocation organization.- Only certain parts of a multilocation organization (under certain conditions).- Separate locations under separate certificates. (This is a more costlyapproach.)The registration body audits your quality system against the requirementsof ISO 9000. It reports its findings in writing. These findings may (and usually do) include noncompliances (Question 96). Major noncompliances must be closed out prior to official registration.
When this has been done, the registration body:- Lists the organization’s name in its book of registered companies—in effect, registers the organization in its book.- Issues a certificate to the registered organization. This registrationincludes:— Identity of the organization.— Location(s) covered by the registration.— A list of products/services supplied by the registered locations.— Revision date of the Standard.— Registration effective dates.— Name and location of registrar.
Most registrars limit registrations to three years. After that, youmust renew your registration by undergoing another complete systemsaudit. Some registrars do not use the renewal approach. They simplykeep checking the system via surveillance audits.
Whichever the scheme, the organization, to keep registration, mustundergo a surveillance assessment every so often. Six months is the typicalinterval. Some registrars offer annual surveillance schemes (notrecommended except for firms with exceptionally well-implementedquality management systems). Surveillance assessments are scheduledevents (there is no such thing as a “surprise” surveillance audit). Onlypart of the quality system is checked at each surveillance. Usually, theregistrar does not disclose what part will be assessed until the day of theassessment, although some registrars will tell you everything up front.The entire quality system is usually checked via surveillance audits overthe course of three years.
There is no way to “fail” a surveillance assessment, just as there isno way to “fail” a registration audit—except by refusingto implement corrective action required by the registrar. Normally,registrars allow adequate time, but corrective actions must be done ina timely and agreed upon manner to keep registration.One final note: As mentioned, each registrar publishes a list ofthe firms it has registered to ISO 9000.

ISO 9001:2008 FAQ

ISO 9001:2008 FAQ
What Is The ISO 9001: 2008 Standard?
The latest edition of the ISO 9001 standard ISO 9001: 2008, Quality Management Systems – Requirements, was officially published by (ISO) the International Organization for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 standard since it was first published in 1987.
Who Is Responsible For Revising The standards?
The ISO Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) is responsible for the revision process in collaboration with consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties.
Does ISO 9001:2008 Have Additional Requirements Beyond ISO 9001:2000 ?
This latest (4th) edition of ISO 9001 contains no new requirements compared to the (3rd) year 2000 edition, which it replaces. What it does is provide clarification to the existing requirements of ISO 9001:2000 based on eight years’ experience of worldwide implementing of the standard and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.
The clarifications and changes in ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. The changes are minor in nature and address such issues as the need to clarify, provide greater consistency, resolve perceived ambiguities, and improve compatibility with ISO 14001. The numbering system and the structure of the standard remain unchanged. As a result, the new standard looks much like the old standard.
ISO has grouped the changes incorporated in this ISO 9001:2008 edition into the following categories:- No changes or minimum changes on user documents, including records- No changes or minimum changes to existing QMS processes- No additional training required or minimal training required- No effects on current certifications
In contrast, the 3rd edition, ISO 9001:2000 published in 2000, represented a major overhaul of the standard, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.
Then Why Was It Necessary To Introduce This Revision?All ISO standards – currently more than 17 400 – are periodically reviewed. To ensure that ISO standards are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a decision taken to confirm, withdraw or revise the documents. The review process must be initiated within 3 years of publication of a standard. The review considers several factors such as technological evolution, new methods and materials, new quality and safety requirements, or questions of interpretation and application.
The review of ISO 9001 resulting in the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176. This subcommittee, which is responsible for the ISO 9000 family, unites expertise from 80 participating countries and 19 international or regional organizations, plus other technical committees.
This review has a number of inputs that help it:
A global user questionnaire/survey
A market Justification Study
Suggestions arising from the ISO/TC 176 interpretation process
Opportunities for increased compatibility with ISO 14001
The need for greater clarity, ease of use, and improved translation
Current trends – keeping up with recent developments in management system practices.
How Does The New ISO 9001 Edition Affect Existing ISO 9001 QMS’s?
As organizations start looking at ISO 9001:2008, they will wonder to what extent the changes might affect them. To a large extent, the new standard will not result in significant change to existing quality management systems (QMS).
ISO/TC 176 was careful in not making change for change sake. In the case of editorial changes, this was especially true. This could have lead to a false impression that there was a change in requirements, carrying greater significance than was intended. In those instances, when the committee members couldn’t come to a consensus in determining if a change added or deleted a requirement, they opted to retain the existing text. They decided it was better to err on the side of caution rather than to contribute to any misunderstanding in the marketplace.
The changes that have been incorporated into this edition of the ISO 9001 standard include changes that should lead to a better understanding across a broader range of product types, including service organizations; use of deliberate wording to minimize the potential for incorrect user interpretation; and reflect nuances of similar concepts. Lastly, some of the changes to specific clauses were made based on the 2004 International User Feedback Survey. This survey was conducted after the publication of ISO 9001:2000 and had invited respondents to identify areas they most wanted to see improved.