ISO 9000 Standards
ISO 9000 is a written set of rules (a “Standard”) published by an internationalstandards writing body (International Organization for Standardization. The rules define practices that are universally recognized and accepted for assuring that organizations consistently understand and meet the needs of their customers.ISO 9000 is also highly generic. Its principles can be applied to any organization providing any product or service anywhere in the world.Since meeting customer needs is one of the (many) definitions of quality, ISO 9000 is often called a quality system or a quality management system. But the rules, referred to as requirements, go beyond quality matters as they are traditionally understood. The requirements fall roughly into the following types:
a. Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making, and keeping, them happy.)
b. Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objectiveaudit.)
c. Requirements for practices that measure the effectiveness of variousaspects of the system. (In God we trust; all others bring data.)
d. Requirements that support continuous improvement of the company’sability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)
Nothing in ISO 9000 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9000 have been in use in industries of various kinds for decades. One intent of ISO 9000 is to simplify things for organizations. ISO 9000 strives to harmonize the sometimes conflicting, sometimes redundant quality programs that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9000 is not meant to supersede customer, legal, or regulatory requirements.)
Very often, major customers require or strongly “suggest” that their suppliers implement ISO 9000 systems. Equally often, such customers require independent verification that suppliers are meeting the equirements.
So third-party registration bodies audit suppliers, confirm compliance to the ISO 9000 standard, and register the suppliers. It does not stop there. To stay registered, suppliers must undergo periodic (often semi-annual) surveillance audits, also carried out by their registration body.
Implementing an ISO 9000 quality system is neither cheap, nor easy. How costly and difficult it can be depends on:
a. The level of commitment of senior management. (The single most important factor.)
b. Where you are when you start. If you have already implemented a disciplined, documented quality system, you will have a less difficult time migrating to ISO 9000. (But that does not mean you will waltz to registration, either.)
c. Whether your company (or any part of it) is “design responsible” or not.
d. How much time you have. If you are under the customer’s gun and have merely months to get the job done, the process will be highly stressful.
e. The physical size and configuration of your company.
The bottom line is this. ISO 9000 is a comprehensive set of rules—a business system, really—that can cause the way your organization runs to profoundly change, almost always for the better. Yet, because it is often customer-mandated, many suppliers regard ISO 9000 as “just another hoop to jump through to keep our customers happy.”
They see their choice as swallow hard, pony up, and jump through the hoops; or walk away from the customer. What many do not fully appreciate is that implementing ISO 9000—expensive, exhausting, and annoying as it can be—can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.
Saturday, September 26, 2009
Goal and Scope of an ISO 9000 quality system
Goal and Scope of an ISO 9000 quality system
The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart ofour organization.b. Continually improving the system. The QMS is never done. Afterall, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving theprocesses of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and theQMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customersatisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.
The ISO 9000 Standard states its goal in two blunt words: customer satisfaction.How do we achieve customer satisfaction? By meeting customer requirements.The quality management system (QMS) helps us to dothis by:
a. Applying the system. Actually using it. Putting it at the heart ofour organization.b. Continually improving the system. The QMS is never done. Afterall, customer requirements do not stand still—they evolve and grow tougher.So we have to improve continually in order to survive.
(The guidance document, ISO 9004: 2000, sets a compatibleand in some respects more ambitious goal: “improving theprocesses of an organization to enhance performance.”) Prevention of nonconformity. Prevention is the key term here: prevention,rather than detection. Quality management has longsince evolved away from the old “inspect quality in” approach.Prevention is cheaper, more effective, and more protective of thecustomer. Detection is also a different mindset. It requires a veryhigh degree of process orientation, upstream thinking, and relentlessanalysis.To what types of organizations does the Standard apply? Alltypes. The requirements “are generic and applicable to all organizations,regardless of type and size.” A compliant QMS can be implementedby any organization, producing any product or service,anywhere in the world.Within the organization, the impact of the requirements and theQMS are similarly broad. The Standard “applies to the activities of organizationsfrom the identification of customer requirements, throughall quality management system processes, to the achievement of customersatisfaction.” Every activity within the organization that impactsthe process of creating customer satisfaction is affected by therequirements of the Standard.
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.
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.
Wednesday, September 23, 2009
ISO 9001 Standards New Blogs
Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
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