Anova Quality Systems Services Inc.

Assisting Organizations in Quality Improvement Since 1993

FAQ


The following questions are the typical questions that people ask, if you have additional questions please pose your question on the Contact Us page and we will answer your question.


What is ISO?

ISO stands for International Standardization Organization also preferably referred to as equal or uniform as “isos”, the Greek word meaning equal. For frequently asked questions on ISO 9001 check:

Short video on ISO from ISO organization:

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What is ISO 9000?

ISO 9000 series of standards consists of three set of documents:

  • ISO 9000 – Fundamentals and Vocabulary. Provides basic concepts and the language used for adopting ISO 9001
  • ISO 9001:2008 – Quality Management Systems Requirements. Specifies requirements for implementation of the QMS to international standards requirements for quality management.
  • ISO 9004:2009 – Guidelines for performance improvement. Provides guidance to further enhance customer satisfaction.

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What are Eight Management Principles?

ISO 9000 family of international standards is based on eight management principles that are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee, which is responsible for developing and maintaining the ISO 9000 standards.

The eight principles are as follows:

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Can companies get registered to all ISO 9000 standards?

No companies can only register to ISO 9001:2008, and the other two standards (ISO 9000 and ISO 9004) are supporting standards developed for information and guidance.

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What is the advantage of implementing an ISO 9001 program?

There are many internal as well as external advantages in implementing an ISO program. See the research conducted by BSI on this topic.

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What is ISO 14001?

ISO 14001 is standard for environmental management system. ISO 14000 is a series of international, voluntary environmental management standards.

The ISO 14000 series of standards effectively address the needs of organizations worldwide by providing a common framework for managing environmental issues.

For information on ISO 14000 check:

Short video on ISO 14000 from ISO organization:

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What is ISO 13485?

ISO 13485 is a standard for particular application quality standards for medical devices. For information on ISO 13485 check:

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What is ISO 17025?

Formerly known as Guide 25, ISO 17025 is a standard for General Requirements for the Competence of Testing and Calibration Laboratories. Guide 25 was published in 1990 as internationally agreed set of quality system requirements applicable to laboratories who perform calibration and/or testing services. It was superseded in early 2000 by ISO/IEC 17025 which will form the basis for laboratory accreditation in the future.

For information on ISO 17025 check:

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What is ISO 16949?

ISO 16949 is a standard for Particular Requirements for the Application of ISO 9001:2000 for Automotive Production and Relevant Service Part Organizations. For information on ISO 16949 check:

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What is ISO 22000?

ISO 22000 specifies the requirements for a food safety management system in the food chain where an organization needs to demonstrate its ability to control food safety hazards in order to provide consistently safe end-products that meet both the requirements agreed with the customer and those applicable to food safety regulations. The standard combines generally recognized key elements to ensure food safety along the food chain including interactive communication, system management, control of food safety hazards through pre-requisite programmers and HACCP plans and continual improvement and updating of the management system.

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What is AS 9100?

AS 9100 is the latest standard replacing AS9000, for Particular Requirements for the Application of ISO 9001:2000 for Aerospace industries. AS9000 and AS9100 were developed by the Americas Aerospace Quality Group (AAQG), a committee of the Society of Automotive Engineers (SAE) International. AS9000 is the original version; AS9100 is a more recent and more internationally compatible version developed by the International Aerospace Quality Group and adopted by AAQG. Both standards apply to organizations that supply parts and services to the aerospace industry (from SCC website).

For information on as 9100 check:

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What is OHSAS 18001?

OHSAS 18001, Is equivalent to ISO standards for Occupational health and safety management systems. For information on OHSAS 18000 check:

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How much does it cost?

Cost of development and implementation of any quality management system is dependent on the size, complexity, and the current status of the management system.

The cost consists of: cost of system development (either by internal resources orconsultant), cost of implementation, cost of making required changes, and cost of auditing.

For cost of consulting please fill in the attached Get Quote and we will provide you with a firm quote.

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How long will it take?

For a medium size company, typically between nine months to a year, don’t forget that the purpose is making radical changes in the culture of the organization and there is no advantage in quick fixes and superficial implementation of the program.

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What resources do I have to allocate?

You need to assign a management representative to oversee the effectiveness of the program, and the role of the departments will be to participate in development and maintenance of the system.

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How do I keep current with ISO 9000 developments?

It is important for quality practitioners to maintain current at all times on the development of ISO standards. The best place to keep pace with the development of ISO standards is to visit the following websites:

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Where do I find information on ISO registered companies?

One of the sources on the web to find out about ISO registered companies is Quality Digest, you can access Quality Digest at www.qualitydigest.com and the ISO database.

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Where do I buy quality related standards from?

Most quality related standards can be purchased from the following on-line stores:

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What is Registrar Accreditation?

Accreditation is given to registrars by the National Standards organizations (accreditation bodies) that are member of ISO organization. Registrars gain accreditation after a rigorous assessment of their practices by the accreditation bodies. Some registrars have one accreditation and some have many. Also see Assessing quality value, And:

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What is the Scope of Accreditation?

Scope of accreditation is areas of expertise that the registrar has demonstrated confidence that the required qualification as required by the accreditation body has been achieved for conducting management system audit. Most auditors are accredited for general manufacturing or service organizations, however, for specialized products or services you may need to check if your registrar is accredited for your audit.

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Where can I use the ISO logo?

Once you are registered to any of the ISO standards you can use the logo to promote your business, there are regulations in the use of logo and should always confer with your certification body for permission to use its logo. For more information see ISO guidelines for the use of Logo.

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What is the difference between “Certification”, “Registration” and “Accreditation”?

According to the standardized definitions, they are not quite the same thing. In the context of ISO 9001:2000 or ISO 14001:2004, “certification” refers to the issuing of written assurance (the certificate) by an independent external body that has audited your management system and verified that it conforms to the requirements specified in the standard. “Registration” means that the auditing body then records your certification in its client register. In the ISO 9001:2000 and ISO 14001:2004 contexts, “certified” and “registered” are equivalent in meaning and you can use either term. (from ISO website “Publicizing your certification”)

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Can consulting companies perform audits?

Because of the independency of Quality System Audits, the consultant that has assisted the organization in development of the Quality Management system can not perform Registration Audit, however, internal audits can be performed by the consultant.

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What is Six Sigma?

Six Sigma stands for Six Standard Deviations from the mean which implies to a system that will produce less than 3.4 defects per million. In practical terms Six Sigma is a methodology that provides the techniques and tools to improve the capability and reduce the number of defects or opportunities for defects within a process.

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What is Lean Manufacturing?

A philosophy of production that emphasizes the minimization of the amount of all the resources (including time) used in the various activities of the enterprise. It involves identifying and eliminating non-value-adding activities in design, production, supply chain management, and dealing with the customers. Lean producers employ teams of multiskilled workers at all levels of the organization and use highly flexible, increasingly automated machines to produce volumes of products in potentially enormous variety. It contains a set of principles and practices to reduce cost through the relentless removal of waste and through the simplification of all manufacturing and support processes. (Source http://www.apics.org/)

See our partner’s website Mfg. Matters for Lean Consulting by Dennis Hobbs the author of Lean Manufacturing Implementation

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