F.A.Q.


ISO 9001 SERIES OF STANDARDS

What is ISO?
What are the ISO 9001 Series standards?
What is an accreditation body?
What is a quality systems registrar?
Are the standards readily understood?
How much will it cost and how long will it take to implement these standards?
Will my company be required to use these standards to do business globally?
Does ISO 9001 ensure world-class quality?
What is the difference between quality control and quality assurance?
What are the advantages or benefits of registration to ISO 9001?
Do any of the ISO 9001 documents give guidelines for services?
What ISO 9001 standards can a company become registered to?
What quality tools and techniques are mandated by ISO 9001?
Do the standards require firms to set up any type of formal qualifications for employees?
What are the Standard’s documentation requirements?
What is the purpose of a quality manual?
What are work instructions?
What are the requirements for Document Control?
What is the purpose of internal quality audits?
Does the standard specify any requirements for Marketing activities?

CHANGES TO THE ISO 9001 SERIES OF STANDARDS

What are the significant changes?
What will Quality Express do to assist you in adopting the new standard?
How can I get more information?


What is ISO?

The International Organization for Standardization (ISO) is the specialized international agency for standardization, at present comprising the national standards bodies of over 156 countries. The objective of ISO is to promote the development of standardization and related world activities with a view to facilitating international exchange of goods and services and to developing cooperation in the sphere of intellectual, scientific, technological, and economic activity.

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What are the ISO 9001 Series standards?

The ISO 9001 Series is a set of individual, but related, international standards on quality management and quality assurance. They are generic, not specific to any particular products. They can be used by manufacturing and service industries alike. These standards were developed with the goal of effectively documenting the quality system elements to be implemented in order to maintain an efficient quality system in your company. The ISO 9001 series standards do not themselves specify the technology to be used for implementing the quality system elements.

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What is an accreditation body?

Accreditation bodies are organizations that evaluate, approve, and accredit quality system registrars. Usually, accreditation bodies are government agencies or organizations sanctioned by their national governments.

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What is a quality systems registrar?

A quality system registrar audits quality systems, registers conforming quality systems to ISO 9001, and oversees continued conformance to the Standard. All registrars differ with respect to accreditation status and scope of accreditation.

The objective of an ISO 9001 quality system is to ensure that the facility’s output – hardware, software, processed materials, and services – conforms to specified requirements. A specified requirement is the term the Standard uses to meet the customer’s expectations, both stated and unstated.

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Are the standards readily understood?

The standards were designed to be user-friendly. They are generic in nature and follow a logical, easily understood format. However, each company is unique and there may be wide differences in companies’ readiness to implement the standards.

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How much will it cost and how long will it take to implement these standards?

Unfortunately there is no set answer. Each company is different. The answer really depends on how developed your present system is and the implementation strategy you adopt.

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Will my company be required to use these standards to do business globally?

Not by any law, for most products and services. The possibility that compliance will be commercially driven, however, is already a reality in many industries

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Does ISO 9001 ensure world – class quality?

Of course not – nor is it meant to. The quality system required in the ISO 9001 standards is only a beginning. These standards are the bare basics of planned, verifiable quality assurance.

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What is the difference between quality control and quality assurance?

Quality assurance is much more comprehensive than quality control. Quality assurance embraces the planning and implementation of systems designed to ensure that quality requirements are met. Quality assurance is mostly about prevention, while quality control is mostly about detection.

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What are the advantages or benefits of registration to ISO 9001?

Implementation of an ISO 9001 quality system brings great benefits to the organization. A few of the many key benefits of ISO 9001 registration are: strengthened customer confidence, access to markets, reduced operating costs, competitive advantage and reduced number of customer audits

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Do any of the ISO 9001 documents give guidelines for services?

Yes. Service quality differs significantly from, say, manufacturing quality, and ISO 9001 recognizes that by recommending a different array of quality system components. ISO 9004 Guidelines for Service, describes the elements of a quality system specifically for a process that is either partially or totally devoted to providing services.

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What ISO 9001 standards can a company become registered to?

ISO 9001:2008 published December, 2008 is the latest revision of the ISO 9001 Standards.

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What quality tools and techniques are mandated by ISO 9001?

None. ISO 9001 does not describe techniques; it sets general objectives. There are no requirements for the use of scatter diagrams, FMEAs, design of experiments, Pareto charts, problem solving systems, fishbone diagrams, or any others. Of course these, as well as other, may be important – if not essential – to proper operation of your quality system

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Do the Standards require firms to set any type of formal qualifications for employees?

Yes. The Standard expects management to “determine the level of competence, experience, and training necessary to ensure capability of personnel”. Basically, the management is required to set levels for positions in terms of education, training and experience.

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What are the Standard’s documentation requirements?

The facility must maintain documentation sufficient to prove the implementation, effectiveness, and results of the quality system. The standard requires the facility to prepare documented quality manual and documented procedures covering the tasks that affect quality.

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What is the purpose of a quality manual?

The quality manual is a relatively short, controlled circulation document that describes the facility’s scope of the quality management system, including details of and justification for any exclusions (see ISO 9001 section 1.2); cross references the documented procedures established for the quality systems and a description of the interaction between the processes of the quality management system. The quality manual typically lacks in details and specifics. The details and specifics are found in the procedures and, possibly, the work instructions.

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What are work instructions?

Work instructions are task-level, step-by-step “how to” documents. Work instructions are required only “where the absence of such would adversely affect quality.” They are indeed working documents often found in regular use at employee work stations.

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What are the requirements for Document Control?

All documents used in the control and operation of the quality system must be controlled. The creation, approval, distribution, updating and withdrawal of documents affecting the quality system must be planned, documented and controlled.

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What is the purpose of internal quality audits?

Internal quality audits are just one way that the ISO 9001 quality system manages, adjusts, and improves itself. The audits are carried out by employees, which helps keep employees active, involved, and interested in the quality system. Under ISO 9001, internal quality audits are mandatory.

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Does the standard specify any requirements for Marketing activities?

ISO 9001 specifies no mandatory requirements related to marketing or communications. Marketing does have a vital influence on the quality of products and services, through its activities at the front end (market research and analysis) as well as the back end (gathering and analysis of feedback).

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CHANGES TO THE ISO 9001 SERIES OF STANDARDS

Why have the Standards been revised?

ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 have been replaced in December 2000 with ISO 9001:2000 and later in 2008 replaced by ISO 9001:2008 is the newest standard which;

  • Allows for user-friendly introduction of Quality Management Systems into an organization;
  • Introduces consistent terminology and format with the ISO 14001 Standard;
  • Expands the scope of the standard to other areas of quality management, such as continuous improvement and customer satisfaction

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What are the significant changes?

The most significant changes are:

  • The elimination of the ISO 9002 and ISO 9003 standards. ISO 9001 will be the only remaining standard containing quality system requirements used for registration purposes. It will be applicable to all organizations, products and services. As with the existing standards, if an element is not applicable to your organization, i.e. Design Control, it may be declared not applicable.
  • The restructuring of the ISO 9001 standard. ISO 9001:2008 contains only five major elements instead of the previous twenty. In this way, the standard will follow a typical format of the main processes of an organization and will enable the quality system to be aligned to its operations. This (more logical) format will be based on the following general areas of requirements:
° Quality Management System;
° Management responsibility;
° Resource management;
° Product and/or service realization;
° Measurement, analysis and improvement.

Please note that it is not mandatory to restructure your organizations system to align with the new standard. Although most of the current requirements will be included in the new standard, some requirements will be changed or added. The most notable changes are related to an increased focus on:

  • Continual improvement;
  • Evaluation of customer satisfaction;
  • Availability of resources (such as information, communication, infrastructures and work environment protection).

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What will Quality Express do to assist you in adopting the new standard?

Quality Express will assist firms in adopting the standard through the following methods:

  • Training/information sessions organized by Quality express. The sessions will cover the standard and their interpretations.
  • The Quality Express website will be updated with further information, as it becomes available. Any questions asked by our clients will be posted on the Frequently Asked Questions section of our web page. Our website is located at www.quality express.ca.
  • Auditing your current system against the standard and performing a gap analyses. This will allow our auditors to identify the deficiencies in your quality system against the standard.
  • Quality Express will provide all clients with gap analyses, identifying strengths and weaknesses, and issuing guidelines on interpretations.
  • Quality Express representatives are available to answer your questions at any time.

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How can I get more information?

Visit the ISO website at the following location:www.iso.org
Purchase a copy of the latest committee draft of ISO 9001 from ASQ: phone 1-800-248-1946.
Contact Quality Express

 

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