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ISO - Overview

The International Organization for Standardization (ISO) is a worldwide federation of national standards boards from 91 countries. The work of preparing International Standards is carried out through ISO technical committees. Each federation member interested in a subject for which a technical committee has been established has the right to be represented on that committee. External international organizations also take part in the work.

Important: Please refer to the website of the International Organization for Standardization for updated information.

Contents:

ISO 9000/9001 Overview
ISO 9000 Structure
ISO 9000 Purpose
Why ISO 9000?
ISO 9001 Characteristics
ISO 9001 Elements
ISO 9001 System Overview
Preparation for Audit
ISO 9000 Glossary

Background:

Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the ISO Council. They are approved in accordance with ISO procedures requiring at least 75% approval by the members voting.

Quality standards were initially applied in military specifications. After successive releases, ISO 9000 became the European Economic Community (EC) norm and was approved by the European standard-setting organization on a "fast track" to be called EN29000.

Today, worldwide ISO 9000, the EC's EN29000, national standards such as BS-5750, and the United States ANSI/ASQC Q9000 series all describe the same set of quality principles. Currently 106 countries have adopted ISO 9000 as the quality standard. In Europe more than 50,000 businesses are ISO 9000 certified and in the U.S. approximately 3,500 businesses are ISO 9000 certified/registered.

ISO 9000 Structure

The intent of ISO 9000 is to fit the appropriate standard to "How you do business" not fit "How you do business" to ISO 9000. The ISO 9000 series can be used in conjunction with other contract quality requirements.

The ISO 9000 series of quality standards provides requirements and guidelines for quality management system elements and quality assurance. ISO 9000 Quality Management and Quality Assurance consists of five standards:

ISO 9000 is a guide to selection and use of the remaining standards.

ISO 9001 is a specification for design/development, production, installation and servicing.

ISO 9002 is a specification for production, installation and servicing.

ISO 9003 is a specification for final inspection and test.

ISO 9004 describes the principal concepts and applications for a complete quality management system.

ISO 9000 is further divided into four parts:

Part 1 (ISO 9000) - Guidelines for selection and use.

Part 2(1SO 9000-2)- Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003.

Part 3 (ISO 9000-3) - Guidelines for the application of ISO 9001 to the development, supply and maintenance of software.

Part 4 (ISO 9000-4) - Guide to dependability program management.

ISO 9000 Purpose

ISO 9000 involves two basic actions:

Establishing the proper quality management controls.

Documenting these controls (developing a Quality Manual) which creates a detailed record of an organization's quality procedures and practices.

Companies demonstrating compliance with ISO 9000 standards deliver products and services verified by a repeatable and consistent quality system. Registration of compliance with the standards requires an on-site audit of the quality system by an impartial, accredited auditor who verifies that the quality system complies with ISO 9001 standards and that everyone involved is following documented procedures. Surveillance audits are conducted by the auditor every six months.

One of the key aspects of ISO 9000 is that these quality standards do not apply to specific products. The standards are generic in nature and are intended to enable a supplier (through internal and external audits) to provide assurance that it has a quality system in place. The quality system, in turn, allows the supplier to meet its published quality objectives. The end product or service produced is essentially irrelevant to the registration process.

The ISO 9000 registration is, in effect, a confirmation of the "processes" only. The ISO 9000 registration cannot appear on the products, but can appear on the product literature or advertising.

Why ISO 9000?

Competitive Advantage:

Registration to the ISO 9001 standard sends a message to all prospective customers of your commitment to meet their needs and expectations and to produce quality products and services.

Worldwide acceptance and recognition of ISO 9001 as "The Quality System Standard" places the organization that has implemented it above the organization that has not. With ISO 9001 registration, the "world" is our marketplace. More than 100 countries have adopted ISO 9000 as their "Quality System Standard." Many European Community countries will not do business with organizations that are not ISO 9000 registered or certified.

ISO 9001 Characteristics

The following list of characteristics are important for all businesses to know and understand:

Quality systems serve as models for quality assurance in design/development, production, installation and servicing.
ISO 9001 is the most stringent of the three Quality Systems Standards (ISO 9001, ISO 9002 and ISO 9003).
Twenty elements of ISO 9000 cover all activities that affect the quality of the product or service produced.
Each of the 20 elements:

ISO 9001 Elements

ISO 9001 compliance is based on adherence to the requirements contained in the 20 elements listed below. Familiarity with these elements is very important and requires the attention, assistance, cooperation, and effort of business management and employees.

ISO 9001 - 20 Elements:

	4.1Management Responsibility
	4.2 Quality System
	4.3 Contract Review
	4.4 Design Control
	4.5 Document and Data Control
	4.6 Purchasing
	4.7 Control of Customer Supplied Product
	4.8 Project Identification and Traceability
	4.9 Process Control
	4.10 Inspection and Testing
	4.11 Control of Inspection, Measuring and Test Equipment
	4.12 Inspection and Test Status
	4.13 Control of Nonconforming Product
	4.15 Handling, Storage, Packaging,Preservation and Delivery
	4.16 Control of Quality Records
	4.17 Internal Quality Audits
	4.18 Training
	4.19 Servicing
	4.20 Statistical Techniques

ISO 9001 System Overview

Quality System at Work:

A quality system should detect, correct, and prevent product quality problems. The primary role of a quality system is to ensure that:

	All activities are planned.
	Activities are performed in a predetermined way.
	Clearly defined channels for communication of information and instructions exist and are used.

Documentation:

The quality system must be well documented in the quality manual, operating procedures and work instructions. The quality system manual contains policies; operating procedures contain and regulate main activities; work instructions explain specific tasks.

Audits/Corrective Actions:

Internal audits determine if the quality system is being used and if it is effective. Corrective actions are initiated to fix quality problems and to deal with their root causes so problems do not recur.

ISO 9001 Compliance Audit

What happens during the audit?

Auditors familiarize themselves with the operations and processes of the departments selected. They review documents and records and interview personnel about the quality system. At the end of the audit, the auditors present their findings and judge the company's suitability to ISO standards.

How do auditors work?

Auditors gather facts, collect evidence, and draw conclusions. They look for indications of non-compliance, such as a lack of continuity in dates on records and documents. They expect employees to know where procedures are located and how to verify latest revision level. They also ask questions that encourage employees to speak freely about concerns.

Where do auditors look?

Office Areas

Documents awaiting processing

What questions do auditors ask?

Auditors generally:

	Inquire about the company, the quality system and the company's stated quality policy
	Focus on a department or an area
	Examine compliance to instructions and procedures
	Investigate potential noncompliance
	Require supporting documentation or records to substantiate compliance

How do auditors examine documents and records?

Most non-compliance’s found during an ISO audit relate to a problem with a document or a record. All documents must be dated and must identify the using party. Most should also have a revision number and, when relevant, a distribution list.

Typical questions asked by auditors:

Do you have a quality policy here?

Tell me about your procedures; how do you implement and use them?

Where are the procedures you consult if you have any questions? (The employee must be able to have easy access and personally show the auditors.)

Were you trained before you started working alone, and can you show me the record?

How do you know when you are making the product correctly?

Can you tell when it is good or bad? Show me. (Ensure that there is some documented method for differentiation and that it is included as part of the training record.)

If you have a problem with the development of your product, what do you do? (You will need a documented process outline on how you control nonconforming material.)

How do you know the tools you are using are acceptable? Which ones need to be calibrated? How do you know when to send them back?

What do you do when data on a control chart indicates a process problem? What happened and what did you do? Could you show me how you were trained to make and understand these charts? (Make sure you are keeping records on out-of-control events; the auditors are looking for some form of documented proof that appropriate action was taken. Also ensure that your charts are maintained in an on-line dynamic fashion. Charts updated after the product has left the area are ineffective to your preventative program.)

How do you know you are building the right product? Can you show me the assembly documents or model?

Preparation for Audit

How you should prepare for the compliance audit?

Ensure that Your employees:

	Know and understand the Company's quality policy. Ensure that a copy of it is available in each department area.
	Are very familiar with directives and processes/procedures that relate to their job and know how to access them online or find current copies of each.
	Know what ISO 9001 is and why your Company seeks registration.
	Know about the 20 elements of the ISO 9001 Standard and the elements specific to their own area.
	Check documents and records. Know the location of procedures, instructions, specifications and drawings, and ensure that all are at the latest revision. Check for unauthorized changes and uncontrolled work instructions. Organize and index files; label folders and file cabinets.
	Do all work using written instructions and procedures.
	Clean up their work area. Remove scrap, trash, broken equipment, and other items not being used.
	Are prepared to answer questions to the best of their knowledge.
	That if they don't know the answer, they know to state that they don't know but will find out. That they are friendly and courteous.
	Say what They do (establish appropriate quality controls and systems).
	Do what they say (ensure everyone involved follows established procedures).
	Prove it (demonstrate compliance of the quality system to an "external auditor").

ISO 9000 Glossary

Every process has its own glossary of terms and ISO 9000 is no exception. ISO 8402, Quality Management and Quality Assurance - Glossary, is the standard that defines terms used in the ISO standards. It is important to become familiar with the following terms:

Subcontractor: Organization that provides a product to the supplier. Supplier: Organization that provides a product or service to the customer. The company that maintains the quality system required by ISO 9000. Validation: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

	Contractor: Supplier in a contractual situation.
	Contract Review: Systematic activities carried out by the supplier before signing the contract to ensure that requirements for quality are adequately defined, free from ambiguity, documented and can be realized by the supplier.
	Customer: Recipient of a product or service provided by a supplier.
	Entity: That which can be individually described and considered (e.g., product, activity, process, organization, or combination thereof.)
	Management Review: Formal evaluation by top management of the status and adequacy of the quality system in relation to quality policy and objectives.
	Nonconformity: Non-fulfillment of specified requirement (e.g., materials, components, and products that are defective or are not the same as specified.) It could also mean not fulfilling quality system requirements; for example, using an outdated drawing or test or equipment that is overdue for calibration.
	Objective Evidence: Information which can be proved true, based on facts obtained through observation, measurement, test or other means.
	Organization: Company, corporation, firm, enterprise or institution, or part thereof, whether incorporated or not, public or private, that has its own functions and administration.
	Organizational Structure: Responsibilities, authorities and relationships, arranged in a pattern, through which an organization performs its functions.
	Procedure: Specified way to perform an activity.
	Process: Set of interrelated resources and activities which transform inputs into outputs.
	Product: The result of activities or processes. The final product or service. May include hardware, processed materials, software or a combination thereof. Could also include all materials, components, and other elements needed to build the product.
	Purchaser: Customer in a contractual situation.
	Quality: All the features and characteristics of a product or service that affect its ability to satisfy stated or implied needs. Quality means "Fitness for Use," "Customer Satisfaction," and/or "Conformance to Requirements."
	Quality Management: All activities of the overall management function that determine the quality policy, objectives and responsibilities and implement them by means such as quality planning, quality control, quality assurance, and quality improvement, within the quality system. Quality management is the responsibility of all levels of management but must be led by top management. Its implementation involves all members of the organization.
	Quality Manual: Sometimes referred to as the Quality System Manual, covers the requirements of the ISO 9001 standard. The Quality Manual includes or makes reference to the quality system procedures and outlines the structure of documentation used in the quality system.
	Quality Planning: Activities that establish the objectives and requirements for quality and for the application of quality system elements.
	Quality Policy: Overall intentions and direction of an organization with regard to quality, as formally expressed by top management.
	Quality System: Organizational structure, procedures, processes and resources needed to implement quality management. Everything that a company plans to do to manage the quality of its product.
	Quality System Audit: Systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. An independent examination to determine whether a quality system satisfies the requirements of ISO 9000 and whether all policies and procedures of the quality system are followed and audit trails have been documented.
	Record: Document which furnishes objective evidence of activities performed or results achieved.