ISO 9000

Many countries have published their own equivalents of the ISO 9000 series in their native language; the US English version is called the ANSI/ASQC Q9000 series.

ISO 9000 describes “what” must be accomplished in a generic way.

Section 4.5.1 states “the supplier shall establish and maintain a documented Quality System as a means of ensuring that product conforms to specified requirements.”

The word “product” includes the result of services as well as manufacturing.

ISO 9000 is designed to address all of the most important processes affecting quality, from the initial review of contracts received from customers, to the packaging and delivery of the finished product.

“HOW” the system is implemented is left up to each individual organization.

Their documents are published by the International Organization for Standardization (IOS). Based in Switzerland since 1946, the organization is composed of the national standards bodies of 91 countries.

This organization is not an enforcement agency.

Adherence to the standard is voluntary. But many companies do business exclusively with suppliers which have had their quality systems "registered".

A ISO 9000 certificate doesn't warrant whether specific products are any good — ISO 9000 deals with the environment for producing goods and services, not specific products.

Purchasers of goods and services ask their suppliers to be certified to ISO 9000 because they want to be assured that suppliers are competent to conduct business. Customers don't want to send their own inspectors to inspect how their suppliers conduct business.

But the most common way to show compliance is to obtain a certificate from an independent organization which is not affliated with the company — a Third-Party registrar, also called an “Assessment Body.”

Auditors (also called Assessors ) employed by the Registrar seek objective evidence to answer the following questions:

• Is the documented system consistent with the standard? (Do you describe what you do?)
• Are activities consistent with the documentation? (Do you actually do what you say you do?)
• Do documented systems and non-documented activities help your company meet its goals and objectives (especially quality objectives)? (Is it effective?)

To answer these questions, they:

• Read the organization's Quality Manual and other documentation.
• Observe and interview workers to determine whether they understand the documentation and can effectively apply it to their individual job.
• Select and review historical Quality Records created during the conduct of business.
• Write a Report documenting non-conformances.

Readiness for performance results from a mix of several conditions. The will of an organization to achieve registration is determined by the attitudes shared by workers as well as the capabilities they exercise. Education can be provided to transfer knowledge to workers. However, people's attitudes affect their sensitivity to information. It usually requires a shift to authority based on documents rather than rank, popularity, or other sources of power.

The consistency sought by ISO 9000 is often achieved with some loss in flexibility.

To determine whether the organization's documentation is being used effectively, assessors observe and interview workers.

1. Management responsibility:
   define, document, and implement a policy for quality. Included in this element are requirements for periodic management review of Business Plans (4.1.4), Data Analysis (4.1.5), and Customer satisfaction (4.1.6).
2. Quality system:
   establish, document, and maintain a quality system which includes a quality manual, system procedures, and quality planning.
3. Contract review:
   establish and maintain documented procedures for controlling the scope of contracts and subsequent amendments.
4. Design control:
   establish and maintain documented procedures to control and verify the design of the product to ensure conformance to specified requirements.
5. Document and data control:
   establish and maintain documented procedures to control all documents and data (including hard copy and electronic media) including such documents as standards and customer drawings. This includes the scope of documents, other procedures referenced, and change control procedures.
6. Purchasing:
   establish and maintain documented procedures to ensure that purchased product, associated documents and data conform to requirements.

   The standard includes the evaluation of sub-contractors based on their ability to meet subcontract requirements and the type and extent of control exercised by the supplier over sub-contractors.

7. Control of customer-supplied product:
   establish and maintain documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies or for related activities.
8. Product identification and traceability:
   where appropriate, establish and maintain documented procedures for identifying the product from receipt and during all stages of production, delivery and installation.
9. Process control:
   identify and plan the production, installation and servicing processes which directly affect quality, and to ensure these processes are carried out under controlled conditions.
10. Inspection and testing:
    establish and maintain documented procedures for inspection and testing activities, in order to verify that the specified requirements for the product are met.
11. Control of inspection, measuring and test equipment:
    establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by the supplier to demonstrate the conformance of product to the specified requirements.
12. Inspection and test status:
    the inspection and test status of product shall be identified and maintained throughout the production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed.
13. Control of non-conforming product:
    establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from un-intended use or installation.
14. Corrective and preventive action:
    establish and maintain documented procedures for implementing corrective action in the handling of customer complaints, product non-conformities, and the application of controls to ensure corrective action is taken and that it is effective. Preventive action procedures will detect, analyze, and eliminate potential causes of non-conformities.
15. Handling, storage, packaging, preservation and delivery:
    establish and maintain documented procedures to prevent damage or deterioration of product.
16. Control of quality records:
    establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.
17. Internal quality audits:
    establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.
18. Training:
    establish and maintain documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality. Appropriate records of training shall be maintained.
19. Servicing:
    where servicing is a specified requirement, establish and maintain documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.
20. Statistical techniques:
    the supplier identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics, and shall establish and maintain documented procedures to implement and control their application.

The QS-9000 standard drafted by the Automotive Industry Action Group (AIAG) extended ISO 9000 to include

• Production Part Approval Processes,
• Continuous Improvement, and
• Manufacturing Capability analysis.

• A description of the benefits and risks from this project.
• A Timeline of tasks and milestones for each phase of the project.
• The resources needed to achieve this timeline:
  • Training materials, trainers, and consultants needed;
  • When workers are expected;
  • Equipment (flip charts, computers, printers, copiers, etc.);
  • Facilities (meeting rooms, etc.).
• Policies and procedures for obtaining resources and providing status updates.

Month

Phase

Tasks and Milestones

1
Nov.

2
Dec.

3
Jan.

4
Feb.

5
Mar.

Conduct Work Instruction Writing Workshops
Work Instructions reviewed and approved

6
Apr.

7
May

9
Jul.

10
Aug.

11
Sep.