NOTES on ISO 9000
THE ISO 9000 Series - Notes
ISO 9000 consists of five primary parts numbered as 9000 through 9004
(Exhibit 5.17). if we were to display them
on a continuum of an operating firm, the series would range from design
and development through procurement, production, installation, and servicing
(Exhibit 5.18). While ISO 9000 and 9004 only
establish guidelines for operation, ISO 9001, 9002, and 9003 are well-defined
standards.
Quite a bit of work and expense may be needed to be accredited at the
highest level, which is 9001. Furthermore, some firms may not need ISO
9001 accreditation. For example, note that in Exhibit
5.18, ISO 9003 covers quality in production's final inspection and
testing. A firm can be accredited at this level of final production only.
This would essentially guarantee the firm's quality of final output and
be attractive to customers A broader accreditation would be 9002, which
extends from purchasing and production through installation.
There are 20 elements in the ISO 9000 standards that relate to how the
system operates and how well it is performing. These are contained in section
4 of the ISO 9000 Guidelines (Exhibit 5.19).
Each of these elements applies in varying degrees to the three standards
9001, 9002, and 9003. (ISO 9001 contains all of them.)
ISO 9000 is somewhat intentionally vague. A firm interprets the requirements
as they relate to its business. From a practical and useful standpoint
for businesses, ISO 9000 is valuable to firms because it provides a framework
so they can assess where they are and where they would like to be. In its
simplest terms, it is sometimes stated that ISO 9000 directs you to "document
what you do and then do as you documented."
EXHIBIT 5.17
ISO 9000 Series Systems and Guidelines for Use
Quality System
9001: Model for Quality Assurance in Design, Production Installation,
and Servicing. (To be used when conformance to specified requirements is
to be assured by the supplier during several stages which may include design/development,
production. installation, and servicing)
9002: Model for Quality Assurance in Production and Installation. (To
be used when conformance to specified requirements is to be assured by
the supplier during production and installation)
9003: Model for Quality Assurance in Final Inspection Test. (To be used
when conformance to specified requirements is to be assured by the supplier
solely at final inspection and test)
Guidelines for Use
9000: Quality Management and Quality Assurance Standards - Guidelines
for Selection and Use.
9004: Quality Management and Quality System Elements - Guidelines.
EXHIBIT 5.18
ISO 9000 Standards and Their Areas of Application in Production Flow
EXHIBIT 5.19
The 20 Elements to Be Addressed in an ISO 9000 Quality System
1. Management Responsibility
- a. The quality policy shall be defined, documented, understood, implemented,
and maintained.
- b. Responsibilities and authorities for all personnel specifying, achieving,
and monitoring quality shall be defined. In-house verification resources
shall be defined, trained, and funded. A designated management person sees
that the Q91 program is implemented and maintained.
2. Quality System
- a. Procedures shall be prepared.
- b. Procedures shall be implemented.
3. Contract Review
- a. Incoming contracts (and purchase orders) shall be reviewed to see
whether the requirements are adequately defined, agree with the bid, and
can be implemented.
4. Design Control
- a. The design project shall be planned.
- b. Design input parameters shall be defined.
- c. Design output, including crucial product characteristics, shall
be documented.
- d. Design output shall be verified to meet input requirements.
- e. Design changes shall be controlled.
5. Document Control
- a. Generation of documents shall be controlled.
- b. Distribution of documents shall be controlled.
- c. Changes to documents shall be controlled.
6. Purchasing
- a. Potential subcontractors and subsuppliers shall be evaluated for
their ability to provide stated requirements.
- b. Requirements shall be clearly defined in contracting data.
- c. Effectiveness of the subcontractor's quality assurance system shall
be assessed.
7. Customer-Supplied Material
- a. Any customer-supplied material shall be protected against loss or
damage.
8. Product Identification and Tractability
- a. The product shall be identified and traceable by item, batch, or
lot during all stages of production, delivery, and installation.
9. Process Control
- a. Production (and installation) processes shall be defined and planned.
- b. Production shall be carried out under controlled conditions: documented
instructions, in-process controls, approval of processes and equipment,
and criteria for workmanship.
- c. Special processes that cannot be verified after the fact shall be
monitored and controlled throughout the processes.
10. Inspection and Testing
- a. Incoming materials shall be inspected or verified before use.
- b. In-process inspection and testing shall be performed.
- c. Final inspection and testing shall be performed prior to release
of finished product.
- d. Records of inspection and test shall be kept.
11. Inspection, Measuring, and Test Equipment
- a. Equipment used to demonstrate conformance shall be controlled, calibrated,
and maintained:
- · Identify measurements to be made.
- · Identify affected instruments.
- · Calibrate instruments (procedures and status indicators).
- · Periodically check calibration.
- · Assess measurement validity if found out of calibration.
- · Control environmental conditions in metrology lab.
- b. Measurement uncertainty and equipment capability shall be known.
- c. Where test hardware or software is used, it shall be checked before
use and rechecked during use.
12. Inspection and Test Status
- a. Status of inspections and tests shall be maintained for items as
they progress through various processing steps.
- b. Records shall show who released conforming product.
13. Control of Nonconforming Product
- a. Nonconforming product shall be controlled to prevent inadvertent
use or installation.
- b. Review and disposition of nonconforming product shall be accomplished
in a formal manner.
14. Corrective Action
- a. Problem causes shall be identified.
- b. Specific problems and their causes shall be corrected.
- c. Effectiveness of corrective actions shall be assessed.
15. Handling, Storage, Packaging, and Delivery
- a. Procedures for handling, storage, packaging, and delivery shall
be developed and maintained.
- b. Handling controls shall prevent damage and deterioration.
- c. Secure storage shall be provided. Product in stock shall be checked
for deterioration.
- d. Packing, preservation, and marking processes shall be controlled.
- e. Quality of the product after final inspection shall be maintained.
This might include delivery controls.
16. Quality Records
- a. Quality records shall be identified, collected, indexed. filed,
stored, maintained, and dispositioned.
17. Internal Quality Audits
- a. Audits shall be planned and performed.
- b. Results of audits shall be communicated to management.
- c. Any deficiencies found shall be corrected.
18. Training
- a. Training needs shall be identified.
- b. Training shall be provided.
- c. Selected tasks might require qualified individuals,
- d. Records of training shall be maintained.
19. Servicing
- a. Servicing activities shall be performed to written procedures.
- b. Servicing activities shall meet requirements.
20. Statistical Techniques
- a. Statistical techniques shall be identified.
- b. Statistical techniques shall be used to verify acceptability of
process capability and product characteristics.
Source: Dennis R. Arter, "Demystifying the ISO 9000/290
Series Standards," Quality Progress, November 1992, p. 66.
(c) 1992 American Society for Quality Control. Reprinted with permission.
