6. Quality Standards
• Originally developed by the ISO Technical Committee TC 176.
• A standard aimed at certifying products for quality (e.g., when taking a drivers licence test, they don’t care how you learned to drive, only if it conforms to the legal requirements).
• This is the first Globally accepted quality designation, and it is replacing many existing quality certification programs, such as those of,
GM, Chrysler, and Ford
US Department of Defense
• There are designated certification agencies throughout the world.
• The philosophy,
should be open about all processes, no hiding, no “back-rooms” where ‘skeletons’ are hidden.
common agreement about quality objectives between suppliers, producer, customers.
a product, and quality responsibility should be traceable from start to end.
documentation is required to indicate how production goes from the front end to the customer.
the documents are to be signed and copies given to everybody responsible. It becomes a “quality bible” for a product.
• The standards,
ISO9000: directs the selection of the other ISO900x standards and general management policies.
ISO9001: The most stringent quality standard requiring conformance from design to service.
ISO9002: Looser than ISO9001, requiring excellence in production and installation.
ISO9003: Best when only capable of inspection and testing. Even easier than ISO9002.
• Approach to certification.
• Information is available from,
(USA) the National Institute of Science and Technology (NIST), the Department of Commerce, Phone:(301) 975-4031, Fax:(301) 963-2871
• What is required for an effective quality system?
Organizational Structure and Responsibilities
Processes and Procedures
Documentation and Implementation of Quality Policy
• Standard compliance can be determined by,
Second party: a customer may audit the suppliers quality system, and verify compliance to one of the standards, with periodic reviews.
Third party: The accreditation body certifies the program, and conducts periodic monitoring of procedures.
• Basic steps for implementation
1. Make a decision to seek certification
- is it required for commercial needs?
- is the organization committed to certification?
2. Determining the state of the existing facility
- assess and identify gaps in processes and documentation
- determine existing compliance
- begin promoting and training for compliance
- select a registration body
- continue training
- conduct internal and external audits
- close quality gaps
- auditors will visit and review the application, and the state of the document, etc.
- continued monitoring
• ISO 9001 is the most stringent standard, and the ISO 9002, and ISO 9003 standards are subsets of this, as shown in the table below,
• The principles that must be applied to the above areas are,
each element must be addressed
the process must be defined
develop and maintain evidence of implementation
• The most typical initial impacts on a company are,
a culture change where procedures must now be followed
addition of a system for controlling documents
• Significant long term impacts on a company are,
use of documents to direct work
ongoing review of quality methods
6.2 ISO 14000
• A set of standards that address environmental issues. This initiative began in 1993 when the ISO formed TC207 (technical committee).
• This set of standards is designed to be administered like the ISO9000 quality standards. Basically, documenting the process, and ensuring that the documented process is followed.: “say what you do, do what you say”.
• ISO 9000 and 14000 are compatible and can be integrated.
• The standards include,
environmental performance evaluation
life cycle assessment
• The standard includes the following sections,
14000: the main guide to the 14000 standards
14001: the most stringent environmental certification
14010-14019: guidelines for auditing
14010: the general principles of environmental auditing
14011-1: auditing of environmental management systems
14011-2: audits to check for compliance
14012: qualification of auditors
14014: a guide to performing an initial environmental review
14020-14024: environmental labeling
14020: basic principles for environmental labeling
14021: terms and definitions for labeling
14022: symbols used in labeling
14023: testing and verification methods for labeling
14024: methods used by labeling teams
14031: methods for evaluating environmental performance
14041-14044: life cycle assessment
14041: code of practice
14043: impact analysis
14044: improvement analysis
14050: terms and definitions
14060: inclusion of environmental aspects in product standards
• As with ISO9000 the basic process is,
1. Make a decision to obtain certification.
2. Plan the preparation process (possibly hire a consultant).
3. Assess current practices.
4. Make required changes.
5. Document the corrected system.
6. Request a certification visit.
7. The certification team visits to ensure compliance.
8. Certification may be granted.
9. Internal audits and updates done as called for in ISO14000 documents.
10. Occasional visits to ensure compliance to renew certification.
Problem 6.1 Give examples of local companies that would be well suited to different ISO certifications.
a) ISO 9001
b) ISO 9002
c) ISO 9003
Problem 6.2 List 5 types of companies that might seek ISO 14000 certification. State why they would need the certification.