ISO/TC 176 Quality Management Standards “Meet the Family” Presented by David Zimmerman Project Manager Project Manager ISO/TC 176 Secretariat

ISO/TC 176 Quality ISO/TC 176 Quality Management StandardsManagement Standards

“Meet the Family”“Meet the Family”Presented by

David ZimmermanDavid Zimmerman

Project ManagerProject Manager

ISO/TC 176 SecretariatISO/TC 176 Secretariat

ISO TC176 Update - BIS

Presentation OutlinePresentation Outline

TC 176 BackgroundTC 176 Background Review of Management Review of Management

Systems StandardsSystems Standards InterpretationsInterpretations Sector Activities Sector Activities Coordination with ISO/CASCO Coordination with ISO/CASCO

and IAFand IAF


TC 176 BackgroundTC 176 Background Scope:Scope: Generic quality Generic quality

management systems and management systems and toolstools.. Vision:Vision: Facilitate world trade Facilitate world trade

and contribute to the and contribute to the improvement of individuals and improvement of individuals and organizationsorganizations..

Membership (95):Membership (95): 75 75 Participating Countries, 21 Participating Countries, 21 Observing Countries, 36 Liaison Observing Countries, 36 Liaison organizationsorganizations– ISO’s largest committee!ISO’s largest committee!


TC 176 – Strategic TC 176 – Strategic Plan “Horizon 2010”Plan “Horizon 2010” Mission:-Identify and understand the needs of

society, users, and of their customers.-Develop, support and improve generic or

sector QMS standards.-Safeguard the integrity of its standards in

their use, including conformity assessment activities.

-Minimize proliferation of QMS standards.-Contribute to the compatibility of

management system standards (MSS).


ISO/TC 176 Management ISO/TC 176 Management System StandardsSystem Standards

• ISO 9000 – Fundamentals + Vocabulary- Sets the stage for the other standards in the

TC 176 family- Fundamentals – rationale & process

approach - Definitions – provides a clear understanding

of terms used in our quality management system standards


The Process ApproachThe Process Approach


Quality Systems StandardsQuality Systems StandardsThe “Consistent Pair”

ISO 9001:2000 – RequirementsForms the basis for 3rd party certification

ISO 9004:2000 – Guidelines for Performance Improvements Includes the requirements cited in ISO 9001 plus

supporting guidance for improvementsOften overlooked by users


Quality Systems StandardsQuality Systems Standards CONT’D

ISO 10005:1995 – Quality PlansGuidance on the use of quality plans throughout

the quality system Includes sample formatsNew edition available by mid 2005

ISO 10006:2003 – Quality Management in ProjectsGuidance on applying quality management in

projectsParallel structure to ISO 9001:2000


Quality Systems StandardsQuality Systems Standards CONT’D

ISO 10007:2003 – Guidelines for Configuration Management can be used to meet the product identification

and traceability requirements specified in ISO 9001

applies over the life cycle of a product, its configuration items, and related product configuration information


Supporting ToolsSupporting Tools

ISO 10012 – Measurement management systems Includes requirements and guidance on how

to manage measurement processes and metrological confirmation of measuring equipment.

Highlights the quality management requirements of a measurement management system to ensure that metrological requirements are met


Supporting ToolsSupporting Tools CONT’D

ISO TR 10013:2001 – DocumentationGuidelines for managing the documentation

needed in an effective QMS Including examples of document hierarchyCan also be use for other management

systems – eg, Environment, OHS

ISO TR 10014:1999 – Economics of Quality Guidance on achieving economic benefits

from the application of quality management



ISO TR 10015:2000 – TrainingGuidelines cover the development,

implementation, and improvement of training systems that affect the quality of products and services supplied by an organization

ISO TR 10017:2003 – Statistics “what you can’t measure you can’t improve”Guidance on the selection of appropriate

statistical techniques



ISO 19011:2003 – AuditingA critical part of the implementation of a

management system, these guidelines cover auditing principles, audit activities and development of suitable criteria for auditor competence

ISO 10002:2004 – Complaints Handling New initiative in the area of customer

satisfaction, a key feature of the ISO 9000Forms part of a package of customer

satisfaction guidance



Customer Satisfaction Standards Under Development …

ISO 10001 – Market-Based Codes of Conduct To prevent customer dissatisfaction by

encouraging organizations to operate fairly in its dealings with its customers

ISO 10003 – External Dispute Resolution SystemsFocus on how to handle customer complaints when

internal system is not successful


TC 176 – Interpretations Working GroupTC 176 – Interpretations Working Group

Purpose is to provide interpretations on ISO 9001 using ISO member body input

WGI Convenor and Secretariat – Brazil Over 40 requests have been processed

by the WGI An operational entity – results are posted

on the TC 176 website for public use


TC 176 Sector TC 176 Sector ActivitiesActivities TC 176 encourages effective liaisons to TC 176 encourages effective liaisons to

improve the uptake of TC 176 productsimprove the uptake of TC 176 products 12 Internal Liaisons including: 12 Internal Liaisons including:

IEC (JTC/SC7 and TC 56), CASCO, TC IEC (JTC/SC7 and TC 56), CASCO, TC 69 (statistics), TC 207 (environment), 69 (statistics), TC 207 (environment), TC 210 (medical devices), TC 212 TC 210 (medical devices), TC 212 (labs) (labs)

23 External Liaisons including:23 External Liaisons including:

AKMS, ASQ, BIPM, EFQM, IAEA, IAF, AKMS, ASQ, BIPM, EFQM, IAEA, IAF, ILAC, INLAC, IQNet, etc. ILAC, INLAC, IQNet, etc.


Current Sector ApplicationsCurrent Sector Applications ISO 13485 and ISO 13488 (medical) ISO IWA 1(health care) ISO IWA 2 (education) ISO TS 16949 (automotive) TE-9000 (tools) TL 9000 (telecommunications) AS 9000 and AS 9001(aerospace) FS 9000 (financial) & More !


Coordination with ISO Coordination with ISO CASCO and the CASCO and the International International Accreditation Forum (IAF)Accreditation Forum (IAF)

TC 176 formed a Conformity Assessment Liaison Group to facilitate our liaison relationships with IAF and CASCO.

Joint Frameworks for Cooperation have been established with both of these bodies, and this group will be instrumental in coordinating TC 176 input into their work.


The FutureThe Future

2323rdrd ISO/TC 176 annual plenary ISO/TC 176 annual plenary meeting in Panama 3meeting in Panama 3rdrd Quarter 2005 Quarter 2005

Improve implementation toolsImprove implementation tools Increased Coordination with ISO TC Increased Coordination with ISO TC

207 (environment) on the 207 (environment) on the development of management development of management systems standards in the ISO systems standards in the ISO communitycommunity

Management of issues related the Management of issues related the credibility of the ISO 9001 standardcredibility of the ISO 9001 standard


For More Information ...For More Information ...David ZimmermanProject ManagerTC 176 Secretariat Canadian Standards [email protected] +1 416-747-2479

Thank You!

Documents

ISO/TC 176 Quality Management Standards “Meet the Family” Presented by David Zimmerman Project Manager Project Manager ISO/TC 176 Secretariat