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INSTALLING AN ISO -9001 QM SYSTEM:Implementation, Audit and Registration

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Total Quality Management ­ MGT510
VU
Lesson # 29
INSTALLING AN ISO -9001 QM SYSTEM
ISO 9001's requirements for quality management systems are also generic in nature, and are applicable
to organizations in any industry or economic sector. Whether the organization manufactures a product
or provides a service, whether it is a company or a governmental agency, whether it is large or small,
ISO 9000 can apply, and be used to advantage. To be registered the organization must go through a
process that includes the following steps:
8.
Develop (or upgrade) a quality manual that describes how the company will assure the quality
of its products or services.
9.
Document procedures (or upgrade existing documentation) that describe how the various
processes for design, production, continual improvement, and so forth, will be operated. This
must include procedures for management review/audits and the like.
10.
The organization must provide evidence of top management's commitment to the QMS and its
continual improvement.
11.
The organization's top management must ensure that customer requirements are determined and
met.
12.
The organization must hire an accredited registrar company to examine its systems, processes,
procedures, quality manual, and related items. If everything is in order, registration will be
granted. Otherwise, the registrar will inform the company of which areas require work (but will
not inform the company specifically what must be done), and a second visit will be scheduled.
13.
Once registration is accomplished, the company will conduct its own internal audits to ensure
that the systems, processes, and procedures are working as intended.
14.
Also once registered, the outside registrar will make periodic audits for the same purpose. These
audits must be passed to retain registration.
An important point to understand about ISO 9000 is that the organization has to respond to all ISO 9000
requirements and tell the registrar specifically what it is going to do and how. ISO does not tell or advise
the organization. Assuming the registrar agrees with the organization's plan, registration is awarded. To
retain that registration, the organization must do what it said it would do.
Implementation, Audit and Registration
The registration process includes document review by the registrar of the quality system documents or
quality manual; pre-assessment, which identifies potential noncompliance in the quality system or in the
documentation; assessment by a team of two or three auditors of the quality system and its
documentation; and surveillance, or periodic re-audits to verify conformity with the practices and
systems registered. During the assessment, auditors might ask such question as (using management
responsibility as an example):
Does a documented policy on quality exist? Have job descriptions for people who manage or perform
work affecting quality been documented? Are descriptions of functions that affect quality been
documented? Are descriptions of functions that affect quality available? Has management designated a
person or group with the authority to prevent nonconformities in products, identify and record quality
problems, and recommend solutions? What means are used to verify the solutions?
Re-certification is required every three years. Individual sites ­ not entire companies ­ must achieve
registration individually. All costs are borne by the applicant, so the process can be quite expensive.
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Table of Contents:
  1. OVERVIEW OF QUALITY MANAGEMENT:PROFESSIONAL MANAGERIAL ERA (1950)
  2. TOTAL QUALITY MANAGEMENT AND TOTAL ORGANIZATION EXCELLENCE:Measurement
  3. INTEGRATING PEOPLE AND PERFORMANCE THROUGH QUALITY MANAGEMENT
  4. FUNDAMENTALS OF TOTAL QUALITY AND RATERS VIEW:The Concept of Quality
  5. TOTAL QUALITY MANAGEMENT AND GLOBAL COMPETITIVE ADVANTAGE:Customer Focus
  6. TOTAL QUALITY MANAGEMENT AND PLANNING FOR QUALITY AT OFFICE
  7. LEADERS IN QUALITY REVOLUTION AND DEFINING FOR QUALITY:User-Based
  8. TAGUCHI LOSS FUNCTION AND QUALITY MANAGEMENT
  9. WTO, SHIFTING FOCUS OF CORPORATE CULTURE AND ORGANIZATIONAL MODEL OF MANAGEMENT
  10. HISTORY OF QUALITY MANAGEMENT PARADIGMS
  11. DEFINING QUALITY, QUALITY MANAGEMENT AND LINKS WITH PROFITABILITY
  12. LEARNING ABOUT QUALITY AND APPROACHES FROM QUALITY PHILOSOPHIES
  13. TOTAL QUALITY MANAGEMENT THEORIES EDWARD DEMING’S SYSTEM OF PROFOUND KNOWLEDGE
  14. DEMING’S PHILOSOPHY AND 14 POINTS FOR MANAGEMENT:The cost of quality
  15. DEMING CYCLE AND QUALITY TRILOGY:Juran’s Three Basic Steps to Progress
  16. JURAN AND CROSBY ON QUALITY AND QUALITY IS FREE:Quality Planning
  17. CROSBY’S CONCEPT OF COST OF QUALITY:Cost of Quality Attitude
  18. COSTS OF QUALITY AND RETURN ON QUALITY:Total Quality Costs
  19. OVERVIEW OF TOTAL QUALITY APPROACHES:The Future of Quality Management
  20. BUSINESS EXCELLENCE MODELS:Excellence in all functions
  21. DESIGNING ORGANIZATIONS FOR QUALITY:Customer focus, Leadership
  22. DEVELOPING ISO QMS FOR CERTIFICATION:Process approach
  23. ISO 9001(2000) QMS MANAGEMENT RESPONSIBILITY:Issues to be Considered
  24. ISO 9001(2000) QMS (CLAUSE # 6) RESOURCES MANAGEMENT:Training and Awareness
  25. ISO 9001(2000) (CLAUSE # 7) PRODUCT REALIZATION AND CUSTOMER RELATED PROCESSES
  26. ISO 9001(2000) QMS (CLAUSE # 7) CONTROL OF PRODUCTION AND SERVICES
  27. ISO 9001(2000) QMS (CLAUSE # 8) MEASUREMENT, ANALYSIS, AND IMPROVEMENT
  28. QUALITY IN SOFTWARE SECTOR AND MATURITY LEVELS:Structure of CMM
  29. INSTALLING AN ISO -9001 QM SYSTEM:Implementation, Audit and Registration
  30. CREATING BUSINESS EXCELLENCE:Elements of a Total Quality Culture
  31. CREATING QUALITY AT STRATEGIC, TACTICAL AND OPERATIONAL LEVEL
  32. BIG Q AND SMALL q LEADERSHIP FOR QUALITY:The roles of a Quality Leader
  33. STRATEGIC PLANNING FOR QUALITY AND ADVANCED QUALITY MANAGEMENT TOOLS
  34. HOSHIN KANRI AND STRATEGIC POLICY DEPLOYMENT:Senior Management
  35. QUALITY FUNCTION DEPLOYMENT (QFD) AND OTHER TOOLS FOR IMPLEMENTATION
  36. BASIC SQC IMPROVEMENT TOOLS:TOTAL QUALITY TOOLS DEFINED
  37. HOW QUALITY IS IMPLEMENTED? A DIALOGUE WITH A QUALITY MANAGER!
  38. CAUSE AND EFFECT DIAGRAM AND OTHER TOOLS OF QUALITY:Control Charts
  39. STATISTICAL PROCESS CONTROL (SPC) FOR CONTINUAL QUALITY IMPROVEMENT
  40. STATISTICAL PROCESS CONTROL….CONTD:Control Charts
  41. BUILDING QUALITY THROUGH SPC:Types of Data, Defining Process Capability
  42. AN INTERVIEW SESSION WITH OFFICERS OF A CMMI LEVEL 5 QUALITY IT PAKISTANI COMPANY
  43. TEAMWORK CULTURE FOR TQM:Steering Committees, Natural Work Teams
  44. UNDERSTANDING EMPOWERMENT FOR TQ AND CUSTOMER-SUPPLIER RELATIONSHIP
  45. CSR, INNOVATION, KNOWLEDGE MANAGEMENT AND INTRODUCING LEARNING ORGANIZATION