
QUALITY MANAGEMENT SYSTEM. ISO9001: 2000 SHIP BUILDING AND SHIP REPAIR INDUSTRY. 1. QUALITY MANAGEMENT SYSTEM. * What is Quality, Quality Management System * Product Certification/ System Certification * What other standards are available, Who made these standards?
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* What is Quality, Quality Management System
* Product Certification/ System Certification
* What other standards are available, Who made these
standards?
* Main Changes from 1994 to 2000 Standards
* Transition Steps
* Appreciation of some clauses as applied to Shipbuilding
and Ship repair Industry
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Quality
( ISO9000 )
Degree to which a set of inherent characteristics fulfils requirements
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MAJOR QUALITY PROBLEMS(RESULTS SURVEY OF ENGINEERING INDUSTRIES IN BRITAIN IN 1970)
* Human Error…………………………….. 12%
* Bad Inspection Method…………………. 10%
* Lack of and/or wrong specification……. 16%
* Lack of Proving (new design, materials, manufacturing
processes) ………………………………. 36%
* Poor Planning……………………………. 14%
* Unforeseeable & other………………….. 12%
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Quality Management System
( ISO9000 )
Coordinated activities to direct and control an organization with regard to quality
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* Product Certification Vs Management System Certification
* Management System Certification Schemes
- Quality Management ( ISO9000/AS9000/QS9000/TickIT etc)
- Environmental Management ( Greenhouse Gas Services/
ISO14000:1996 etc )
- Safety Management ( OHSMS/SSC or VCA )
- Food Safety ( HACCP/GHP/GMP/BRC)
- Information Security Management ( BS7799 )
- Social Accountability ( SA8000 )
- Integrated Management Systems
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What is this ISO…… ?
ISO is an International Standards Organization having
office at Geneva, Switzerland
ISO (The International Organisation for Standardisation is a World- wide
Federation of National Standard Bodies (ISO -Member Bodies e.g. IS -
BIS)
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Who Makes Standards?
* International Standards are Prepared through ISO Technical Committees
* Each Member Body interested in a Subject for which a Technical -
Committee is established has the Right to be Represented on that Committee
*International Organisations, Government and Non-Governmental, in
liaison with ISO, also Take Part in Work
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How Standards are made……?
* Draft International Standards adopted by the Technical committee
are circulated to the member bodies for comments/approval before
their acceptance as International Standards by the ISO council.
* They are approved in accordance with ISO procedures requiring at
least 75% approval by the member bodies voting
* ISO 9000 series International standards is the responsibility of ISO
Technical Committee 176, Quality Management & Quality
Assurance.
*ISO/TC 176 adopted in 1990 a strategy for revision of the ISO9000
series originally published in 1987. The present standard was released
in 1994 which is again revised/released now in Dec’2000
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ISO 9000 Family of Standards
Revised Structure : four Primary Standards
* ISO 9000 Concept & Vocabulary( rev. of ISO 8402 & 9000-
1:94)
* ISO 9001 QMS Requirements( rev. of ISO 9001/2/3:94)
* ISO 9004 Guidelines( rev. of ISO9004-1,-2,-3,-4:94)
* ISO 19011Guidelines for Auditing
Note : The Clauses of ISO 9000-1 (Guidelines for selection and use) that constitutes the ‘road map’ to the ISO 9000 family of standards, will be published as a separate brochures
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ADVANTAGES OF QMS
* A systematic, methodical approach in way business is done
* A tool for consistent delivery
* Continuous improvement in quality
* System dependent regime instead of person dependent
* Efficiency in sub-processes
* Positive impact on customer satisfaction
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ISO9001:1994 Standards
4.1 Management responsibility
4.2 Quality systems
4.3 Contract Review
4.4 Design Control
4.5 Document & Data Control
4.6 Purchasing
4.7 Control of customer supplied product
4.8 Product identification & traceability
4.9 Process Control
4.10 Inspection & testing
4.11 Control of inspection, measuring and
test equipment
4.12 Inspection & test status
4.13 Control of non-conforming
product
4.14 Corrective & preventive
action.
4.15 Handling, storage,
packaging, delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
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ISO9001:2000 Standards
4 Quality Management System ( Documentation/Manual/Records )
5 Management Responsibility ( Commitment/ Customer Focus/
Quality Policy/ Objectives/ Planning/Responsibility/MR/ Internal
Communication/ Reviews )
6 Resource Management ( Human Resources/Infrastructure )
7 Product Realization ( Planning/Customer requirements & review/
Communication/Design & Development/Purchasing/Production
and Service Provision ie Validation of Processes/ Identification &
Traceability/ Care of Customer Property and Preservation/ Control
of Monitoring & Measuring Devices )
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ISO9001:2000
8 Measurement, Analysis and Improvement
( Customer Satisfaction/Internal Audit/ M&M of Processes and Product/ Control of Non - confirming product/ Analysis/ Continual Improvement/ Corrective & Preventive Actions )
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Changes from ISO9001:1994 to ISO9001:2000
* Another Creation of Trade Barrier ?
* Consultants and Certification Bodies Continue to
Make Money ?
* To Confuse the Organisation Using the Standards ?
* Additional Investments with No Returns ?
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ISO9001:2000 Need of Changes ?
“ NOTHING IS CONSTANT IN THE WORLD EXCEPT CHANGES.”
ISO Rules require the review of all standards every 5 year,
to ensure that they reflect the best practices, and
take into account the lessons learnt
OUTCOMEStandards confirmed, revised or withdrawn ?
In 1990, TC176 adopted a two-phase revision process :
First Phase completed in 1994 : Minor Changes pertaining to Tidying up, clarified ambiguity
andbetter use of English
Second Phase undergone now : Has significant number of changes both in style and content
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ISO9001:2000 Need of Changes ?
In 1997, TC176 undertook a global survey of ISO9000
users and the need of significant changes was felt as a
result of analysis of responses :
Revised standards should have increased compatibility with ISO14000
Revised standard should have a common structure based on a process model
Provision should be made for tailoring the requirements to omit elements not applicable
Requirements should include demonstration of continuous improvement and prevention of non
conformity
ISO9001 should address effectiveness while ISO9004 should address efficiency and effectiveness
ISO9004 should help achieve benefits for all interested parties, e.g. Customers, Owners, Employees,
Suppliers & Society
Revised standard should be simple to use, easy tounderstand and use clear language and
terminology
Revised standards shouldfacilitate self - evaluation
Manufacturing orientation of current standards be removed
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ISO9001:2000 Need of Changes ?
In 1997, TC176 issued a document entitled “Quality Management Principles and Guidelines on their Application” ( ref. ISO/TC176/SC 2/N130 )
This document formed one of the other design inputs to the ISO Working Group responsible for the development of a consistent pair of standards
i.e. ISO9001:2000 and ISO9004:2000
A Quality Management Principle(QMP) is defined as:
“ a comprehensive and fundamental rule or belief, for leading and operating an organisation, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stakeholders”
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* Customer Focus
* Use of Demming’s
( Process Approach )
PLAN- DO-CHECK-ACT Cycle
Check
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Continual Improvement of the Quality Management System
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Measurement,
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Product
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Product
Process Based Quality Management system
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ISO9001:2000
THE PRINCIPLES BEHIND MANAGEMENT SYSTEMS
What we want
Policy
How we organize
and control
System
Who does what
and when
Procedures
How
Instructions
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DYNAMICELEMENTS
Improvements
POLICY
Management review
SYSTEMS
Corrective/preventive
actions
PROCEDURES
Nonconformities
Internal Audits
WORK INSTRUCTIONS
STRUCTURE OF A MANAGEMENT SYSTEM eg. ISO 9000 & its DYNAMICS
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ISO9001:2000
Basic principles in system development
( Documented Procedure needed for SIX activities only : Control of Documents, Control of Records, Internal Audits, Control of Non conforming Products, Corrective Actions and Preventive Actions )
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ISO9001:2000
Conditions for success
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ISO9001:2000
Steps in writing procedures
Benefits:
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ISO9001:2000
Certification Process
INQUIRY
QUOTATION
CERTIFICATION AGREEMENT
DOCUMENTATION REVIEW
INITIAL VISIT
INITIAL AUDIT
FOLLOW - UP AUDITS
PERIODIC AUDITS
RENEWAL AUDIT
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ISO9001:2000
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ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
5.4.2 Quality Planning
Quality Planning should focus on identifying processes needed to meet effectively and efficiently the
organizations quality objectives and requirements
Input :Strategies, Objectives, Need & Expectations, statutory & regulatory
requirements, evaluation of performance data, lessons learnt from previous
experiences, related risk assessments etc
Output: Need for skill, resources, responsibilities, improvement in process/tools,
records etc
A quality plan is normally prepared for a new ship or a series of ships ( ships with
same design ), coverage of the plan may vary depending upon experience
In case of repair units, a quality plan is to be made for each product and/ or process
QUALITY PLAN may be in the form of ITP, traveller’s card , control
plan etc
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ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
6.2.2 Competence, Awareness and Training
For each position job description and qualification to be defined.
Welding, heat treatment, NDT and painting are special processes
which normally require specific qualification of personnel
7.2.1 Identification of Customer Requirements
Specified :
Ship Building: Contract Documents normally include commercial terms, contract
specifications and the basic drawings
ShipRepairs : is carried out as per Class rules and/or suppliers’ standards based on
the industrial standards
Not specified:
Supplies to EC countries, special requirements for particular flag vessel.
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Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled
Validation: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended usage are fulfilled
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ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
7.5.4 Preservation of Product
Storage conditions should be suitable to prevent rust, pitting, etc and prevent grits and dirt's contaminating the inside of piping.
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