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QUALITY MANAGEMENT SYSTEM

ISO9001: 2000

SHIP BUILDING AND SHIP REPAIR INDUSTRY

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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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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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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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ISO9001:2000 What are Changes ?
Change in Management System Philosophy itself
Changes reflect an approach which is more complete and consider
management principles that go towards Total Management
Main Changes

* Customer Focus

* Use of Demming’s

( Process Approach )

PLAN- DO-CHECK-ACT Cycle

Check

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ISO9001:2000 Summary of Changes :
Continual Improvement of the System is Mandatory
Approach is based on “Input”, “process” and “Out Put”
Competency of Personnel requirement made more
elaborate
Quality Objectives - SMART ( specific, measurable, achievable, result oriented and time bound )
QM to define the SCOPE of certification
Product requirements to include specified & intended use
Proactive customer satisfaction measures
Requirements for Effective Communication defined
Internal Audits to confirm compliance to ISO9001
More complete as a Management System Specification

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Continual Improvement of the Quality Management System

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Process Based Quality Management system

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I

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

Utilise existing documentation and routines
Limit the System to what is vital
Limit the documentation

( 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 )

Organise the System to get ADEQUATE control
Avoid overlapping systems/instructions/routines

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ISO9001:2000

Conditions for success

Management commitment
Information and training
Motivation and involvement of employees
Project organisation and management
A detailed and strict project plan

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ISO9001:2000

Steps in writing procedures

Describe the main steps in a flow diagram
Analyse the need for more details
Add necessary details
Make references

Benefits:

Employees can start to contribute at any given time
No QA knowledge and experience are needed
Easy control with format and style

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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

IMPLEMENTATION/TRANSITION

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ISO9001:2000

AUDIT
( a systematic and independent verification )
Why quality audits?
health of unit
compliance to a standard
to determine effectiveness of system
identify and prioritize area of improvement
What auditor looks for?
Existence of system
operation of system
effectiveness

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ISO9001:2000
SHIPBUILDING and SHIP REPAIR Industry
( Where these slides do not refer to ISO elements, the standard interpretation is applicable )
Process Description
Hull Processes
Pre - treatment/ Marking and Cutting/ Bending( cold or hot )/ Block Assembly/ Pre -
erection and Erection
Outfitting Production/ Installation Process
Covers all outfitting to be installed on hull e.g.Piping, fittings, equipment and Cable etc
- Manufacturing ( marking, cutting, bending, fit up, welding and painting and galvanizing)
- Installation ( fit up and welding, bolting and bushing )
Painting Process
Cleaning, pre treatment ( blasting and shop priming ) and coating
Repair and/or Reconditioning of machinery

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ISO9001:2000
4.2.3 Control of Documents
* Drawing control is the key area of document control
* Other documents e.g. WPS, Quality Plans, Inspection Procedures
including NDT, DT, Calibration and Qualification records
* External documents to be checked are :
class rules, legislations, regulations
industrial standards/ codes e.g. AWS, ASME

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ISO9001:2000

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

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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ISO9001:2000
7.2.1 Identification of Customer Requirements
The process shall consider:
extent to which customers have specified requirements
requirements not specified by the customer
product and/or service obligations, including regulatory and legal requirements
( e.g.API, ASME, ASTM, IBR, CE etc)
requirements for availability, delivery and support
The object of this process is to develop a clear picture of what are the customer needs and expectations, both in terms of the product/ service itself and its delivery.

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ISO9001:2000
7.3 Design and/or Development
Ship design function are hull, hull outfitting, machinery, electrical etc
Design stages can be grouped as basic design, detailed design and production
design. They can be conducted by separate or in the same organization ( depending
upon the size of shipyard )
Design input shall consider class rules, customer requirements and statutory and/or
regulatory requirements
Design verification includes design reviews, ship’s model test, drawing review
against design input checklist etc
Design validation normally includes inclined test and sea trial

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
7.4.1 Purchasing Control
Check if supplier evaluation includes the suppliers capability to get the supplied product certified by the Class (e.g., DNV), when required ( steel plates, welding fillers, machinery & spares etc )
Purchasing documents should be checked at both design & purchasing functions.
Purchasing documents shall include requirements of product certification by the class, and verification requirements of shipyard and/or ship owner's inspectors at source.

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ISO9001:2000
7.4.3 Verification of Purchased Product
Receiving inspection shall include that all applicable class certificates and/or manufacturer’s certificates have been received. (When not received with the product, positive recall procedure shall apply.

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ISO9001:2000
7.5.1 Operations Control
In the process of block assembly, pre-erection and erection, fit-up and welding
processes are most important.
Monitoring and control should include following process.

- Material Identification, Dimensions for hull and piping,
during marking, cutting, bending and assembly (fit-up and
welding) process.
- Welding being a special process need following controls:
Procedure should comply with the reference standards/codes e.g. AWS
codes, ASME codes, Class rules etc.
Qualification test results should be recorded in PQR
Contd…..

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ISO9001:2000
7.5.1 Operations Control
Procedure may be documented in WPS and shall normally include specifications of
welding materials, welding equipment, welding parameters ( voltage, current, speed ) ,
welding environment ( temp, wind speed, pre heat ) and criteria for workmanship ( e.g.
groove angle, root gap etc )
Externally qualified WPS may also be used, such as customer supplied WPS,
manufacturer’s WPS or WPS in the reference standard/ code.
Monitoring and/or operating criteria ( this is a special process ) - monitoring as per quality
plan and WPS. Shall cover welding consumable, welding parameters and environment
and criteria for workmanship
Qualification requirements for welders shall be specified and maintained as quality
records

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ISO9001:2000
7.5.2 Identification & Traceability
Identification and/or traceability of the structural plates and shapes,
and of pipes are critical, during the process of marking, cutting and
assembly.
Identification of machinery and components are important, during
storage and installation onboard.
Check if inspection (including NDT) status is identified when hull
blocks and pipe spools are painted, erected and/or installed.

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ISO9001:2000
7.5.3 Customer Property
It is normal that ship owners are supplying some equipment to be installed onboard
Inventories are partly supplied by the ship owners

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ISO9001:2000

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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ISO9001:2000
7.6 Control of Measuring & Monitoring Devices
Equipment to be calibrated included welding equipment (except SMAW ( shielded metal arc welding ) equipment), temperature gauges of drying ovens for welding consumables, temperature gauges and recorders of heat treatment equipment.
Equipment used for hull inspection, painting inspection, outfitting inspection including inclining test, deadweight measurement and sea trial also requires to be calibrated and cover Non destructive, mechanical and chemical testing.

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