ASSIGNMENT OF TOTAL QUALITY
MANAGEMENT
Topic- Q.S.9000 and ISO
Submitted by Rohit Singh
Submitted to –Mr. Vijayant Maan
SCRIET(CCS University)
ABOUT ME
• Name- Rohit Singh
• Roll. Number- 100160234
• Class- Btech
• Branch- Mechanical (4th year)
• SCRIET (CCS University)
OBJECTIVE OF THIS OVERVIEW
This ISO/QS- 9000 Overview is designed to:
• Present an understanding of ISO 9000 and QS-9000 .
• Offer basic background and evolution of ISO 9000.
• Explain what ISO 9000 means to your company and how it relates
to your industry.
• Identify your roles and responsibilities in the successful
implementation of an ISO 9000 Quality System.
BACKGROUND
• ISO-900 was first published in 1987 by the International Organization of Standards (consisting
of 110 countries).
– Revised in 1994 (Same year as QS-9000 was introduced)
– Has 20 elements related to quality assurance for design, development, production, installation and
service.
– Next version to be published in the year 2000.
• QS-9000 is a common quality system model introduced by Chrysler, Ford and General Motors in
September 1994. It includes almost all of IS 9000 standards.
- QS-900 Quality System Requirements replaces Chrysler’s Supplier Quality Assurance Manual, Ford’s Q-
101 Quality System Standard, and General Motors’ North American Operations’ Standard for Excellence.
- By standardizing their business practices, suppliers to the Big Three no longer have to satisfy individual
individual customer requirements.
CONSTITUENTS OF QS-9000
• ISO 9000 is the main building block of QS-9001
• Sector specific requirements - these requirements address Production Part
Approval Process(PPAP), Continuous Improvement, and Manufacturing
Capabilities.
• Customer specific requirements - these are the individual requirements
each automaker has established for its suppliers.
WHAT IS ISO 9000 ???
• ISO 9000 is the most accepted International Quality System.
• ISO 9000 standards describe the minimum requirements for an effective
quality system.
• ISO 9000 helps companies improve quality by emphasizing need for
documentation and continuous improvement. It does not dictate methods
for achieving specific business objectives.
ORIGIN OF ISO 9000
• ISO 900 is a quality system standard created by the International Standard for
Standard. The Organization is presently comprised of more than 100 national
standards bodies, with each member representing a different country.
– The American National Standard Institute (ANSI) is the member body
representing the United States
• ISO 9000 is a series of standards on quality assurance and quality management.
The standard are generic so that they can be used by manufacturing and
service industries worldwide.
ORIGIN OF ISO (CONTD.)
• The first standard is ISO 9000 which provides basic definitions and concepts.
ISO 9001, 9002, and 9003 are actual quality system models which a supplier
must implement in order to become registered to the international standard.
• The first standard is ISO 9000 which provides basic definitions and concepts.
ISO 9001, 9002, and 9003 are actual quality system models which a supplier
must implement in order to become registered to the international standard.
• Today European businesses place great weight on ISO 9000 certification
because it is a credible tool for ensuring the quality of a company’s product
and service.
REGISTRATION REQUIREMENTS
• Chrysler - All production and service Part Suppliers
must be Third Party Registered by July 31, 1997.
• Ford - Suppliers to Ford are not required to pursue
third party registration at this time.
• General Motors - All production and Service Part
Suppliers must be Third Party Registered by
December 31, 1997.
ROAD TO REGISTRATION
• Implement a quality system that meets the Big 3’s QS-9000/ISO
9000 technical requirements
• Create a quality manual which stipulates quality policies,
procedures, and practices. This manual must also address, point
by point, all of the QS-900/ISO 9000 requirements.
• Institute and practice the quality system for three to six months.
• Establish relationship with a registrar and build working
relationships. File application for registration, etc.
INDUSTRIES WHICH BENEFIT FROM ISO/QS-
9000 STANDARDS
– Electronic
– Automotive
– Computer
– Construction
– Transportation
– Manufacturing
– Service Providers like Hospitals, Engineering Consulting Firms, Law Firms, Commercial Aviation Companies,
Manpower Staffing Companies, Governmental Agencies, Insurance Companies, etc.
– These standards are generic - they apply only to the process, not the specific products or service.
– Firms of all sizes (regardless of number of employees)
– Domestic or International
GENERAL BENEFITS OF ISO/QS- 9000
• Improve Quality and Customer Satisfaction
• Increase Profits and Gain Competitive Advantage
• Simplified industry specific requirements
• Elimination of redundant procedures by using one common standard.
• Absence of multiple on-site supplier audit and inconsistent reporting format. Through
QS-9000 most of the procedures are harmonized.
• Reduced cost of quality and documentation for suppliers.
• Better positioning for international market.
• Competitive advantage over companies which are not registered.
ISO 9000 STANDARDS
REGISTRATION
• ISO 9001 - includes all 20 elements and applies to companies who provide
Design/Development, Production, Installation and Service. It is the most
comprehensive standard.
• ISO 9002 - applies to companies which have no design responsibility and
includes 19 of the 20 elements. It applies to companies engaged in Production,
Installation and Service only.
• ISO 9003 - includes of the 20 elements and applies to only to companies
involved with Final Inspection and Test Procedures.
ELEMENTS OF ISO 9000
4.1 Management Responsibility
4.2 Quality System
4.3 Contract Review
4.4 Design Control
4.5 Document and Data Control
4.6 Purchasing
4.7 Control of Customer Owned Product
4.8 Product Identification and Tractability
4.9 Process Control
4.10 Inspection and Testing
4.11 Inspection, Measuring and Test Equipment
4.12 Inspection and Test Status
4.13 Nonconforming Product
4.14 Corrective and Preventive Action
4.15 Handling, Storage, Packaging, Preservation and delivery
4.16 Control of Quality Records
4.17 Internal Quality Audits
4.18 Training
4.19 Servicing
4.20 Statistical Techniques
MANAGEMENT RESPONSIBILITY:
Element 4.1 Management Responsibility
4.1.1 Quality Policy - The supplier’s management with executive
responsibility shall define and document its policy for quality, including
objectives for quality and its commitment to quality. The quality policy
shall be relevant to the supplier’s organizational goals and the
expectations and needs of its customers. The supplier shall ensure that
this policy is understood, implemented and maintained at all levels of the
organization.
“SHALL” AND “SHOULD” IN ISO
“Shall” - Implies a mandatory requirement. There are 138 shall statements
in the ISO 9000 standards.
“Should” - Means a preferred approach. Companies adopting other
approaches must be able to demonstrate that their approach meets the
intent of the standard.
ISO 9001 ELEMENTS (4.1 - 4.4)
4.1 Management Responsibility
4.3.3 Amendment to
– 4.1.1 Quality Policy
contract
– 4.1.2 Organization
4.3.4 Maintain records
• Responsibility and Authority
4.4 Design Control
• Resources 4.4.1 Maintain Documented
• Management Representative Procedures
– 4.1.3 Management Review 4.4.2 Plan Design Activities
4.4.3 Organization and
4.2 Quality System
Technical Interface
– 4.2.1 Quality Manual 4.4.4, .4.4.5 & 4.4.6 Design
– 4.2.2 Quality System Procedures Input & Review
– 4.2.3 Plan Quality Activities 4.4.7 Design Verification
4.3 Contract Review
4.4.8 Design Validation
4.4.9 Design Change
– 4.3.1 Document procedures for contract review
– 4.3.2 Review customer orders
• Verbal Orders
• Resolve differences
• Determine capability
ISO 9001 ELEMENTS (4.5 - 4.9)
4.5 Document and Data Control 4.7 Customer Supplied
– 4.5.1 Documented procedures (hard copy and/or Product
electronic media) Documented procedures for
the control of verification,
– 4.5.2 Review, Approve & Issue
storage and maintenance of
• Master list of documents customer supplied product
• Current revision status 4.8 Product Identification &
• Obsolete documents removed and suitably identified Traceability
Documented procedures for
4.6 Purchasing
product identification from
– 4.6.1 Procedures to ensure purchased product receipt and during all stages
meets requirements 4.9 Process Control
– 4.6.2 Evaluation of subcontractors (i.e., - Plan production activities
Approved customer list) carried out under controlled
– 4.6.3 Clear and accurate purchasing documents conditions
Documented procedures
– 4.6.4 Verification of purchased product
Suitable equipment and
working environment
Standards/codes compliance.
Criteria for workmanship
Equipment maintenance
ISO 9001 ELEMENTS (4.10 - 4.13)
4.10 Inspection and Testing 4.12 Inspection and Test
– 4.10.1 Plan and document inspection Status
and testing activities Inspection and test status of
product is suitably identified
– 4.10.2 Receiving
throughout production to
– 4.10.3 In-process ensure that only product that
– 4.10.4 Final Inspection and Testing has passed customer
requirements is dispatched,
– 4.10.5 Records
used or installed. (Tagging,
4.11 Control of Inspection, Measuring marking, etc.)
and Test Equipment 4.13 Nonconforming Product
– 4.11.1 Documented procedures to 4.13.1 Documented
control, calibrate and maintain procedure to prevent
equipment unintended use
4.13.2 Review and disposition
– 4.11.2 Appropriate equipment
rework
capable of necessary accuracy accepted with concession
• Maintain calibration records re-graded for alternative
• Identify calibration status application
rejected or scrapped
• Safeguard from adjustments re-inspect repaired or
reworked product
ISO 9001 ELEMENTS (4.14 & 4.15)
4.14 Corrective and Preventive 4.15 Handling, Storage,
Action Packaging, Preservation and
Delivery
– 4.14.1 Documented procedures Prevent damage or
for implementing corrective and deterioration:
preventative action 4.15.1 Documented
– 4.14.2 Corrective Action - Procedure
4.15.2 Handling to prevent
• Effective handling of customer damage and/or
complaints deterioration
• Investigate cause of non- 4.15.3 Storage - uses of
conformities designated storage areas
• Take effective corrective action 4.15.4 Packaging to ensure
conformance to specific
• Controls to ensure corrective
requirements
action is effective
4.15.5 Preservation and
– 4.14.3 Preventative Action and segregation
• Use of appropriate sources to 4.15.6 Protection of
detect, analyze and eliminate product after final
cause of non-conformities inspection and test,
including delivery to final
• Controls to ensure preventative
ISO 9001 ELEMENTS (4.16 - 4.20)
4.16 Quality Records
4.18 Training
– Documented procedure for
Identify training needs,
identification, collection, indexing,
provide training and
access, filing, storage, maintenance and
maintain records for all
disposal of quality records.
personnel performing
– Legible, readily retrievable and activities affection quality.
protected from damage or loss 4.19 Servicing
4.17 Internal Quality Audits Documented procedures
– Documented procedure for planning and for performing, verifying
implementing internal quality audits and reporting that service
– Scheduled on basis of status and meets requirements.
importance 4.20 Statistical Techniques
4.20.1 Identify the need
– Performed by independent personnel
for statistical techniques
– Record results 4.20.2 Documented
– Follow -up to verify effectiveness of procedures
corrective action
ISO 9000
DOCUMENTATION REQUIREMENTS
Level 1 Documentation - Policies
Quality Policies are contained in the Quality Manual. Policies state the “intent” of your quality system and
responsibilities.
Level 2 Documentation - Procedures
Procedures describe “what is done and who does it” to implement the policies.
Level 3 Documentation - Work Instructions
Work Instructions describe “how” a job is done.
Level 4 Documentation - Records
Records offer the “evidence” that procedures and work instructions are followed and maintained.
REGISTRATION PROCESS
Application to the Registrar
Select a registrar organization based on expertise in you industry. File application for
review.
Review of Quality Manual
Registrar performs a “Desk Audit” of your Quality Manual and determines compliance to the standard.
Registrar responds in writing.
Review of On-Site Readiness
To assess your procedures and related documents, the Registrar visits your site. (Report issued)
On-Site Registration Audit
This is the formal audit. The Registrar visits your sites and audits the effectiveness of your quality syste.
(Report issued)
Registration
Upon completion of audit, the Registrar reviews audit results for recommendation of
certification.
Surveillance Audits
To maintain the registration, the Registrar conducts surveillance audits. (Usually every 6
months for a period of 3 years)
RESULTS OF AUDITS
Full Conformance - This would mean that there has been no Nonconformance found in the audit conducted.
Major Nonconformance - This would be cited when audit found absence or complete breakdown of a
quality system element. Aditionally, when a large number of minor non-conformances for one quality
system element are found, it may be considered a major non-conformance.
Minor Nonconformance - Single observed nonconformance would result in such notice. Time is allowed to
correct the problem and submit request for re-evaluation.
Opportunity for Improvement - It is an observed deficiency in quality improvement and is not considered a
nonconformity.
DEALING WITH AUDIT AND AUDITORS
* Do cooperate, but don’t volunteer any information.
* Do not try to cover up and do not elaborate.
* Do tell the truth. Give him or her the information he/she is looking for unless it is may be
confidential. In such a situation, don’t argue; simply get your supervisor or the registrar
guide.
* Do not answer questions that are outside your responsibilities. Instead, direct them to the
proper responsible person.
* Don’t complain about your job. Auditors are not interested, nor are they able to do anything
about your complaints.
* When you don’t understand a question, it is alright to ask the auditor to repeat it.
* Be well familiar with your job instructions and your quality policy.
QUESTIONS YOU MAY EXPECT FROM
AUDITORS
An auditor may ask questions of following nature:
• Can you describe your job and what you do in this area?
• Is there work instructions that describes your job?
• Did you have any job related training for this activity?
• Is the measuring instrument you are using, calibrated?
• Can you tell me how your job affect quality?
• Can you show me where do you keep records after your job is done?
• What do you do with parts that do not meet specifications?
• What is your quality policy?
• Who is your customer?
• What do you do when machines breakdown or materials not available?
WHAT YOU NEED TO DO TO BE READY
FOR AN AUDIT
• Memorize your company’s quality policy
• Know your management representative
• Review the Procedure and Work Instructions pertaining your job
• Know where your quality Records are kept and how to retrieve it
• Know your roles, responsibilities and authority within the Quality System.
• Take part in Continuous Improvement efforts in your activity
REASONS YOU SHOULD CONSIDER
ISO 9000 REGISTRATION:
• Establishes standard operating system for the business
• Emphasizes Continuous Improvement and Prevention instead of
Reaction.
• Empowers employees by establishing responsibilities and decision making
process
• Improved communication and cooperation within the organization
• Institutes procedures for greater customer satisfaction by joint efforts by
Management, all employees, and the Quality Department.
SLIDE TITE
Thank You!
