pe 6421 chapter 3 iso 9000 quality system oct 13 2014
DESCRIPTION
Quality Engineering Six SigmaTRANSCRIPT
The ISO 9000Quality System
CHAPTER THREE (3)
1
PE 6421 Quality Engineering
PROF. CHARLTON S. INAODefence University
College of Engineering, Bishoftu ,Ethiopia
Topics
I. The ISO 9000 Family of Standards
II. Quality System Documentation and
Auditing
III. ISO : 9000 Related Aspects
ISO 9001:2008
Course Objectives:
Appreciate the significance of ISO 9001:2008 to organizational performance and to business development;
Understand the requirements of ISO 9001:2008;
Implement ISO 9001:2008 requirements, for certification purposes.
At the end of the seminar, the participants will be able to:
Course Outline:
What is ISO?History of ISO 9000Benefits of Quality Management SystemRelated Management SystemsEight Quality Mangement Principles
Part I:
Understanding the Requirements of ISO 9001:2008
Part II:
Steps to ISO 9001:2008 Certification
Part III:
Part I: What is ISO? History of ISO 9000 Benefits of Quality Management
System Related Management Systems Eight Quality Management Principles
ISO 9001:2008
Because "International Organization for Standardization"
would have different acronyms in different languages
"IOS" in English
"OIN" in French for Organisation Internationale de Normalisation)
its founders decided to give it also a short, all-purpose name.
Short name (ISO) was derived from the Greek word,
“ISOS” meaning equal.
WHAT IS ISO???WHAT IS ISO???
WHAT IS ISO???WHAT IS ISO???
• An International Standard and a Set of Guidance Documents Intended for Organizations in all Types of Industries
HISTORY OF ISO
HISTORY OF ISO
ISO was founded in 1947 as anon-governmental organization withthe goal of facilitating internationaltrade and developing international
cooperation in scientific, technological,
and economic arenas.
FOUNDER - Worldwide federation of national standard bodies, based in Geneva, Switzerland.
Now comprises 162 members, one in each member country out of 203 total countries in the world.
THE INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION (ISO)
ISO 9001:2008 – Quality Management Systems
ISO 14001:2004 – Environmental Management Systems
ISO/IEC 17025:2005 – Testing & Calibration Laboratories
THE INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION (ISO)
ISO 9001:2008 – Quality Management
ISO 14001:2004 – Environmental Management
OHSAS 18001 – Occupational Health & Safety
INTEGRATED MANAGEMENT SYSTEMS
ISO 9000 is a set of
standards for
Quality Management
System that
is accepted around the
world
The ISO 9000 Family
of Standards
WHAT IS THE ISO 9000 FAMILY?The 4 primary standards of ISO 9000 family:
ISO 9000:2005Quality
Management Systems- Fundamentals and
Vocabulary
ISO 19011:2011Guidelines for Quality and/or
Environmental Systems Auditing
ISO 9001:2008Quality
Management Systems- Requirements
The ONLY standardwhich third-party
certification can be carried.
ISO 9004:2009Quality
Management Systems- Guidelines for Performance Improvements
contains the fundamentals and vocabulary,which are vital information for an organization that wishes to establish a quality management system.
ISO 9000:2005Quality Management Systems: Fundamentals and Vocabulary
consists of the requirements, laying down the groundwork for building a QMS according tointernationally accepted standards.
The standard is the only standard in the ISO family which an organization’s quality management system can be certified by an external certifying body.
ISO 9001:2008
Quality Management Systems: Requirements
provides guidelines into continually improving the established system and extending the benefits of ISO 9001:2008 to business stakeholders such as the organization’s employees, owners, suppliers and the society.
ISO 9004:2009
Quality Management Systems: Guidelines for Performance Improvements
Contains guidelines on how to audit QMS or EMS (Quality or Environmental Management
Systems)
ISO 19011:2011
Guidelines on Quality and /or Environmental Management Auditing
The Development of theISO 9000 Family of Standards
1987 Initial release
1994 First revision
2000 Second revision
2008 Third revision
ISO 9001, like other management system standards is subject to periodic
review to determine whether it is still relevant, whether it needs to be updated or whether it is to be
discontinued.
The Development of theISO 9000 Family of Standards
Why should an organization needs to set up a QMS?Why should an organization needs to set up a QMS?
For internal purposes For certification purposes Contractual purposes
Our Customers
Quality Service Increased Confidence in Service Less number of non-compliance's. Improved Supply/Consistent Quality Helps in Planning Activity Competitive Pricing/Lead Time Reduction
The benefits of ISO to ……..The benefits of ISO to ……..
Our Company Reduced Number of defects Increased Customer Satisfaction Consistency in Output Assured Customer/Market Share Reduction in costs due to reduction of defects Involvement of Personnel and consequent Higher
Productivity
The benefits of ISO to ……..The benefits of ISO to ……..
Our Employees Defined Directions Improved Performance Better and improved relation. Increases Motivation Job Satisfaction Involvement Pride of working in an ISO 9001 Certified company.
The benefits of ISO to ……..The benefits of ISO to ……..
Stability
Growth
Partnership and mutual understanding
Our Suppliers
The benefits of ISO to ……..The benefits of ISO to ……..
Fulfillment of legal and regulatory requirements
Improved health and society
Reduced environmental impact
Increased security
Our Society
The benefits of ISO to ……..The benefits of ISO to ……..
EXPECTED QUALITY
by the Customer
PLANNED QUALITY
by the Company
PRODUCED QUALITY
by the Company
PERCEIVEDQUALITY
by the Customer
Measurement of the Performance of the Company
Measurement of theClient’s satisfaction
The ISO 9001:2008 requirements
A quality management principle is a
comprehensive and fundamental rule or
belief, to lead and operate an
organization successfully designed to
continually improve performance over
the long term by focusing on
customers while addressing the needs
of all other interested parties.
Quality Management Principles: Definition
EIGHT ( ) QUALITYMANAGEMENT PRINCIPLESEIGHT ( ) QUALITYMANAGEMENT PRINCIPLES
ISO 9001:2008
Mutually beneficial supplier relationship
Customer focus Leadership
Involvement of people Process approach
System approach to Mgt. Continual improvement
Factual approach to decision making
Principle 1: Customer Focus
Organizations depend on customer
Determine customer needs & expectations
Requirements
Customer Satisfaction
Create unity of purpose, common goals, one direction.
Principle 2: Leadership
Principle 2: Leadership
They create and maintain the internal environment in which people become effectively involved in achieving the organization’s objectives
Leaders must be people thatHave the ability to think in time spans of years instead of months Visualize life in 5 years--what do you want it to beStresses corporate “big picture”LeadersDevelop a participative climate
PartnershipsMake others responsibleEmployee participation
“Walk what you talk”“Say what you mean, mean what you say”
Customer
requirements
determined
and met
Principle 2: Leadership
People at all levels are the
essence of an organization
and their full involvement
enables their abilities to be
used for the organization’s
benefit.
Principle 3: Involvement of People
A desired result is
achieved more efficiently
when related resources
and activities are
managed as a process.
Principle 4: Process Approach
PROCESS
“set of interrelated or
interacting activities
which transforms inputs
into outputs.”
Input OutputPROCESS
Customers
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
Clause 5
Clause 6 Clause 8
Clause 7
Service/Product
realization
Value adding activitiesInformation flow
InputRequirement
s
Output
Customers
Satisfaction
Service
Product
Resource
Management
Measurement, analysis and improvement
Management responsibility
Process Approach
“Identifying,
understanding and
managing interrelated
processes as a system
contributes to the
organization’s
effectiveness and
efficiency in achieving
its objectives.”
Principle 5: Systematic Approach to Management
Organizational Structure
Responsibilities
ProcessesProcedures
ResourcesSYSTEM
SYSTEM APPROACH
“Continual improvement of the
organization’s overall performance should
be a permanent objective of the organization.”
Principle 6: Continual Improvement
PDCA CYCLE
“Effective decisions
are based on the
analysis
of data and
information.”
Principle 7: Factual Approach to Decision Making
“An organization and
its suppliers are
interdependent and a
mutually beneficial
relationships enhances
the ability of both
to create value.”
Principle 8: Mutually Beneficial Supplier Relationships
Summary
Implementing the Eight Principles is not easyTakes a good leaderTakes vision/perseveranceAn infrastructure must be establishedCommunication needs to be done Much planning should start immediatelyGoes along well with ISO 9000 implementation
Quality Systems Documentation and Auditing
Part II: Understanding the
Requirements of ISO 9001:2008
ISO 9001:2008
1. Control of Documents
2. Control of Records
3. Control of Nonconforming Products
4. Internal Audit
5. Corrective Action
6. Preventive Action
• Administrative and Explanatory Notes Section 1 – Scope Section 2 – Normative Reference Section 3 – Terms & Definition
• Core Requirements Section 4 – Quality Management System Section 5 – Management Responsibility Section 6 – Resource Management Section 7 – Product Realization Section 8 – Measurement, Analysis & Improvement
1. SCOPE
The Scope of the Quality Management System
Those parts of the business that are included within the system for certification (inspection services, product being inspected, report, etc.)
51
ISO 9001:2008 StandardISO 9001:2008 Standard
CUSTOMER
CUSTOMER
Customer Supplied Materials
CustomerComplaints/Satisfaction
Internal Audit & Analysis of Data
C & P Action
Measurement, Analysis & Improvement
Control of NC Product
QMS Performance Data
Planning & Objectives
Mgt. Review
Mg
t R
espo
nsib
ility P
rocesses
Continual Improvement
Policies &Directions
Policies &Directions
Resource Mgt Processes
Personnel Competence
& Skills
Facilities, Eqpt & Work Environment
Financial Require-
ments
Resource NeedsResources
Purchasing
Receiving & Inspection
Operation
Warehousing Delivery
Operations Planning
Work Order Requirements
Processing
SAMPLE BUSINESS PROCESS MAP
SCOPE OF ACTIVITIES
CERTIFICATE OF REGISTRATION
This is to certify that
XYC CompanyDebre Zeit, Oromia
operates a Quality Management System which has been assessed as conforming to
ISO 9001:2008
for the scope of activities
Design, Machining, Casting, and Fabrication
CERT NO.: ___________ Issue Date: 14 October 2014
Valid until 14 October 2017 subject to the adherence of the ongoing audit programme, successful endorsement of certification, following each audit and compliance with the certifying body regulations.
2. NORMATIVE REFERENCES
Make references to:Applicable: Standards, Directives, Codes, etc.
appropriate to the Scope
55
ISO 9001:2008 StandardISO 9001:2008 Standard
In this instance, the only reference is:
“ISO 9000:2005, Quality Management Systems
– Fundamentals and Vocabulary”
3. TERMS & DEFINITIONS
The business terms defined within the trade As understood by the organization
56
ISO 9001:2008 StandardISO 9001:2008 Standard
This third section explains wherever the term
“product” occurs, it can also mean “service”
throughout the text of the International
Standard.
CODE
4 Quality Management
System 5 Management Responsibility 6 Resource Management 7 Product and/or Service
Realization 8 Measurement, Analysis and
Improvement
MAIN GROUPING OF QMS REQUIREMENTS
CLAUSES
4 – Quality Management System
5 – Management Responsibility
6 – Resource Management
7 – Product Realization
8 – Measurement, Analysis and Improvement
4.1 General Requirements
4.2 Documentation Requirements
4.2.2 Quality Manual4.2.3 Control of
Documents4.2.4 Control of
Records
Clause 4 – Quality Management System (Structure and Components)
4.1 General requirements
• Processes needed for QMS includes 4 areas corresponding to QMS clauses 5 to 8.
• Ensure control over outsourced process
• Factors that can affect type and extent of control
- potential impact to organization’s products/ service
- degree to which the control for the process is shared
- application of Purchasing (7.4)
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
Processes, interaction, improvement The focus is on looking at:
What we do.
Who we are doing it for.
Improving how we provide
service.
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
4.1 General requirements
4.2 Documentation requirements• Develop a quality system and a manual that
describes it.
• Quality system procedures are consistent with your quality policy.
• Develop quality plans for products, processes, projects, and customer contracts.
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
Level 2
Level 3
Level 4
Hierarchy of QMS DocumentationHierarchy of QMS Documentation
4.2 Quality Manual
• Describes intent to establish a quality management system with an emphasis on continual improvement.
• Specifies the scope of QMS
• Includes the policies and targets, process description, process instructions and process responsibility.
• States the justification for exclusions, if any
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
- Approve documents for adequacy prior to issue
- Review, update as necessary and re-approve documents
- Changes and current revision status of documents are identified
4.2 Document control
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
- Relevant versions of applicable documents are available at points of use
- Documents remain legible and readily identifiable
- External documents are identified and their distribution controlled
4.2 Document control
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
- Prevent the unintended use of obsolete documents, and identify them if they are retained for any purpose
- Documented procedure required
4.2 Document control
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4.2 Document control
The procedure of Control of Document comprises,
• the creation, the determination of marking, storage, protection /data security, retrievability, safekeeping periods and responsibilities of who possesses the document or has access.
For example: • Where and how long are the documents stored?• Which documents are useful?• How are outdated documents marked?
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
Certain records need to be kept to demonstrate how the
QMS is operating effectively.
- Records must be legible, readily identifiable, accessible, protected, retained within prescribed period and disposed properly.
- Documented procedure must describe how they are identified, stored, protected, retrievable, and define their retention and disposal time.
4.3 Control of Records
CLAUSE 4: QUALITY MANAGEMENTCLAUSE 4: QUALITY MANAGEMENT
MANAGEMENT RESPONSIBILITYMANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.2 Customer Focus5.3 Quality Policy5.4 Planning5.5 Responsibility,
Authority & Communication
5.6 Management Review
4 – Quality Management System
5 – Management Responsibility
6 – Resource Management
7 – Product Realization
8 – Measurement, Analysis and Improvement
5.1 Management Commitment
• A QM system is a matter for the Management
• It is no longer possible to delegate the responsibility
• Communicate the requirement to your staff
• Make Quality policy and quality objectives at relevant functions
• Management reviews conducted
• Resources made available
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
5.2 Customer focus
• Quality is what the customer requires.
• The top most aim must be to meet your customers’ requirements and win, retain and further increase their confidence and satisfaction.
• Identify your customers’ desires and expectations
• Clarify product-related obligations e.g. legal requirements
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
5.3 Quality policy
• Should be written down in your QM manual.
Aims: • Customer satisfaction, development of staff, future improvement• Which resources do you provide• Customer requirements should be at the centre of attention. • Mandatory: The commitment to continual improvement
• On-going review of the quality policies and its adequacy for the company
• Formulate the guidelines concerning the planned business position and development very clearly, and underpin them with quantifiable aims, so that they can be put into practice.
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
What is Quality Policy?
"The overall intentions and direction of an organization related to quality as formally expressed by top management."
This policy is meant to be an outward statement of its commitment to its customers and to the provision of quality products.
It should be in line with the purpose and mission of the organization.
It should be practical and aligned with measurable expression in the Quality Objectives.
It also should be understandable by all members of the organization, employees, managers as well as other stakeholders.
What is Quality Policy?
VISION
"To become the most successful and respected lift truck company in
the U.S.”
Toyota Vision Statement
MISSION
"To sustain profitable growth by providing the best customer
experience and dealer support."
Toyota Mission Statement
QUALITY POLICY• Total Quality Control based on mutual trust among
ourselves and involvement of every single member of our organization is our Company Lifestyle. We cannot compromise for quality in anything we do.
• We are committed to continuous improvement (Kaizen) in all our activities and practices.
• We shall cooperate with and assist our suppliers for continuous improvement in their products, services and practices.
• Our quality target is to be always better than competitors
and also to be better than other Toyota Motor Corporation plants, producing CS No. 1 vehicles.
5.4 Quality objectives and planning
• Quality policies are the orientation frame for the formulation of measurable quality targets and means that are necessary to achieve these targets.
• Identify the procedures that have a direct impact on company success and customer satisfaction.
• Determine measurable targets that concretely state what you intend to achieve in a defined period.
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
5.4 Quality objectives and planning
• Define the activities necessary for achieving the targets.
• Communicate these targets and measures and provide the necessary resources.
• Moreover, you have to plan changes in your QM system in such a way that the system can seamlessly continue to function.
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
QUALITY OBJECTIVES
CORPORATE OBJECTIVE:To attain a “very satisfactory” customer satisfaction rating through the continual improvement of our QMS.
FUNCTIONAL OBJECTIVES:Human Resource
To provide requested manpower within 5 days upon receipt of personnel request.
FUNCTIONAL OBJECTIVES
Operations
To ensure not to exceed 0.5% rejects.
Maintenance To ensure that 98% machine availability”
5.5 Responsibility, authority and communications• Delegate responsibilities and authorities to employees in
the whole company, you will achieve that quality becomes the concern of employees at all level.
• By systematically promoting internal communication you can make sure that quality policies become well-known, your staff feels included.
• Define responsibilities and authorities of those employees who will have to take decisions that are relevant to quality.
• Identify a QMR who is a member of the topmost management..
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
must be a member of the organization’s management
ensures processes of QMS are established, maintained, and implemented
reports on the performance of QMS and any need for improvement
promotes awareness of customer requirements throughout the organization
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
5.5.2 Management Representative
set up an effective system of communication to ensure effective operation of the QMS
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
5.5 .3 Internal Communication
5.6 Management review
• Required inputs and outputs
• Evaluates suitability, adequacy and effectiveness of QMS
• Involves TOP Management
CLAUSE 5: MANAGEMENT RESPONSIBILITYCLAUSE 5: MANAGEMENT RESPONSIBILITY
CLAUSE 5.6: MANAGEMENT REVIEWCLAUSE 5.6: MANAGEMENT REVIEW
5.6 .3 Review Input
The input to management review shall include information on:
a) results of audits,b) customer feedback,c) process performance and product conformity,d) status of preventive and corrective actions,e) follow-up actions from previous management
reviews,f) changes that could affect the QMS, andg) recommendations for improvement.
CLAUSE 5.6: MANAGEMENT REVIEWCLAUSE 5.6: MANAGEMENT REVIEW
5.6 .2 Review Output
The output to management review shall include any decisions and actions related to:
a) improvement of the effectiveness of the QMS and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
RESOURCE MANAGEMENTRESOURCE MANAGEMENT
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure6.4 Work
Environment
4 – Quality Management System
5 – Management Responsibility
6 – Resource Management
7 – Product Realization
8 – Measurement, Analysis and Improvement
to improve processes and
enhance customer satisfaction
to improve processes and
enhance customer satisfaction
Human Resource
InfrastructureWork
Environment
CLAUSE 6: RESOURCE MANAGEMENTCLAUSE 6: RESOURCE MANAGEMENT
6.1 Provision of Resources
Human Resource
InfrastructureWork
Environment
Determine competence on the basis of education, training, skills and experience
Provide training or other action.
Evaluate effectiveness of action.
6.2 Human Resources
CLAUSE 6: RESOURCE MANAGEMENTCLAUSE 6: RESOURCE MANAGEMENT
Human Resource
Infrastructure Work Environment
Buildings, workspace, utilities.
Materials, plant and process equipment.
Computer system and information technology
Support services (i.e. transport and communication)
6.3 Infrastructure
CLAUSE 6: RESOURCE MANAGEMENTCLAUSE 6: RESOURCE MANAGEMENT
Human Resource
Infrastructure Work Environment
Human Resource
Infrastructure
Must be the right
work environment to
achieve conformity
to product
requirements Physical,
environmental and
other factors (i.e.
noise, temperature,
lighting, humidity,
etc.)
6.4 Work Environment
CLAUSE 6: RESOURCE MANAGEMENTCLAUSE 6: RESOURCE MANAGEMENT
MANAGEMENT RESPONSIBILITYMANAGEMENT RESPONSIBILITY
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.3 Design and Development
7.4 Purchasing7.5 Product &
Service Provision7.6 Control of
Monitoring & Measuring Eqpt.
4 – Quality Management System
5 – Management Responsibility
6 – Resource Management
7 – Product Realization
8 – Measurement, Analysis and Improvement
• Quality objectives and requirements for product need to be determined
• Processes and documents shall be established
• Resources specific to the product
• Required verification, validation, monitoring, measurement, inspection and test activities
• Records of effective implementation
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.1 Planning of Product or Service Realization
• Customer and regulatory requirements related to the product
• Additional requirements considered by the organization
• Post delivery activities
• Review of requirements related to the product
• Customer communication
- Product information
- Contracts including amendments
- Customer feedback/complaint
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.2 Customer-related Processes
• Design and development planning
• Design and development inputs
• Design and development outputs
• Design and development review
• Design and development verification
• Design and development validation
• Control of design and development change
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.3 Design and Development
Make a clearly defined order which contains quantities, price and date of delivery, clear quality statements with technical details.
Make a list of suitable suppliers.
Assess your suppliers. Document the assessment.
Is your supplier certified?
Make goods inward test to ensure that requirements are met.
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.4 Purchasing
Provide the adequate manufacturing facilities, auxiliary means, documents, staff and their qualification.
State the requirements in e.g. QM process instructions, work instructions, process descriptions, workflows, hiring plans and shop floor papers.
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7.5 Production and Service Provision
• Appropriate production facilities have to be selected.
• Measurement equipment is available.
• The staff needs to be qualified by training and instructions
• Has to document the measurement.
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.5.1 Control of Product and Service Provision
• Processes performed under controlled conditions if inspection/testing can not be done before release of product to customer
• Required where destructive testing is involved
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.5.2 Validation of Processes of Production and Service Provision
Identify what the product is throughout product realization
Trace where the product/service has gone or come from
Important for monitoring and measurement purposes
In case of non-conformity the product must be traceable all over product lifetime.
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.5.3 Identification and Traceability
Includes customer’s information/data and/or hardware, used to produce customer’s product/ service
Has to be carefully handled
Make a goods inward inspection (completeness, identity and transport damages) and ensure correct storage
Subject to protection and other controls while at organization’s custody
Report to customer if lost or damaged
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.5.4 Customer Property
In-house treatment of products
Attention when shipping the product: Possibility of corrosion on ships
Needed time for transport, sensitivity to shock and vibration, other environmental conditions and the means of travel and transportation required by the customer.
Consistency with the shipping documents and legal requirements (for example military goods).
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.5.5 Preservation of Product
• Ensure that any equipment used for measurement is accurate, precise
• Calibration needed for measurements with direct impact on product conformity
• Measurement equipment shall be calibrated or verified or both, adjusted or re-adjusted, have calibration status, safeguarded and protected
• With records of calibration and/or verification
• Verification and configuration of computer software
CLAUSE 7: PRODUCT REALIZATIONCLAUSE 7: PRODUCT REALIZATION
7.6 Control of Monitoring & Measuring Equipment
Measurement, Analysis and ImprovementMeasurement, Analysis and Improvement
8.1 General8.2 Monitoring and
Measurement8.3 Control of
Nonconforming Product
8.4 Analysis of Data8.5 Improvement
4 – Quality Management System
5 – Management Responsibility
6 – Resource Management
7 – Product Realization
8 – Measurement, Analysis and Improvement
Monitoring and measurement of:
Customer satisfactionInternal (quality system) auditingProcess performance / improvementProduct conformity / non-
conformance
106
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
“When you can measure what you are speaking about and express it in numbers, you know something about it. When you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind”.
Lord Kelvin — Physicist
107
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
Definitions of procedures to ensure product conformity.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.1 General
8.2 Measurement and Monitoring
Continual adaption to new requirements of market and customers.
Adapt also effectiveness and efficiency of the processes and the QM system.
On the basis of data, facts and information analyses have to be made and the foundation for making decisions has to be prepared.
Customer feedback, complaints and surveys, sales information, field studies, etc.
The information should be analyzed systematically in order to obtain statements on developments, e.g. by means of a defined process of complaints.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.2.1 Customer Satisfaction
Plan internal quality audit systematically.
Define responsibilities and frequency as well as the areas to be audited.
Process auditors should be independent of their own work.
Make sure in a system audit that your QM system is effective and complete.
Carry out process audits by checking the effectiveness of your instructions and processes.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.2.2 Internal Audits
Define the time frame for the internal audits. You can commission a customer of yours or an external auditor.
Make sure that the results summarized in an audit report are discussed with the persons concerned
Results of quality audits are an integral part of the management assessment.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.2.2 Internal Audits
Demonstrate achievement of planned results.
• The basis of improvement of processes is controlling and measuring them.With regard to serial production, fulfil the requirements by examining machine capabilities.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.2.3 Monitoring and Measurement of Processes
• It is possible to conclude whether the customers’ requirements are met by means of testing the product.
• Documented tests serve as a proof that your product has left your factory flawlessly.
Monitor and measure characteristics. Conformity with acceptance criteria. Waivers / concessions.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.2.4 Monitoring and Measurement of Product
Elimination or correction of nonconforming processes.
Defective products must not be processed further or delivered.
Mark defective parts and products, write down defects which were discovered.
Parts which were reworked will be tested once again with regard to the concerned characteristics before releasing them.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.3 Control of Nonconforming Product
Decisions should be made based on data.
Suitable data has to be determined which will support in assessing the effectiveness of the QMS.
The data analysis has to present evidence on Customer Satisfaction particularly on:- meeting the product requirements,- process and product characteristics and their further development
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.4 Analysis of Data
• Analysis of the results of internal audits, data analyses, preventive and corrective measures as well as management assessments help you to improve your QM-system.
• Measures to stop the following problems:
• - Customer complaints: Show your customers that you take their complaints seriously.
• - Being open towards mistakes and giving and receiving constructive criticism, not only with regard to the employees, but also the management and direction are essential.
• The employees’ motivation to take part in the process of constant improvement will be destroyed if no measures are following the proposals.
MEASUREMENT, ANALYSIS, AND IMPROVEMENTMEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.5 Improvement
8.5.1 Continual improvement
• Continually improve the effectiveness of QMS
through the use of the quality policy, quality
objectives, audit results, analysis of data,
corrective and preventive action and
management review.
8.5.2 Corrective Action
• Take action to eliminate the cause of
nonconformities in order to prevent recurrence
• Corrective Action is appropriate to the effects of
nonconformities encountered
8.5.2 Corrective Action• A documented procedure is established to
define requirements for
- reviewing nonconformities
- determining the causes of nonconformities
- determining required action to ensure that
NC does not recur
- implementing, monitoring and evaluating
effectiveness of corrective action• Maintaining records
8.5.3 Preventive Action
A documented procedure is established to define
requirements for• Determining potential nonconformities and their
causes• Evaluating the need for action to prevent
occurrence of nonconformities• Determining and implementing action needed• Recording results of action taken• Reviewing effectiveness of preventive action taken
What’s the difference between corrective and preventive action?
CORRECTIVE ACTIONS are steps that are taken to
remove the causes of existing nonconformities.
PREVENTIVE ACTIONS are steps that are taken to
remove the causes of potential nonconformities.
CORRECTIVE ACTIONS addresses actual problems,
ones that have already occurred, while PREVENTIVE
ACTIONS addresses potential problems, ones that
haven’t occurred yet.
Copyright ©2012
Related Aspects
Related Aspects
Registration Procedures
• Awareness Seminar on ISO 9001:2008• Compares Company Operations to
9001:2008 Requirements• Prepares Gap Analysis• Drafts Custom Quality & Procedure
Manuals • Company Reviews and Approves Manuals• Trains Internal Auditors
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Registration Procedures (Cont.)
• Auditor Seeks Documented Evidence of ISO System Implementation
• Implementation Verified• Issuance of the ISO Registration
Certificate• Mandatory Annual Renewals --
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Certification audit
• adequacy audit– evaluation whether the documented
procedures comply with the standard’s requirements
• compliance audit– evaluation whether the documented
procedures are followed by the employees
Time Line - Zero to Certification
Generate Documented Evidence
Assessment & Implementation
Milestone
Audit & Registration
September OctoberAugust DecemberNovember
to ISO 9001:2008
QUALITY MANAGEMENT SYSTEMQUALITY MANAGEMENT SYSTEM
To meet the requirements you must:
Document Write down what you do.
Document Write down what you do.
Continually Improve EffectivenessUse corrective/preventive action to improve your service to your customers.
Continually Improve EffectivenessUse corrective/preventive action to improve your service to your customers.
ImplementDo what you wrote down.
ImplementDo what you wrote down.
MaintainShow evidence that you are doing what you said you were doing.
MaintainShow evidence that you are doing what you said you were doing.
CERTIFICATION
Procedure by which a third party giveswritten assurance that a product, processor service conforms to specific requirements.
CERTIFYING BODY OR REGISTRAR
A third party company, (i.e., a companyindependent of the supplier and its customer)whose business is to evaluate the organization’squality system for conformity to ISO 9001:2008
Certification Bodies in Ethiopia(accredited by
An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body.
REMEMBER!!!
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