Académique Documents
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COURSE OBJECTIVES
Participants to be aware of the following:
Basic concepts on ISO9001:2008 Benefits/Importance of ISO9000 ISO9000 Requirements
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formed and began its official function on 23rd February 1947 non-governmental organization mission is the promotion of the development of standardization and related activities in the work with a view to: Facilitate the international exchange of goods and
services, and; To develop co-operation in the spheres of intellectual, scientific, technological, and economic activity
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The word ISO is not as many people think the acronym for the organization but is derived from the Greek word isos meaning equal; as in isobars, isonomy (equality of laws or of people before the law).
ISO 9000 Quality Standards focus on the SYSTEM, not the Product.
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A hierarchy of technical committees (TCs); subcommittees (SCs) and working groups (WGs) carries out the work of ISO.
Qualified industry representatives Research institutes Consumer bodies Government authorities, and Worldwide international organizations
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The administrative responsibility for a standards committee is accepted by one of the national standards bodies.
The Central Secretariat of ISO, located in Geneva, coordinates the dissemination of documentation; facilitates clarification with chairmen and the agreement of technical content by committees; coordinates meetings and generally provides overall support.
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Improved productivity
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1. Provides opportunities to streamline the companys processes Integrates systems and procedures using the ISO Framework 2. Identifies critical points in the organization to be controlled and measured (quality objectives) 3. Provides a structured approach in identifying areas for improvement/enhancement 4. Establishes clear position descriptions - identifies overlapping functions, reinforces performance management system 5. Establishes an efficient records and files management system 6. Promotes total organization involvement/sense of ownership.
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Provides confidence to the organization and its customers that it is able to provide products that consistently fulfill the requirements.
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APPLICATION/CERTIFICATION FRAMEWORK
1st PARTY 2nd PARTY ASSESSMENT ASSESSMENT
Internal Quality Audit (IQA) - Site - 1st party assessment Internal Quality Audit (IQA) - Customer Assessment 2nd Party Certification
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1. Customer Focus
3. Involvement of People
6. Continual Improvement
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a. CUSTOMER FOCUS
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
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b. LEADERSHIP
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.
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c. INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.
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d. PROCESS APPROACH
A desired result is achieved more efficiently when activities and related resources are managed as a process.
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Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives.
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f. CONTINUAL IMPROVEMENT
Continual improvement of the organizations overall performance should be a permanent objective of the organization
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An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
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cont e. Establishing methods to measure the effectiveness and efficiency of each process; f. Applying these measures to determine the effectiveness and efficiency of each process; g. Determining means of preventing the nonconformities and eliminating their causes; h. Establishing and applying a process for continual improvement of the quality management system
Such an approach is also applicable to maintaining and improving an existing quality management system.
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Management Responsibility
Resource Management
Requirements
Product Realization
Product
Satisfaction
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MODEL OF QMS
Documentation
Enables communication of intent and consistency of action. Its use contributes to: a. Achievement of conformity to customer requirements and quality improvement; b. Provision of appropriate training c. Repeatability and traceability d. Provision of objective evidence, and e. Evaluation of the effectiveness and continuing suitability of the quality management system Generation of documentation should not be an end in itself but should be a value-adding activity.
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Types of Documents a. Documents that provide consistent information, both internally and externally, about the organizations quality management system; such documents are referred to as quality manuals; b. Documents that describe how the quality management system is applied to a specific product, project or contract; such documents are referred to as quality plans
c. Documents stating requirements; such documents are referred to as specifications;
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cont
d. Documents stating recommendations or suggestions; such documents are referred to as guidelines; e. Documents that provide information about how to perform activities and processes consistently; such documents can include documented procedures, work instructions, and drawings; f. Documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records.
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cont
Each organization determines the extent of documentation required and the media to be used.
This depends on factors such as type and size of the organization, the complexity and interaction of processes, the complexity of products, customer requirements, the applicable regulatory requirements, the demonstrated ability of personnel, and the extent to which it is necessary to demonstrate fulfillment of quality management system requirements.
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ISO 9001:2008
1. Scope
2. 3. 4. 5. 6. 7. 8.
Normative Reference Terms and Definition Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis & Improvement
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1. Scope
1.1 General
This International Standard specifies requirements for a QMS where an organization
Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
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1. Scope
1.1 General
Notes: In this International Standard, the term product applies to the product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing. Statutory and regulatory requirements may be expressed as legal requirements.
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1. Scope
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
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Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
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2. Normative Reference
ISO 9000:2005 Quality management systems Fundamentals and vocabulary.
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Where an organization chooses to OUTSOURCE any process that affects product conformity with requirements, the organization shall ensure control over such processes.
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The type and extent of control of such outsourced processes shall be identified within the QMS
Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements.
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D E S C R I P T I O N O F
P R O P E R T I E S / O B L I G A T I O N T O
Acco un t So licitation
B E
I N S U R E D
Po licy Writing Po stin g, Billing & Co llection Claims Pro cessing
I N S U R A N C E P O L I C Y
SUPPORT SERVICES
SUPPLIERS
Office Supplies, Spare Parts
OUTSOURCED
Agents, Brokers, Re-insurers, Adjusters, Repair Shops
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Documents, including records, needed to ensure the effective planning, operation and control of processes
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To define controls Approve documents for adequacy prior to issue Review and update as necessary and re-approve documents, Changes and the current revision status of documents are identified Relevant versions of applicable documents are available at points of use Documents remain legible and readily identifiable Documents of external origin determined by the organization to be necessary for the planning and operation of the QMS are identified and their distribution controlled Prevent unintended use of obsolete documents, and to apply suitable identification to them if they are retained
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5. Management Responsibility
5.1 Management Commitment
Provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness by:
Internal Communication Quality Policy Established Quality Objectives Management Reviews Availability of Resources
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5. Management Responsibility
5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority
Responsibilities and authorities are defined and communicated within the organization.
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5. Management Responsibility
5.5 Responsibility, authority and communication 5.5.2 Management Representative
Appoint a QMR who, irrespective of other responsibilities, shall have responsibility and authority that includes:
Ensuring that processes needed for the QMS are established, implemented and maintained Reporting to top management on the performance of the QMS and any need for improvement Promotion of awareness of customer requirements
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5. Management Responsibility
5.5 Responsibility, authority and communication 5.5.3 Internal Communication
Appropriate communication processes are established within the organization Communication takes place regarding the effectiveness of the QMS
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1. MANCOM Meeting
Discussion of general issues and concerns such as admin policies, financial performance, A/R, and operational highlights Discussion of sales performance, and other concerns directly affecting sales
Weekly
General Manager
2. Sales Meeting
Weekly
Area Managers, Asst. Area Managers, Account Executives, Operation Managers, Corporate Affairs Manager, Finance Manager Operations Manager, Asst. Export Manager, Seafreight Manager, Export Supervisor, Import Supervisor, Dispatchers, Customer Service Assts., Asst. Area Managers
Area Managers
3. Operations Meeting
Discussion of matters directly affecting operations such as service irregularities and customer requirements
Weekly
Operations Manager
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5. Management Responsibility
5.6 Management Review 5.6.1 General
Review the QMS at planned intervals to ensure its continuing suitability, adequacy and effectiveness. Shall include assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives. Records shall be maintained
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5. Management Responsibility
5.6 Management Review
5.6.2 Review input
Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous management reviews Changes that could affect the quality management system Recommendations for improvement
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5. Management Responsibility
5.6 Management Review
5.6.3 Review output
Improvement of the effectiveness of the QMS and its processes Improvement of product related to customer requirements Resource needs
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6. Resource Management
6.1 Provision of Resources To implement and maintain the QMS and continually improve its effectiveness To enhance customer satisfaction by meeting customer requirements
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6. Resource Management
6.2 Human Resources 6.2.1 General
Personnel performing work affecting conformity to product requirements shall be competent on the basis of education training skills experience
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6. Resource Management
6.2 Human Resources
6.2.2 Competence, awareness and training
Determine the necessary competence for personnel performing work affecting conformity to product requirements, Where applicable, provide training or take other actions to achieve the necessary competence Evaluate the effectiveness of the actions taken Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives Maintain appropriate records of education, training, skills and experience
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6. Resource Management
6.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable -
Buildings, workspace and associated utilities Process equipment (both hardware and software) Supporting services (such as transport or communication or information systems)
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6. Resource Management
6.4 Work Environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
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7. Product Realization
7.1 Planning of product realization
The organization shall determine the following, as appropriate:
Quality objectives and requirements for the product Establish processes, documents and provide resources specific to the product Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance Records needed to provide evidence that the realization processes and resulting product meet requirements
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7. Product Realization
7.1 Planning of product realization
The output of this planning shall be in a form suitable for the organizations method of operations.
A document specifying the processes of the QMS (including product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan
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QUALITY PLAN
Process Name
Account Solicitation
Item to be Controlled
Prospective Accounts
Dimension
Timeliness
Standard
Person Responsible
Control Methodology
Checking and review of prospective accounts by FVPCOO
Frequency of Monitoring
Monthly
Support Documentation
SLS-7.2.1-001 SLS-7.5.1-003
Prospective accounts must be sent to Sales Supervisor / th FVP-COO every 10 of the Month Branch Head Retail: Minimum of 3 prospective accounts (for all lines) Corporate: Minimum of 3 prospective accounts (for all lines) Branch corporate account: Minimum of 2 prospective accounts (for all lines) Must be validated and sent to clients not less than 60 days before expiry date
Volume
Renewal of Policies
Renewal Proposals
Timeliness
Checking of remarks thru the CGIC Integrated System or mail registry by AVPSales/Branch Head
Monthly
Completeness Risk Identification, Analysis and Control (Applies only for new accounts and late renewals) Motor vehicle Completeness
All policies due for renewal must be validated and sent to clients Minimum information must be identified and encoded in CGIC Integrated System: OR/CR, vehicle details, physical condition, vehicle usage Notes: 1. for late renewal, only the physical condition of the vehicle will be checked 2. At least 10% of total units for fleet accounts must be inspected Must be performed on the agreed inspection schedule with the client
Account Officer
Per account
UND-7.2.1-001 UND-7.5.1-007
Timeliness
Sum insured
Accuracy
Policy Proposal
Accuracy
Sum insured must be within capacity as agreed in the Reinsurance Contract Applicable information in the proposal must be adherent to PIRA
Checking of Vehicle Inspection Checklist / Sample pictures by AVPSales/Branch Head Renewal of Reinsurance Contract Review and approval of
Per account
Per account
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7. Product Realization
7.2 Customer-related processes
7.2.1 Determination of the requirements related to the product
Requirements specified by the customer, including the requirements for delivery and post-delivery activities, Requirements not stated by the customer but necessary for specified or intended use, where known Statutory and regulatory requirements applicable to the product Additional requirements considered necessary by the organization
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7. Product Realization
7.2 Customer-related processes
7.2.2 Review of requirements related to the product
Shall be conducted prior to the organizations commitment to supply a product to the customer and shall ensure that:
Product requirements are defined Contract or order requirements differing from those previously expressed are resolved The organization has the ability to meet the defined requirements
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7. Product Realization
7.2 Customer-related processes
7.2.3 Customer Communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to:
Product information Inquiries, contracts or order handling Customer feedback, including customer complaints
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7. Product Realization
7.3 Design and Development 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7
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7. Product Realization
7.4 Purchasing
7.4.1 Purchasing processes
Ensure that purchased product conforms to specified purchase requirements Evaluate and select suppliers based on their ability to supply product Establish criteria for selection, evaluation and reevaluation Maintain records of the results of evaluations and any necessary actions arising from the evaluation
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7. Product Realization
7.4 Purchasing
7.4.2 Purchasing information
Shall describe the product to be purchased, including where appropriate:
Requirements for approval of product, processes and equipment Requirements for qualification of personnel QMS requirements
Shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier
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7. Product Realization
7.4 Purchasing
7.4.3 Verification of purchased product
Establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements Where the organization or its customer intends to perform verification at the suppliers premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
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7. Product Realization
7.5 Production and Service Provision 7.5.1 Control
Organization shall plan and carry out production and service provision under controlled conditions and shall include, as applicable:
Availability of information that describes the characteristics of the product Availability of work instructions, as necessary Use of suitable equipment Availability and use of monitoring and measuring devices Implementation of monitoring and measurement Implementation of release, delivery and post-delivery activities
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7. Product Realization
7.5 Production and service provision 7.5.2 Validation of processes
Organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement
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7. Product Realization
7.5 Production and service provision 7.5.3 Identification and traceability Shall identify the product by suitable means throughout product realization Shall identify product status with respect to monitoring and measurement techniques
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7. Product Realization
7.5 Production and service provision 7.5.4 Customer property
Shall exercise care with customer property while it is under the organizations control or being used by the organization Shall identify, verify, protect and safeguard customer property provided for use or incorporation If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained.
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7. Product Realization
7.5 Production and service provision 7.5.5 Preservation of product Shall preserve the conformity of product during internal processing and delivery to the intended destination Preservation shall include identification, handling, packaging, storage and protection.
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7. Product Realization
7.6 Control of monitoring and measuring devices
Shall determine the monitoring and measurement to be undertaken and the monitoring and measurement devices needed
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8.1 General
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to:
Demonstrate conformity of the product Ensure conformity of the QMS Continually improve the effectiveness of the quality management system
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8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction Shall monitor information relating to customer perception as to whether the organization has met customer requirements Methods for obtaining and using information shall be determined
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8.4 Analysis of Data The analysis of data shall provide information relating to:
Customer satisfaction Conformity to product requirements Characteristics and trends of processes and products including opportunities for preventive action Suppliers
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Quality policy Quality objectives Audit results Analysis of data Corrective and preventive actions Management Review
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Determining potential nonconformities and their causes Evaluating the need for action to prevent occurrence of nonconformities Determining and implementing action needed Records of results of action taken Reviewing preventive action taken
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Thank You
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