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Transcript of ISO 9001 PPT
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ISO 9001:2008 Requirements
QMS
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Participants to be aware of the following:
Basic concepts on ISO9001:2008 Benefits/Importance of ISO9000 ISO9000 Requirements
COURSE OBJECTIVES
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a worldwide federation of national standards bodies.
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formed and began its official function on 23rd February 1947
non-governmental organizationmission 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 – International Organization for Standardization
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• 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.
Within these committees there are:
Qualified industry representatives Research institutes Consumer bodies Government authorities, and Worldwide international organizations
whose objective is the resolution of global standardization issues.
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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, co-ordinates 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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BENEFITS OF STANDARDIZATION TO ISO9001
• Improved productivity
• More Market Competitiveness
• Better Export Capability
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1. Provides opportunities to streamline the company’s processes
Integrates systems and procedures using the ISO Framework2. Identifies critical points in the organization to be
controlled and measured (quality objectives)3. Provides a structured approach in identifying areas for
improvement/enhancement4. 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.
BENEFITS OF GOING INTO ISO
Based on Customers’ Feedback
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Quality management systems can assist organizations in enhancing customer satisfaction
Encourages organizations to analyze customer requirements, define the processes that contribute to the achievement of a product which is acceptable to the customers, and keep these processes under control.
Provides the framework for continual improvement to increase probability of enhancing customer satisfaction and the satisfaction of other interested parties.
Provides confidence to the organization and its customers that it is able to provide products that consistently fulfill the requirements.
Rationale for the QMS
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APPLICATION/CERTIFICATION FRAMEWORK
1st PARTY ASSESSMENT
2nd PARTYASSESSMENT
3rd PARTYASSESSMENT
Internal Quality Audit (IQA)- Site- 1st party assessment
2nd Party Certification
Internal Quality Audit (IQA)- Customer Assessment
- Internal Quality Audit (IQA)- Desk Study- Compliance Audit- Follow-up Assessment (if any)- 3rd Party Certification- Surveillance Visit
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1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System ApproachTo Management
6. Continual Improvement
7. Mutually BeneficialSuppler Relationship
8. Factual Approach to Decision-Making
8 Quality ManagementPrinciples
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Eight Quality Management Principles
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
a. CUSTOMER FOCUS
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Eight Quality Management Principles
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 organization’s objectives.
b. LEADERSHIP
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Eight Quality Management Principles
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.
c. INVOLVEMENT OF PEOPLE
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Eight Quality Management Principles
A desired result is achieved more efficiently when activities and related resources are managed as a process.
d. PROCESS APPROACH
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Eight Quality Management Principles
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
e. SYSTEM APPROACH TO MANAGEMENT
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Eight Quality Management Principles
Continual improvement of the organization’s overall performance should be a permanent objective of the organization
f. CONTINUAL IMPROVEMENT
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Eight Quality Management Principles
Effective decisions are based on the analysis of data and information
g. FACTUAL APPROACH TO DECISION-MAKING
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Eight Quality Management Principles
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
h. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS
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An approach to developing and implementing a quality management system consists of several steps including the following:
a. Determining the needs and expectations of customers and other interested parties;
b. Establishing the quality policy and quality objectives of the organization;
c. Determining the processes and responsibilities necessary to attain the quality objectives
d. Determining and providing the resources necessary to attain the quality objectives
Quality Management Systems Approach
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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
con’t…
Such an approach is also applicable to maintaining and improving an existing quality management system.
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Continual Improvement of the Quality Management SystemContinual Improvement of the Quality Management System
Customers(and other interestedparties)
Customers(and other interestedparties)
SatisfactionRequirements
ManagementResponsibility
ResourceManagement
ProductRealization
Measurement, analysis & improvement
Product
MODEL OF QMS
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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 trainingc. Repeatability and traceabilityd. Provision of objective evidence, ande. 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 organization’s 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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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.
con’t…
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con’t…
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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Evaluating the QMS
When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated -
a. Is the process identified and appropriately defined?
b. Are responsibilities assigned?c. Are the systems implemented and
maintained?d. Is the process effective in achieving the
required results?
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ISO 9001:20081. Scope
2. Normative Reference
3. Terms and Definition
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis & Improvement
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1.1 General
• Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements
1. Scope
• 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.
This International Standard specifies requirements for a QMS where an organization
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1.1 General
• 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.
1. Scope
Notes:
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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.
1. Scope
• 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 organization’s ability or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
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ISO 9000:2005 Quality management systems - Fundamentals and vocabulary.
2. Normative Reference
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3. Terms and Definitions
• The terms and definitions given in ISO 9000:2000 apply.
• Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
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4. Quality Management System
• Establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the requirements of this International Standard.
4.1 General Requirements
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Processes needed for the QMS and their application
Sequence and interaction of these processes Criteria and methods needed to ensure that
processes are effective Availability of resources and information Monitor, measure (where applicable) and analyze
the processes Implementation of planned results and continual
improvement of these processes
4. Quality Management System4.1 General Requirements
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Notes:1. Processes needed for the QMS include processes for
management activities, provision of resources, product realization and measurement, analysis and improvement.
2. An outsourced process is identified as one being needed for the organization’s QMS but chosen to be performed by a party external to the organization.
4. Quality Management System4.1 General Requirements
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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.
The type and extent of control of such outsourced processes shall be identified within the QMS
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Influencing factors for the type and nature of control to be applied to the outsourced process:
• the potential impact of the outsourced process• the extent to which the control for the process is shared;• the capability of achieving the necessary control through the
application of clause 7.4.
Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to allcustomer, statutory and regulatory requirements.
4. Quality Management System4.1 General Requirements
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Sample Business ProcessINPUT
POLICY HOLDERS
OUTPUTCUSTOMERS
KEY PROCESSES
DESCRIPTION
OF
PROPERTIES/OBLIGATION
TO
BE
INSURED
Account Solicitation
Risk Identification,Analysis & Control
Proposal Negotiation & Agreement
PolicyWriting
Posting, Billing &
Collection
Claims Processing
INSURANCE
POLICY
Account Maintenance
Management Responsibility
Resource Management
Control of Documents and Records
Measurement, analysis and improvement
Office Supplies, Spare Parts
SUPPLIERS
Finance & Accounting; LGC: HRMD, ICTD, IAD
SUPPORT SERVICES
Agents, Brokers, Re-insurers, Adjusters, Repair Shops
OUTSOURCED
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4.2 Documentation Requirements
Quality Policy and Quality Objectives A Quality Manual Documented procedures required by this International Standard
(IQA, Control of Non-Conforming, Document & Data Control, Control of Records, Corrective Action, Preventive Action)
4.2.1 General
Documentation shall include:
4. Quality Management System
Documents, including records, needed to ensure the effective planning, operation and control of processes
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Scope of the QMS, including permissible exclusions
Documented procedures established for the QMS Description of the interaction between the
processes of the QMS
4.2.2 Quality Manual
Includes:
4.2 Documentation Requirements
4. Quality Management System
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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
4.2.3 Control of DocumentsTo define controls -
4.2 Documentation Requirements
4. Quality Management System
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Records established to provide evidence of conformity to requirements and of the effective operation of the QMS shall be controlled
Shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
Shall remain legible, readily identifiable and retreivable.
4.2.4 Control of Records4.2 Documentation Requirements
4. Quality Management System
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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
5.1 Management Commitment
5. Management Responsibility
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5.2 Customer Focus
Customer requirements are determined and are met with the aim of enhancing customer satisfaction.
5. Management Responsibility
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5.3 Quality Policy
Appropriate to the purpose of the organization Commitment to comply with the QMS
requirements and to continuously improve Quality Objectives are established and reviewed Communicated and understood by all Reviewed for continuing suitability
5. Management Responsibility
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5.4 Planning
Established at relevant functions and levels within the organization.
Shall be measurable with the quality policy.
5.4.1 Quality Objectives
5. Management Responsibility
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To meet the requirements given in 4.1, and the Quality Objectives
The integrity of the QMS is maintained when changes to the system are planned and implemented
5.4.2 Quality management system planning5.4 Planning
5. Management Responsibility
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5.5 Responsibility, authority and communication
Responsibilities and authorities are defined and communicated within the organization.
5.5.1 Responsibility and authority
5. Management Responsibility
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Appoint a QMR who, irrespective of other responsibilities, shall have responsibility and authority that includes:
5.5.2 Management Representative
5.5 Responsibility, authority and communication
5. Management Responsibility
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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Appropriate communication processes are established within the organization
Communication takes place regarding the effectiveness of the QMS
5.5.3 Internal Communication
5.5 Responsibility, authority and communication
5. Management Responsibility
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MEETINGS PURPOSE FREQUENCY ATTENDEES RESPONSIBLEUNIT
RECORDSUSED
1. MANCOM Meeting
Discussion of general issues and concerns such as admin policies, financial performance, A/R, and operational highlights
Weekly All Managers and Account Executives
General Manager Minutes of the Meeting
2. Sales Meeting Discussion of sales performance, and other concerns directly affecting sales
Weekly Area Managers, Asst. Area Managers, Account Executives, Operation Managers, Corporate Affairs Manager, Finance Manager
Area Managers Minutes of the Meeting
3. Operations Meeting
Discussion of matters directly affecting operations such as service irregularities and customer requirements
Weekly Operations Manager, Asst. Export Manager, Seafreight Manager, Export Supervisor, Import Supervisor, Dispatchers, Customer Service Assts., Asst. Area Managers
Operations Manager
Minutes of the Meeting
SAMPLE OF INTERNAL COMMUNICATION PLAN
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5.6 Management Review
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
5.6.1 General
5. Management Responsibility
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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
5.6.2 Review input5.6 Management Review
5. Management Responsibility
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Improvement of the effectiveness of the QMS and its processes
Improvement of product related to customer requirements
Resource needs
5.6.3 Review output5.6 Management Review
5. Management Responsibility
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6. Resource Management6.1 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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6.2 Human Resources
Personnel performing work affecting conformity to product requirements shall be competent on the basis of
education training skills experience
6.2.1 General
6. Resource Management
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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
6.2.2 Competence, awareness and training6.2 Human Resources
6. Resource Management
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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)
6. Resource Management
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6.4 Work Environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
6. Resource Management
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7. Product Realization7.1 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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• 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
7. Product Realization7.1 Planning of product realization
• The output of this planning shall be in a form suitable for the organization’s method of operations.
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QUALITY PLANProcess Name
Item to be Controlled
Dimension Standard Person
Responsible Control
Methodology Frequency of Monitoring
Support Documentation
Account Solicitation
Prospective Accounts
Timeliness Volume
Prospective accounts must be sent to FVP-COO every 10th of the Month
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)
Sales Supervisor / Branch Head
Checking and review of prospective accounts by FVP-COO
Monthly
SLS-7.2.1-001 SLS-7.5.1-003
Renewal of Policies
Renewal Proposals
Timeliness
Must be validated and sent to clients not less than 60 days before expiry date
Account Officer / Branch Personnel
Checking of remarks thru the CGIC Integrated System or mail registry by AVP-Sales/Branch Head
Monthly CGIC Integrated System SLS-7.5.1-001 SLS-7.2.1-002 SLS-7.5.1-009
Completeness All policies due for renewal must be validated and sent to clients
Risk Identification, Analysis and Control (Applies only for new accounts and late renewals)
Motor vehicle Completeness 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
Account Officer Checking of vehicle information by AVP-Sales/Branch Head
Per account UND-7.2.1-001 UND-7.5.1-007
Timeliness Must be performed on the agreed inspection schedule with the client
Checking of Vehicle Inspection Checklist / Sample pictures by AVP-Sales/Branch Head
Per account
Sum insured Accuracy Sum insured must be within capacity as agreed in the Reinsurance Contract
Underwriting Manager / Branch Head
Renewal of Reinsurance Contract
Per account Reinsurance Contract UND-7.2.1-008
Preparation of Policy Proposal
Policy Proposal Accuracy Applicable information in the proposal must be adherent to PIRA
Account Officer / Underwriting
Review and approval of
Per Policy Proposal
SLS-7.5.1-004
Sample Only
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7.2 Customer-related processes7.2.1 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
7. Product Realization
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7.2.2 Review of requirements related to the product
Shall be conducted prior to the organization’s 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
7. Product Realization7.2 Customer-related processes
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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
7. Product Realization7.2 Customer-related processes
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7.3 Design and Development
7.3.1 Planning7.3.2 Inputs7.3.3 Outputs7.3.4 Review7.3.5 Verification7.3.6 Validation7.3.7 Control of changes
7. Product Realization
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7.4 Purchasing7.4.1 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 re-evaluation
Maintain records of the results of evaluations and any necessary actions arising from the evaluation
7. Product Realization
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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
7.4 Purchasing
7. Product Realization
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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 supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
7.4 Purchasing
7. Product Realization
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7.5 Production and Service Provision7.5.1 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
7. Product Realization
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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
7.5 Production and service provision
7. Product Realization
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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
7.5 Production and service provision
7. Product Realization
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7.5.4 Customer property
Shall exercise care with customer property while it is under the organization’s 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.
7.5 Production and service provision
7. Product Realization
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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.
7.5 Production and service provision
7. Product Realization
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7.6 Control of monitoring and measuring devices
Shall determine the monitoring and measurement to be undertaken and the monitoring and measurement devices needed
7. Product Realization
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8. Measurement, Analysis and Improvement
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
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
8.2.1 Customer Satisfaction
8. Measurement, Analysis and Improvement
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Shall conduct internal audits at planned intervals to determine whether quality management system Conforms to the planned arrangements Is effectively implemented and maintained
Audit program shall be planned Audit criteria, scope, frequency and methods shall be defined Selection of auditors and conduct of audits shall ensure objectivity and
impartiality of the audit process Auditors shall not audit their own work Responsibilities and requirements for planning and conducting audits,
and for reporting results and maintaining records shall be defined in a documented procedure.
8.2.2 Internal Audit8.2 Monitoring and Measurement
8. Measurement, Analysis and Improvement
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Shall apply suitable means for monitoring Methods shall demonstrate the ability of the processes to
achieve planned results When planned results are not achieved, corrective and
preventive action shall be taken
8.2.3 Monitoring and Measurement of Processes
8.2 Monitoring and Measurement
8. Measurement, Analysis and Improvement
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Shall monitor and measure the characteristics of the product Evidence of conformity with the acceptance criteria shall be
maintained Product release and service delivery shall not proceed until
the planned arrangements have been completed
8.2.4 Monitoring and Measurement of Product
8.2 Monitoring and Measurement
8. Measurement, Analysis and Improvement
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8.3 Control of Non-Conforming product
Shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.
Controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
8. Measurement, Analysis and Improvement
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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
8. Measurement, Analysis and Improvement
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8.5 Improvement
The organization shall continually improve the effectiveness of the QMS through the use of: Quality policy Quality objectives Audit results Analysis of data Corrective and preventive actions Management Review
8.5.1 Continual Improvement
8. Measurement, Analysis and Improvement
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Shall take action to eliminate the cause of nonconformities in order to prevent recurrence
Documented procedure shall be established to define requirements for: Reviewing nonconformities (including customer
complaints Determining the causes of nonconformities Evaluating the need for action to ensure that
nonconformities do not recur Determining and implementing action needed Records of the results of action taken Reviewing corrective action taken
8.5.2 Corrective Action8.5 Improvement
8. Measurement, Analysis and Improvement
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Shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence
Preventive actions shall be appropriate to the effects of the potential problems
8.5.3 Preventive Action8.5 Improvement
8. Measurement, Analysis and Improvement
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Documented procedure shall be 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 Records of results of action taken Reviewing preventive action taken
8.5.3 Preventive Action8.5 Improvement
8. Measurement, Analysis and Improvement
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Thank You
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