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ISO 9001:2008 Requirements

COURSE OBJECTIVES
Participants to be aware of the following:
Basic concepts on ISO9001:2008 Benefits/Importance of ISO9000 ISO9000 Requirements

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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 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 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, 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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BENEFITS OF STANDARDIZATION TO ISO9001

Improved productivity

More Market Competitiveness

Better Export Capability

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BENEFITS OF GOING INTO ISO


Based on Customers Feedback

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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Rationale for the QMS


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.

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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

3rd PARTY 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

8. Factual Approach to Decision-Making

8 Quality Management Principles


2. Leadership

7. Mutually Beneficial Suppler Relationship

3. Involvement of People

4. Process Approach 5. System Approach To Management

6. Continual Improvement

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Eight Quality Management Principles

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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Eight Quality Management Principles

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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Eight Quality Management Principles

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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Eight Quality Management Principles

d. PROCESS APPROACH

A desired result is achieved more efficiently when activities and related resources are managed as a process.

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Eight Quality Management Principles

e. SYSTEM APPROACH TO MANAGEMENT

Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives.

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Eight Quality Management Principles

f. CONTINUAL IMPROVEMENT

Continual improvement of the organizations overall performance should be a permanent objective of the organization

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Eight Quality Management Principles

g. FACTUAL APPROACH TO DECISION-MAKING

Effective decisions are based on the analysis of data and information

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Eight Quality Management Principles h. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

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Quality Management Systems Approach


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

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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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Continual Improvement of the Quality Management System

Management Responsibility

Customers (and other interested parties)

Resource Management

Measurement, analysis & improvement

Customers (and other interested parties)

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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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 9001:2008
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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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


4.1 General Requirements
Establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the requirements of this International Standard.

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4. Quality Management System


4.1 General Requirements
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
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4. Quality Management System


4.1 General Requirements
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 organizations QMS but chosen to be performed by a party external to the organization.

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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

4. Quality Management System


4.1 General Requirements
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 all customer, statutory and regulatory requirements.

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Man ag ement Responsibility


Reso urce Management Co n trol o f Do cuments an d Records INPUT OUTPUT

CUSTOMERS POLICY HOLDERS

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

KEY PROCESSES Pro p osal Neg o tiation & Ag reemen t

Acco un t So licitation

Risk Identification, Analysis & Control

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

Acco un t Main ten ance

SUPPORT SERVICES

Fin an ce & Acco unting; LGC: HRMD, ICTD, IAD

SUPPLIERS
Office Supplies, Spare Parts

OUTSOURCED
Agents, Brokers, Re-insurers, Adjusters, Repair Shops

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Measuremen t, an alysis and imp rovement

4. Quality Management System


4.2 Documentation Requirements 4.2.1 General Documentation shall include:
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)

Documents, including records, needed to ensure the effective planning, operation and control of processes

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4. Quality Management System


4.2 Documentation Requirements 4.2.2 Quality Manual

Includes : Scope of the QMS, including permissible


exclusions Documented procedures established for the QMS Description of the interaction between the processes of the QMS

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4. Quality Management System


4.2 Documentation Requirements
4.2.3 Control of Documents

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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4. Quality Management System


4.2 Documentation Requirements
4.2.4 Control of Records
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.
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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 5.2 Customer Focus


Customer requirements are determined and are met with the aim of enhancing customer satisfaction.

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5. Management Responsibility 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

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5. Management Responsibility 5.4 Planning


5.4.1 Quality Objectives
Established at relevant functions and levels within the organization. Shall be measurable with the quality policy.

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5. Management Responsibility 5.4 Planning


5.4.2 Quality management system planning
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

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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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SAMPLE OF INTERNAL COMMUNICATION PLAN


MEETINGS PURPOSE FREQUENCY ATTENDEES RESPONSIBLE UNIT RECORDS USED

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

All Managers and Account Executives

General Manager

Minutes of the Meeting

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

Minutes of the Meeting

3. Operations Meeting

Discussion of matters directly affecting operations such as service irregularities and customer requirements

Weekly

Operations Manager

Minutes of the Meeting

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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

Account Officer / Branch Personnel

Checking of remarks thru the CGIC Integrated System or mail registry by AVPSales/Branch Head

Monthly

CGIC Integrated System SLS-7.5.1-001 SLS-7.2.1-002 SLS-7.5.1-009

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

Checking of vehicle information by AVP-Sales/Branch Head

Per account

UND-7.2.1-001 UND-7.5.1-007

Timeliness

Sum insured

Accuracy

Preparation of Policy Proposal

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

Underwriting Manager / Branch Head Account Officer / Underwriting

Checking of Vehicle Inspection Checklist / Sample pictures by AVPSales/Branch Head Renewal of Reinsurance Contract Review and approval of

Per account

Per account

Reinsurance Contract UND-7.2.1-008 SLS-7.5.1-004

Per Policy Proposal

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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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Planning Inputs Outputs Review Verification Validation Control of changes

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. 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. Measurement, Analysis and Improvement

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. Measurement, Analysis and Improvement

8.2 Monitoring and Measurement 8.2.2 Internal Audit


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.

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8. Measurement, Analysis and Improvement

8.2 Monitoring and Measurement


8.2.3 Monitoring and Measurement of Processes 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

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8. Measurement, Analysis and Improvement

8.2 Monitoring and Measurement


8.2.4 Monitoring and Measurement of Product 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

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8. Measurement, Analysis and Improvement

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.

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8. Measurement, Analysis and Improvement

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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8. Measurement, Analysis and Improvement

8.5 Improvement 8.5.1 Continual 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

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8. Measurement, Analysis and Improvement

8.5 Improvement 8.5.2 Corrective Action


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

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8. Measurement, Analysis and Improvement

8.5 Improvement 8.5.3 Preventive Action


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

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8. Measurement, Analysis and Improvement

8.5 Improvement 8.5.3 Preventive Action


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

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Thank You

International Business Center

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