Você está na página 1de 83

Fitness for use Conformance to requirements Accuracy Perfection Zero Defect Adequacy Cost Effectiveness


A group of interacting, interrelated, or interdependent elements forming a complex whole Set of detailed methods ,procedures and routines established or formulated to carry out a specific activity , perform a duty , or solve a problem

Quality Management System

A System of coordinated activities which is meant to direct and control an organization with regard to quality.

International Organization for Standardization Founded in 1946 in Geneva , Switzerland ISO is a non-governmental organization that forms a bridge between the public and private sectors.
World's largest developer and publisher of International Standards.

ISO is composed of more than 90 members countries

"ISO", derived from the Greek. ISO, meaning "equal". Whatever the country, whatever the language, the short form of the organization's name is always ISO. "ISO", is a system audit not for product audit

ISO 9001:2008 - Quality Management Systems Requirements ISO 9000:2000 - Quality Management Systems fundamentals and vocabulary ISO 9004:2000 - Quality Management System guidelines for performance improvements ISO 19011:2000- Guide for Auditing Management System

ISO 9000 series evolution:

1987199420002008initial publishing first revision Second revision Current edition

Principle 1

Leaders must set the direction of the organization

Leaders must create and maintain internal environment that encourages people to achieve the organizations objectives

Principle 2

Must help people to develop and use their abilities

Must encourage the involvement of people at all level

Principle 3



Activities + Resources


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

Principle 4

Processes understand interaction

Process A

Process C

Process B Input Output Control

Process D

Any activity that takes inputs and converts them to outputs

Process Approach
The systematic identification and management of these activities and the interaction between activities.

Example - Purchasing Process

Demand for material Item specs and Date Supplier source Suppliers capability to meet our requirements

Purchasing Procedure

Interactions to
Storage Inspection and Testing Manufacturing Finance

Outputs Receipt of Material on right condition Right Quality Right Quantity Right Time

Performance Measurements Delivery status On-time, On spec, etc Supplier evaluation

Identifying , understanding and managing a system of interrelated process for a given objective improves the organization effectiveness and efficiency

Principle 5

Customer Focus

Demings wheel (P.D.C.A.)


ISO 9000


Continual Improvement

Principle 6

Continual improvement of the organization's overall performance should be a permanent objective of the organization.

The Plan-Do-Check-Act Cycle (Demings Cycle)

Effective decisions are based on the analysis of data and information

Principle 7

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

Principle 8

Continual improvement of the Quality Management System

Management Responsibility




Resource Management Requirements

Measurement, Analysis and Improvement

Input Data

Product / Service Realization

Output Data

Product Service

The Structure
0 1 2 3 4 5 6 7 8 Introduction Scope Normative reference Terms and definitions Quality management system requirements Management responsibility Resource management Product realization Measurement, analysis and improvement

System Requirements / Structure of the Standard

4 Quality Management System

5 Management Responsibility

6 Resource Management

7 Product Realization

8 Measurement Analysis & improvement

General requirements (4.1) Documentation Requirements(4.2)

Management Commitment(5.1)

Provision of resources(6.1)


General (8.1)
Customer related processes(7.2)

Customer focus (5.2)

Quality policy(5.3)

Human resources(6.2)

Monitoring & measurement(8.2)


Infrastructures(6.3 ) Work environment(6.4)

Design & development(7.3)

Control of NCP(8.3)

Analysis of data(8.4)
Production & service provision(7.5)

Responsibility, authority & communication(5. 5) Management Reviews (5.6)


Control of monitoring & measuring devices(7.6)

4.1 General requirements

Establish , document , implement and maintain a QMS and continually improve its effectiveness in accordance with the standard

4.1 General Requirements

Determine the processes necessary for QMS Determine the sequence and interaction of processes Determine criteria & methods to ensure effective operation & control of the processes Ensure availability of resources and information needed to support the operation & monitoring of the processes Measure , monitor and analyze processes Implement action necessary to achieve planned results & continual improvement

4.2 Documentation Requirements

General Extent Size and type of organization Complexity and interaction of processes Competence of personnel Note3 (Documentation may be in any type of media) To Include Documented procedures required by standard Documents required by organization to ensure effective operation and control process Note 1 (Where the term documented procedure appears)

4.2 Documentation Requirements

4.2.2 Quality Manual The organization shall establish a Quality Manual that include: Scope of QMS Documented procedures or reference to them Description of interaction between the process of QMS

4.2 Documentation Requirements

4.2.3 Control of Documents
Documents required by the quality management system shall be controlled Documented procedures to: Approve documents prior to issue Review , update as necessary and re-approve documents To identify the changes and the current revision status of documents To ensure documents remain legible , readily identifiable Ensure relevant versions of applicable documents are available at points of use Ensure that the documents of external origin are identified and distribution controlled Obsolete documents are prevented from unintended use and identified if kept for any reason

4.2 Documentation Requirements 4.2.4 Control of Records

Records must be established and maintained Records must be legible , readily identifiable and retrievable Documented procedure for control of identification , storage , retrieval ,retention time and disposition of quality records

5.1 Management Commitment 5.2 Customer Focus 5.3 Quality policy 5.4 Planning 5.4.1Quality objectives 5.4.2 Quality Planning

5.5 Responsibility, authority and communication 5.5.1 Responsibility & authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management Review 5.6.1 General 5.6.2 Review input 5.6.3 Review output

5.1 Management Commitment

Provide evidence of commitment to the development and improvement of QMS by: Communicating the importance of meeting customer and legal/regulatory requirements. Establishing quality policy and objectives. Management Reviews Provision of resources.

5.2 Customer Focus

Top Management shall ensure that customer needs & expectations are determined, converted into requirements & fulfilled with the aim of achieving customer satisfaction

5.3 Quality Policy

Appropriate to the purpose of organization. Commitment to meeting requirements and continual improvements Frame work for establishing and reviewing quality objectives Communicated and understood at appropriate levels Is reviewed for continuing suitability

5.4 Planning 5.4.1 Quality Objectives (Cont)

Establish quality objectives at relevant functions and levels Objectives must be measurable and consistent with the quality policy including the commitment to continual improvement Include those needed to meet requirements for product

5.4 Planning 5.4.1 Quality Objectives (Cont)

Quality Objectives should be: Set Measurable Achievable Realistic Timed

5.4.2 Quality Management System Planning

Identify and plan processes needed to achieve quality objectives

Plan the development of QMS Plan the implementation of QMS Plan the improvement of QMS


Responsibility, Authority and Communication

5.5.1 Responsibility and authority Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management

5.5.2 Management Representative

Member of the management who has responsibility and authority for
ensuring that processes of the QMS are established and maintained Reporting on performance of QMS including needs for improvement Promoting awareness of customer needs and requirements

Note: Responsibilities may include liaison with external parties in relation to QMS

5.5.3 Internal Communication Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness

5.6 Management Review 5.6.1 General

Review of QMS by top management at planned interval to; ensure QMS suitability, adequacy and effectiveness Evaluate the need for changes to QMS including policy and objectives

Records from Management Reviews shall be maintained (see 4.2.4).

5.6.2 Review Input

Review performance and improvement opportunities related to: Audit results Customer feedback Process performance and product conformance Status of preventive and corrective actions Follow up actions from earlier reviews Change that could affect the QMS Recommendations for improvement

5.6.3 Review Output

Output to include actions related to improvement of the effectiveness QMS and its processes improvement of product related to customer requirements resource needs

6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training 6.3 Infrastructure 6.4 Work environment

6.1 Provision of Resources The organization shall determine and determine the resources needed for : implement and maintain the QMS and continually improve its effectiveness. Enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources

6.2.1 General

Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education, training, skills and experience

6.2.2 Competency, Awareness and Training

Identify competency needs Provide required training Evaluate the effectiveness of training provided Ensure staff is aware of relevance and importance of their activities and contribution to achieving quality objectives Maintain appropriate records of education, training, qualification and experience

6.3 Infrastructure
Identify, provide and maintain the infrastructure needed to achieve product conformity This shall include : Workspace & associated utilities Equipment, hardware and software Supporting services (transport or communication)

6.4 Work Environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

7 Product Realization
7.1 7.2 7.3 7.4 7.5 7.6 Planning of product realization Customer related processes Design & development Purchasing Production & service operation Control of measuring & monitoring devices


Planning of Product Realization

Sequence of process to achieve product Consistent with QMS and documented to suit method of operations Quality objectives and requirements for the product The need for processes, documentation, resources and facilities specific to the product Verification and validation activities and acceptance criteria Records


Customer Related Processes

Determination of requirements related to the product 7.2.2 Review of product requirements 7.2.3 Customer communication

7.2.1 Determination of requirements related to the product

Product requirements specified by the customer including requirements for delivery and postdelivery activities Requirements not specified but necessary for intended or specified use Obligations related to product, including regulatory and legal requirements any additional requirements determined by the organization

7.2.2 Review of requirements related to the product

Review identified requirements and ensure before commitment to supply product that; Product requirements are defined For verbal orders requirements are confirmed Difference between tender and contract are resolved Organization has ability to meet the requirements Records of the results arising from the review shall be recorded.

7.2.3 Customer Communication

Identify and implement arrangements for communication with customers relating to: product information inquiry, contract or order handling, including amendments Customer feedback including complaints

7.3 Design & Development

7.3.1 Design & development planning 7.3.2 Design & development inputs 7.3.3 Design & development outputs 7.3.4 Design & development review 7.3.5 Design & development verification 7.3.6 Design & development validation 7.3.7 Control of design and development changes

7.4 Purchasing
7.4.1 7.4.2 7.4.3 Purchasing process Purchasing information Verification of purchased product

7.4.1 Purchasing Process

Purchased product meets requirements Type & extend of control depends on effect purchased product may have on realization processes and their output Selects suppliers based on their ability to supply conforming product Define criteria for selection and periodic evaluation and re-evaluation of suppliers Results of evaluation and follow up actions must be recorded

7.4.2 Purchasing Information

Purchasing information shall describe the product to be purchased, including where appropriate: Requirements for approval of product,procedures, processes and equipment. Requirements for qualification of personnel.

Quality management system requirements.

7.4.3 Verification of Purchased Product

Identify and implement activities needed to verify purchased product Where organization or its customer purpose verification at supplier premises, organization must specify in purchasing information: verification arrangements method of product release.

7.5 Production & Service Provision

7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer Property Preservation of Product

7.5.1 Control of production and service provision

Control production & services operations through:

Availability of information specifying product characteristics Work instructions available where necessary Use and maintenance of suitable equipment Availability & use measuring and monitoring devices Implementation of monitoring

7.5.2 Validation of Processes

Validation arrangements must be defined and must include as applicable qualification of the process qualification of equipment and personnel use of defined methodologies & procedure requirements for record re-valuation

7.5.3 Identification & Traceability

Where appropriate identify product through all stages of operations Identify status with respect to measurement & monitoring requirements Where traceability is required control & record unique identification of product
I can not remember

7.5.4 Customer Property

Care for customers property being under organizations control or being used by organization Identification, verification, protection & maintenance of customer property provided for use or incorporation Any customer property that is lost, damaged or found un- suitable must be recorded & reported to customer Customer Property tangible / intangible

7.5.5 Preservation of Product

Preserve conformity of product during internal processing and final delivery to intended destination Include identification, handling, packaging, storage and protection This applies to constituent parts of product

7.6 Control of monitoring & measuring devices

Calibrate & adjust measuring and monitoring devices at specified intervals as prior to use Traceability to international or national standards. Where no such standard exist record the basis Safeguard MMD from adjustments invalidating calibration Protect MMD from damage or deterioration during handling, maintenance or storage Record results of calibration Assess validity of previous results when devices found to be out of calibration

Measurement, Analysis and Improvement

8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

8.1 General 8.2 Monitoring & Measurement 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product

8.1 General

Define, plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement
This include determination of the need and use of applicable methodologies and statistical techniques


Monitoring and Measurement 8.2.1 Customer Satisfaction

Organization shall monitor information on customer satisfaction and /or dis-satisfaction

The methodologies for obtaining and utilizing such information must be determined

8.2.2 Internal Audit

Conduct periodic internal audit to determine if QMS:
Conforms to the requirements of the standard Has been effectively implemented & maintained

Plan the audit program considering:

Status and importance of the activity results of previous audits

Define audit scope, frequency and methodologies performed by personnel not performing audited work

8.2.2 Internal Audit

The documented procedure must cover: Responsibilities & authorities for conducting audits Ensuring independence Recording results and reporting to management Timely corrective actions Follow up to verify & report implementation of verification results

8.2.3 Measurement and Monitoring of Processes

Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customers requirements.

8.2.3 Measurement and Monitoring of Product

Measure & monitor product characteristics to verify conformance at appropriate stages of realization processes Evidence of conformity with the acceptance criteria must be documented, records must indicate the authority responsible for release of product Release or delivery must not

8.3 Control of Non conforming Product

Documented procedures for control of non conforming product to prevent unintended use or delivery Non conforming product shall be corrected Re-verify after correction If non-conformance

8.4 Analysis of Data

Collect & analyze data, determine suitability and effectiveness of QMS and to identify improvements that can be made Data from measurement & monitoring & other related sources Analyze data provide info on: Customer satisfaction and/or dissatisfaction Conformance to customer requirement Process, product characteristics and their trends Suppliers

8.5 Improvement 8.5.1 Continual improvement

Planning for Continual Improvement The organization must plan and manage processes necessary for continual improvement of the QMS Facilitate continual improvement using:
quality policy objectives audit results analysis of data corrective actions preventive actions

Management Review

8.5.2 Corrective Action

Organization must take corrective action to eliminate the causes of non-conformance to prevent recurrence Action appropriate to the impact of problem Documented procedures shall define requirements for: identifying non conformities determine the causes evaluating the need for corrective action determine corrective action needed and implemented Recording results of action

8.5.3 Preventive Action

Organization must identify preventive action to eliminate the causes of potential non conformances to prevent occurrences Actions appropriate to the impact of potential problem Documented procedures must define the requirements for Identification of potential non-conformances and their causes Determining and ensuring implementation of preventive action needed Recording results of action taken

Situation Warranting Corrective Action

Identification of major non-conformance. Large number of minor non-conformities. The reoccurrence of a problem with a process or activity. Non-conformities observed during audits. Customer Complaints. Non-conforming deliveries from vendors.

Stages of Corrective & Preventive Action


Transparency in working at all level Data availability : Hidden Factors are open Creates Accountability Planning & scheduling improved Rework & Rejection are known and being controlled Customer feedback through regular surveys Employees Participation enhanced

Thank You !