Quality and safety aspects in hospitals

Quality system

These are the organizational structures, responsibilities, procedures ,

processes and resources for implementing quality management.

- International Organisation for standardization (ISO)

These are the collective plans, activities and events that are provided to
ensure that a product, process or service will assure customer quality
satisfaction and economical costs of quality.
American National standard Institute (ANSI) / American Society for
Quality Control (ASQC)

THE TOOLS, TECHNIQUES, METHOD S AND MEASURES THAT AIM AT

ASSISTING IN THE PLANNING, DESIGN , CONTROL AND IMPROVEMENT
OF QUALITY TOGETHER COMPRISE QUAITY SYSTEM.

Elements of a Total Quality system

- Policy,Planning, organization and administration

- Product Design assurance, specification development

- Control of raw materials and component parts

- Production quality control

- User contact and field performance

- Corrective action

- Employee selection, training and motivation

- Legal requirements- Product liability and user safety

 - Statistical analysis technique

ISO

The international organization for Standardisation (1946) Geneva,

Switzerland

Specialised agency for standardization

Primary objective is coordination and unification of International

standards

Is an association of National Standards bodies of more than 150

countries.

Employs a system of technical committees, sub- committees and

working groups to develop international standards.

Works in accordance with an agreed set of rules of procedures, the ISO

directives.

Bureau of Indian Standards (BIS) is the national standard body of India

represented on ISO.

Reasons for implementing a quality system that conforms to an ISO

standard:

Improved employee involvement

Improved house keeping

Improved customer satisfaction

Improved safe working

Reduced customer complaints

Reduced quality cost

“ To assure quality one has to ensure quality. To ensure quality it is

necessary to make quality assurance sysyem. A good quality assurance
requires well defined quality sytem standards”.

ISO 9000 and ISO 14000

- Generic management standards

- Same standards can be applied to any organization type, large or

small, whatever its product and whether it is a business
enterprise, a public administration or private.

ISO 9000 Quality Management Standards

- Customer quality requirements are fulfilled.

- Applicable regulatory requirements aiming to

o Enhance customer satisfaction

o Achieve continual improvement of its performance in pursuit

of these objectives;

ISO 14000 Environmental Management Standards

- Minimize harmful effects on the environment caused by its

activities

- Achieve continual improvement of its environmental

performance.

ISO 9000 Quality system

ISO 9000 standards are a collection of formal International standards,
technical reports, handbooks and web based documents on quality
management and quality assurance.

Elements or Clauses of ISO 9000 (Quality system Requirements)

 Management Responsibility

 Quality System

 Contract Review

 Design Control

 Document control

 Purchasing

 Control of supplied products

 Product identification & Traceability

 Process control

 Inspection and Testing

 Control of inspection, Measuring and test equipment

 Inspection and test status

 Control of non – conforming standards

 Corrective and preventive action

 Handling, storage, packing, preservation and delivery.

 Control of quality records

  Internal Quality Audit

 Training

 Servicing

 Statistical Technique

Implementation of Quality system( Steps to Registration)

Top management Commitment

Appoint the management representative

Awareness

Appoint an implementation team

Training

Time schedule

Select Element owners

Review the present system

Write the documents

Install the new system

Internal Audit

Management Review

Preassessment

Registration

Award of ISO 9000 certificate

Documentation of Quality system

Serves as a reference

Brings about clarity of objectives and targets

Provides standardization in work procedures

Brings about consistency in operations

Provides a basis for continuous improvement

Documents to be prepared

Quality policy manual

This document defines ‘What will be done ‘ and ‘why’

Quality system procedures (QSPs)

These procedures define who should perform specific tasks, when the
task should be done and where documentations will be made.

Work Instructions ( WIs)

It gives details of how individual work processes are carried out

within a company.

Records/ Formats/ Forms

These provide evidence of activity having been performed in

compliance with quality system procedure.

Documentation Pyramid
Classification of ISO 9000 Quality system standards

ISO 9000

Quality Management and Quality Assurance Standards

Contractual Situations

ISO 9001

Quality systems: Model for QA in design / development , Production ,

Installation and Servicing

ISO 9002

Model of QA for production and Installation

ISO 9003

QA model for final inspection and Testing

ISO 9004

Quality management system standards and elements

Features of ISO 9001-9004

ISO 9001: QA in design, development , production, Installation and

servicing.

The ISO 9001 standard gives a model for quality assurance at all
stages starting from designing the product and continuing even after
the product is delivered to the customer.

To be used when conformance to specified requirements is to be

assured during design, development, production , installation and
servicing.
Can be applied to industries who design, produce, install product and
provide service after sales as per the requirements of the customer.

Examples of such products are heat exchangers, coolers, filters , pumps

etc., for process industries.

ISO 9002 : QA in production and installation

To be used when conformance to specified requirements is to be

assured during production and installation.

Can be applied to some products which require quality assurance only

during production and till they are delivered to the customer or
installed in their premises.

Examples of such products are civil structures, construction of bridge.

ISO 9003: QA in Final Inspection and Test

To be used when conformance to specified requirements is to be

assured only at final inspection and testing.

Can be applied to some products which require quality assurance only

after they are manufactured.

Examples: Almost all the consumer items like domestic appliances,

petroleum products, automobile components.

ISO 9004: Gives guidelines for quality managements

Advantages of ISO 9000 certification

Marketing Muscle

Contractor selection
Supplier Selection

Enforce the discipline of control to pursue continuous improvement in

performance.

Requirements of periodic audits reinforce the stated quality system

until it becomes ingrained in the company.

Rigorous documentation standards help uncover problems and improve

their processes.

Helps companies in gaining a competitive advantage, in meeting

contractural obligations with their customers.

Quality Auditing

A Quality system audit is defined as a systematic and independent

examination to determine whether quality activities and related results
comply with planned arrangements , whether these arrangements are
implemented effectively and whether these are suitable to achieve
objectives.

Objective:

To determine the effectiveness of implemented quality system

Products are fit for use and safe for the user

Assure that there is conformance to specifications

Deficiencies are identified and corrective action is taken

Oppurtunities for improvement are identified.

Stages of an Audit
 i. Audit Planning

a. Audit Schedules

b. Audit Personnel

c. Notification to the auditee

d. Preparation of Checklist

ii. Audit Performance

a. Opening meeting

b. Audit Process

c. Audit deficiencies

iii. Audit Reporting

a. Recording of non- conformity

b. Summary of audit findings

c. Corrective action requests

iv. Audit Follow – up

a. Initiating Corrective action

Types of Audit

1. First Party

2. Second Party

System Audit

Process Audit
Product Audit

Auditee---- Client Auditor