ISO 9001:2015 QUALITY MANAGEMENT SYSTEM

ISO 9001 aims for

• • Meeting a customer requirements and enhancing customer satisfaction,.
• • Compliance with regulatory requirements.
• • Achieving organization’s continual improvement.
• • It is the forerunner and basis on which all other ISO Management Standards are developed.
• • It is generic and applicable to all organizations irrespective of its size, product, location & whether private/public Government.

It is based on the Eight Management Principles

• 1. Customer Focus
• 2. Leadership
• 3. Involvement of People
• 4. Process Approach
• 5. Systems Approach
• 6. Continual Improvement
• 7. Factual Approach
• 8. Mutually Beneficial Supplier Relations

ISO 9001:2015 QUALITY MANAGEMENT SYSTEM

It is based on the Eight Management Principles

• 1. Customer Focus
• 2. Leadership
• 3. Involvement of People
• 4. Process Approach
• 5. Systems Approach
• 6. Continual Improvement
• 7. Factual Approach
• 8. Mutually Beneficial Supplier Relations

ISO 14001:2004 ENVIRONMENTAL MANAGEMENT SYSTEM

Policy and Objectives address issues related to
Pollution of air, water, land
Depletion of natural resources

• • Addresses the Environmental concerning the organization and extended to its surrounding.
• • Environmental Aspects and impacts
• • Includes Legal Requirements.
• • How an organization is taking actions to Eliminate/Minimize/Control the same,
• • Support Environmental protection & prevention of pollution to create cocio- Policy and Objectives.
• • Address issues related to economic imbalance.

OHSAS 18000 OCCUPATIONAL HEALTH AND SAFETY

• • It enables the organization to manage operational risks reduction and the wellbeing of employees
• • Extent of application depends on nature of activities, complexity and other stake holders
• • Prioritize the same and take action to eliminate the cause
• • Minimize the impact through Hazard Identification & Risk Assessment (HIRA)

ISO 22000 FOOD SAFETY MANAGEMENT SYSTEM

Addresses the issues concerning Food Hazards in the entire Food Chain, i.e from agriculture including usage of pesticide in the fields. The Certification covers for manufacturing, transport & storage operators, process industries and retail & food outlets including catering and packing companies.
Key Elements include

• • Interactive System Management
• • Control of food safety hazards through pre-requisite programmes and HACCP plans
• • Continual improvement and upgrading the Management System
• • Organization’s preparedness to deal with contamination of product which becomes unsafe for human consumption.

ISO 13485 MEDICAL DEVICES

• • Comprehensive Management System for the design and manufacture of medical devices and related services for regulatory requirements.
• • Sterilization(Gas, Steam, IR radiation) and its validation play a very important and crucial role
• • Electro Medical devices need EMC/ Electricity Safety Compliance
• • Three categories of Medical Devices: General / Active Implantable / In vitro Diagnostic Devices
• • Global Harmonized Task Force (GHTF) working with regulatory markets such as EU (CE Mark), and other developed countries.
• • This standard superseded earlier standards such as ISO 46001 and ISO 46002.

ISO 27001 INFORMATION SECURITY MANAGEMENT SYSTEM (ISMS)

• • Focus for providing a model for establishing, implementing, operating, monitoring, reviewing, maintaining and improving an Information Security Management System. ISMS were published in Oct 2005
• • ISO/IEC 17799 Implementation guide and replaces old BS7799-2 standard

Addresses the security issues related to the Information System Management though Security Policy, Control Objectives, Asset Management & Access Control