Overview of ISO 9001:2015 Awareness

Program

Vinay Kumar Srivastava

Agenda What does the term ISO mean? What is ISO? Quality Management Principles PDCA Cycle Model of Process Based QMS ISO 9001: 2015 Clauses

What does the term ISO mean? • “International Organization for

Standardization”.

• Word derived from the Greek “isos”, meaning "equal".

• Whatever the country, whatever the language, the short form of the organization's name is always ISO.

Network of national standards institutes of 162 countries, Is a non-governmental organization.Based in Geneva, Switzerland.BIS represents India.Total no. of Standards over 21,000, touching almost all aspects of life.

What is ISO

What is a standard?A standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

Quality Management Principles

1. Customer Focus• To meet customers’ requirements and strive

to exceed the expectations.2. Leadership

• Leaders at all levels-direct and provide conditions to all people to achieve quality objectives of the organization.

3. Engagement of people• People should be competent, empowered

and engaged to deliver and create values4. Process Approach

• Activities must be understood to achieve consistent and predictable results

Quality Management Principles

5. Improvement• On going focus on improvement of

processes 6. Evidence- based Decision Making

• Decisions based on analysis and evaluation of data and information produce desired results

7. Relationship Management• Manage good relationship with interested

parties.

Some Common ISO StandardsQuality Management System ISO 9001:2015Environment Mgmt. System ISO 14001:2015 Food Safety Mgmt. System ISO 22000:2005Complaints Management ISO 10002:2004Medical Device Manufacturing ISO 13485:2016Information Security management System

ISO 27001:2013

Some Common ISO Standards

Identification cards system ISO 7810:2003 Paper — Holes for general filing purposes

ISO 838:1974

Paper Size System ISO 216:1974Occupational Health and Safety

ISO 45001:2016 (P)

International Standard for country codes

ISO 3166-1:2006

How to read the Standard?

• Like

Issuing Body Standard ID Year of Issue:

ISO 9001 2015:

ISO 14001 2015:

ISO 13485 2016:

ISO 22000 2005:

Benefits of ISOImprovement of credibility and image.

Powerful marketing tool.

Increase customer satisfaction through improved safety, quality and processes.

Better alignment of organization’s mission, vision, objectives and action plans.

Better process integration.

…. BenefitsConsistent processes and evaluation tools to demonstrate and increase effectiveness and efficiency Improve evidence based decision making.Lesser repetition of errors/mistakes. Widened participation of interested parties Stimulation of excellence and innovation

Process Approach

Plan-Do-Check-Act Cycle

The Plan Phase• Includes-

– Understanding of context of the organization

– Defining Scope, and Quality Policy– Addressing Risks and opportunities– Setting Quality Objectives– Planning control of processes

• Documenting he procedures –organizational control

• Implementing new technology or change in processes – engineering control

• Training –HR related control, etc.

The Do Phase• Includes

– Implementation of different processes for fulfilling the QMS and achieving quality objectives

– Implementation of control processes

The Check Phase• Includes following-

– Regular monitoring and measuring– Internal audits and management

review

The Act Phase• Includes-

– Corrective actions– Implementation of improvement

initiatives.

ISO 9001: 2015 Clauses0. Introduction1. Scope2. Normative references3. Terms and Definitions4. Context of the Organization5. Leadership 6. Planning 7. Support8. Operations9. Performance Evaluation10. Improvement

Introduction to ISO 9001

Internationally recognized standard.Specifies the requirements for

establishing, implementing and maintaining QMS in an organization.

Comprises of 11 clauses.Clauses 0 to 3- describe standard

itselfClauses 4 to 10- Set requirements for

QMS to for the compliant with the standard.

ISO 9001 a generic standard.

The Structure of ISO 9001• Clause 0- Introduction- General

view of the standard, its purpose and compatibility with other standards.

• Clause 1- Scope- defines the scope of this standard as it is applicable in all types of organizations

• Clause 2- Normative references• Clause 3- Terms and definitions

The Structure of ISO 9001Plan Phase

• Clause 4- Context of the organization– To understand the external and

internal issues, interested parties, their requirements, and scope of QMS

• Clause 5- Leadership- – Management responsibilities,

defining roles and responsibilities, and content of Quality Policy.

The Structure of ISO 9001The Plan Phase

• Clause 6- Planning- – Assessments of risks and

opportunities, Quality Objectives and achievement plans.

• Clause 7- Support- – Requirements for availability of resources,

competence, awareness, communication and control of documents & records.

The Do Phase• Clause 8- Operation-

– Operational planning and control; design and development; control of externally provided processes, products and services; production and service provision; release of products and services and nonconforming outputs.

The Check Phase• Clause 9- Performance evaluation-

– Monitoring, measuring and evalution, analysis; internal audit and management review.

The Act Phase• Clause 10- Improvement-

Nonconformities, corrective action and continual improvement.

Context of the organization

• External Context include-– cultural, social, political, legal,

regulatory, financial, technological, economic, natural and competitive environment, whether international, national, regional or local;

– relationships with, and perceptions/values of external stakeholders

Context of the organization

• Internal context includes-– Organizational knowledge– organization culture; – governance, organizational structure, roles and

accountabilities; – policies, objectives, and strategies – resources (capital, time, people, processes,

systems technologies); – information systems, information flows and

decision-making processes (both formal and informal)

• Interested parties-– Clients, partners, suppliers, local authorities,

employees

Documented information

• Scope, Quality Policy, Quality objectives and plans to achieve them,

• records of training, skills, experience and qualification

• Criteria for evaluation and selection of suppliers

• Monitoring and measuring equipments, calibration records

• Product/service requirements, review records• Records about design and development

output review• Records about design and development inputs• Records of design and development control• Records of design and development output

Documented information

• design and development change records• Characteristics of product to be produce and

services to be provided• Customer property• Production and service provision change control

records• Records of conformity of product/service with

acceptance criteria• Records of non conforming outputs• Monitoring and measuring results• Internal audit program• Results of internal audits• Results of Management review• Results of the corrective actions

Q & A

For further information & training

Vinay Kumar Srivastavakvsrivastava@gmail.com

91+9044453244