iso 900:12015 awareness__
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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
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
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