ISO-9001-2015 Quality Management System

A Simplified and Brief Overview

WHAT IS ISO

In 1946, delegates of 25 countries gathered in London to form an international body for coordination and development of industrial standards, which later became an independent non-governmental organization of 164 national standards bodies, named “The International organization for standardization”. Members of these bodies are experts and share knowledge to formulate standards. ISO has developed 24656 standards so far.

WHAT IS ISO 9001

A quality management system standard, states requirements for quality management system of organization to achieve quality objectives, customer satisfaction and sustained success.

HOW ISO 9001 WORKS

The requirements of ISO 9001 require organization to establish processes, procedures, quality policy and objectives, in line with customer requirement/requirements of interested parties and context of organization. To achieve quality objectives, processes are monitored and continually improved. Audits are conducted to evaluate the conformity of organization’s QMS to this standard’s requirements.

REVISION HISTORY

·        ISO 9001-1987

·        ISO 9001-1994

·        ISO 9001-2000

·        ISO 9001-2008

·        ISO 9001-2015

INTRODUCTION- ISO 9001-2015: 

      ISO 9001-2015 provides a framework of requirements to establish, maintain and continually improve quality management system. It promotes the process approach with incorporation of risk based thinking and PDCA cycle.

     PURPOSE: To transform requirement of customer into product or service of intended quality through a quality management system.

     GENRAL BENIFITS: Increasing efficiency and productivity, conforming to requirements products and services, customer satisfaction, continually improving business, recognition and reputation, new business opportunities, risk management.

    OUTPUT OF QMS:

(ISO 9001-2015)

· Determined context of the organization

· Quality policy and objectives

· QMS processes and procedures

· Responsibilities and authorities

· Resource management

· Retained, maintained documented information (e.g.: Records, forms, quality manual and plan, documents, SOPs etc.)

· Documented organizational knowledge

· Continual improvement practices and audits

· Surveys, Management review meetings, quality meetings, effective communication

FRAMEWORK:

ISO 9001-2015 consists of 10 clauses. First three are introductory and next seven clauses set the requirements of QMS. A clause wise brief explanation is given below:

     Clause 4 requires an organization to define its context (the boundaries and environment within which an organization operates). It includes determining issues (external and internal), needs and expectations of interested parties, scope of QMS and establishing processes.

     Clause 5 states responsibilities and leadership of top management for: ensuring Integrity and effectiveness of QMS, establishing quality policy and quality objectives, promoting focus on process approach, risk based thinking, continual improvement, customer satisfaction, ensuring resource availability, delegating authorities and responsibilities as per QMS requirement.

     Clause 6 sets requirement for: planning for QMS (by using information obtained from clause-4), determining risks and opportunities, setting quality objectives and planning to achieve them, and planning for changes.

     Clause 7 sets requirements for: resources and support required to achieve QMS objectives, organizational environment for processes, measuring & monitoring resources, organizational knowledge, competences and QMS awareness of employees, communication (internal, external), documented information and their extent and control. 

     Clause 8 sets requirement for operational processes, design and development of products and services as per requirement and their control, implementing and controlling the processes, protection of external properties and products, control of provisions, changes, external providers, outsourced processes and nonconforming outputs.

     Clause 9 is about performance evaluation, planned Monitoring of QMS, determining customer perception and satisfaction needs, evaluating the QMS, its implementation and effectiveness, internal auditing, management review meetings, and performance of external providers.

     Clause 10 is about non conformities and corrective actions, root cause analysis and correction of non-conformities, reviewing the effectiveness of corrective actions, assessing and addressing risk and opportunities associated with changes, and continually improving the QMS.

QMS PRINCIPLES:

QMS Principles serve as a guide at every step of QMS to achieve effectiveness.

     1-Customer focus: Primary focus of ISO 9001, focusing and continuously striving to meet and exceed customer’s needs and expectations.

     2-Leadership: Effective leadership and top management’s role in QMS to achieve objectives in line with quality policies and objectives.

     3-Engagement of People: Giving best by people in organization results in efficient QMS.

     4-Process approach: Considering organization as a set of processes. Processes must be planned, monitored, controlled and continually improved.

     5-Improvement: Continually improving QMS to make it error-proof and a value creating system.

     6-Evidence Based Decision Making: Ddcision based on facts and data are effective and reliable.

     7-Relationship Management: Collaboration with stakeholders and providers for success.

THE CERTIFICATION PROCESS:

Certification is done by Independent bodies (which Conform to the ISO/IEC 17021-1:2015). An organization usually conducts gap analysis of its QMS to address gaps and establish a QMS system prior to go for certification. After application for certification, the Independent certification body conducts a document review and then onsite review. Any nonconformity is conveyed to organization. Upon satisfactory compliance to the requirement of ISO 9001(latest version), certification is awarded with a validity of 3 years. During 3 years period, surveillance audits are conducted for recertification (validity3 years).Organization maintains established QMS on regular basis to stay compliant.