Fundamentals of ISO

Quality Quality is Conformance with requirements Quality is fitness for purpose Quality is fitness for use Quality is user dependent To achieve consistency in output, it is quality of everything that we do, which can be improved.

Quality The extent to which a set of inherent characteristics fulfills requirements/specifications

Need for Quality Every organization would like to improve in different ways i.e. Improving customer satisfaction In means of operations Increasing market share driving down costs managing risk more effectively.

Core Principles of Quality Management Customer Focus. Leadership. Involvement of People. Process Approach. System Approach to Management. Continual Improvement. Factual Approach to decision Making. Mutually beneficial supplier relationships.

Quality Management System A quality management system gives you the Framework and guidelines you need to monitor and improve performance in any given area Management System to direct and control an organization with regard to quality Assess the processes and measure the same

ISO Quality management -key requirements QMS - Document processes necessary to ensure product or service is of high quality and conforms to customer requirements. Management Responsibility - Provide a vision. Show commitment. Focus on the customer. Define policy. Keep everyone informed. Resource Management - Assign the right person to the job. Create and maintain positive workspace. Product Realization - Clearly understand customer, product, legal and design requirements. Ensure specifications are followed. Check your suppliers. Measurement, Analysis & Improvement - Identify current and potential problems. Monitor and measure customer satisfaction. Perform internal audits. Fix problems.

ISO To address this need of the customers and also to ensure that organization would improve their working internally, system standards were released by ISO, in the year 1987 which have been revised once in 1994 and latest version standards have been released in 2000. ISO stands for “International Organization for Standardization”

ISO Core Standards ISO 9000:2000 Series, 1994 family of standards have been reduced to 4 core standards: ISO 9000:2005 - Fundamentals and Vocabulary ISO 9001:2000 – Requirements ISO 9004:2000 – Guidelines for performance improvements ISO 19011:2002 – Guidelines for Auditing Quality and/ or Environmental Management Systems Auditing ISO 90003: 2004 - Guidelines for the application of ISO 9001:2000 to computer software.

Process The ISO standards are structured around the Process Approach concept. Two of the eight quality management principles are key to understanding this principle: Process Approach - Understand and organize company resources and activities to optimize how the organization performs. System Approach to Management - Determine sequence and interaction of processes and manage them as a total system. Processes must meet customer requirements.

Work Process Monitoring and Measurement opportunities before, during and after the process Method INPUT (Includes resources) PROCESS Output Product (Result of Process)

Documentation Management should define the documentation, including the relevant records, needed to establish, implement and maintain the quality management system and to support an effective and efficient operation of the organization’s processes.

Typical Structure of Documentation The number and levels may be adjusted to meet the organization’s needs. Forms may be applicable at all levels of the hierarchy. Quality manual (Level A) Quality Management System Procedures (Level B) Work Instructions, Process maps and other documents for QMS (Level C) Forms and Records (Level D)

Documentation Quality Manual: The quality manual gives the management’s directions for Quality Management system, in which it will define the departments/ Areas to be covered in the process system. QMS - Procedures/ SOP: Control of Documents Control Records Internal Audits Control of Nonconformity Corrective Action Preventive Action

ISO clause Clause4: Quality management system Clause5: Management responsibility Clause6: Resource Management Clause7: Product realization Clause8: Measurement, analysis and improvement

Audit Systematic Approach Independent and well documented Process for getting evidence Evaluating objectively Check if the audit criteria is fulfilled

Quality System Audit An investigation of the intent and the implementation of selected aspects of the quality system of an organization.

Types of Audit Internal Audits External Audits Second party audits Third party audits

Audit Activities Initiating an Audit Conducting document review Preparing for onsite activities Conducting onsite activities Preparing, approving and distributing the audit report Complete the audit Conducting the audit Follow-up.

Audit Plan Sample Template Audit objective Audit criteria and reference documents Audit scope - Coverage Area and aspects Dates and places for audit activities Audit meeting Times Allocation of resources for critical areas.

Audit Template Purpose: Dept/Function: Auditee: Auditor: Date & Time: Remarks/comments:

Types of Checklist Bulleted specific Question "Look AT" and "Look FOR" Model

Sample Template "Look AT" and "Look FOR" Model Function : HR Dept - Recruitment Area Activity : Updating the skills of Employee Look AT : Employee Details Screen- (SPCG) Look FOR: Skill Type, Skill Rating, Employee joining date, Frequency of updating the skill. Sample size : 10 Time : 30 min Remarks:

Non conformance Not meeting customer requirements Not meeting our own defined processes Not meeting management commitments

Types of Non conformity Major Non conformity Minor Non Conformity Observation

Major Non conformity The absence or total breakdown of a system to meet the ISO 9000 requirement.   A bunch of number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity. Any noncompliance that would result in the probable shipment of nonconforming product to the customer. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose at customer place Anything that can affect the quality system itself

Minor Non Conformity A failure in some part of the documented quality system relative to ISO 9000, or A single observed lapse in following one item of the company's quality system as an isolated case.

Observation An observation is essentially an OPINION. Some say you can ignore it while others expect the Observation to be addressed in some manner - such as through the corrective action system.

Audit Finding Template