Quality Management System

Table of Contents Why ISO 9001:2015 Benefits of ISO 9001 Terms & Definitions Key Changes of QMS New Concept of QMS Principles of QMS Plan Do Check Act

Why ISO 9001:2015

ISO 9001:2015 specifies requirements for a quality management system when an organization:a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and

Why ISO 9001:2015

b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Why ISO 9001:2015All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

Benefits of ISO 9001:2015The new version of the standard brings the user a number of benefits.

• Puts greater emphasis on leadership engagement • Helps address organizational risks and opportunities in a structured manner • Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity • Addresses supply chain management more effectively • Is more user-friendly for service and knowledge-based organizations

Benefits of ISO 9001

Terms & DefinitionsQuality : Degree to which a set of inherent characteristics of an

object fulfills requirementRisk : Effect of uncertainty on objectivesInformation : Meaning dataDocumented Information : Information required to be controlled and maintained by an organization and the medium on which it is containedMonitoring : Determining the status of a system, a process or an activityMeasurement : Process to determine a valueContinual Improvement : Recurring activity to enhance performance

Terms & DefinitionsCorrective Action : Action to eliminate the cause of a nonconformity and to prevent repetitionService : Intangible output that is the result of at least one activity necessarily performed at the interface between the

provider and the customerProduct : The result of a processOutsource : Make an arrangement where an external organization performs part of an organization’s function or processNonconformity : Non fulfillment of requirementConform to : To obey a rule or reach the necessary stated standard

Key Changes of QMSMain Changes The Adoption of High Level Structure An explicit requirement for Risk-Based thinking to support and improve the

understanding and application of the process approach Fewer prescribed requirements Less emphasis on documents Improve applicability for service A requirement to define the boundaries of the QMS Increased emphasis on organizational context Increase leadership requirements Greater emphasis on achieving desired outcomes to improve customer

satisfaction

Key Changes of QMSStructure and Terminology

ISO 9001 : 2008 ISO 9001 : 2015

Products Products & Services

Exclusions Not Used

Documentation, Records Documented Information

Work Environment Environment for the operation of process

Purchased Product Externally provided products and services

Supplier External Provider

Key Changes of QMS

New Concept of QMSRisk Management

An organization needs to plan and implement actions to address risks Identify the risk Assess the impact of risk Action to manage the addressed risk Risk Reporting & Monitoring

New Concept of QMSChange Management

Change management starts with identifying the change requirement. Change in the scope of the QMS Policy change Product Change (Technology improvement, raw material change, change in

customer requirement etc.) Process Change (Quality improvements and Productivity increase) Procedure Change (Equipment changes, new equipment, raw material changes

etc.)

New Concept of QMSChange Management

Change in Employees (New positions, new recruitments, resignations, long leave etc.)

Change in Management (Mergers, take-overs etc.) Changes in Requirements (Customer

requirements, code requirements, legal requirements, QMS requirements etc.)

New Concept of QMS

New Concept of QMS

The Role of Top ManagementTop management shall demonstrate leadership and commitment with respect to the quality management system by: (5.1.1)

a) taking accountability for the effectiveness of the quality management system;b) ensuring that the quality policy and quality objectives are established for the

quality management system and are compatible with the context and strategic direction of the organization;

New Concept of QMS

The Role of Top Managementc) ensuring the integration of the quality management system requirements into the

organization’s business processes;d) promoting the use of the process approach and risk-based thinking;e) ensuring that the resources needed for the quality management system are

available;f) communicating the importance of effective quality management and of

conforming to the quality management system requirements;

New Concept of QMS

The Role of Top Managementg) ensuring that the quality management system achieves its intended results;h) engaging, directing and supporting persons to contribute to the effectiveness of

the quality management system;i) promoting improvement;j) supporting other relevant management roles to demonstrate their leadership as it

applies to their areas of responsibility.

Principles of QMSThis International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle. The quality management principles are:— customer focus;— leadership;— engagement of people;— process approach;— improvement;— evidence-based decision making;— relationship management.

Plan-Do-Check-Act

Plan-Do-Check-ActThe PDCA cycle can be briefly described as follows:— Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies;— Do: implement what was planned;— Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and report the results;— Act: take actions to improve performance, as necessary.

Plan-Do-Check-Act