What is ISO 9001 certification?

The World Standard Cooperation (WSC) based in Geneva is a collaboration between International Standard Organisation (ISO), International Electrochemical Commission (IEC) and International Telecommunication Union (ITU).WSC  Promotes Standardisation program Coordination group (SPCG)for the Latest digital Platforms such as Artificial intelligence, Machine learning and Augmented Reality.

International Standard is useful for boosting global trade and Economic development.

International Standard Organisation (ISO) is an independent non-governmental organisation.

ISO 9000,ISO 9001 and related ISO  Standards are based on Quality Management Principles and provides a frame work for the companies to control processes and thus control products and services

Implementation of ISO 9001 system can help the organisation to improve productivity

This blog highlights ISO 9001

Quality Management System Principles

PDSA cycle adapts Process approach, where Process is divided into small processes and are interconnected. Identification and analysis of their sequence, interaction, input/output of each small processes can be done through process flow diagrams  and have the characteristics of continuous improvement .

Quality Management System (QMS):

The quality management system is a system which direct and control an organisation with reference to Quality.

ISO 9001-2015 is an international standard for the specification of QMS.

QMS is based on 7 management principles

Guide lines for developing a quality management system

1. Customer focus: Main focus is to transform the Voice of the customer into product/service characteristics. More profits can be achieved through customer loyalty and satisfaction.

2. Leadership qualities: Aligning the Quality objectives, policies and commitment of the Management. Communicating Quality Policy, Mission, vision, values to all stake holders.

3. People: Coordination, empowerment of all employees can create and deliver value.
4. Process approach: Identification and analysis of the sequence, interaction, input/output of each small processes using PDSA cycle for Optimising the performance of the system.In Process approach Inputs, Outputs, resources and activities are to be considered.
5. Continuous improvement: Provide training to employees on continuous improvement. Root cause analysis is performed to take corrective and preventive actions.
6. Decision making: Data analysis using documented information which helps in Decision making
7. Relationship management: Establishing long term relationship with all stake holders, eg. Vendors

ISO 9001 Clauses List

The clauses provided  in international standards are [QMS (4),   Leadership(5),Planning(6),support(7),Operation(8),Performance evaluation(9),improvement(10)]

4. QMS defining the scope and identifying the processes, identifying input and output of the processes and risk factors to be considered.
5. Leadership: In clause 5 requirements of a committed Leadership with customer focus is specified. Management should develop a quality policy which must be communicated to all stakeholders. Responsibilities of employees must be assigned.
6. Planning: In Planning stage objectives are selected. The risks are considered in detail.

The ISO standard is based on PDCA cycle in which Planning stage consists of selecting the objectives and all planning activities .In Do stage implementation of all control activities for Process, Product/service are considered. In check stage after identifying all Positives and negatives, negatives are removed. In act stage selected procedures are standardized.

7. Resources: In this clause Allocation of resources, Manpower, Infrastructure and the detailed documentation are covered
8. Operation: To sort out risks and implement all operational control activities related to processes, products and services are covered in this clause in detail.
9. Performance evaluation: Internal audit is used to measure the effectiveness and conformance of process. Performance evaluation is carried out by performing data analysis, management review, and analysis of customer satisfaction
10. Improvement: this clause includes system for non-conformity, corrective action taken and Steps needed for continuous improvement process

Benefits of ISO 9001 are

International recognition for the Organisation

Coordination of employees and higher Productivity

Higher Profits

Improved Quality

ISO 9001 certification cost

Cost of Implementation of ISO system depends upon variables such as the size of the organisation, number of employees and Selection of Registrars.