ISO 9001:2015 Standard: What is it?

ISO 9001 is basically an ISO standard which sets out the requirements for a Quality Management System(QMS). The first edition was published in 1987 and the latest revision was made in the year 2015 .The ISO 9001 standard is part of the ISO 9000 family of certifications which look over various aspects of Quality Management. The ISO 9000 family is known to have some of the best-known ISO standards. These standards provide the proper guidance and empower companies with the tools to implement customer satisfaction by consistently meeting their requirements via products and services offered. These standards also have provisions to help companies ensure that apart from customer satisfaction, the quality of goods is also improved on a constant basis. ISO 9001

What is a Quality Management System(QMS)?

A Quality Management System basically outlines the methods of defining how organizations can keep up with the ever-changing requirements of customers as well as shareholders affected by its work. The objectives for meeting requirements however, are not defined and varies from organization to organization. The ISO 9001 standard requires that companies should define these objectives themselves and keep refining their processes to continually maintain high standards.

Topics Covered under ISO 9001:2015 Standard

The basic methodology of ISO 9001 is based on the Plan-Do-Check-Act procedure and it strives to accomplish a process-oriented approach in a quest to achieve effective quality management in an organization. The quality management is done by effectively documenting and constantly reviewing structure, responsibilities, and procedures for production of goods or delivery of services. The ISO standard through specific sections addresses the following information.

• Requirements for a QMS inclusive of documented information,planning and determining process interactions
• Management’s responsibilities
• Effective management of resources including Human Resources and work environment of the organization.
• The process of product realization every step of the way from design to delivery
• Internal audits along with corrective and protective actions to facilitate Measurement, analyses as well as improvements to the existing QMS

ISO 9001:2015 Objectives

The ISO 9001: 2015 standard generally focuses on the objective of continual improvement in the quality of goods and services and in turn improving customer satisfaction. The standard can be used for all kinds of enterprises regardless of size and their sector of operation. There have been multiple success stories of companies improving their overall customer satisfaction with quality improvement. Over 1 million companies across 170 countries have benefitted from the implementation of the ISO standard.

These are a few basic objectives ISO 9001:2015 will help you accomplish.

• Improve overall customer satisfaction with better quality of goods and services.
• Assess overall context of the organization to define segment of people affected by your work and what their expectations are.
• Enables an organization to clearly identify and lay down business objectives and work efficiently towards them.
• Helps organizations put customers at the forefront of the business and treat their satisfaction as a key motivator for constantly refining and upgrading the quality of goods and services delivered .
• Identify new business oppurtunities and attract a new consumer base by expanding into new markets by assuraning great quality .
• Meeting statutory as well as regulatory requirements of products or services.
• Identify risks associated with the organization.

Certification Procedure

The certification procedure for ISO 9001 standard is a 5-step process and it goes as follows.

Stage 1- Initial Assesment- The initial assessment is used to determine if the standard’s mandatory requirements are being met and if the QMS is functional enough to proceed to stage 2.

Stage 2– This step helps in ascertaining the effectiveness of the QMS and confirming that there is an implementation of the QMS within the organization

Stage 3- Corrective actions are taken to address issues and corrective actions raised at stages 1 and 2. Certification is recommended after completion of this step

Stage 4- The Recommendation for certification along with the organizations is reviewed by a panel and certification decision is made

Stage5- The certificate is issued after Communication of successful certification is passed onto the organization.

How long does ISO 9001:2015 Certification Last?

Certification to the ISO 9001:2015 standard is valid and holds for a maximum time period of 3 years. In this 3 year period, the company will be subject to mandatory audits to ensure compliance with the regulations

Adaptation of ISO 9001 for Sector-Specfic Applications

Based on the ISO 9001 , ISO has made standards that are adapted to quality management for specific sectors and industries . Here’s a list of the ISO standards based on ISO 9001:

• ISO 13485- Medical Devices
• ISO 17582- Electoral organizations at all government levels
• ISO 18091- Local Government
• ISO/TS 22163 – Business Management system requirements for rail organizations
• ISO/TS 29001- Petroleum , Petrochemical and Natural Gas industries
• ISO/IEC 9003- Software Engineering

Cost of ISO 9001 certification

• Organisations have to frame a Quality Management System
• Organisations would require outside help and hire consultants
• Have to pay certificate and audit costs.

Cost of ISO 9001 certification

ISO itself does not issue any certificates. This task is performed by external certification bodies.