Latest News on IS0 9001 Revision and Quality Concept

As we know all the ISO Standards are precisely revised every 5 years to establish or know if there is need to revise or keep the standard current and relevant for the users. Through the revised version new requirements and concepts arise for the companies to consider and demonstrate leadership/ commitment to the quality management system.

Today, we talk about ISO 9001. Basically, ISO 9001 QMS Standard gets revised every 6 to 8 years. Have a look at the revision history

First issue published – 1987

First revision – Second issue published – 1994 – after 7 years

Second revision – Third issue published – 2000 – after 6 years

Third revision – Fourth issue published – 2008 – after 8 years

Fourth revision – Fifth revision published – 2015 – after 7 years

The revised version does not need to be part of company’s ISO 9001 Documentation, but they encourage to make use of the new concepts that works best for them. If you are planning on upgrading your quality management system, you will need to be familiar with the latest surprising news, its terminology, its structure, requirements etc.

Recently, members of International Organization for Standardization (ISO) Technical Committee 176, Sub Committee 2 (TC 176/SC2) have taken a firm decision of not to update current ISO 9001:2015 format. After conducting a systematic review of ISO 9001:2015 Quality Management System Requirements they agreed that the format currently does not need change. Also, as per the current scenario we may not see the next revision of the standard until the estimated year till 2030.

So, here is the 9 main requirements or changes as per the ISO 9001:2015 Revision Format –

1. ISO 9001:2015 Has 10 Clauses – ISO 9001:2008 Had 8

The 10 clauses are

• Introduction
• Scope
• Normative references
• Terms and definitions
• Context of the organization
• Leadership
• Planning
• Support
• Operation
• Performance evaluation
• Improvement

Accordingly, clauses ranging from 4 – 10 contains the actual requirements to be followed and its set up resembles following PDCA Cycle which promotes continuous improvement.

• ISO 9001:2015 Follows the New High Level Structure (Annex L) Guidelines

High Level Structure means making the management system format more consistent across all standards which means the structure, punctuation, choice of words, basic terminology will be precise/consistent and match wherever possible. The new structure has little impact on companies as implementing the HLS can lead to better compatibility, clarity and more efficiency.

• Some Terminology Is Different in 2015 vs. 2008

The difference is that the ISO is trying to make the standard easier to understand such that it is applicable to every business of every industry and every part of the world. It wants to make sure that the IS0 9001 requirements applicable for a multinational company is also applicable to a hospital in remote areas. Basically, the idea is to give ISO 9001 broad application to infinite number of potential users in every industry, thus making the newest language work well for everybody.

• ISO 9001:2015 Is Process-Based

The past concept of process approach was not properly addressed and utilized by companies, the latest version has much greater emphasis on the process. The concept is about integration of processes which means the output of one process is the integration of one or more other processes. The idea is to manage company as system of interrelated processes.

• ISO 9001:2015 Puts More Focus on Input and Output

The input and output here is closely related to process based approach and refers to the starting point/start of process and result of the activities. The focus is how the process takes input and uses it to result in an output. A simple example is the process of turning raw material into a finished product that will include a number of smaller interrelated process along the way.

• Risk-Based Thinking Is at the Core of ISO 9001:2015

The risk based thinking is a new concept and only an expansion of preventive action (ISO 9001:2008 concept). Companies with a good preventive action system in place will find that little change is required, while companies that never paid much attention to preventive action will find that ISO 9001:2015 gives them some useful tools to address this rather important issue.

• Context of the Organization Important in ISO 9001:2015

This refers to reviewing, knowing and understanding the internal / external environment influences that shape a company. It encourages to analyse company’s strengths, weaknesses, opportunities and threats. Through this the company can determine the interested parties, their requirements, expectations, their importance and impact.

• Leadership and Commitment in ISO 9001:2015

Maximum leadership and commitment will be attained from the top management as QMS will put in action with overall strategic direction of the business.

• Better Integration with Other ISO Standards

ISO 9001:2015 is designed in such a way such that it is more compatible with other ISO Standards. With QMS in place it will be easier to implement ISO 14001, ISO 45001 or any other ISO standard that are specific to their industry without duplication of efforts.