Part One – ISO 9001:2015 Quality Management System
Many businesses with ISO 9001:2008 are aware that the new Standard, ISO 9001:2015, is already on the streets and that they have a grace period to transition over or lose their accreditation. All businesses that already have ISO 9001:2008 have until September 2018 to transition across. Businesses that are now looking to gain accreditation will be using the new Standard.
However, not many businesses realise that ISO 14001:2004, Environmental Management and ISO 18001:200, OHAS Management have also been upgraded!
In this post we will quickly look at the main differences that have taken place in the ISO 9001 Management Systems:
ISO 9001:2015 HAS TEN CLAUSES INSTEAD OF EIGHT
ISO 9001:2015 has Ten clauses instead of Eight. The following table shows the relationship of the ISO 9001:2008 clauses to those in the new ISO 9001:2015.
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative reference 2. Normative reference
3. Terms and definitions 3. Terms and definitions
4. Quality management system 4. Context of the organisation
5. Management responsibility 5. Leadership
6. Planning 6. Resource management
7. Support 7. Product realisation
8. Operation 8. Measurement, analysis and improvement
9. Performance evaluation
The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onward. The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act).
Clauses 4, 5, 6 and 7 of ISO 9001:2015 come under PLAN, clause 8 comes under DO, clause 9 comes under CHECK and clause 10 is covered by ACT.
With this new arrangement, the new ISO 9001:2015 strives to give additional momentum to the continuous and systematic improvement of processes within organisations.
ISO 9001:2015 PUTS MORE FOCUS ON INPUT AND OUTPUT
There is more emphasis in ISO 9001:2015 on measuring and properly assessing the input and output of processes. According to ISO 9001:2015, you must closely monitor which articles, information and specifications are involved in the production process. You must also clearly check whether good articles come out of the production process.
RISK-BASED THINKING IS AT THE CORE OF ISO 9001:2015
Risk-based thinking has a very important place in ISO 9001:2015. You are now strongly encouraged as an organisation to use risk analysis in order to decide for yourself which challenges you see in the management of your business processes.
To emphasise their dominance, the concept of ’risk’ occurs forty-eight times in ISO 9001:2015, compared with only three times in ISO 9001:2008.
The new Standard requires an organisation to construct its quality management system from now on from the specific context within which it is active. This means, among other things, that, as an organisation, you have to take into account the needs and expectations of interested parties and that you evaluate and deal with internal and external strategic questions. You have to show that, as an organisation, you understand and respond to the expectations of all the parties concerned.
CONTEXT OF THE ORGANISATION IMPORTANT IN ISO 9001:2015
It also requires an organisation to construct its quality management system from now on from the specific context within which it is active. This means, among other things, that, as an organisation, you have to take into account the needs and expectations of interested parties and that you evaluate and deal with internal and external strategic questions. You have to show that, as an organisation, you understand and respond to the expectations of all the parties concerned.
LEADERSHIP AND COMMITMENT IN ISO 9001:2015
ISO 9001:2015 also places more emphasis on leadership and management commitment. It requires greater involvement by top managers and business leaders in controlling the quality management system.
This way, the new Standard is intended to encourage integration and harmonisation with business processes and business strategies. The top management now has to take more responsibility for the effectiveness of the quality management system.
Because ISO 9001:2015 pays more attention to risk management, interested parties and the context of the organisation, the quality management system also fits in better with the needs of the top management.
The quality management system is now more than ever a means for being strategically successful by addressing the needs of interested parties and by managing opportunities and threats.
In our next post we will be looking at ISO 14001:2015 and the changes that will affect businesses already accredited with the old Standard.
For more information on the changes to ISO standards visit our website: www.csa-consultants.me