The ISO 9000 series of quality standards is by far the best selling and most extensively used management system worldwide. Like all ISO standards ISO 9001 generally undergoes a revision every five years.
The International Organisation for Standardisation (ISO) is currently undertaking a process for updating the ISO 9001:2008 Quality Management System standard. The process is well underway and a Committee Draft has been published (ISO/CD 9001:2015). The process involves a number of draft releases and interested parties are invited to comment at various stages of the standard production.
Once the draft has been finalised and accepted it is expected to be published and will become ISO 9001:2015.
The main reasons for the change is to keep ISO 9001 relevant, reflect changes in its environment and ensure it continues to deliver “confidence in the organization’s ability to consistently provide product that meets customer and applicable statutory and regulatory requirements”.
The current focus on effective process management is to be maintained but greater emphasis will be placed on producing desired outputs and providing confidence in product.
Structure of the proposed revision ISO/CD 9001:2005
The structure of the new standard will be significantly changed in accordance with Annex SL which was issued by ISO in 2012 to define the framework for a generic Management System Standard.
All new ISO management system standards will adhere to this framework and all current ISO management system standards (MSSs) will migrate at their next revision.
In future, all ISO MSSs should be consistent with this format and will all have the same look and feel.
The 2015 version of ISO 9001 will therefore be based on this Annex SL framework.
Other standards which will change include:
ISO/IEC 27001:2013 Information security management systems, will be the next ISO standard to be based on Annex SL
ISO 14001:2015 Environmental Management, will be the next published shortly before ISO 9001:2015 Quality management
ISO 22301: 2012 Business Continuity Management, based on an early version of Annex SL (Guide 83)
The following clause structure and proposed changes are included in the ISO/CD 9001:2015
- Normative References
- Terms and Definitions
- Context of the Organization
- Performance Evaluation
Summary of Main Changes
- The term “product” will be replaced by “goods & services” and the word “continual” will be dropped from “continual improvement.”
- “Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”
- CD/9001:2015 puts a greater emphasis on the definition of scope, which has always been the most important and critical aspect of a quality management system.
- It is proposed to replace preventive action in the current edition of the standard. References are made to risk, identification of risks and opportunities and planning actions to address risks and opportunities identified.
- CD/9001 will take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. The proposed standard addresses risks which can affect conformity of goods and services as well as customer satisfaction.
- Senior management will be required to take a more active involvement in the quality management system.
- There will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records. The Committee Draft refers to “Documented Information.”
- The need for exclusions may not be considered to be necessary in the new version of the standard but feedback on this is being sought as part of the revision process.
- June 2013 – Committee Draft Issued – ISO/CD 9001
- September 2013 – Cut-off Date for Comments & Votes – ISO/CD 9001
- April 2014 – Draft International Standard (DIS) – Ballot opens
- August 2014 – Draft International Standard (DIS) – Ballot closes
- July 2015 – Final Draft International Standard (FDIS) – Ballot opens
- August 2015 – Final Draft International Standard (FDIS) – Ballot opens
- September 2015 – Target date for publication of International Standard (ISO 9001:2015)
Impact of the changes:
The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.
Organisations may have to align their management systems with the structure of the revised standard, for example:
- As an example the organization’s quality manual may need to be amended.
- A risk management processes may need to be developed to determine the level and extent of control for “external provision of goods and services”, if not already in place. This will have implications for the organisations procurement and outsourcing activities and therefore has implications for suppliers.
- Auditors will need to become familiar with the revised ISO 9001:2015 standard and so training may need to be considered.
These are just some of the possible effects on the organisation but until the final version is published it will not be possible to definitively know the implications of revised requirements, put in place detailed plans for revising internal processes or procedures, or plan the arrangements for transition or certification to ISO 9001:2015.
The transition period is expected to be around three years as there are over one million registered ISO 9001 organisations worldwide. The revised ISO 9001:2015 standard should provide a stable set of requirements at its core for the next 10 years or more.