Key Amendments in A nutshell
The key changes in ISO 9001 2015 are:
- Emphasis on Top Management Leadership
- Risk Management in a better way
- Performance measurement
- Better ways of Communication and Creating Awareness
- Prescriptive Requirements for the System
Eight Concrete Reasons to Publish New Version
- Getting better integration with other management systems
- Creating more integrated approach for organizational management. ISO 9001
- Make complex environments to reflect easily under which processes are being operated
- Better representation of the needs of potential users and their groups
- Enabling organizations to go beyond the satisfaction levels of their customers
- Increasing involvement of top leadership team to grass root levels
- Create awareness about risk and opportunity management
Brand New Concepts in Latest Version of ISO 9001 2015 Transition
Following are the few clauses that draws the line of difference between ISO 9001’s older and new version:
Clause # 04 – Context of the Organization
It is mandatory to have a context of the organization first and by having organizational context, one must have determined internal organizational issues that are relevant to the organizational purpose or most likely have an impact on the organizational performance and employees’ behavior. The sole purpose of adding clause 04 is to put special focus on establishing, implementing, maintaining and updating and continually improving QMS (Quality Management System) in depth keeping the requirements of the standard in consideration.
Clause # 05 – Management Leadership
The group who controls and direct teams of various departments is top management leadership. The greater the involvement of top management the more the ratio of employees’ engagement will be observed. Leadership team must ensure integration of requirements of standards’ and organizational policies, objectives and goals leading to strengthening of business code of conduct throughout the organization helping more to achieve certification.
Clause # 06 – Effective Planning
Risk assessment and risk treatment are both important segments of Planning in latest version of ISO 9001 in which crying need is highlighted to address risks and improvement opportunities so that evaluation of actions can be assessed.
Clause # 07 – Support
All the necessary supporting documents that are mandatory for establishment, implementation, maintenance and continually improvement of QMS must be ensured at all levels. The requirement of “Documented Information” has been highlighted in this clause which is relatively a new term that has replaced ISO 9001:2008 standard terms’ like documents and records.
Clause # 08 – Operation
Any sort of plans and processes or any part of the process that helps to enable fulfillment of customers’ requirements be it about product or services. Clause 08 has the inclusion of previously referred term that was mentioned in ISO 9001:2008 version. The updated version concerns more about contractors and sub-contractors for outsourcing.
Clause # 09 – Performance Evaluation
Monitoring, continuous gauging, analysis and evaluation are important aspects of performance being exhibited in an organization by the people. The need for internal audits must be addressed through proper channel and it should be conducted religiously after periodic gaps. In newer version, performance evaluation is preferred to done in a way in which customers look at your organization that means organizations must be able to get perspective from customers about themselves. Internal audits and management reviews are part and parcel requirements for ISO 9001:2015.
Clause # 10 – Improvement
There is no preventive action requirements in this clause. However the need for corrective actions remains the same. In order to address nonconformity correctly, the first and foremost step is to take appropriate actions so that the non-conformity can be controlled and its consequences can easily be deal with. The extension of continual improvement has been highlighted so that stability and adequacy of QMS can be ensured at all levels of organization but it do not specifies the way of achieving that stability. The need for finding room for improvement has also been emphasized in newer version of ISO 9001 keeping future requirements of the customers in mind.
Highlighting the Difference of Terminologies between ISO 9001:2008 and ISO 9001 2015
- ISO 9001:2008 concerns more about Products while ISO 9001 2015 transition considers products and services both.
- ISO 9001:2008 deals with documentation and records while ISO 9001 2015 transition considers Documented Information.
- ISO 9001:2008 concerns with work environment while ISO 9001:2015 deals with the environment for operation of processes.
- ISO 9001:2008 concerns with purchased products while ISO 9001:2015 deals with externally provided products and services.
- ISO 9001:2008 deals with Supplier while ISO 9001:2015 deals with external providers.
Your Transition Journey Begins Here!
Take baby steps towards your ISO 9001 2015 transition
- Study QMS again in depth with your team.
- Hire a trainer to get yourself trained about transitioned ISO 9001 standard or self-study with your team to understand the updated clauses of ISO 9001 standard.
- Jot down key amendments and brainstorm with team.
- Make amendments to current documentation system accordingly with latest updates.
- Implement updated amendments in current management in accordance with the updates in standard.
- Review effectiveness of new changes being made.
- Ensure Impact assessment conduction to review the implementation and to seek any area of betterment.