Keshav Ram Singhal
It is a strategic decision for an organization to adopt ISO 9001:2015 QMS standard. Once the top management of an organization takes a decision to develop and implement ISO 9001:2015, following step-by-step process may be useful.
Step 1 - Leadership and Commitment from Top Management
Following three things from the top management will facilitate proper development and implementation of ISO 9001:2015 QMS:
- Leadership role
- Active involvement
It is necessary for the top management to demonstrate leadership and commitment to implement ISO9001:2015 QMS standard. Top management of the organization must be convinced that implementing ISO 9001:2015 QMS standard will provide a number of potential benefits to the organization. Top management must know that although certification and registration is not mandatory, however certification and registration will enable the organization to demonstrate a visible commitment to quality, quality management system and sustainable development initiatives. Top management must be aware of the overview of ISO 9001:2015 QMS standard, for which one-day presentation training can be organized covering the following issues:
- ISO 9001:2015 QMS Overview
- Importance of understanding the organization and its context
- Risk-based thinking
- Identification of goals and expectations
- Leadership role
- Quality policy
- Quality objectives
- Engaging persons to contribute QMS effectiveness
- Establishing a steering committee
- Establishing a task force
- Appointing a consultant
- Implementation process
Presentation training covering the above issues can be organized by a personnel, who is well aware of ISO 9001:2015 QMS standard. An outside consultant or trainer may be asked to organize the training.
Top management of the organization should demonstrate leadership, commitment and determination to implement ISO 9001:2015 QMS standard by involving themselves actively in the following tasks:
- Ensuring people in the organization understand the importance of meeting requirements
- Establishing organization's quality policy and quality objectives
- Integrating quality management system requirements into the organization's business processes
- Promoting the use of the process approach and risk-based thinking
- Engaging, directing and supporting people in the organization
- Providing necessary resources
- Promoting improvements
- Performing 'management reviews' at planned intervals to ensure continuing suitability, adequacy, effectiveness and alignment of organization's quality management system with the strategic direction of the organization.
Top management of the organization should identify objectives or goals the organization wants to achieve. Typical objectives or goals of an organization ma b following:
- Providing more efficient products and services
- Be more profitable
- Producing products and services that consistently meet requirements
- Achieving customer satisfaction
- More business for the organization
- Maintaining market share (business)
- Improving processes in the organization
- Improving communication in the organization
- Improving morale in the organization
- Reducing costs
- Reducing liabilities
- Reducing waste
- Reducing rework
- Increasing confidence in the production process
- Technical up-gradation
Top management needs to ensure that intended results are achieved. So, top management must take all possible steps to develop and implement ISO 9001:2015 QMS standard as per the requirements stated in the standard and determined by the organization.
Step 2 - Assigning responsibilities and authorities
ISO 9001:2008 QMS standard has a requirement to appoint a management representative to coordinate quality management systems activities. ISO 9001:2015 QMS standard does not have a requirement to appoint a management representative. However, the standard requires assignment of responsibilities and authorities for relevant roles within the organization. As such, top management of the organization should assign the responsibility and authority for :
- Ensuring that the organization's quality management system conforms to ISO 9001:2015 QMS requirements
- Ensuring that the organization's processes deliver intended outputs
- Reporting quality management system performance to the top management
- Reporting opportunities for improvement to the top management
- Ensuring the promotion of customer focus throughout the organization
- Ensuring maintaining quality management system's integrity while planning and maintaining changes to the quality management system
One or more persons can be selected and assigned above mentioned responsibilities and authorities or the top management can perform such role.
Step 3 - Establishing a steering committee
ISO 9001:2015 QMS standard does not mention requirement for establishing a steering committee, however, it is better a better idea to establish and set up a steering committee. A member of the top management of the organization should head the steering committee and other members of the steering committee should be:
- Persons selected and assigned specified duties as mentioned in step 2
- Department and functional heads
The steering committee should be responsible for the overall planning of the implementation process, giving directions and allocating resources. The members of steering committee should be trained on ISO 9001:2015 QMS by a professional trainer, consultant or training organization.
Step 4 - Establishing a task force
The steering committee should determine whether a task force is required and if determined then it should set up a task force with a coordinator. Its coordinator can be selected from persons selected and assigned duties as mentioned in step 2. The task force should be allocated the work of determining documented information and their creation.. It can also be assigned the job of: (i) identifying organization's risks, (ii) determine how critical each risk is, and (iii) determine actions to be taken.
The task force members should have good understanding of the organization's processes and also good communication-writing skills. The members of the task force should be trained on 'ISO 9001:2015 QMS' and specially on 'QMS Documented Information' by a professional trainer, consultant or training organization.
To be continued .....
Organizations, desirous of conducting or participating 'ISO 9001:2015 QMS Awareness' training, may contact your training and development partner.