Evaluate the Organization’s need/goals for Implementing a QMS
Identify the goals which you would like to achieve through a QMS (iso 9001), such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing or implementation of a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
Awareness and Training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals, on procedures, on QMS planning, on how to identify and implement improvement processes and on how to audit compliance with the QMS, etc.
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including planning for any additional resources required.
Product realization processes
.Design and development
.Production and Service Provision
.Control of measuring and monitoring devices
.Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
Planning a time frame
Prepare a complete plan to close the gaps identified to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. The total time required for each phase (planning, documentation,implementation and evaluation) depends on the extent of the gaps in your existing QMS.
Draft a Quality Manual
An organization’s Quality Manual should:
Include how the QMS applies to the products, processes, locations and departments of the organization. Exclude any requirement with justification for doing above.Refer to or include documented procedures for QMS. Describe the interaction between the processes of the QMS, e.g. the interaction between product realization processes and other management, measurement and improvement processes. Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use. The effective date of implementation should also be decided.
Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit,the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.