ISO 9001 Implementation and Process Definition
Why ISO 9001?
ISO 9001 accreditation has huge advantages for any organization since the model touches best practices from various process faculties. ISO certification (Quality Management System) will lay a strong foundation and a conducive environment for the effective Continual improvement Process.
Identify the reasons for going for ISO 9001 certification.
It is mandatory for any organization to introspect the need for the ISO certification, but there should not be any second thought in practicing the ISO Processes. ISO certification may be obtained to satisfy Customer requirements or to have a marketing edge over others. However, Process approach and Engineering Methodology are vital for survival of any organization.
The 2015 version of the standard requires that top management demonstrate to all interested parties that the organization is committed to quality.
Strategy definition and Quality Policy. Our ISO 9001 Consulting services include all these steps.
The most important aspect of any management system implementation in general, and ISO 9001 Quality Management System (QMS) in particular, is to come out with a Quality Policy statement by the senior management to show their commitment towards QMS and drive the quality system initiative. While the top Management is primarily responsible, participation from the tactical and operational levels in establishing the Quality Policy, is encouraged. The requirements of the quality policy must be measurable so that we can demonstrate continuous improvements.
Planning resources and time lines.
The senior management of any organization striving for ISO 9001 implementation certification, should commit resources both human and technical for the team to achieve the compliance. The time frame should be set keeping in mind the realistic and practical situation so that there may not be any surprises during implementation lifecycle. A formal implementation project plan is required by ISO 9001, to identify needs and check implementation progress.
While the Quality system is developed, the implementation project plan should be reviewed by senior management regularly.
Identify Processes and their Interaction.
As per the 7 Quality Principles of QMS, the organization should identify various process which are relevant to the quality systems and also establish the interaction among those processes.
The various processes that are applicable in general to organizations are management processes, engineering processes, Human Resource processes, Admin and IT Admin processes, Audit Processes, etc. Adequate resources needs to be provided by senior management to ensure these processes are carried out and their interactions targeted towards the quality objective of the organization.
Training needs.
ISO 9001 requires that awareness and competence of employees coming within the scope of the Quality Management System, are essential for effective implementation of QMS. Training needs are identified for all levels based on Skill Matrix. The other most important aspect of the training is to measure and demonstrate the effectiveness of training.
Develop documentation.
ISO 9001:2015 requires mandatory documentation of the Scope of the Quality Management System, a Quality Policy, Quality Objectives, Management Review process, Project Planning SOPs, Operation Processes, Measurement and Audit Procedures.
Apart from Process definition, there could be requirements for templates, Checklist, guidelines etc. to ensure ease of QMS implementation.
Usage of tools is also encouraged to maintain the version control and integrity of the documents. These tools may be used to demonstrate the evidences during Audits.
Implementing the QMS, Measurement, Internal Audits and Management Reviews
Once the QMS has been developed, it should be implemented and the Quality facilitators identified within the organization. Implementation of QMS is applicable for all types of Projects mentioned in the scope document. During implementation of QMS Quality documented information or records will be generated which are subjected to Audits both from Process and Work product perspective. During this stage there are measurement points from which Process Data will be collected with respect to Process and Product Quality Also there are measures for Project Management related data which will be collated to study the nature of Process Stability across Project.
The Metrics sheet will be planned at the beginning of ISO initiative to align with Quality Goals and Objectives.
Internal Quality Audits are conducted at frequent intervals based on the Organization Strategy and the nature of QMS implementation. Each Audit is followed by Management Review meeting to discuss the agenda points including Audit Results.
The results of Audits are shared to the relevant stakeholders and the deviations are addressed. Periodically a SWOT Analysis is performed by the Software Quality Assurance team to study the trend of Quality Processes.
Independent Audit by a 3rd Party
This is not a requirement of ISO 9001 standard; but an independent audit of the various processes and their compliance towards ISO 9001 will be extremely useful to assess the strength and weaknesses of the Quality System objectively. These types of audits are not mandatory as per ISO 9001 standard but could be done at periodic intervals preferable before certification and surveillance audits.
Certification Audit.
This Audit is carried out by the certification body (IRCA). The findings during the certification audit are addressed by the organization for continual improvement and subsequent Surveillance Audits.
