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

The first step in the actual implementation is for top management to define and write a formal document containing the Quality Policy and Objectives as per the requirements of the ISO 9001:2015 standard. 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.

Resources should be made available and realistic time lines set to ensure that the QMS can be implemented within a reasonable time. Segregation of duties and responsibilities should be shared within the organization and as top managements is ultimately responsible. 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.

Identity Processes and their Interaction.

A key requirement of ISO 9001 is that there is a need to follow a process-based approach, prescribed in 7 Quality principles. We need to describe the interaction between the processes within the organization. A simple process map specific to your company can be used for this.

For each key process, identify the controls, resources, records and documentation, input & output needed to meet requirements. This process map is validated across the complete business to ensure no interactions or areas are missed out.  This process map should be used, reviewed and updated during all stages of implementation and should eventually be included in the Quality system.

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.

Pre-Assessment Audit.

This is not a requirement of ISO 9001 standard; however, a pre-assessment audit by the certification body will help to identify any gaps between the requirements of the standard and your existing processes. This audit can be done at any stage and does not form part of the certification process.

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.