ISO 9000 - An Integrated Approach

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Business Strategy
The decision to obtain ISO 9000 certification is based on a variety of reasons both at the strategic as well tactical level -

• At the strategic level, ISO implementation decisions are based on parameters such as obtaining international acceptance for the products/services, maximizing customer satisfaction, reducing lead times and demonstrating management commitment towards quality
• At the tactical level, the decision to implement ISO is based on factors such as contractual requirements of the customer, pre requirement to do business in a specific nation or business segment

Implementation of ISO 9000, if done properly, is a sound business strategy and has a significant impact on the bottom line. In addition to improving product/service quality, it helps in lowering costs in terms of reduced wastage, more efficient process and reduced lead time.

Implementation Efforts
ISO 9000 implementation requires resources in terms of time, effort and management bandwidth. While it is true that successfully executed implementations improve bottom line, there are number of issues to be tackled and pitfalls to be avoided to realize the benefits.

The common pitfalls associated with the implementation efforts -

• Lack of Top Management support - No commitment and support from the top with a superficial dedication to adopting the quality culture
• Lack of Understanding about the existing processes - Mistake of recreating the processes/procedures/documentation solely for the purpose of certification instead of understanding how existing procedures currently meet business requirements
• Lack of clear communication - No clear communication of the objectives/rationale behind the ISO 9000 efforts and how it impacts business
• Failure to involve everyone in the process - Failure to involve people/end users who will be affected by the implementation
• Lack of follow-up /Review - Ineffective monitoring of the progress of the implementation schedule and inability to enforce deadlines
• Over documentation - Creating huge amounts of documentation and procedures for the purpose of registration rather than for the use of the people in the process
• Lack of Validation - Failure to conduct internal audits in an unbiased atmosphere to understand why the procedures may not have been implemented
• Premature implementation efforts - No gap/requirements analysis before implementation efforts and rushing to registration to compress time cycles before being ready for it
• Lack of organizational fit - Redesigning the workflow/business processes may help in complying with ISO certification requirements, but may not fit with the organizations culture or method
  of doing business.
• Not selecting the right registrar - Selection of consultants/auditors who do not understand the business of the organization

ISO certification process is biased towards standardized procedure and requires that all changes must be well documented and effects on all other elements in the process must be both considered and documented. While such review may be a good thing, the increased level of paperwork is likely to discourage innovative changes or restrict creativity.

Successfully executed ISO implementation efforts contain the following elements -

• Project Team, Management Committee - Formation of a project team and management committee to supervise and monitor the implementation milestones, assist in solving problems faced during implementation and to provide overall direction to the efforts
• Identify, Document and Understand - Identification, understanding and documentation of the current quality management processes and systems
• Gap Analysis - Identify and understand the gaps between current processes and required processes under ISO certification
• Development and Documentation of polices - Develop a manual describing the organization, quality mission, responsibilities and policies for each element of the business and describe the purpose and scope of each activity the company performs
• Identify and Develop Procedures - Identification and development of procedures which meet the business needs of the organization and its comparison with ISO 9000 to determine whether requirements are being met or not
• Implementation Milestones - Implementation of identified procedures with defined milestones in terms of time as well as procedures modification
• Audit - Performing internal audit to evaluate whether procedures are being understood and followed by end users.
• Third-party Registrar - Pre-assessment by a third party registrar to identify and sort out any possible obstacles to registration
• Review - Review by registrar to see whether the organization meets the ISO requirements
• Assessment - Final assessment by registrar for ISO certification

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