An Implementation Strategy for ISO 9001:2015

Jeffrey Lewis, CEO, Safety in Your Hand, Inc., Palo Alto, CA, USA

Keywords: Implementation,  ISO 9001:2015,  Establish

Industry: Manufacturing

Level: Intermediate


Implementation of ISO 9001:2015 is perplexing even to the most experienced practitioners. The transition is seemingly difficult as potential adopters still think in terms of the Standard as ‘procedures’, identified by clause numbers. History has shown that past implementations were clause focused or the PDCA not applied or processes were ill-defined, as a process considered as a line between two functions. Process as it is defined within the standard, is perhaps the most mis-understood term in the Standard e.g the Corrective Action process is not the same type of process which requires a measurable objective. To the uninformed at their desk the Standard is the already prepared procedures. At their desk, company employees seldom see the Standard in order to understand the source of their procedures. Configuring the clauses is left up to a single person, without challenges on the interpretation of the respective clauses by the desk personnel. In other cases the Standard’s operation, was left up to the ‘Quality Manager’ as the sole person operating the Standard. In other instances, Quality Control Inspectors were appointed as ISO 9001 Manager, on the basis that the term ‘Quality’ was stated. In many instances the standard was applied as a ‘bolt-on’ to the existing practices- never really operating as a ‘system’, as is the intention of Management Standards. It was also observed external parties acted as Management Representative or periodically visited to look after corrective actions and/or analysis of data, all this without the engagement of the organization’s personnel. In practice the seven principles of Customer focus, Leadership, Engagement of People, Process Approach, Improvement, Evidence-based decision making, Relationship management are not widely incorporated into the language of Management Review – as a way of expressing the degree to which company’s has adopted these principles. The characteristics of these principles and possible actions referenced in ISO 9000 are not checked off to determine the extent that possible actions are met. Consideration of the principles is not part of the requirements for certification, although the principles are the foundation of the Standard. The intent of the Standard on the adoption by a company, is its demonstration as a way a company does business. Many companies are led to believe that auditor training lends itself to implementation that will enable effectiveness of the Quality Management System. Auditor training programs are just that, auditor training; and does not offer a methodology for implementation that drives opportunities for improvement towards on-going customer satisfaction. A specific strategy implementation strategy needs to result in the intended outcome to enable the standard to be a management system. 

This presentation demonstrates an implementation methodology to create a management system framework, which stands on the seven principles and assure registration in the shortest possible time.