Sandy Carson Hessen, Marketing Communication Manager, Pilgrim Quality Solutions
For more than half a century, the International Standard for Organizations (ISO) has been developing standards to protect society from potential errors. It’s been 26 years since the introduction of the Quality Management System standards model, ISO 9001, specifically.
The most current version, ISO 9001:2008 was adopted to address fulfilling regulatory requirements and customer satisfaction through continuous improvement of the quality system. The standards apply worldwide and provide consumers with a base-level confidence in an organization’s ability to provide conforming products. Theoretically, it’s been working, but for those concerned with quality, it certainly makes sense to evaluate whether there’s room for improvement.
A systematic review of ISO 9001 completed in March 2012 indicated that while there was still significant satisfaction with the current version of the standard, most people considered a revision appropriate. ISO’s Technical Committee (TC 176/SC 2) spent the last three years planning the standard’s next iteration which is expected to guide quality management system standards for, at minimum, the decade ahead. ISO 9001: 2015 is due for release this fall.
Ensuring a Passing Grade
The intention of the 2015 revision is to keep ISO 9001 relevant, reflect changes in its environment, and ensure it continues to deliver “confidence in the organization’s ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.”
According to ISO’s Technical Committee, the revised standard should (among other things):
- Remain generic, and relevant to all sizes and types of organization operating in any sector;
- Maintain the current focus on effective process management to produce desired outcomes;
- Take account of changes in quality management systems practices and technology since the last major revision in 2000;
- Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate;
- Apply Annex SL of the ISO Directives to enhance compatibility and alignment with other ISO management system standards;
- Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties;
- Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements; and,
- Provide a stable core set of requirements for the next 10 years or more.
A Primer for Quality
With these intentions met as a whole, global commerce should see a bump in overall quality levels going forward, but no one should panic that “everything is about to change.” For example, let’s focus on the last bullet point. The core set of requirements within the revised ISO 9001 standard will not differ from the current requirements. However, the language will be standardized, as will the approaches to management, based on the introduction of eight major quality management principles.
These principles were developed in the mid-1990s by a small group of experts who were familiar with the teachings and philosophies of the well-known quality gurus of the last century.
The eight principles are:
Organizations can establish this focus by trying to understand and meet their customers’ current and future requirements and expectations.
Organizations succeed when leaders establish and maintain the internal environment in which employees can become fully involved in achieving the organization’s unified objectives.
Involvement of people
Organizations succeed by retaining competent employees, encouraging continuous enhancement of their knowledge and skills, and empowering them, encouraging engagement and recognizing achievements.
Organizations enhance their performance when leaders manage and control their processes, as well as the inputs and outputs that tie these processes together.
System approach to management
Organizations sustain success when processes are managed as one coherent quality management system.
Organizations will maintain current levels of performance, respond to changing conditions, and identify, create and exploit new opportunities when they establish and sustain an ongoing focus on improvement.
Factual approach to decision making
Organizations succeed when they have established an evidence-based decision making process that entails gathering input from multiple sources, identifying facts, objectively analyzing data, examining cause/effect, and considering potential consequences.
Mutually beneficial supplier relationships
Organizations that carefully manage their relationships with suppliers and partners can nurture positive and productive involvement, support and feedback from those entities.
These principles form the conceptual foundation for the ISO portfolio of quality management standards and serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies. But these principles are not just the backbone of quality systems; they’re also simply good business principles to put into practice across an enterprise. The standardization of management approach based on them will be driving global improvement and process excellence for at least the next 10 years.
Ringing in the New Standard Era
Organizations can continue to audit their existing integrated management systems against the current revisions of ISO 9001 (2008 version) until September 2015. After that, with the ISO 9001:2015 standard in place guiding users toward better quality practices, organizations will find it easier to incorporate their quality management system into the core business processes and gain greater business benefit.
Putting it all into Practice
Like the eight quality principles, an automated enterprise quality management system built on the ISO standard has far-reaching impact on the total operation of an organization. SmartSolve® quality management software from ISO 9001-certified Pilgrim Quality Solutions, provides the tools to automate quality processes but also makes it easier to deploy them across an organization’s entire value chain, impacting the opportunity for success from top to bottom.
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