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Inderjit Arora

Standards

Use PDCA to Meet ISO 9001:2015 Revision Deadlines

Ensuring that the system positively contributes to the organization’s bottom line is important

Published: Tuesday, November 7, 2017 - 12:00

With the cutoff date of Sept. 15, 2018, looming for transitioning to ISO 9001:2015 and ISO 14001:2015, there will be organizations chasing certificates. However, certificates can’t improve the system, guarantee better products, or render better service. The fundamental changes to the ISO standards will positively affect business outputs if implemented correctly. However. There’s the possibility that the pressure of deadlines hanging like the sword of Damocles over leaders may result in hurriedly obtained but ultimately worthless paper certificates. Leaders may want to give this a thought as they manage their organizations’ transition or first-time implementation of the standards.

It’s the organization’s well-implemented management system that will enable employees to perform well and produce conforming outputs. The changes in ISO 9001, ISO 14001, as well as the 2016 high-level structure (HLS) revisions to the AS9100 family of aerospace standards, need timely and correct implementation. The changes in these new revisions involve a fundamental rethink of the approach to implementation.

There is a call to make ISO standards’-based management systems more proactive by considering risks within the context of the organization, keeping the priorities of interested parties in mind, and managing the internal issues that need planning and thought. Organizational knowledge, per clause 7.1.6 of ISO 9001, needs deliberation to determine how that knowledge can propel the organization to better performance and risk management, and lead to innovation. A robust quality management system (QMS) is an asset that should deliver.

This transition phase requires expertise in correctly interpreting the standard and identifying gaps in the system while respecting the “as-is” of the system. This must be followed by systematic incorporation of the changes within the context of the organization. Using the plan-do-check-act (PDCA) cycle can help. The (good) plan stage must be followed by orientation, motivation, and correct implementation during the do stage, followed by an audit during the check stage to ensure that the system is not only functionally aligned but also meeting the requirement of clause 5.1.1 b and c (i.e., that the QMS is compatible with the strategic direction of the organization). Per clause 5.1.1, there is a tremendous amount of responsibility for top management to ensure a customer focus throughout the organization.. The act stage of the PDCA cycle come about through the management, which is require per clause 9.3 of the standard. This review must be done soon after the transition audit to give confidence to top management that the system will work.

This additional emphasis in the revised standard to ensure the system positively contributes to the organization’s bottom-line is  important. Nonconforming outputs must be reduced and not leave the organization as defective product or services. To do this,  it’s important to consider the following:

Risk based thinking must become second nature to the organization so that risks are managed and analyzed to consider opportunities for improvement. Outsourced procedures and services must perform to expected standards to meet customer requirements. The work environment, per clause 7.1.4, should ensure that processes achieve product and service conformity to requirements. The combination of competence (clause 7.2), awareness (clause 7.3), a knowledgeable workforce (clause 7.1.6) that can ensure controlled production and services (clause 8.5.1) is a responsibility of top management.

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About The Author

Inderjit Arora’s picture

Inderjit Arora

Inderjit Arora is the president and CEO of Quality Management International Inc. (QMII). He serves as a team leader for consulting, advising, auditing, and training regarding management systems. He has conducted many courses for the United States Coast Guard, and is a popular speaker at several universities and forums on management systems. Arora is a Master Mariner who holds a Ph.D., a master's degree, an MBA, and a 32-year record of achievement in the military, mercantile marine, and civilian industry.