Use PDCA to Meet ISO 9001:2015 Revision Deadlines

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

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.

By CEO and President, Captain Inderjit Arora

The Cost of Certification: A deterrent to system implementation?

Certifications often drive the implementation of a system approach, based on ISO standards. The primary implementation demand is for ISO 9001.

Certifications do have initial costs and then recurring costs for surveillance and re-certification visits. This is a responsive approach to business requirements, invariably driven by a forthcoming contract that mandates the system approach. Prudent businesses appreciate the risk of not having a process-based system.

When budgets are tight, supply chains are challenging, and retaining employees is difficult, it is all the more essential that organizations invest in a good management system. As W. Edwards Deming said, “A bad system will let down a good person every time.”

An efficient management system should be an essential asset of any good organization. Certification should not be the primary driver of this requirement. The optimum return on investment is by effective process performance based on objective information analysis, which in turn is based on data from within the organization or an appreciation of inputs publicly available. Organizations’ leaders should look beyond certifications to implementing and maintaining systems that drive continual improvement. Continual improvement drives organizations to find cheaper and quicker solutions while improving the quality of their products and services. After all, is that not what customers expect? The best quality for the cheapest price point?

Organizations can, and should, consider the option of self-declaring their conformity to ISO 9001, without incurring the added expense of certification, especially when customer requirements do not mandate it. Meeting customer requirements, ensuring continual improvement, and leading the organization to innovate cannot be achieved without a system in place. Effectiveness and efficiency is achieved when employees use system processes to achieve objectives. Customers’ confidence in the organization comes from trusting that they will receive conforming products/services consistently. The cost of not following a system approach can lead to work performance that is not optimized and results in losses.

ISO 9001:2015 requires an appreciation of the context of the organization, as well as the risks and expectations of the interested parties. This enables the organization’s leaders—in fact, requires them in clause 5.1.1 b—to define quality policy and objectives for the quality management system (QMS) that is aligned to the strategic direction of the organization. The QMS now is not an add-on to the business strategy but is integrated with it.

Experience has repeatedly shown that the lack of customer focus is the major cause of businesses failing or not performing, of governmental agencies overshooting budgets, and sensitive organizations (e.g., nuclear facilities, military bases, hospitals) making fatal errors. The cost of not having a system is so high and the consequences so dangerous that it would be almost suicidal not to have a management system in place.

Once the decision to implement the system has been made, why reinvent the wheel?

The well-tried, regularly updated ISO 9001 standard, which encompasses years of global wisdom, is the correct choice. Once the system is implemented and the organization’s leaders have confidence in the system’s performance based on objective inputs (such as audits, inspections, feedback, and other inputs), top management can self-declare the system as conforming to ISO 9001. There is no cost to this except the minor investment in using a competent consultant who comes in respecting the existing system and then identifies and addresses any gaps. After all, every functioning organization has a system.

The next stage, requiring investment in the certification, is a decision to be made by top management when a business requirement necessitates this. When it does, then the work will pay for it.