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By Curtis Lopez, Missouri Enterprise Project Manager and ISO Expert

The changes in ISO 9001:2015 are here, and they include a big adjustment in how companies view their Quality Management Systems.  You may have heard the statement, “No more quality management department!” to describe those changes.  It’s a great sentence that captures the essence of the evolution to the new ISO 9001:2015, because now, everyone is responsible for quality, from top management, to middle managers, plant people, machine operators, back-office personnel…everyone has a part to play.

To effectively achieve and fully implement this cultural change in the new ISO standard, manufacturers need to align their organization’s strategy, business processes and quality management systems to create a written Strategic Plan that defines the actions needed to achieve the right goals and to effectively communicate those goals to the entire organization.  The Strategic Plan needs to put everyone on the same page towards managing, achieving and maintaining quality.

Developing an effective Strategic Plan is not a simple thing.  It takes time and effort to produce, and it takes critical insight into how your company operates on a day-to-day basis today, so you can see where improvement needs to occur for tomorrow.  Because of the importance of truly understanding your company’s strengths and weaknesses, the help of an outside expert in ISO 9001:2015 can be an invaluable asset for developing your strategic plan. 

An expert will guide you through the Strategic Planning exercise, keep you on track for completion and offer you those critical outside eyes that will see things people may have missed or ignored or swept under the carpet.  Candor is critical to the assessment phases of Strategic Planning.

Here are some very basic phases of the Strategic Planning process, followed by an illustration of other critical steps in the exercise:

  1. Analysis / Assessment – Develop an understanding of the current internal and external environment.
  2. Strategy Formulation – Create and document a high level strategy and a basic organizational level strategy.
  3. Strategy Execution – Translate the plans into action, where more operational planning and specific action items are identified and addressed.
  4. Evaluation / Sustainment / Management – Perform ongoing refinement and evaluation of performance, culture, communications, data reporting, and other strategic management issues. 

KSFs and KPIs

As part of the Strategic Planning process, organizations are tasked with identifying their Key Success Factors (KSFs). A way to think of Key Success Factors is to view the business from the market and customer perspective.  What functions, activities or business practices are valued and demanded by market conditions and customer needs?  What must the company must do to compete in the market and to be perceived by the customer as adding value to the business relationship?  What factors are important in the customer decision-making process that generate orders?  Why does the customer select your company over the competition?

Once KSFs are defined, then Key Performance Indicators can be developed to support your organization’s strategic direction. KPI’s are performance measures that indicate progress toward a desirable outcome. Strategic KPIs monitor the implementation and effectiveness of an organization's strategies, determine the gap between actual and targeted performance and determine organization effectiveness and operational efficiency.

Good KPIs…

  • Provide an objective way to see if strategy is working.
  • Offer a comparison that gauges the degree of performance change over time.
  • Focus employees' attention on what matters most to success.
  • Allow measurement of accomplishments, not just of the work that is performed.
  • Provide a common language for communication.
  • Help reduce intangible uncertainty.
  • Are valid, to ensure measurement of the right things.
  • Are verifiable, to ensure data collection accuracy.

What is a Strategy?

The term “Strategic Planning” implies the employment of a “strategy”, so lest we assume everyone truly knows what a strategy means in its fullest business sense, let’s take a moment to define it.  A strategy is all about integrating organizational activities and utilizing and allocating the limited resources within the organizational environment so as to meet the present objectives. 

While planning a strategy it is essential to consider that decisions are not taken in a vacuum and that any act taken by a firm is likely to be met by a reaction from those affected - competitors, customers, employees or suppliers. Strategy can also be defined as knowledge of the goals, the uncertainty of events and the need to take into consideration the likely or actual behavior of others.

ISO 9001:2015 Changes are here NOW.

As stated earlier, the Strategic Planning process takes time and effort, and if you have yet to begin planning for implementation of the changes in the new ISO 9001:2015 standard, you need to get moving right now.  If you’ve begun the process and aren’t moving quickly to meet your objectives, you need to push for completion now.  Either way, consider the value and return on investment you’ll get from bringing in an outside expert like Missouri Enterprise to help your organization through the Strategic Planning process to meet the new ISO 9001:2015 standard.

Strategic Direction as Currently Stated in ISO 9001:2015

Clause 4.1 The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affects its ability to achieve the intended results of its quality management system.

Clause 5.2: Top management shall establish, implement and maintain a quality policy that is appropriate to the purpose and context of the organization and supports its strategic direction.

6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.

The quality objectives shall:

a) be consistent with the quality policy;

b) be measurable;

c) take into account applicable requirements;

d) be relevant to conformity of products and services and to enhancement of customer satisfaction;

e) be monitored;

f) be communicated;

g) be updated as appropriate.

The organization shall maintain documented information on the quality objectives.

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

a) what will be done;

b) what resources will be required;

c) who will be responsible;

d) when it will be completed;

e) how the results will be evaluated.

Clause 9.3: Top management shall-review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.