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Patel’s Perception Creating Value for the Customer is the Most Important Component for Long Term Business Success

From the very beginning, when I started in the field of engineering and quality, my focus was always on doing it better…and to do that, I had to know our customer’s needs. Taking an eye off of that means taking a step off course. Just ask Chrysler, Apple, or a former employee of Digital Equipment Corporation. Value your customer, your people, and then your business; the rest will follow.

There are many tools and techniques we use to enable our clients to best determine their course, their goals, and their strategy. The key to their success is our laser focus on what their customers want and what the future issues might be. Is everything aligned? Our program starts at the beginning, doing a gap analysis to determine how and what the plan is for meeting your goals. We can help build on current and future plans to meet your needs, keeping resources and staffing in mind. We provide training to all levels of staff from management to the production line employee, with your goals in mind.

Whether it be improvement in product, service, cost performance or systems, we have the proven knowledge and expertise in all Management Systems as well as creating customized master plans to achieve and maintain it to your needs, at your pace and at a reasonable cost to you. Need a registered business system to build sales? QPS has Exemplar and ASQ certified professionals who have successfully completed documentation, trained workforces and helped clients achieve first time ISO 9001 registration in less than six months! Need to get lean? Our Master Black Belts and PMP/Agile consultants and trainers will enable you to build on your bottom line in weeks, not months. We help manage any culture change; building confidence in the system and support management to make your business systems successful. Contact us today to create the program to build real value in your product, your processes and your business.

In this Issue • • •

Transitioning from ISO 9001:2008 to ISO 9001: 2015

Page 2-4

NEQC Conference Fun Page 5

November 2016

“To add value to others, one must first value others.”

- John Maxwell

Experts in Lean Six Sigma, Management Systems, Supply Chain, Project Management & Professional Development

November 2016

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Transitioning from ISO 9001:2008 to ISO 9001:2015 by Jay P. Patel

The ISO 9001 standard was just revised in September, 2015, by the International Organization for Standardization (ISO). Companies have until September 2018 to be certified to the most recent version of the ISO 9001:2015 Standard. At the outset, ISO 9001:2015 has taken a different approach to the way in which its requirements are stated, when compared to the ISO 9001:2008. Consequently, there should no longer be any technical reasons for an organization's QMS not to be able to meet all the requirements of the future standard.

Why The Radical Changes to ISO9001:2008? To make it really generic and applicable to all types of organizations producing any type of product or services, ISO 9001:2015 aims to:

• Harmonize Management System Standards such as QMS, EMS, En-MS, ISMS, FSMS, ITMS and OHMS

• Eliminate Unnecessary Documented Procedures Requirement • Introduce Risk Based Thinking • Introduce Common Text, Common Structure and Common Terms

Scope Modified There has been a perception that the ISO standard continues to be biased towards manufacturing-type organizations with "hardware" products as it uses the term “Product.” To make the standard relevant to the service sector, ISO 9001:2015 is enhanced by introducing “Goods & Services” deliverables for the customer in the place of “Product” (Clause 1.0).

The Scope under ISO 9001:2015 must demonstrate: • Commitment to Enhance Customer Satisfaction • Commitment to Continual Improvement of the System • Commitment to Meet Customer and Regulatory Requirements

Context of the Organization In order to make development of the quality management system (QMS) sound, two new clauses have been added in ISO 9001:2015:

4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties

These clauses require the organization to determine the issues and requirements that can impact the planning portion of the QMS. The organization shall determine the boundaries and applicability of the quality management system to establish its scope.

While stating the scope, the organization shall document and justify any decision not to apply a requirement of this International Standard and to exclude it from the scope of the quality management system. Any such exclusion shall be limited to clauses 7.1.4 and 8 and shall not affect the organization’s ability or responsibility to assure conformity of goods and services and customer satisfaction, nor can an exclusion be justified on the basis of a decision to arrange for an external provider to perform a function or process of the organization.

The organization shall focus on the following relevant interested parties, in addition to any other relevant interested parties it identifies:

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a. Direct customer b. End users c. Suppliers, distributors, retailers or others involved in the supply chain d. Regulators

The Process Approach While ISO 9001:2008 considered the process approach, it was very generic in nature. ISO 9001:2015 introduced clause 4.4.2, whereby it is setting explicit requirements to be addressed, such as:

• Determine the processes needed for the quality management system and their application throughout the organization, including the sequence and interaction of these processes, the inputs and resources required; ensure their availability and the outputs expected from each process

• Determine the risks to conformity of goods and services and customer satisfaction, if unintended outputs are delivered or process interaction is ineffective

• Determine the criteria, methods, measurements, and related performance indicators needed to ensure that both the operation and control of these processes are effective

• Identifying and assigning responsibilities and authorities for processes • Implementing actions necessary to achieve planned results • Ensuring that these processes are monitored, analyzed, and changed if needed in order to

continue to deliver the intended outputs • Ensure continual improvement of these processes

The Leadership ISO 9001:2015 requires a more stringent leadership commitment. This can be demonstrated through:

• Ensuring that quality policies and quality objectives are established for the quality management system and are compatible with the strategic direction of the organization

• Ensuring the integration of the quality management system requirements are incorporated into the organization’s business processes

• Communicating the importance of effective quality management and conforming to the quality management system requirements

• Directing and supporting persons to contribute to the effectiveness of the quality management system

• Ensure that even without a designated ISO Management Representative, more prescriptive activities are achieved and demonstrated

The quality policy shall be: • Available as documented information • Communicated within the organization • Available to interested parties, as appropriate • Measurable through goals and objectives • Reviewed for continuing suitability

Planning QMS ISO 9001:2015 mandates not just to plan for Quality Objectives but plan to achieve them with the application of risks and opportunities plus change planning by taking actions to address risks and opportunities.

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While planning the QMS, it is required that the quality objectives be: • consistent with the quality policy • relevant to conformity of goods and services and customer satisfaction • measurable (to practicable limits) • based on applicable requirements • monitored, communicated and updated as appropriate

Documented Information ISO 9001:2015 has done away with the term “Document” and “Records” replacing them with “documented information” throughout the requirements text. It is explicit in terms of the documented information, as:

• Evidence of focused documents with clear requirement, responsibility and evidence of conformity

• Develop evidence providing documents/forms/checklist • It is available and suitable for use, where and when it is needed, and • It is adequately protected

For the control of documented information, the organization shall address the following activities:

• distribution, access, retrieval and use • storage and preservation, including preservation of legibility • control of changes (e.g. version control) • retention and disposition

Operation and Its Measurement ISO 9001:2015 requires that the organization shall plan, implement and control the processes needed by:

• Establishing criteria for the processes • Implementing control of the processes in accordance with the criteria, and • Keeping documented information to the extent necessary to have confidence that the processes

have been carried out as planned.

It also requires that operational performance is evaluated by: • Monitoring, measurement, analysis and evaluation of critical processes • Monitoring measurement and analyze of Customer Satisfaction data • Capturing process performance metrics which drive comprehensive improvement • Undertaking periodical Internal Audit • Planning and carrying out Management Review

The ISO 9001:2015 is thus more focused on the ongoing, continual improvement of the entire QMS system. The organization shall strive to continually improve the suitability, adequacy and effectiveness of the quality management system. The organization shall evaluate, prioritize and determine the improvement to be implemented. A detailed synopsis of changes can be found on our website, http://www.qpsinc.com/resources/. If you have any questions, we would love to help! Contact us today and learn how the changes will affect your business. We make life easier and less complicated.

–Jay Patel

“…more focused on the ongoing, continual improvement of the entire QMS system.

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61st NEQC Conference World Class Global Management System: Performance thru 6Ps

October 3, 6-7. 2016

At top: Keynote Speakers with QPS President Jay Patel—Dr. Joseph

DeFeo, Chairman and CEO of Juran Global, and James Wade, VP Mission Assurance of Raytheon Company. Bottom left: On tour at Dunkin Donuts, bottom right: Sanjay and Jay Patel with NEQC Speakers and Members