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ISO 9001 (2015 Update)

ISO 9001 Quality System New Revision Update 2015

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ISO 9001:2015 Quality Management System Requirements

This article on the newly revised ISO 9001 Quality Management System provides a down to earth explanation, predominantly to business owners who have companies already registered to ISO 9001:2008.  It is with the understanding that there are many other reference documents, particularly online, that go into greater detail on this topic but the authors have taken a different approach for ease of understanding…and eventual implementation.

ISO 9001:2015 represents a major shift of emphasis from ISO 9001:2008.  Quality Management now resides in the front office as opposed to its prior home with middle-management.  There is an overall focus on risk based thinking and planned actions aimed at preventing undesirable outcomes.  There are no longer the infamous requirements for documented procedures.   Many questions are being raised regarding how to perform a 3rd party audit.  The days of easy, canned and generic efforts with template software or checklists will no longer be effective and thus, there is a clear need for a more customized approach to deployment and implementation.

Here are some specific changes, and they include:

  • The term “products and/or services” replaces “products. It is by default that this new version of the standard is now expanding to other business sectors not exclusive to manufacturing as an example. Many companies also provide service aligned with their products.
  • A new clause structure as to attain alignment with other ISO standards now exists.
  • The elimination of the “designated management representative”, making this a truly, company-wide initiative, and placing the ultimate responsibility where it should be at the executive levels of the organization:
    • Makes top management totally responsible. This will direct third party auditors to top management during visits instead of the designated management representative.
    • Quality belongs to everybody in the company as it should be and not just to one person.
    • The requirements now require the company to “maintain documented information” of 17 specified records and three specified documents. They are the Scope Statement, Quality Policy and the Quality Objectives. Most companies already have this in place and this is a plus. There is no specific requirement for a Quality Manual…but it may pose problems for third party auditors. They will now have to gain a deeper understanding of the business and its management system.
  • There is an increased emphasis on the Scope Statement with its new title for Clause 4, Context of the Organization. This emphasizes the new role (involvement) of top management as previously stated. It also points to the alignment with organizational strategies and goals:
    • Section 4.1: Understanding the organization and its context
    • Section 4.2: Understanding to needs and expectations of interested parties (internal and external)
    • Other: Determining the scope of the Quality Management System (QMS)
  • A clearly specified top management role, as defined in Clause 5, Leadership
  • A new Clause 6.1, Actions to address risks and opportunities:
    • With the elimination of “Preventive Action”, the thinking of risk management is now spread throughout every process in the company.
  • A more vigorous Clause 6.2, Quality objectives and plans to achieve them is established.
    • In the past, quality objectives were mostly “lip-service” ISO 9001:2015 presents a clearly defined plan of action as to the resources, responsibility, schedule, and so forth. Basically, who does what by when and how.
  • The previously categorization of records, documents, procedures, etc. is now categorized as “documented information”:
    • This stresses controlling only, as appropriate, distribution, storage, revision, retention, disposition and other important aspects as specifically needed by that unique process
  • Finally, an increased focus towards external providers of products and services is established. Formerly, this was under the Clause of Purchasing and treated as a secondary level of importance. In today’s world, supply chains are becoming more integrated, dependent and leveraged for an organization to succeed by being more competitive in terms of delivering its products or services, on time, within budget, with high quality, exceptional customer service and enhancing the value of the business.

Conclusion

ISO 9001:2015 Quality Management System is now here to stay and with it, a more effective and efficient standard that will enhance the performance of businesses in terms of long term profitability, quality of work life, customer loyalty and employment security.

ISO 9001 (revision update 2015)

Arthur Gold and Nelson Wax co-wrote this article.  Art is an internationally recognized expert in the field of ISO 9000 terminology. He has served as a United States delegate of the International Committee ISO TC 176, formulating the core of ISO 9000 quality standards. Arthur has aided numerous companies to implement and deploy effective, registered ISO 9001 compliant systems.  Nelson is a Certified Management Consultant and an ISO 9000 Quality Systems Auditor. His expertise is in the area of Organizational Leadership, Manufacturing Operations and Performance Improvements. He has successfully assisted many businesses in building more value from their operations. Nelson, as an example, had facilitated a manufacturing organization to win the annual U.S. Department of Commerce “National Minority Manufacturer of the Year” award.

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