Now that we are solidly in the new 2015 year, we should start getting ready for the new ISO 9001:2015 standard that is currently under final construction. This is the first in a series of articles that will be published by the Quality Institute of America (QIA), aimed at helping organizations understand and implement the new standard.
ISO 9001 is one of ISO’s most well-known standards, with more than 1.1 million certificates worldwide. ISO 9001 is undergoing the periodic revision standards generally go through every 3 to 5 years to ensure they are relevant and up-to-date. The new edition, expected in 2015, will feature some important changes.
The latest draft (Draft International Standard – DIS) was approved with a 90% favorable vote in October 2014, and is now in progress to the next stage: Final Draft International Standard (FDIS), which is expected in spring of 2015. Once the FDIS is published, only ‘finishing’ touches are made to get to the new International Standard, which is expected towards the end of 2015. Based on these time-tested assumptions, we are presenting what has been already published in the DIS, as a pretty accurate predictor of what will be in the actual International Standard.
The new version is very strongly based on three basic core concepts:
- process approach (product is the result of a process), first reinforced and popularized with the 2000 version.
- plan-do-check-act methodology, which has been found to be the bed-rock of sound management principles resulting in control that yields predictable performance, and continual improvement
- a third core concept which is new in the 2015 version is risk based thinking, aimed at preventing undesirable outcomes.
Milestones in Quality System Standards (including Military Standards)
– Progression from (customer) command & control to more and more self-governance
- 1987 and 1994:
– Task oriented- 9001, 9002, 9003
- 2000 and 2008:
– Process based, emphasis on customer satisfaction, more inclusive of non-manufacturing organizations
– Annex SL, uniformity across all MSS (Management System Standards): Quality, Environmental, Safety, IT Security etc.
– All MSS will have 10 sections, with section number 8 that will have requirements
Notable Changes in Draft International Standard (DIS:2014)
- 7.1.6 Organizational knowledge- New concept of determining necessary knowledge for operation of processes and conformity of products and services.
- 7.5 Documented information- Essentially combines requirements for documented procedures and records into one section with similar treatment.
- 8.4 Externally provided products and services– incorporates requirements of purchasing and outsourcing into one; includes products from customers
- Some specific requirements have been dropped from ISO 9001: 2008– ISO 9001:2015 may not be as prescriptive in requiring certain documents or specific roles. As examples:
- Quality Manual-not specifically required, nor mandated as to its content.
- Documented Procedure-none specifically called out, but left to the organization’s determination and needs. (4.4, 7.5.1).
- Preventive action-not a specific clause/record moving forward, but effectively usurped by the “Risk Based Approach” to be applied throughout the QMS.
- Management representative-not specifically called out as an individual having the sole responsibility and authority for the QMS; now considered part and parcel of the organization’s leadership and top management (5.1.1,5.3). Some related changes:
- Clause 5, previously “Management Responsibility”, now becomes “Leadership”.
- There is a need for top management to be actively involved in the operation of their quality management system.
- The removal of the role of “management representative” reinforces need for quality management systems embedded into routine business operations
- Discourages operating as an independent system in its own right with its own dedicated management structure.
- Some specific changes DIS 9001:2014
- Clause 10 title changed to “Improvement”: Improvement not only consists of incremental (continual) improvement, can also arise as a result of periodic breakthroughs, reactive change or as a result of reorganization.
- Two new clauses (4.1 and 4.2) are introduced relating to the context of the organization.
Identify explicitly any internal and external issues that may impact their quality management system’s ability to deliver its intended results.
- Understand the needs and expectations of “interested parties” – those individuals and organizations that can affect, and/or be affected by, organizations decisions or activities.
- Greater emphasis on the definition of scope of the quality management system.
Clause 4.3 requires scope to be determined in consideration of the organizations context. Scope sets the boundaries for, and identifies the applicability of, an organizations QMS.
- References to a documented quality manual, documented procedures and to quality records have been removed. Instead, throughout DIS 9001:2014 there are specific references to “Documented Information”. This is information that the organization is required to keep, control and maintain. How it wishes to record this information is up to the organization itself.
- Several of the familiar requirements from 1987 to 2008 versions are no longer specifically mandated. Underlying principles and requirements are common sense, and are still required by implication. Companies are empowered to decide how they will meet the underlying requirements.
- None of the original requirements have been “banned”. Companies must still comply--- they need to figure out how. The old methods are just fine, if that’s what you want to use.
- There are net additions: Formal requirement for new processes for Risk Management, Management of Change and Contingency Planning.
The above has been a summary of the new standard, presented in relation to the current standard. The next instalment in this series of articles will go into details of the new (draft) standard, and will help you understand the full standard spread over several such instalments. We will also suggest several methods for dealing with the changes. Over the next few months, you will have collected all you will need to solidify your plans for the new standard. Incidentally, we have already included new modules in our QISS software that will address the topics of risk assessment, contingency planning and management of change.
Quality Management System Software QISS provides the Central Quality Nervous System through an integrated network of modules that separately handle a section of the management system, and collectively provides for the deployment and operation of the complete management system. Although the QISS software is focused on Quality Management Systems, it will work well for Quality Control Management Systems too. The two phrases are many times used interchangeably, although purist would frown upon it. More on that later. So, take a look at the different modules in descriptions and the video presentations visit us at www.qi-a.com or send us e-mail at firstname.lastname@example.org.