ISO 9001:2008 standard is based upon the 8 Principles:
- Customer Focus
- Involvement of People
- Process Approach
- System Approach to Management
- Continual Improvement
- Factual approach to decision making
- Mutually beneficial supplier relationships
ISO 9001-2015 Quality Management System:
The 2015 QMS standard can boast the most radical changes ever, when compared with previous standards. The biggest change is of the structural and philosophical variety. Our experience with ISO systems, auditing and consulting will provide a client with the latest in business expertise related to the new standard.
The 2015 standard follows a harmonized structure that all management system standards will follow. This structure has 10 sections, in which all but one (section 8) applies to the discipline specific to the subject standard (quality, environment…et al). Section 8 (Operation) will apply to the specific discipline.
MAJOR CHANGES IN 2015
Structural and Philosophical
Those of us who have been around these standards for a while might have the most difficulty with the changes. The reason could be two-fold. One is that the standard has had practically no change since 2000, or for the last 15 years, and we are used to the same standard for a long time. Even though it is all for the better- harmony with all other management standards, it is a change nevertheless, and a major one.
Perhaps the biggest change is that the standard has matured. With the publication of the new version, the standard is now 28 years old. Perhaps consequently, those of us accustomed to the standard prior to 2000 will have the most difficulty, since the familiar requirements/ restrictions/ admonitions seem to have disappeared. This has left many with the impression that the standard has been watered down.
The fact is that not a single requirement has been eliminated. It just (may) seem that they have been. We will see why it seems that way when we get into the details of the new requirements, and the language/ style of presentation in the 2015 version.
In fact, there are net additions. Here again, some may argue that these were previously implied, and not really new. Regardless, now they are explicitly required. Following are synopses of some of the major additions:
Context of the Organization
- Organizations are now required to determine external and internal issues that impact its purpose and strategic direction and ability to achieve goals of the QMS.
- Understanding who are interested parties, and the requirements of these interested parties on the organization
Risk Based Thinking
- Clause A.4 gives detail on this topic, but Clause 6 is likely one of the most clear in the requirement to make risk based thinking the foundation of a QMS complying with ISO 9001:2015
Management of Change
- Clause 6.3 requires the organization to carry out change in a planned manner, and address purpose of change, and risk associated so as to minimize it.
- Organizations are now required to determine the knowledge necessary for the operation of its processes, and to achieve conformity of its product.
- This knowledge must be maintained, and made available as necessary.
Certification to the ISO standard (2008 and 2015)
Quality Institute of America QIA has a tool called ISO Easy which allows a company to become certified to the above standard(s) in as little as 4-5 months! ISO Easy is a combination of consulting, training, auditing and the use of our Quality Management software, QISS to effectuate a streamlined approach to certification.
Consulting and auditing services are provided to setup the structure a company needs in order to be certified. Documents and procedural templates are provided which cut down on wasted time and effort and provide the client with the needed, and required, tools for successful certification.
Training, both in the use of Quality Management software QISS and in the specific clauses of the standard, will be provided by authorized personnel of QIA. Audit functions are provided by certified quality auditors (certified by ASQ).
QISS software is an automated software system designed to follow the ISO standard and the user will be in compliance with the requirements of the standard by utilizing the patented workflow provided in the software.