ISO 9001 – 2015 CERTIFICATION

ISO 9001 – 2015 CERTIFICATION ISO standards are reviewed every five years and revised if required. This supports make sure they remain helpful tools for the market. The challenges faced by business and organizations today are very different from a few decades ago and ISO 9001 has been updated to take this new environment into account.

Both old and new standards cover effectively the same topics. However, there are some essential differences. Some of these are discussed below.

Structure of the standard

A general structure is possible because basic concepts such as management, client, needs, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are general to all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic needs, it may cause some disturbance in the short run as organizations get used to the new structure.

A common structure is possible because basic concepts such as management, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity are common to all management system standards. While this will make it easier for organizations to implement multiple standards because they will all share the same basic requirements, it may cause some disruption in the short run as organizations get used to the new structure.

Documented information

The new ISO 9001 2015 standard has also eliminate the long standing distinction between documents and records. Now they are both referred to as “documented information”. Why ISO chose to abandon two common sense concepts and replace them with one that is needlessly awkward and esoteric is not entirely clear.

Objects, outputs, products, and services

The definition of the term “object” is new. The introduction of the term “object” to mean anything conceivable or perceivable and its use in a variety of definitions (quality, design and development, innovation, review, traceability) appear to suggest that the new ISO 9001 standard can be applied to any object whatsoever. In theory at least, this greatly expands its scope.

What ISO 9000 2005 used to call a “product” the new standard now calls an “output”. The two definitions are the same. Since the term “output” was not defined in 2005, this shift in terminology suggests that the procedure approach is now even more central to the new standard.

And to further complicate things, the old definition of “product” has now been split into three separate definitions for the terms output, product, and service. “Output” is the general concept since both “products” and “services” are now thought of as “outputs”.

Other clarifications and modifications

While the earlier changes could be the most important ones, the new standard has also clarified some concepts and modified others. Some of these changes are listed below.

The old standard said that a “service” was a type of “product”. Now, the phrase “products and services” is used throughout the new standard and the term “service” has received its own definition. This should help out make it clear that ISO 9001 2015 applies not only to manufacturers but also to all types of service providers.

What used to be called “customer property” has been customized and greatly expanded to include products, services, and processes belonging to all types of external providers (including clientele). The new standard now expects you to control externally provided products and services if they are included in your products or services or if they are provided directly to clients.

The old definition of “continual improvement” has changed. When ISO 9001 2008 asked you to make continual improvements it was asking you to improve your ability to fulfill needs. Now, ISO 9001 2015 says it means enhancing performance (getting better results). This is an important shift.

According to the new standard, organizations must now recognize, acquire, and share the “knowledge” that personnel need in order to support procedure operations and achieve conformity of products and services.

The old concept of “product realization” is gone. Most of the material in the old product understanding section has been customized and moved to the new ISO 9001 2015 section on Operations.

The term “management representative” has been dropped. The management duties and responsibilities that were earlier assigned to someone called a “management representative” may now be assigned either to one person or to many people.

“Preventive action” has also disappeared. It’s been replaced by “risk-based-thinking”, evidently because both approaches try to achieve the same thing. Both try to prevent future problems. Once you introduce risk-based thinking, you no longer need a separate clause on preventive action. It’s redundant.

While the old standard asked you to use monitoring and measuring “equipment”, the new standard refers to monitoring and measuring “resources”. This is a more bendy approach to monitoring and measuring because it identify the fact that these activities can often be carried out without the use of equipment.

Clause by Clause Comparison

Benefits of ISO 9001:2015 Certificate

The new version of the standard brings the user a number of benefits:

• Addresses supply chain management more effectively
• Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity
• Puts greater emphasis on leadership engagement
• Supports address organizational risks and opportunities in a structured manner
• Is more user-friendly for service and knowledge-based organizations

Section Changes in ISO 9001:2015