For those new to ISO standards, it can be overwhelming and confusing regarding how it is meant to be applied to each individual organization. For many years ISO 9001 was thought to be applied purely to manufacturing organizations and their quality control of products. However more recently ISO 9001 is being adopted by service providers as well, with the newer versions of ISO 9001 incorporating this into its guidelines.
When an organization attempts to become certified without knowledgeable support it can be drawn out longer than necessary, with lots of difficulties along the way. Misinterpretation of the terminology and trouble gaining understanding from the workforce as to the benefits of the certification could cause problems applying new processes throughout the organization. Although for larger organizations these terms maybe understandable, and even used already, for smaller organizations this is where the biggest problems arise during certification.
Terms which may be difficult to understand are those such as:
- Dispositioning Authority – an individual, or group of individuals, with assigned responsibilities and authority to make decisions on the configuration. This includes interested parties inside and out outside the organization.
- Configuration Management – Generally technical and organizational activities that establish, or maintain, control of the product or service. It also includes management of the product configuration information for the life cycle of the product.
- Metrological Confirmation – the confirmation that measuring equipment required conforms to the requirements. This includes calibrations, or verifications, any adjustments, or repairs. These are then compared with the requirements required for the intended use of the equipment, including labeling and sealing. These requirements include considerations such as maximum permissible errors and does not include the products themselves.
- Product or Service – these terms seem obvious enough but when in regard to ISO 9001:2015 a product is an item that has been produced without a specific request from an individual customer. Such as an item of clothing in a store. Whereas a service would include at least one interaction between the organization and the customer prior to purchase. Such as a customer placing an order in a restaurant for a meal and having it delivered.
That is why it is strongly recommended to hire a consultant to assist in the interpretation and adoption of ISO 9001. Although, this can put off smaller organizations who have limited funds and time, yet would benefit hugely from certification.
The biggest benefit is they will bring with them knowledge and expertise in ISO standards, acting as a trainer and a translator. They will work with an organization to break down the terms used in the guidelines so that all members of an organization can easily understand them, making them easier to adopt them and use them in daily working practices. Having the standard interpreted for an organization reduces the risk of problems arising. With risk-based thinking being a major aspect of ISO 9001:2015, it is worth considering a consultant.
If you wish to discuss how a consultant could benefit your organization through its certification process then do get in touch and see how The McDonald Consulting Group could benefit you.