Mark Hammar With the new 2015 version of ISO 9001, the structure of the requirements for a Quality Management System (QMS) have changed, as have some of the terminology and requirements. So, how can you better understand these changes? This will be important for you to ensure that any changes you make to your QMS meet the intent of the updated terminology and concepts.
This is why the ISO 9001:2015 standard includes Annex A as part of the document. Because there have been changes in the structure, terminology, and concepts used in the standard, there is a need to explain these changes so that QMS implementation teams can better understand why the changes were made and what they were intended to accomplish.
What is included in Annex A?
Annex A is entitled “Clarification of new structure, terminology and concepts,” and this is exactly what it does: it gives further explanation on some of the changes and updates to ISO 9001. Annex A is split into eight sections that give further explanation, and this is a summary of these eight sections:
- A1 Structure and terminology: In this section the annex explains that the structure of the clauses is meant to be clearer; it is not intended to dictate how the documented information is to be organized or that terms already in use need to change. It then proceeds to explain the changes in terminology in the new standard, such as the term “Environment for the operation of processes” rather than “work environment,” and the removal of the management representative from the standard requirements.
- A2 Product and service: This section explains that although ISO 9001:2008 used the term “product” to mean both products and services, the ISO 9001:2015 standard uses “products and services” throughout the standard to highlight that there is a difference between products and services in the application of the requirements. It is important to note that this implies that the requirements are applicable to the services provided by the company, such as delivery of products, and not just the services of a service-based company.
- A3 Understanding the needs and expectations of interested parties: This section specifies that even though ISO 9001:2015 demands that you identify the requirements of interested parties, it is the company that decides if a requirement of an interested party is relevant to the QMS. Requirements that are not relevant to the QMS are not intended to be controlled by ISO 9001:2015.
- A4 Risk based thinking: While this seems to be a new concept in the ISO 9001 standard, it has been considered around the quality community for a few years and has been implicit in previous editions of ISO 9001. The details highlight that planning for risk is a key purpose of a QMS, but there is no requirement for formal risk management or a documented risk management process within the ISO 9001:2015 requirements.
- A5 Applicability: Where the previous version of the standard allowed for exclusions, this standard uses the term “applicability” and defines in clause 4.3 the conditions when an organization can decide that a requirement is not applicable to their QMS.
- A6 Documented information: The annex explains that the term “documented information” has come into use to align ISO 9001 with other management system standards, rather than using separate terms like “documented procedure” or “records,” but the organization needs to determine what documented information needs to be maintained.
- A7 Organizational knowledge: The annex explains how organizational knowledge is meant to address the need for organizations to manage the knowledge necessary to safeguard the organization from loss of knowledge and encourage the acquisition of organizational knowledge.
- A8 Control of externally provided processes, products and services: In this section it is explained that the requirements in clause 8.4 are intended to be applicable to purchasing from suppliers, arrangements with associate companies, and outsourcing processes to external providers. The organization is no longer to consider only suppliers for these requirements.
Why is Annex A important?
Annex A does not include any requirements for a QMS, so it is often overlooked as unimportant by many who are implementing ISO 9001. However, it is important to remember that this part of the standard is there to better explain the concepts that are included in the requirements, and can help you to make sure that you have properly interpreted what the requirements intended to say.
Remember, the certification auditors are also using this annex as a guide to interpreting the standard, and this gives you some insight into how they will interpret any new requirements. By checking that you understand the requirements well, you will know that any changes you make meet the intention of the new concepts so that you do not have a conflict during your re-certification audit. This will save you money because you won’t need to make changes twice – and saving money is one of the reasons you implemented ISO 9001 in the first place, isn’t it?
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