Managing one standard is tough enough, but what do you do when you need to manage multiple standards at the same time? In our latest webinar with ANAB, Technical Products Developer, Melanie Ross, gave an overview of the best, most efficient ways of managing multiple standards.
A little about Melanie: she has over 20 years of experience in quality assurance, quality control, and quality management. She has worked in several different industries including chemical, biological, oil, gas, and aerospace. Her main role in each of these industries was the development of management systems, including internal audit programs, vendor qualification procedures, and implementation of lean six sigma. Currently, Melanie is a Technical Products Developer for ANAB designing and delivering training courses and supporting client outreach through business development activities. Her role serves as a technical resource to customers, assessors, and other interested parties.
Some standards that are usually implemented in laboratory settings are ISO/IEC 17043, ISO 17034, ISO/IEC 17025, and ISO 9001 (among others). ISO 9001 is the standard for quality management systems and can be applied to any type of organization. This standard contains the requirements necessary to build a quality management system and is a good resource to laboratories even if the laboratory isn’t considering certification to ISO 9001.
The most common standards from the earlier list are ISO 9001 and ISO/IEC 17025. So, let’s compare.
In this circumstance, ISO 9001 and ISO/IEC 17025 overlap, with ISO/IEC 17025 building on what is already required through ISO 9001.
But how can these standards work together? With so many standards available, how can your organization make sense of it all? ISO along with IEC created directives for committees and subcommittees to follow when creating new, or revising existing, ISO standards (see below). The directives define a high-level structure for all management system standards. All ISO standards begin with clauses 1-3. While the directives are specific to management system standards, like ISO 9001, technical standards like ISO/IEC 17025 have also adopted the common text for management system requirements and common terminology. This makes integration of multiple standards into one management system easier.
A management system is a set of policies, processes, and procedures used by an organization to ensure that it can fulfill the task required to achieve its objectives. In essence, it’s how your organization ensures that work is accomplished. When organizations consider the management system as the business, or the entire organization, it is much easier to integrate multiple standards into it and managing the requirements of the standards becomes much more efficient.
See the below image for a list of management system requirements for both ISO 9001 and ISO/IEC 17025. Regardless of the standard, any organization seeking certification or accreditation must have management system documentation that is controlled. They must also control records and take actions to address risk and opportunities. Organizations must continually improve through improvement initiatives and feedback from staff and customers. You also need to consider corrective actions for non-conformances. All ISO management systems require audits and management reviews performed at planned intervals.
When integrating multiple standards, there are a few things to remember. You need to:
Maintaining multiple accreditation and/or certifications under one management system umbrella allows your organization to gain efficiencies. Laboratory personnel can focus on the technical requirements needed to perform the measurements and tests. It also allows for the staff to focus on resource and process requirements. If you’d like to see how Qualtrax can help your organization manage quality, join us for a demo! You can also watch the full webinar here!