Managing Multiple Standards in the Laboratory

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.

In this webinar, Melanie explains:

• understanding overlapping requirements across ISO standards;
• how to identify common elements, such as internal audits and management review;
• how regulatory requirements fit into ISO standards;
• strategies for meaning multiple standards in the lab (or anywhere);
• methods for integrating multiple standards into the management system.

So, let’s get started!

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.

What is a management system?

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.

Integrating Multiple Standards

When integrating multiple standards, there are a few things to remember. You need to:

• Consider laboratory activities as processes within the management system. This will assist in tying those activities to the appropriate standard and ensure that the management system applies to the lab’s operations.
• Remove silos by harmonizing activities. The activities can be performed in various ways depending on the department, but a harmonized procedure can apply to all departments. Oftentimes, people encounter pushback when they try process harmonization. A good way to determine if processes can be harmonized is to map out each process using sticky notes. Then, overlay the notes that are the same steps.
• Facilitate activities through risk-based thinking. Risk-based thinking can assist in determining the appropriate way to document and organize the management system. Processes with more risk may need more attention and documentation while processes with less risk require less focus.
• Establish policies and objectives throughout the organization. All too often, Melanie sees organizations with accredited laboratories where the policies and objectives pertain to business-related activities (like product orders and sales) and the lab is left out. It is a requirement to establish policies and objectives in both ISO 9001 and ISO/IEC 17025. So, keep that in mind when integrating the management system.
• When managing multiple standards, you need to compare the requirements between the standards. You’ll be surprised with how many overlap. Once you’ve done that, you need to map the clauses to the current documents to ensure that the requirements are met. Knowing how each clause is addressed in the management system is important to ensure that there are no gaps. Gaps can lead to non conformities in internal and external audits or assessments.

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!

Categories: Audits, Quality Managers, Testing Labs

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