Transforming ISO 9001 Quality Objectives into Actionable Goals for Life Sciences

We’ve all seen companies issue statements saying they are “committed to the highest standards of quality” or “promoting a culture of quality.” Too often, that’s just corporate speak that really means “We know quality is important, but setting quantifiable objectives is hard.”

Ideals don’t always equate to goals and wishes most certainly are not objectives. If an executive says, for instance, “We need to reduce the time it takes for critical documents to be reviewed and approved,” it is merely an aspiration that all personnel in the workflow will try harder to conduct reviews in a timely manner. On the other hand, if a manager sets a target to reduce review cycles from an average of 60 days to under 15 days, that is a measurable quality objective that can be achieved by setting deadlines and streamlining processes.

The development and realization of objectives takes work, planning, and foresight. Aligning your company’s quality management practices with the applicable quality principles found in the ISO 9000 standards is a proven approach for turning aspirations into actual quality objectives.

Leveraging ISO Standards for Life Sciences Quality Management

ISO 9000 standards are intended to help companies continually improve their products and consistently meet customer expectations. The requirements for quality management systems (QMS) are delineated in ISO 9001. Even though certification to ISO 9001 is not required, the standard remains one of the most widely used management tools currently employed by companies worldwide. More than one million companies and organizations in over 170 countries are certified to the ISO 9001 standard. ⁽¹⁾ In many respects, it serves as a business infrastructure as much as it does a quality standard.

In terms of what companies can expect to gain by aligning with ISO 9001’s quality goals, examples include:

• A demonstrable ability to consistently provide products and services that meet both customer and regulatory requirements.
• Enhanced customer satisfaction through effective application of a quality management system (QMS), including process improvements and an assurance of conformity to customer and regulatory expectations.⁽²⁾

Key ISO Quality Objectives Examples in Life Science Industries

Your company’s quality objectives will always be unique to the nature of your business, the industry you’re in, and the regulatory and statutory requirements your products must meet. Beyond that, your internal quality objectives will vary as well, depending on whether they’re applicable across the enterprise, only at specific sites, or centered on activities conducted by individuals in specific roles.

The following are key quality principles addressed in ISO 9001 and examples of ways the standard can be leveraged to reach the kinds of objectives your organization may be looking to achieve.

Nonconformities and Corrective Actions

When objectives are clearly tied to the quality improvements you are seeking, such as resolving corrective actions/preventive actions (CAPAs) faster or minimizing nonconformances, it gives your team tangible targets to aim for. Clause 10.2 of ISO 9001 provides a blueprint for steps to take when nonconformities arise and corrective actions that should be implemented. Aligning your objectives with ISO quality event management principles isn’t difficult if you have a digitized system that connects processes and information and gives you real-time insights into actionable data. One health care system’s analyst reported that the various clinical departments in her organization were able to streamline and accelerate the tracking and reporting of CAPAs, deviations, and adverse events by 30% after implementing a digital QMS. ⁽³⁾

Document Control

Clause 4.4 of ISO 9001 requires an organization to “maintain documented information to support the operation of its processes and retain documented information to have confidence that the processes are being carried out as planned.” ⁽⁴⁾ The effort required to document approval cycles, manage change control, and align all the other complex aspects of document control with ISO standards can be overwhelming, especially for companies that use paper-based processes. For one clinical development firm, document control compliance was a three-person job until a digital QMS was implemented. Since formalizing its documentation objectives and processes within a digital system, the company now only needs one staffer to efficiently manage more than 300 core quality documents electronically. ⁽⁵⁾

Training Records

ISO 9001 Clause 7.2 specifies that companies must ensure employee competence, take action to achieve it, and retain accurate records to document competency information. Using email, spreadsheets, and disconnected systems to track and assign competency tasks is time intensive and makes your training records susceptible to errors and omissions. When one compound pharmaceuticals company set an objective to minimize the hours spent printing, binding, and preparing training materials for use in labs and manufacturing rooms, it quickly became apparent that its manual processes would have to go. Since digitizing and centralizing its training processes, the company is saving more than 450 hours per year on time spent preparing training materials. As a bonus, the move from paper to tablets has allowed the global organization to prevent the unnecessary waste of 15,000 sheets of paper at each site. ⁽⁶⁾

Achieving tangible quality objectives like the kinds discussed above requires an organization to:

• Base objectives on sound, up-to-date data.
• Employ analytics tools that allow for objectives to be appropriately defined and monitored.
• Establish visibility into benchmarks and progress indicators that show when milestones are reached and whether expected outcomes are achieved.
• Provide proper assurance to stakeholders that objectives have truly been met.

Conclusion

If your overall quality goal is to adhere to the ISO standards that pertain to your company, you must first develop specific quality objectives. To ensure your quality objectives are aimed at enhancing product conformity and customer satisfaction, they must be effectively communicated across the enterprise and continually updated to meet evolving business needs.

You can learn how digitized quality management systems make it easier for companies like yours to realize quality objectives and maintain alignment with global quality standards by visiting MasterControl’s ISO 9000 page.

References:

1. “ISO 9000 Family – Quality Management,” International Organization for Standardization, accessed Oct. 21, 2021.
2. “ISO 9001:2015 Quality Management Systems – Requirements,” International Organization for Standardization, accessed Oct. 21, 2021.
3. “Quality System Metrics That Matter,” MasterControl, Aug. 2020.
4. “Guidance on the Requirements for Documented Information of ISO 9001:2015,” International Organization for Standardization, accessed Oct. 19, 2021.
5. Supra note 3.
6. Supra note 3.