ISO Certification 9001:2008 for Informatics R&D and Global Support


Do Standards Have a Place in Software Development?

Standards would seem to be anathema to software developers, who might protest that their use would stifle the creativity and flexibility required for agile or iterative development.

By their very definition, standards are a model or example established by authority, custom, or general consent; something set by authority as a rule for the measure of, among many things, quality or value.

Is it possible to create standard requirements to improve the quality or value of software, without affecting the very creativity needed to achieve what the software or application is being designed to do? The simple answer is yes. ISO 9001:2008 certification can improve quality management systems for software. The International Organization for Standardization (ISO) establishes requirements for quality management systems in organizations that seek: 

• to demonstrate their “ability to consistently provide product that meets customer and applicable statutory and regulatory requirements�� and

• to “enhance customer satisfaction through the effective application of the (quality management) system.” This includes establishing processes for continual improvement.

Because ISO 9001:2008 requirements are “intended to be applicable to all organizations, regardless of type, size, and product provided,” they apply well to quality management in software development and service.

This year, PerkinElmer received ISO 9001:2008 certification for its Informatics R&D and Global Support functions - both of which are important to customer satisfaction.  Guido  Lerch, the company’s executive director of quality control and assurance for informatics, and Lillian  Metcalfe, quality system manager, say they saw an opportunity with ISO 9001:2008 certification to proactively invest in implementing standards and thus the overall quality of software delivered.

Measure Inputs and Outputs

Certification provides a framework under which individual companies create the processes and procedures that lead to quality products and services.  It is not ISO mandating what the certified organization does, but rather the organization seeks certification of standards it devises and applies to processes.

For software development, PerkinElmer has not restricted what its development teams can do. Instead, the Company structured the “inputs and outputs” – the precursors for starting development and the processes to evaluate what they release.

“In the middle, we want our developers to go off and experiment and try lots of things,” Lerch says. 

Adherence to ISO 9001:2008 requirements assures that R&D and global support processes are clear, documented, and monitored, and that people are trained. It creates checks and balances to monitor the effectiveness of the quality management system, which leads to improved product quality and more satisfied customers.

It can also reduce the duration or scope of customer audits, as customers gain confidence from the knowledge that standards and processes are in place to develop and build products in a consistent manner. “There are hundreds of questions they won’t need to ask us,” according to Lerch, since PerkinElmer can explain its processes.

ISO 9001:2008 gives customers confidence they know exactly what they are deploying because the software has gone through a thorough testing regimen that follows certified procedures. In addition to knowing there are quality standards in place, there are also two people – Lerch and Metcalfe – whose roles are dedicated to the quality management of all PerkinElmer software released.

Two Important Points

While PerkinElmer Informatics has received ISO 9001:2008 certification for its R&D and Global Support functions, the company has been following such guidelines in principle for many years. Certification formalizes the company’s efforts.

ISO 9001:2008 has now been updated to ISO 9001:2015. PerkinElmer has three years to recertify under the new standards, and is committed to not only achieving certification, but maintaining it.

How confident are you in the quality management of the software and applications you’re deploying? Does ISO 9001:2008 certification increase that confidence?