ISO 9001 Posts

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

Sandy Carson Hessen, Marketing Communication Manager, Pilgrim Quality Solutions

For more than half a century, the International Standard for Organizations (ISO) has been developing standards to protect society from potential errors. It’s been 26 years since the introduction of the Quality Management System standards model, ISO 9001, specifically.

The most current version, ISO 9001:2008 was adopted to address fulfilling regulatory requirements and customer satisfaction through continuous improvement of the quality system. The standards apply worldwide and provide consumers with a base-level confidence in an organization’s ability to provide conforming products. Theoretically, it’s been working, but for those concerned with quality, it certainly makes sense to evaluate whether there’s room for improvement. (more…)

The 5th Incarnation: Proposed Changes to ISO 9001

The 5th Incarnation: Proposed Changes to ISO 9001

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions 

Are radical changes coming? Is this fifth incarnation of ISO 9001 a drastic departure from its predecessor? Will it reshape the world of manufacturing as we know it? Word around the water cooler is “No.” (more…)

Get with the (Management) Program… for a Change

Get with the (Management) Program… for a Change

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions

Social networks, outsourcing, mobile apps, expiring patents, mergers and acquisitions, are but a few landmarks in the last 10 years that have changed the way business is conducted forever.  If nothing else, industries have acknowledged that they must embrace change to remain competitive and protect market share.  As such, regulated industries such as life sciences, must adopt a proactive and systematic method to integrate new technologies and efficiencies while preserving the quality, safety and efficacy of their products and services. (more…)

Don’t Guess on Variation and Corrective Action

Don’t Guess on Variation and Corrective Action

Mark Crawford

Jonathan D. Port, a quality management expert and owner of Beacon Quality Services LLC (www.beaconquality.com), wrote an article on understanding variation in the March 2012 issue of Quality Progress.

“Organizations with quality management systems compliant to ISO 9001:2008 are required to take action to eliminate the causes of nonconformities,” says Port. “Clause 8.5.2 defines steps required for corrective action (CA), including determination of the nonconformity cause, along with determination and implementation of necessary action to prevent recurrence. Similar wording is also present in clause 8.5.3 regarding preventive action (PA).” (more…)

Monitoring Supplier Performance throughout the Product Life Cycle

Knowing your suppliers is as important as knowing the resources themselves. If you have a product defect, it doesn’t matter if it was a supplier’s fault or your own – the only thing the public will see and react to is your product and brand. Ouch. It pays to keep a tight control on supplier management.

The first step in understanding suppliers is through an evaluation and acceptance process. What are their business systems? Are they financially stable? What does Dunn & Bradstreet have to say about them? What percent of their sales is the product or resource you need? If it’s not substantial, will that affect the quality? (more…)

ISO 9001 – It’s All About Continuous Improvement

ISO 9001 was created in response to customers who wanted an assurance of quality. The concept was to limit the risk of delivering defective products to customers, with a focus on prevention, detection and correction. ISO 9001 replaced many customer-specific requirements, which suppliers needed to meet in order to make it easier for them to bid for work.

But ISO 9001 should be a quest for improving quality in all operations and not simply getting and keeping a certificate. It should be viewed as a guide for a management system to satisfy its customers and stakeholders with continual success. (more…)