Standards management

Quality Workbench can help you manage your standards compliance.

ISO 9000 Quality

ISO 9000 is the most widely-known standard and has perhaps had the most impact of the 13,000+ standards published by the International Organization for Standardization. It serves many different industries and organizations as a guide to quality products, service, and management.
The ISO 9000 quality standards series are aimed at creating the highest possible customer value through consistency and continuous improvement throughout the organization. It includes:

• Ensuring and defining responsibility and ownership throughout organizations.
• Ensuring adherence to defined policies, procedures, and work instructions (ISO documentation) developed to meet agreed-upon customer product requirements and levels of service. 

Quality Workbench and ISO 9000 Quality: Quality Workbench provides full history and audit trails throughout the various modules. Every significant action is recorded so a record, exists of who did what and when. Quality Workbench helps you to:

• Manage and control ISO documentation;
• Ensure staff are adequately trained to effectively do their job;
• Ensure that the company works to its defined standard (ISO documentation) and highlights areas for improvement;
• Report issues that do not conform to the defined standard;
• Report and act on customer complaints in an accurate and timely manner;
• Ensure that an organization’s equipment is qualified as suitable for use.

ISO 14000 Environmental

The purpose of the ISO 14000 standard is to minimize organizations’ negative impact on the environment.

Quality Workbench and ISO 14000 Environmental: Quality Workbench controls the environmental documentation (i.e., how processes should be structured in order to minimize negative environmental impact), supports the training of the standard, manages audits of the standard, manages any incidence that is not in conformance with the standard, and manages the equipment from an environmental perspective.

ISO/TS 16949:2009 Automotive

The ISO/TS 16949:2009 Automotive standard is devised specifically by and for those companies involved in the automotive industry. It is an extension of the ISO 9001:2000 standard and covers the management and quality of the products as well as the management methods.

Quality Workbench and ISO/TS 16949:2009 Automotive: Quality Workbench supplies a number of tools to enable companies to manage their ISO/TS 16949:2002 accreditation. The Document Control module handles any of the documentation from policies and procedures to product specification and manufacturing records. The NCR, or Issues Management module, allows you to report product testing anomalies, record the actions taken to rectify those anomalies, and generate full KPI and FMEA reports.

ISO 27001 Information Security

The ISO 27001 Information Security standard provides best practice guidance on protecting the confidentiality, integrity, and availability of the information on which we all depend.

Quality Workbench and ISO 27001 Information Security: Quality Workbench provides the tools for automating vital tasks, such as controlled document approval and issue, and provides easy-to-use audit management tools for an efficient means of driving ISO 27001 Information Security workflows throughout the organization to ensure that compliance is upheld.

OHSAS 18001 Health & Safety

OHSAS 18001 Health and Safety is an international occupational health and safety management system specification. It comprises two parts, 18001 and 18002, and embraces BS 8800 and a number of other publications.

Quality Workbench and OSHAS 18001 Health and Safety: Quality Workbench assists organizations in maintaining this compliance with the ability to control all the relevant documentation, manage audits, and assess all of the identified risks. The software helps ensure that any and all actions are implemented and follow-up assessments are undertaken.

FDA/CFR 21 Part 11

The FDA 21 CFR 11 rule provides requirements under which the Food and Drug Administration (FDA) will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures.

Quality Workbench and FDA 21 CFR 11: Workbench Professional addresses the requirements of this standard through the Document Control module with features such as full audit trails. These audits are available both as an electronic record, and as an integral report that can be printed.

A full workflow can be defined at a system level (i.e., all records are controlled in exactly the same way), at a group or “rules” level (i.e., all records matching certain criteria), or at an individual document level. Access to change this workflow is both controlled and traceable.

Sarbanes-Oxley (SOX)

The Sarbanes-Oxley (SOX) Act of 2002 was established as a result of accounting scandals, specifically Enron and WorldCom in 2001. These scandals resulted in billion dollar losses for investors and employees, and the trust from financial markets and general investors was severely damaged. The SOX Act was developed to protect the shareholders and the general public from fraudulent practices and accounting errors in companies.

Quality Workbench and SOX: Quality Workbench provides secure, complete, and un-editable audit trail for all changes in documents. It provides reports on what was changed, who changed it, and when the change was made. Quality Workbench will retain records securely in accordance to company policy. The retention period can be set differently for different types of documents.

Quality Workbench will securely store all types of documents and will make sure that access to documents is strictly controlled, not only for viewing, but for access to edit and modification of metadata.

GAMP / GXP

Good Automated Manufacturing Practice (GAMP) is a set of guidelines as to best practice for automated systems within a manufacturing environment. It was originally established within the pharmaceutical industry by the International Society of Pharmaceutical Engineering. The GAMP 4 Standard is designed to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry.

Additionally, GAMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process have been validated according to predetermined specifications, to demonstrate that they can perform their purported function(s).

Quality Workbench and GAMP/GxP: An extremely important part of GAMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested (which enables traceability and, in the event of future problems, recall from the market) is not correct and in order, then the product does not meet the required specification and is considered adulterated. Quality Workbench ensures that this risk is avoided.