ISO 9000: 2015
Quality Management Systems
Pragmatic has assisted many organizations develop and implement their Quality Management System (QMS) in accordance with ISO 9000. We have developed a tried and tested approach which ensures success and external registration at the first attempt.
We conduct a "System Review" for many clients involving an "on-site" day, assessing what would be the typical resources needed to implement their QMS. The output from this activity is a high-level project timeline, rough estimate of costs and resources with some initial recommendations.
Alternatively we can conduct a detailed "Gap Analysis" which involves determining the level of conformance in your existing system to every element of the ISO 9000 standard, including any exclusions. The output from this activity is a comprehensive report which identifies the Scope of the QMS, all areas of conformance and nonconformance, specific recommendations and the development of a detailed project plan for implementation.
We also provide ongoing assistance during any phase of your implementation efforts including the development of a conformity schedule, which tracks key activities and resolution of any gaps identified. We create documentation and necessary procedures tailored to the organization and its business processes. We also provide on-site training programs to assist customers "Implement and Document" the system including any tools and training necessary to develop the required processes and documentation.
One of the most important aspects of implementing an ISO based quality management system is the development of an "Internal Audit" program. We provide the necessary training for your internal auditors as an integral part of our consulting activities which gives the opportunity to customize the training to the operational processes being scrutinized.
Our three day "Internal Auditing Course" based on ISO 9000:2015 also conforms to the guidance given in ISO 19011 and gives students the knowledge and skills required to carry out effective audits. The training ensures that auditors are utilizing the latest "process-based" auditing approach and not simply looking at documentation. This course also serves as an excellent refresher for any auditors that were trained in organizations who were using the previous versions of the ISO 9000 standard.
Pragmatic has experience developing "custom" approaches to integrating the requirements of the standard to implementing an effective "Corrective & Preventive Action" system throughout the client's organization. This can range from simple "paper based" processes to the utilization of IT and Web-based solutions, optimizing the resources and effectiveness of this very important aspect of any management system. We supplement this activity by also providing training in the basic quality tools for "Problem Solving" to ensure that this part of the QMS is delivering the benefits to the organization and driving improvement at the Product, Process and System levels.
The "Gap Analysis" is a detailed assessment of the existing system and business processes currently in operation. This assessment is performed by Pragmatics' qualified Lead Auditors, who in some cases perform third party assessments for some of North America's largest Registrars.
The assessment involves interviewing employees and management, recording existing practices and documentation and comparing these with the ISO 9001 requirements.
The output is a comprehensive report which indicates areas of conformance, good practices and ultimately deficiencies in the system compared with ISO 9001.
The report also provides specific guidance and recommendations to guide organizations in establishing the necessary "fixes" in order to move towards conformance.
The report is not generic in nature and will contain examples and guidance specific to the clients' system and methods of operation.
Pragmatic provide Internal Audit Training in (2) day and (3) day formats, the latter includes practical "on-site" audits using a case-study OR client's own processes. The audit course is designed for staff involved in internal audits or supplier audits. The course content is consistent with the guidelines of ISO 9011. Description (Course Outline):
Day 1 - General Quality Principles
Day 2 - Process Flow of Auditing
Day 3 - Practice Audit (Case Study or "Live Client Site")
Pragmatic usually conducts this program on the customer site to take advantage of a third day of real audit experience drawing from processes that exist. This gives students the benefit of some real hands-on experience. We also provide ALL materials including copies of the relevant standards, student manual and various additional exercise handouts.