Stellar

Documentation Preparation

Per an ISO-9000 survey of registered companies in the USA and Canada, approximately 45% of the respondents stated that the greatest barrier in preparing for a successful registration effort is creating the required documentation and records.

We will help you get your operational procedures and work instructions updated and fully compliant with the ISO 9001:2015 standard. We provide you with a minimum list of the required documentation. We help you draft that necessary documentation as well as flow charts depicting process flows and company organization charts. In addition, we recommend methods for implementation. We make the transition to the new standard simple and straight forward; so that you can concentrate on the business of getting your product out the door.

We customize our approach to suit your needs by offering as much or as little assistance as you require.

• - If you just need some advice we are here for you.
• - If you need someone to assist your employees in the process of updating/developing your documentation, we can do that.
• - If you are looking to have all of the documentation updated/developed for you, we can do that as well.

We ensure that all requirements are being met and that our clients are ready for the registrar's audit.

If you so choose, we will be there with you during your audit to help answer any questions regarding the quality management system.

Audits

Gap Assessment

Need help assessing where your current system stands with regard to the requirements of the standard? We provide that service!

We offer a gap assessment to review your documentation compliance to ensure all of the applicable requirements (shall statements) have been addressed adequately, verify that the required records are available and legible, and identify any potential gaps that will need to be corrected prior to your stage 1 and 2 audits by your registrar. The time required for a gap assessment depends on the number of documents you have in your QMS.

Internal Audits

We also offer internal auditing for our clients that do not have the personnel or the time to conduct them in house. The internal audits usually take 2 to 3 days, depending on the size of your company and the number of employees. Our internal audits are thorough and complete. We take the time to examine your processes and documentation to identify any and all problem areas so they can be addressed as soon as possible. Our goal is that no findings are left for the registrar's auditor.

QMS Overview Training for Management and Employees

This training provides an overview, of the requirements for ISO9001:2015 compliance, to Management and Employees. This training can be used as the Introduction to your ISO QMS for an employee's initial training. This training can be developed/customized with the necessary details for Management level orientation and more specific details to address the employee implementation requirements.

Internal Auditor Training course

We provide a 2 day internal auditor course with an optional third day for a mock audit at your facility. During the course, the student will:

• Study all of the requirements of ISO 9001:2015
• Become familiar with things to look for during an internal audit
• Learn the basic principles of auditing - ISO 19011
• Create an audit plan
• Develop a checklist for process audits
• Perform a mock audit (optional – 3rd day)
• Write Noncompliance Reports(NCRs) and Internal Audit Reports

The course goes in depth covering the requirements of the standard and what an auditor should look for as objective evidence for compliance. We go over the principles of auditing. We describe how to go about the process of identifying non-compliances. Then, we look at how to write a non-compliance report (NCR). We have exercises to match the non-compliance to the correct clause number when writing up an NCR. We show how to write the audit report. We talk about what information is necessary to provide a good audit trail and audit report. Quizzes are given to verify the students comprehension of the principles covered and to further solidify their understanding of the clauses of the standard as well as their ability to identify the correct requirement(s) for a possible non-compliance. In addition, true/false quizzes are given to associate the intent of the various requirements with an audit situation. There will also be a question and answer session at the end of the class.

The optional third day is either a real or mock internal audit at the client’s facility or a mock audit of sample procedures and work instructions. Each student is expected to be able to write an NCR, identify the correct clause(s) from the standard, and create an Audit Report and Audit Trail.

At the end of the course, all students will receive a certificate of training.

Records Management

We offer several modules for data management for our clients to control and manage everything from training records to purchasing information. Our system is currently based in MS Access and is designed to specifically address the ISO 9001 requirements.

The four modules are:

1. Training Manager
2. Calibration Manager
3. Audit Manager
4. Purchasing Manager