These following services can be contracted by the day or

fixed-price quotation.

 

• AS9100/20, ISO 9001, ISO 13485, ISO 14001, ISO16949, ISO 17025 and 21CFR§820 Registration Process

  Identify steps required to achieve registration and help select a registrar.

   

• Steering Committee Liaison

  Work with your management team to implement the program.

   

• Implementation Guidance

   Provide one-on-one guidance, in all areas of implementation, as needed.

   

• Implementation Task List

  Develop a detailed task list and schedule identifying what needs to be done and by whom to meet the registration requirements.

   

• Pre-assessment and Post-assessment Corrective Action(s)

  Correct problem(s) found during an assessment.

   

 

 

 

        •   Documentation Structure 

           How to document your company's quality management system.

 

        •   Procedures and Work Instruction Review

           Are they adequate?

 

    •   Quality Manual

        Write a quality manual acceptable to your registrar.

 

    •   Departmental Operating Procedures

        Help your company document its processes.

 

    •   Work Instructions

        Help your company document its work operations.

 

    •   Forms and Records Design

        Provide forms and records that provide objective evidence of conformance.

 

 

     Learn the requirements and what you will need to do to comply with the following standards:

   AS9100/20, ISO 9001, ISO 13485 & 21CFR§820,  

  ISO 14001, ISO 16919, and ISO 17025

 Management Training

 

• Executive Overview

  Inform top management about the Quality Management             System, its requirements, benefits, and responsibilities.

   

     •    Steering Committee

          What implementers need to know about the QMS standard.

   

     •    Supervisor Training

          Inform supervisors of their QMS responsibilities.

  
  Employee Awareness

•  Familiarize employees with the benefits of QMS registration, what is required to become registered or maintain registration, understanding specific QMS requirements, and how your company implemented its QMS.

   

  Introduce employees to the QMS documentation structure.

   

  Inform employees about your registrar’s visit and what to expect from them during the audit.  Coach employees on what to ”say and not say” and what “to do and not do” during the audit.

  
  

• Document & Data Control 

  Learn how to document your company’s QMS, support the documentation and data control system, and ensure that the latest documents are available, where needed.

   

• Effective Procedure Writing 

  Learn how to write documents that conform to the QMS standard and the company’s documentation structure.  When is employee training required versus reliance on employee experience?  When is a written procedure/work instruction required?   Learn how to simplify and improve procedures/work instructions by flowcharting a process.

   

• Corrective Action

  Train employees in the corrective action process and         understanding the difference between a quick fix and effective corrective action.  Comprehend problem solving tools and how to evaluate the effectiveness of corrective action.
   

• Preventive Action

  Learn the difference between corrective action and preventive action and how to implement a preventive action program.

   

• Internal Auditor

  Provide a team of qualified internal auditors.  Training is based upon ISO 10011

  •    Refresher course

  •    Internal Auditor Training

  •    Lead Internal Auditor Training
   

• Statistical Process Control

  Provide employees with SPC concepts, basic tools, use of control charts, and an understanding of process control.
   

• Problem Solving

  Learn a systematic approach to analyze and solve problems.  Discover how to best use various problem-solving tools to correct and prevent problems.
   

• Quality Improvement

  Learn how to identify your internal and external customer needs and satisfy them.  Acquire the skills to set and measure supplier, company, and customer quality objectives and implement product and process improvements.  Help promote continuous management and employee improvement programs.  Learn how to implement effective preventive action.
   

• Cost of Quality

  Understand the Cost-of-Quality benefits, elements, measurement tools, trade-offs, metrics, & reports.  Use as an early warning management tool.
   

 

• Gap Analysis (Facility Survey)

  Documentation Review

  Review your current documentation (quality manual and procedures) against the quality management system requirements and identify any gaps in coverage.
   

        Implementation Audit

        Review your current quality management system practices

        against the quality management system requirements and your

        documented processes and identify gaps in implementation.
 

Ø Internal Audits

        Conduct regularly scheduled independent audits of your company’s quality system to;

             a. determine the level of compliance by the workforce to

                 the documented procedures and work instructions:

              b. provide information to management regarding the health

                  of your quality system;

              c. meet the requirements of the standard.

              Your company may wish to have the quality system

              reviewed prior to your registrar’s surveillance audit.

              GHR Associates can evaluate your audit readiness 4 to 8

               weeks before the surveillance audit and provide a                                                readiness report.
 

Ø Pre-assessment Audit

              Conduct a trial assessment to determine if your company is ready for an assessment by your registrar.