ISO 9001 Documentation 

​Documentation plays an important part of a Quality Management System. I can help you with every level of documention:

1. I can write the documents for you.

2. I can provide templates so you can write them on your own.

3. I can review your current documentation for compliance

4. I can review your current documentation for opportunities for improvement.

 

Typical Documentation Structure

Documentation requirements are usually divided in four Tiers:

1. Quality Policy and Quality Manual

2. Quality System Procedures

3. Work/Job Instructions

4. Quality Records

 

What is a Quality Manual?

A Quality Manual is the statement of the organization's quality policy and describing the quality system of an organization. It is usually written by managers from top level management and the quality department.

 

What is a Procedure?

Procedures defines activities at the departmental level and written by department supervisors. They are usually referred to in a quality system, as a "written" procedure or a "documented" procedure. Procedures should ideally be organized into the ISO 9001 outline structure, indicating the ISO 9001 clauses under which they fall, though is not an ISO 9001 requirement.

 

What is a Work Instruction?

Work instructions describe how work is accomplished, it is 100% of how to complete a specific task or operation, and are usually written by the operators and trainers.

 

What are Records?

Quality records provide the backbone of the quality system.

Quality records consists of all forms, or controlled documents and quality records (hard copy and electronic) necessary for the quality system to operate. Quality records usually consist of all completed forms and charts.

 

Please contact with me about discuss how i can help you meet your objectives.