Quality Management System Documentation

During my visit to different organisations, I get one common question: “How to optimize our documentation”? Most of the time the organisations are overburdened with huge documentation load where I find a major portion is either repetition or not required.
In my opinion, the QMS documentation of a Quality Management System must address two major issues:
· Shall be in line with the size of the organisation and complexity of the processes
· The need for the amount and detail of documentation required must be more relevant to the desired results of the organization’s process activities.
Organizations (and in particular small organizations) may be able to demonstrate conformity without the need for extensive documentation
Management should define the documentation needed to implement, maintain, and improve the quality management system. This documentation may include:
· Policy documents (including the quality manual)
· Process Mapping - Documentation for the control of processes
· Work instructions for specific job tasks
· Standard formats for data collection and reporting

Level 1: ISO 9001 Quality Manual
The quality manual, sometimes referred to as the policy manual, typically includes:
• Organization Quality policy and Objectives • Any exclusions of ISO 9001 requirements and related justification• Overview of the organization and its functions (processes)• Overview of its products, services, and sites• Sequence and interaction of the processes• Management responsibility for policies and processes• Inclusion or references to the next documentation level (procedures)
The quality manual is useful to:• Customers - provides assurance• External auditors - facilitates the audit• Employees - useful as a training aid
The quality manual must be approved by management and placed under document control. Generally it is structured in the order of the ISO 9001 clauses.

Level 2: ISO 9001 Quality System Procedures

· Describes the who, what, when, and where of the quality system processes
· Describes the inter-departmental controls that address the ISO 9001 requirements
· Should include six mandatory procedures as required by ISO 9001:2008
· May be in ISO 9001 order or any order practical to the company
· Should describe the process flow, linkages, combination and interaction among departments
· Should reference the lower level documentation (operational documentation)
· Should involve participation of department personnel in writing them
· Must be available, known, and used by pertinent personnel
· Must be kept up to date and changes controlled

Level 3: Operational documentation (Also known as Work Instruction / OCP - Operation Control Procedure / Protocols / Methods)

· Explains details of specific tasks or activities – the how of performing a specific task, making or verifying process and product activities
· Includes documents such as quality plans, forms, drawings, flowcharts, workmanship standards, work instructions, product or service specifications, machine manuals, visual displays, computer templates, photographs, and illustrations
· Need for documentation may be based on the complexity of products or processes, skills, training, education, stability of the work force, past problems, customer and regulatory requirements, industry standards, and requirements
· Must be available, known, and used by pertinent personnel
· Must be kept up to date and changes controlled

Level 4: Records
· Provide objective evidence that quality activities were carried out and results achieved in accordance with levels 1, 2, and 3 documentation
· May be mandatory or implied for each ISO 9001 clause
· May have records beyond ISO 9001 requirements (if organisation or customers require so)
· Examples are records of inspection, calibration, management review, training, audit reports, design review, purchasing, and nonconforming product reports