ISO 9001 Consulting
QMS Documentation Implementation Checklist
Quality Manual
Does the Quality Manual:
- Outline the structure of the quality management system
- Include the supplier’s name, address, quality policy and objectives and organization structure?
- Define the Scope of the Quality management system for products, services, facilities, applicable quality system standard and elements, and functional activities?
- Define the responsibility and authority for each element of the quality system?
- Define the documentation hierarchy?
- Make reference to relevant procedures?
- Is the extent of documentation relative to methods used, skills needed and training given?
- Is it consistent with the ISO 9001 standard & quality policy?
Processes, procedures & flowcharts:
- Are all processes falling within the scope of the quality management system identified and defined and are their procedures appropriately documented?
- Are the processes fully deployed and implemented as documented?
- Is there a plan & schedule for implementing the quality system? Are flowcharts used as a tool to map out critical or core processes?
- Do the quality system procedures include the following:
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- Purpose, scope, responsibilities and full details of how, what, when and where all relevant activities are performed?
- Purpose, scope, responsibilities and full details of how, what, when and where all relevant activities are performed?
- Work Instructions : Are they required?
- Records & Forms : Are appropriate records & forms used to support the quality management system?
- Are all forms described in the quality system included or referenced ?
- Have all resources needed for implementation (personnel; technology, production, measuring and design equipment; specifications & acceptance standards; quality records) been determined & evaluated (present & needed)?
- Does the quality system satisfy customer requirements & expectations, needs of society?
- Does the quality management emphasize prevention and elimination of nonconformances, reduction of variation and waste.?
- Is the Quality system understood by employees & effective?
- Are quality system & procedures effectively implemented?
- Are they providing the expected results of the quality policy and objectives?
- Are the evaluation tools such as management review and internal quality audits being used to determine effectiveness of the quality system?
Other Useful Training Resources:
“Understanding ISO 9001:2015“ provides a detailed explanation of each ISO 9001 clause
(requirements).
ISO 9001 Consulting – eCourse