This document outlines the structure and requirements for documentation in an ISO 9001:2008 quality management system. It describes four levels of documentation including a quality manual, procedures, work instructions, and records/forms. The six mandatory procedures are also listed. Key requirements for procedures, work instructions, and the 20 mandatory records specified by the standard are provided. Guidance is given on document control including versioning, approvals, and distribution. Contact information is provided for assistance with ISO documentation and implementation needs.

1. Documentation
ISO 9001:2008 Requirements
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2. DOCUMENTATION Structure
LEVELS DOCUMENTS DETAILS
Level-1 QUALITY MANUAL
Apex Manual should address all the requirements of ISO
Sections, VISION,POLICIES & OBJECTIVES are given here.
There can be references to procedures.
Usually manual is 40 page booklet.
Level-2 QUALITY PROCEDURES
Procedure is “WHO DOES WHAT & WHEN”. 6 Mandatory
Procedures as specified by the standard. There can be
additional procedures also.
Level-3
WORK
INSTRUCTIONS
HOW A JOB IS DONE. Step by Step instruction to do a Job.
Linked to procedure. Work Instructions are specific to a job.
Level-4
FORMS, RECORDS &
OTHER DOCUMENTS
OUTPUT OF PROCEDURES & WORK INSTRUCTIONS. 20
Mandatory Records are required by the standard.

3. QUALITY Procedure
STRUCTURE
1. Purpose
2. Point of Use
3. Scope of the Procedure
4. Responsibilities
5. Method or Procedure
6. References
6-MANDATORY PROCEDURES
 CONTROL OF DOCUMENTS
 CONTROL OF RECORDS
 INTERNAL AUDIT PROCEDURE
 CONTROL OF NON CONFORMING PRODUCTS
 CORRECTIVE ACTION
 PREVENTIVE ACTION

4. • Write the Work Instructions in the same
sequence as the job should be done.
• Write it in easy to follow numbered steps.
WORK Instructions
STRUCTURE
1. Purpose
2. Point of Use
3. Scope of the Procedure
4. Responsibilities
5. Steps
6. Applicable Templates

5. MANDATORY Records
 4.1 –Records for control of outsourced
processes
 5.6.1- Management Review General
Requirements
 7.1 –Records to prove realization process
and resulting product meet requirements
 7.2.2- Review of Requirements related to
product
 7.3.2-Inputs related to product
Requirements
 7.3.4-Review of Design & Development
 7.3.5-Design & Development Verification
 7.3.6-Design & Development Validation
 7.3.7-Control of Design & Development
Changes
 Design & Development changes
 Review of Design & Development
changes
 7.4.1- Records on Supplier Evaluation
 7.5.2- Results on validation of processes
 7.5.3- Records on product identification &
Traceability
 7.5.4-Records on Suitability, Loss/damage of
Customer property
 7.6-Records on Calibration
 6.2.2- Competencies, Awareness &
Training
 8.2.2- Internal Audit Planning and
Conducting
 8.2.4- Product Characteristics
 8.3- Nature of Non Conformance and
subsequent action taken
 8.5.2- Records on corrective action
 8.5.3-Records on preventive action.

6. LIST of Other
Supporting Documents?
• Quality Policy
• Quality Objectives
• Optional Procedures
• Plans
• Process flow diagrams
• Organization Charts
• Legal Documents
• MOMs & IOMs
• Checklists
• Surveys
• Document Distribution List
• List of External Documents

7. DOCUMENT Control
• Document Should include the following
– Version and Date
– Document Name
– Reviewer & Approver
– Point of Use
– Details of Change
– Distribution list
• MR Should maintain a master list of documents with the
above said items.
• Obsolete Documents to be removed from point of use.
• External documents should be properly identified.

8. CONTACT us for ISO Initiatives
Contact Mr. G. Sreedharan for the following
ISO 9001:2008 needs
Email: sreedharang@gmail.com
SreeVaniConsultants
Can Assist in the following areas
 Documentation
 Document Review
 Implementation
 Internal Audits
 Certification Process
 Awareness Training Sessions
 Training on Web