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Simple ISO 9001:2008 QMS Documentation
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ISO 9001:2008 Quality Management System Documentation
COURSE OBJECTIVES
• To provide basic knowledge for documenting QMS.
• To understand the importance of documenting a QMS.
• To understand documentation hierarchy and different types of documents.
• To know how to control documents.
SYNOPSIS OUTLINE
• Hierarchy of QMS Documentation• Guidelines for QMS Documentation• Documentation Requirements• Documentation Format• Control of Documents• Documenting a Quality System
HIERARCHY OF QMS DOCUMENTATION
Level 1
Level 2
Level 3
Level 4
QUALITY MANUAL What?
PROCEDURES How?
WORK INSTRUCTIONS How?
REFERENCE/RECORDS Evidence
ACTIVITY
• Group into three.• Make your own version of SOP on “How to take a bath”
GUIDELINES FOR QMS DOCUMENTATION
• QUALITY MANUAL FORMAT AND LAYOUT Is there a standard form for writing quality
manual?
NO!
Because every company makes and offers different products or services and is organized in its own UNIQUE way.
“TELL IT LIKE IT IS”
GUIDELINES FOR QMS DOCUMENTATION
• CONSIDERATIONS UPON MAKING A MANUAL THE USER
Must find what he needs. Must be able to understand the language and style.
DO NOT WRITE TOO MUCH
GUIDELINES FOR QMS DOCUMENTATION
UPDATING
by page By section of chapter Entire document Avoid duplication of information Is influenced by distribution Identification of changes.
DOCUMENTATION REQUIREMENTS
TWO IMPORTANT POINTS Do not forget that the manual must reflect what
you do. The manual is your SERVANT,
not your MASTER.
IT MUST DO WHAT YOU WANT IT TO DO
DOCUMENTATION REQUIREMENTS
Based on ISO 9001: Documentation Requirements
DOCUMENTED PROCEDURES ( 6 MANDATORY PROCEDURES )
1) Control of Documents2) Control of Records3) Internal Audit4) Control of nonconforming products5) Corrective Action6) Preventive Action
DOCUMENTATION FORMAT
FORMAT CONSIDERATIONSShould be well designed to allow easy
recording.Contain everything in one sheet.Contains necessary provisions to ensure
identification and traceability.
DOCUMENTATION FORMAT
DATA NEEDED TO CONTROL A DOCUMENT Type of the Manual Company name/logo Department and Section Reference Code Revision Number Issue number/code Effectively Date Page Number Prepared By Reviewed By Approved By
DOCUMENTATION FORMAT
TYPES OF DOCUMENTS Quality Manual – provide consistent information, both
internally and externally. Procedure Manual – provide how to perform activities and
processes consistently. Work Instruction – detailed steps to be followed in meeting
the requirements for quality. Quality Plan – describes how the quality system is applied. Specification – document stating requirements. Guidelines – document stating recommendations and
suggestions. Records – document that provide objective evidence of
activities.
CONTROL OF DOCUMENTS
CLASSIFICATION DOCUMENTS AS TO ORIGINEXTERNAL – documents that relate to the quality
system which are not developed within organization.
INTERNAL – documents that relate to the quality system which are developed, reviewed and approved by authorize person within the organization.
CONTROL OF DOCUMENTS
CLASSIFICATION DOCUMENTS AS TO ORIGINCONTROLLED – documents which requires for its
development, approval, issue, revision, distribution, maintenance, use storage and disposal is defined.
UNCONTROLLED COPY – documents which maintenance, storage security and disposal is not defined and needs no updating.
DOCUMENTING A QUALITY SYSTEM
ISO 9001:2008
DOCUMENTATION MUST
K*I*S*S
