ISO 9001:2015

QMS
Quality Management System

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Scope
• Manufacturing of ………………..
• Manufacturing of H2SO4 , Caco3 , CaOH & LABSA

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Define the process

Input
Output
Resource Process (Product/
Service )

Control

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Process Flow

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Objective
• Specific
• Measurable
• Achievable
• Realistic
• Time bound

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Objective Analysis
• Achievement Planning
• Achievement Calculation
• Root Cause Identification of Deviation
•

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Quality Policy
• Appropriate to the Organization
• Satisfaction of applicable requirement
• continual improvement

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Policy Communication

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Risk & Control
• Identification of Signification risk
• Sufficient Control
• Responsible

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Opportunities
• Any opportunity
• Online Sales

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Support
• Awareness
• Resource
• Competence
• Communication
• Document Control

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Control of Document
• Approval
• Traceability
• Communicate
• Retention

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Traceability

Date of

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 Internal Audit
A Practice for Continual Development

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Internal audit procedures should state:

• (c) how the audit will be conducted;

• (d) to whom the results will be reported;

• (e) who will initiate any corrective action.

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 Internal Audit
• Internal Audit Procedure
• Internal Audit team
• Internal Audit Schedule
• Opening Meeting
• Performing the Audit
• Writing Observations
• Distinguishing between Minor and Major Observations
• Wrap-up Meeting

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Choosing the Team
• It is important to have a sufficient number of well-trained auditors,
since auditors cannot appraise their own areas

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Functional areas include:
• Management
• Quality Assurance
• Quality Control
• Sales and Marketing
• Customer Service
• Product Development
• Manufacturing
• Materials
• Shipping
• Receiving
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Wrap-up Meeting
• Positive comments may include:
• Cooperation of auditees
• Flexibility of area managers
• Efficiency of locating requested records
• Orderliness and cleanliness of areas
• Improvements over previous audits

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Management Review
• Management reviews should take account of the results of internal
audits and should include:

• Consideration of the overall operation of the GMP inspectorate;

• Uncovering defects or irregularities in the operation of the GMP

inspection system;

• Ensuring that action has been taken to effectively correct defects

revealed in previous reviews and audits.

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Action & Responsibility with target

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Corrective Action Follow-up
• Take the corrective action
• Follow up the effectiveness of the action has been taken

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Question

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