✅ Objective

To successfully complete a third-party ISO 9001:2015 Certification Audit by engaging an accredited certification body, validating that Taj Pharma’s QMS is fully compliant, effective, and aligned with international quality standards.

📋 Certification Audit Overview

A Certification Audit is conducted in two main stages:

🔍 Stage 1: Documentation Review (Readiness Assessment)

  • Verifies the existence and completeness of the documented QMS.
  • Assesses site preparedness for Stage 2.
  • Identifies any major gaps before the main audit.

🔎 Stage 2: Certification Audit (Main Audit)

  • On-site, in-depth audit of all QMS processes and operations.
  • Assesses implementation, effectiveness, and compliance with ISO 9001:2015.
  • Results determine if certification is granted.

🏭 Taj Pharma: Site Scope for Certification

🔬 1. OSD Plant

  • Manufacturing of tablets, capsules, coated and uncoated products.
  • Key processes: granulation, blending, compression, coating, packaging.

🧴 2. External Preparation Plant

  • Manufacturing of creams, ointments, gels, lotions.
  • Key processes: emulsification, homogenization, filling, packaging, stability testing.

Certification scope includes all supporting functions such as:

  • Quality Control (QC)
  • Engineering & Maintenance
  • Stores (RM, PM, FG)
  • Warehousing
  • Human Resources
  • Quality Assurance (QA)
  • Regulatory Affairs

🛠️ Steps in the Certification Audit Process

1. Selection of Accredited Certification Body

  • Must be IAF-accredited (e.g., SGS, TUV, BSI, DNV, Intertek).
  • Evaluate based on industry expertise, cost, audit timeline, and post-certification support.

2. Pre-Audit Preparation

  • Confirm scope, processes, departments, and number of employees.
  • Finalize QMS documentation (Quality Manual, SOPs, records).
  • Perform internal audits and management reviews.
  • Address nonconformities and CAPAs.
  • Train staff on audit readiness and role-based QMS awareness.

3. Stage 1 Audit Activities

  • Review of:
    • Quality Policy and Objectives
    • Organization Context & Interested Parties
    • Risk-based Thinking
    • Process Map and Interactions
    • SOPs and Quality Manual
  • Feedback provided: “Areas of concern,” “Opportunities for Improvement (OFIs)”
  • Outcome: Go/No-Go decision for Stage 2

4. Stage 2 Audit Activities

  • Conducted on-site over 2–5 days (based on plant size).
  • Evaluates:
    • QMS Implementation
    • Operational Controls
    • Monitoring and Measurement
    • Audit & CAPA systems
    • Production records, calibration, training, supplier management
  • Auditor interviews staff, observes processes, reviews records.
  • Nonconformities (NCs) categorized:
    • Major NC: Process failure or regulatory breach.
    • Minor NC: Isolated lapse or documentation issue.
    • Observations/OFIs

5. Audit Report & Corrective Actions

  • Report issued within 5–10 working days.
  • Taj Pharma must:
    • Address major NCs within 30 days
    • Implement CAPAs
    • Provide evidence of correction

6. Certification Decision

  • Based on:
    • Audit findings
    • Evidence of corrective action
  • If successful, ISO 9001:2015 Certificate is issued (valid for 3 years).

🔄 Post-Certification Activities

ActivityFrequencyDescription
Surveillance AuditsAnnuallyVerify continued QMS compliance
Re-Certification AuditEvery 3 YearsFull QMS re-evaluation
Customer/Regulatory AuditsAs requiredSpecific to market or product

📈 Benefits for Taj Pharma

  • Global Credibility: Demonstrates internationally accepted QMS practices.
  • Regulatory Confidence: Enhances audit-readiness for WHO, USFDA, EMA.
  • Customer Trust: Boosts buyer and distributor confidence.
  • Operational Control: Improved consistency, reduced errors.
  • Market Access: Enables tenders and exports to ISO-certified countries.

📦 Deliverables for Taj Pharma

DocumentPurpose
Certification Audit PlanDetails timeline, scope, departments
Stage 1 & 2 Audit ReportsRecords of findings and conclusions
Corrective Action ReportEvidence of CAPA closure
ISO 9001:2015 CertificateIssued by certifying body (3-year validity)

📘 Optional: Pre-Certification Toolkit (Available on Request)

  • Internal Audit Template
  • ISO 9001:2015 Clause Mapping Sheet
  • Employee QMS Awareness Training PPT
  • Mock Audit Checklist for OSD & External Plants