TQCSI Egypt

ISO 9001:2015 Lead Auditor Course
IRCA Approved Training | Online
Elevate your career with the gold standard in Quality Management auditing.
🔹 Start Date: March 11th
🔹 Duration: 5 Days
🔹 Mode: Online Attendance & Exam
🔹 Certification: IRCA Accredited
Company: TQCSI Egypt
📞 For more info, contact us:
01277861114
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📘 ISO 9001:2015 – Clause 7.5.
Documented Information

Wrong document = Wrong product.

Clause 7.5 ensures that all documented information required by the QMS is:
✔ Properly created
✔ Updated
✔ Controlled
✔ Protected

🔎 What Clause 7.5 Covers ?
Clause 7.5 is divided into:

7.5.1 – General
Organization must maintain & retain documented information required by ISO 9001 and its own QMS.

7.5.2 – Creating & Updating:
When creating documents, ensure:
● Identification (Title, number, date, revision).
● Format (soft copy / hard copy).
● Review and approval before issue.

7.5.3 – Control of Documented Information
Documents must be:
● Available where needed.
● Protected from loss or misuse.
● Version controlled.
● Prevent unintended use of obsolete documents.

🏭 Manufacturing Example:

📌 Documents Maintained:
■ Quality Manual
■ SOPs (Mixing, Molding, Curing, Inspection)
■ Work Instructions
■ Control Plan
■ FMEA
■ Drawing & Specifications
■ Calibration Records
■ Inspection Reports
■ CAPA Reports
■ Supplier Evaluation Records
■ Training Records

❌ If Clause 7.5 Fails:
● Old drawing used in production
● Wrong curing parameters applied
● Inspection done as per outdated standard
● Customer complaint due to revision mismatch
● Audit nonconformity.

✅ Practical Implementation in Factory;
✔ Maintain Master List of Documents
✔ Document Control Procedure
✔ ERP-based revision control
✔ Stamp “OBSOLETE” on old hard copies
✔ Backup server for soft copies
✔ Controlled access for editing.

📂 Auditor Will Check:
■ Is document control procedure defined?
■ Are latest revisions available on shop floor?
■ Are records legible & retrievable?
■ Is there evidence of approval before issue?
■ How are obsolete documents controlled?

🎯 Simple Understanding:
👉 Clause 7.5 ensures “Right Document, Right Version, Right Place, Right Time.”

Without strong document control, even the best process will fail.

If you are working in manufacturing, remember:
📌 Production runs on machines
📌 But Quality runs on documents

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