Clause 6 – Planning of ISO 9001:2015 ensures that the organization plans its Quality Management System (QMS) to address risks and opportunities, achieve quality objectives, and effectively manage changes.
Clause 6 consists of three sub-clauses:
6.1 – Actions to Address Risks and Opportunities
6.2 – Quality Objectives and Planning to Achieve Them
6.3 – Planning of Changes
Below is an audit-ready SOP for an API Pharmaceutical Manufacturing Company.
Clause 6 consists of three sub-clauses:
6.1 – Actions to Address Risks and Opportunities
6.2 – Quality Objectives and Planning to Achieve Them
6.3 – Planning of Changes
Below is an audit-ready SOP for an API Pharmaceutical Manufacturing Company.
Standard Operating Procedure (SOP)
Clause 6 – Planning
ISO 9001:2015
Document No.: QMS/SOP/007
Version: 01
Effective Date: __________
Review Date: __________
Approved By: Head – Quality / Site Head
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1. Purpose
To establish a systematic approach for planning the Quality Management System (QMS), addressing risks and opportunities, establishing quality objectives, and managing planned changes in accordance with ISO 9001:2015 Clause 6.
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2. Scope
This procedure applies to all departments involved in the manufacture, testing, storage, release, and distribution of Active Pharmaceutical Ingredients (APIs).
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3. Definitions
Risk: The effect of uncertainty on achieving intended results.
Opportunity: A circumstance that can improve quality, efficiency, compliance, or customer satisfaction.
Quality Objective: A measurable target established to achieve the Quality Policy.
Planned Change: Any intended modification to processes, facilities, equipment, documentation, organization, or resources that may affect the QMS.
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4. Procedure
4.1 Planning the QMS
The organization shall plan the QMS to:
- Meet the requirements of ISO 9001:2015.
- Support the strategic direction of the organization.
- Maintain process effectiveness.
- Enhance customer satisfaction.
- Promote continual improvement.
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4.2 Risk and Opportunity Management (Clause 6.1)
Each department shall identify and evaluate risks and opportunities that may affect:
- Product quality.
- Regulatory compliance.
- Customer satisfaction.
- Process performance.
- Business continuity.
Typical Risks
- Raw material quality failures.
- Equipment breakdown.
- Regulatory observations.
- Supplier performance issues.
- Data integrity failures.
- Human error.
- Utility interruptions.
Typical Opportunities
- Automation of manual processes.
- Digital quality systems.
- Employee skill enhancement.
- Process optimization.
- Energy conservation.
- Reduction of deviations and waste.
Actions shall be planned, implemented, monitored, and reviewed for effectiveness.
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4.3 Quality Objectives (Clause 6.2)
Quality Objectives shall:
- Be consistent with the Quality Policy.
- Be measurable.
- Be communicated to relevant personnel.
- Be monitored periodically.
- Be updated as required.
Example Quality Objectives
- Customer complaints ≤ target defined by management.
- Batch rejection rate below the approved annual target.
- CAPA closure within the defined due date.
- Internal audit completion as per annual schedule.
- On-time training completion for all employees.
- On-time batch release in accordance with internal targets.
Each objective shall define:
- Responsible department.
- Performance indicator (KPI).
- Target value.
- Review frequency.
- Required resources.
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4.4 Planning of Changes (Clause 6.3)
Changes affecting the QMS shall be planned before implementation.
The organization shall evaluate:
- Purpose of the change.
- Potential risks.
- Impact on product quality.
- Availability of resources.
- Responsibilities and authorities.
- Need for validation or qualification.
- Regulatory implications.
Changes shall be managed through the approved Change Control Procedure.
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5. Responsibilities
Top Management
- Approve quality objectives.
- Review strategic risks.
- Provide required resources.
Head – Quality Assurance
- Coordinate risk management activities.
- Monitor achievement of quality objectives.
- Review planned changes for QMS impact.
Department Heads
- Identify departmental risks and opportunities.
- Establish departmental objectives.
- Implement approved changes.
Employees
- Participate in risk identification.
- Report quality risks promptly.
- Follow approved change control procedures.
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6. Documented Information
Maintained Documents
- Risk Management Procedure
- Quality Objectives
- Change Control Procedure
- Annual Quality Plan
- Departmental KPI Plan
Retained Records
- Risk Assessment Reports
- Risk Register
- Opportunity Register
- KPI Reports
- Change Control Records
- Management Review Minutes
- CAPA Records
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7. References
- ISO 9001:2015 – Clause 6
- Risk Management Procedure
- Change Control Procedure
- CAPA Procedure
- Management Review Procedure
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Auditor Expectations
Auditors typically verify that:
- Risks and opportunities are identified and addressed.
- Quality objectives are measurable and monitored.
- Objectives support the Quality Policy.
- Changes are planned before implementation.
- Evidence demonstrates monitoring and continual improvement.
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Typical Auditor Questions
1. How do you identify risks and opportunities?
2. Can you show your departmental risk register?
3. What are your quality objectives?
4. How are objectives monitored?
5. What actions are taken if objectives are not achieved?
6. How are changes planned before implementation?
7. Can you provide an example of a recent planned change?
8. How does planning support continual improvement?
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Expected Employee Response
"My department identifies risks and opportunities during routine operations, meetings, audits, and reviews. We monitor quality objectives using KPIs, implement actions to control identified risks, and manage changes through the approved Change Control Procedure to ensure product quality, compliance, and continual improvement."This SOP provides a practical framework for implementing ISO 9001:2015 Clause 6 in an API pharmaceutical manufacturing environment and serves as a foundation for the more detailed procedures required under Clauses 6.1, 6.2, and 6.3.
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