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ISO 13485 Quality Manual Detailed

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32 views5 pages

ISO 13485 Quality Manual Detailed

Uploaded by

rengasri13953
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Quality Manual

Based on ISO 13485:2016 Standard

1. Scope of the Quality Management System


Describe the scope of the QMS and justify any exclusions.

2. Normative References
List the normative documents relevant to the QMS.

3. Terms and Definitions


Provide definitions as per ISO 13485 and organization-specific terminology.

4. Context of the Organization

4.1 Understanding the organization and its context


Describe internal and external issues relevant to strategic direction.

4.2 Understanding the needs and expectations of interested parties


Identify stakeholders and their requirements.

4.3 Determining the scope of the QMS


Define scope boundaries and applicability.

4.4 Quality management system and its processes


Document processes, interactions, and sequence.

5. Leadership
5.1 Leadership and commitment
Demonstrate top management's commitment.

5.2 Customer focus


Ensure customer and regulatory requirements are met.

5.3 Quality policy


Document and communicate the quality policy.

5.4 Organizational roles, responsibilities, and authorities


Define roles and responsibilities for quality.

6. Planning

6.1 Actions to address risks and opportunities


Plan actions to mitigate risks and enhance opportunities.

6.2 Quality objectives and planning to achieve them


Define measurable quality objectives.

6.3 Planning of changes


Document how changes to the QMS are managed.

7. Support

7.1 Resources
Detail resource provision including infrastructure and environment.

7.2 Competence
Ensure personnel are competent based on education, training, and experience.
7.3 Awareness
Ensure awareness of QMS policies and implications of nonconformance.

7.4 Communication
Outline internal and external communication processes.

7.5 Documented information


Control of documentation and records.

8. Operation

8.1 Operational planning and control


Plan and control operational processes.

8.2 Requirements for products and services


Determine and review product requirements.

8.3 Design and development of products and services


Control the design and development process.

8.4 Control of externally provided processes, products, and services


Ensure control over suppliers.

8.5 Production and service provision


Control of production and service activities.

8.6 Release of products and services


Define criteria and responsibilities for product release.

8.7 Control of nonconforming outputs


Document nonconformance handling procedures.
9. Performance Evaluation

9.1 Monitoring, measurement, analysis, and evaluation


Monitor QMS performance and product conformity.

9.2 Internal audit


Conduct regular internal audits.

9.3 Management review


Perform periodic management reviews.

10. Improvement

10.1 General
Opportunities for improvement should be identified and implemented.

10.2 Nonconformity and corrective action


Document nonconformance and corrective action processes.

10.3 Continual improvement


Describe continual improvement strategies.

 Define the boundaries and applicability of the QMS.


 Include justification for any exclusion of design and development controls if permitted
by regulatory requirements.
 Describe how the organization meets customer and applicable regulatory requirements
for medical devices.
 List of documents referenced by the QMS, particularly ISO 9000:2015 for terms and
definitions.
 Ensure all normative references are current and applicable.
 Include terms defined in ISO 9000:2015.
 Add organization-specific terminology relevant to the QMS and medical devices.
 Identify internal and external issues that affect the QMS.
 Understand the expectations of interested parties such as customers, regulatory bodies,
and suppliers.
 Document the scope of the QMS, including exclusions and justification.
 Outline the processes used and their interactions using a process map or narrative.
 Show evidence of top management’s commitment to the QMS.
 Document the quality policy.
 Define roles, responsibilities, and authorities.
 Describe the appointment of the Management Representative and their responsibilities.
 Explain how internal communication is managed regarding the QMS.
 Describe how risks and opportunities are addressed.
 List the quality objectives and the plans to achieve them.
 Explain the approach to changes in the QMS and how integrity is maintained.
 Describe resources required and how they are determined.
 Detail the process for competency, training, and awareness.
 Outline communication methods and documentation control including retention and
disposal.
 Explain how products and services are planned, developed, and controlled.
 Document the design and development procedures, inputs, outputs, review, verification,
and validation.
 Detail control of suppliers and outsourced processes.
 Cover production, installation, servicing, cleanliness, traceability, and product release.
 Include handling of nonconforming outputs and rework procedures.
 Outline monitoring, measurement, analysis, and evaluation procedures.
 Describe internal audit planning, execution, and follow-up.
 Document management review inputs, outputs, and frequency.
 Explain methods for identifying and implementing improvement.
 Include corrective and preventive actions and the review of effectiveness.
 Detail how continual improvement is embedded in the organization.

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