Uploaded by Rhannie Garcia

ISO 9001-2015

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An ISO 9001:2015-compliant QA/QC (Quality Assurance/Quality Control) inspection
report includes specific elements to ensure products or services meet the quality
standards defined by the ISO 9001:2015 quality management system.
Below are the contents and characteristics based on ISO 9001:2015:
Contents of a QA/QC Inspection Report
1. Title and Identification
Title of the report
Unique report number
Date of the report
Version or revision number (if applicable)
2. Project and Inspection Information
Name and identification of the project
Client or customer's name
Date(s) of inspection
Location of inspection
Inspector's name(s) and credentials
Reference to applicable standards and specifications
3. Scope and Objectives
Detailed description of the scope of the inspection
Objectives and purpose of the inspection
4. Inspection Methodology
Detailed procedures and methods used for the inspection
Equipment and tools utilized during the inspection
Calibration records of the equipment used
5. Items Inspected
List and description of items or processes inspected
Identification numbers, batch numbers, or serial numbers
6. Inspection Criteria
Standards and criteria against which the inspection was conducted
Tolerances and acceptable limits
7. Inspection Findings
Detailed results of the inspection
Measurements and observations
Identification of any non-conformities or defects
Photographic evidence and diagrams (if applicable)
8. Assessment and Analysis
Analysis of findings in comparison to the specified criteria
Statistical analysis (if applicable)
Identification of root causes of any non-conformities
9. Corrective and Preventive Actions
Description of required corrective actions for identified non-conformities
Preventive measures to avoid recurrence
Responsibilities and timelines for implementing actions
10. Recommendations
Suggestions for improvements
Additional testing or inspections required
11. Approval and Signatures
Inspector's signature
Approval signatures from QA/QC manager or relevant authorities
Date of approval
12. Attachments
Supporting documents (e.g., calibration certificates, raw data)
Photos, charts, graphs
13. Conclusion
Summary of the inspection results
Overall assessment of quality compliance
Characteristics of an ISO 9001:2015-Compliant Report
1. Accuracy and Precision
Reports must be detailed and accurate, with precise measurements and
observations.
2. Traceability
All data and observations should be traceable to their sources, including the
identification of inspectors and calibration records of equipment used.
3. Consistency
Standardized formats and consistent terminologies should be used to ensure
clarity and uniformity across reports.
4. Objectivity and Impartiality
Inspections and reports should be free from bias, with objective assessments
based on predefined criteria.
5. Clarity and Readability
Information should be presented in a clear, concise, and organized manner to
facilitate easy understanding.
6. Confidentiality
Sensitive information must be handled with confidentiality and disclosed only to
authorized personnel.
7. Compliance with Standards
The report should adhere to relevant standards and specifications, including ISO
9001:2018 requirements.
8. Documentation and Record-Keeping
Proper documentation and record-keeping practices should be followed to ensure
records are maintained and easily retrievable for future reference.
These contents and characteristics ensure that a QA/QC inspection report aligns with
the principles and requirements of ISO 9001:2015, promoting a systematic approach to
quality management and continuous improvement.
Key Focus Areas Based on ISO 9001:2015 Principles
1. Customer Focus
o The report should reflect a clear understanding of customer requirements
and satisfaction criteria.
2. Leadership
o The inspection and reporting process should demonstrate the involvement
and commitment of leadership in maintaining quality standards.
3. Engagement of People
o The report should highlight the competencies and engagement of
personnel involved in the inspection process.
4. Process Approach
o The inspection should be based on a systematic process approach,
ensuring all relevant processes are considered and inspected.
5. Improvement
o Continuous improvement should be emphasized, with actionable insights
and recommendations provided.
6. Evidence-Based Decision Making
o Decisions and conclusions in the report should be based on solid evidence
and data analysis.
7. Relationship Management
o
The report should consider the relationships with suppliers and other
interested parties, ensuring a comprehensive view of quality management.
By adhering to these contents and characteristics, a QA/QC inspection report can
effectively support quality management in compliance with ISO 9001:2015, facilitating
continuous improvement and customer satisfaction.
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