Procedure · SOP-05
Corrective Action and Improvement
Raising, investigating, implementing and verifying corrective actions; capturing improvement opportunities.
Purpose
To define how the Laboratory reacts to nonconformities, determines and eliminates their causes so that they do not recur or occur elsewhere, verifies the effectiveness of the action taken, and identifies and implements opportunities for improvement, including the use of customer feedback.
What is inside
11 sections, about 3 pages when printed.
- 1. Purpose
- 2. Scope
- 3. References
- 4. Definitions
- 5. Responsibilities
- 6. Process overview
- 7. Procedure
- Records generated by this procedure
- Monitoring and performance indicators
- Assessment readiness notes
- Related documents
Records it generates
Applying this procedure produces the following records, which are the evidence an assessor samples.
- –Corrective action register and requests
- –Root cause analysis worksheets
- –Effectiveness verification evidence
- –Improvement proposals and outcomes
- –Customer feedback and analysis
What an assessor looks for
The document closes with these points, so you can check your own practice before someone else does.
- –Whether root causes go beyond 'human error' and whether the extent check was done.
- –Whether effectiveness was verified with evidence after a suitable period, not closed on the day the action was implemented.
- –Whether accreditation-body findings from the last visit were closed with corrective, not just corrective-looking, action.
- –Whether customer feedback is actually sought, analysed and used.
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
- Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.
Related documents
- QM-01
Quality Manual
Top-level description of the management system against every clause of ISO/IEC 17025:2017.
- FRM-06
Audit Finding and Nonconformity Report
Records an audit finding with classification, objective evidence and required response.
- FRM-08
Corrective Action Request
Nonconformity description, containment, root cause, action plan, verification of effectiveness.
- FRM-09
Root Cause Analysis Worksheet
Five-whys and cause-and-effect (fishbone) worksheet supporting corrective action.
- FRM-43
Customer Feedback Survey
Structured customer feedback used as an improvement input.
- CHK-01
ISO/IEC 17025:2017 Gap Analysis and Self-Assessment
Clause-by-clause self-assessment with evidence, gap and action columns.
- SOP-01
Control of Documents
Creation, review, approval, issue, change and withdrawal of internal and external documents.
- SOP-02
Control of Records and Technical Records
Identification, storage, protection, retention, amendment and disposal of quality and technical records.