ISO9001：2015过程审核检查表-英文版

Process Audit Checklist

System & Process Compliance Auditing

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ISO 9001:2015 Process Audit Checklist

System & Process Compliance Auditing

Guidance

About this Checklist

The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary requirements. It stands as a reference point before, during and after the audit process and if developed for a specific audit and used correctly will provide the following benefits:

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Ensures the audit is conducted systematically; Promotes audit planning;

Ensures a consistent audit approach;

Actively supports your organization’s audit process (ISO 9001:2015, Clause 9.2.1); Provides a repository for notes collected during the audit; Ensures uniformity in the performance of different auditors; Provides reference to objective evidence.

This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 10.0 of ISO 9001:2015, each required is phrased as a question. This audit checklist may be used for element compliance audits and for process audits. If you wish to create separate process audit checklists, select the clauses from the tables below that are relevant to the process and copy and paste the audit questions into a new audit checklist. We suggest that you retain this audit checklist as your ‘master copy’.

Document Ref:

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ISO 9001:2015 Process Audit Checklist

System & Process Compliance Auditing

Audit Scoring Criteria

A risk-based internal audit approach allows the internal audit to concentrate on reviewing the major risks to your organization. The audit’s role is to provide assurance that key risks to your organization’s objectives are being well controlled.

The audit findings ‘traffic lights’ are intended to visually communicate the risk posed by the audit finding of any system or processes being audited. The rating system is stratified from ‘compliant’ to ‘major non-conformance’ to convey a concise and consistent method for scoring each audit finding. At the end of the audit, you can transfer the findings into an Excel spreadsheet to create charts, summary tables and trend data to paste into your audit report or management review documentation.

This methodology should be uniformly applied to all types of internal audit (gap analysis, system audits and process audits) that your organization will likely undertake. Finding COMPLIANT Definition/Impact Compliant means adherence with the requirements of the standard and the QMS. The process is implemented and documented and records exist to verify this. A low risk issue that offers an opportunity to improve current practice. Processes may cumbersome or overly complex but meet their targets and objectives. Unresolved OFIs may degrade over time to become non-compliant. A medium risk, minor non-conformance resulting in deviation from process practice not likely to result in the failure of the management system or process that will not result in the delivery of non-conforming products nor reduce the effectiveness of the QMS. A high risk, major non-conformance which directly impacts upon customer requirements, likely to result in the customer receiving non-conforming products or services, or which may reduce the effectiveness of the QMS. Action/Mitigation Continue to monitor trends/indicators. OFI Review and implement actions to improve the process(s). Monitor trends/indicators to determine if improvement was achieved. Investigate root cause(s) and implement corrective action by next reporting period or next scheduled audit. Implement immediate containment action, investigate root cause(s) and apply corrective action. Re-audit in 4 weeks to verify correction. MINOR N/C MAJOR N/C Document Ref:

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ISO 9001:2015 Process Audit Checklist

System & Process Compliance Auditing

Process Activity Map

EQUIPMENT & FACILITIES: PERSONNEL: Review employee skill lists for the process. Are there lists of skills for each position? Do they show enough detail? This is often a finding, where lists are generic with inadequate detail. Training is a key process of any system. Are there particular skills you want to evaluate? CONTROL PROCESSES: How is the process defined and who is responsible? How are customer requirements defined? What specifications apply defined? What objectives and targets apply process? What controls/check points are there? What acceptance criteria exist? What equipment and resources are required? Is equipment suitable and properly maintained? Is the work environment maintained? Is there evidence of appropriate maintenance of all equipment used by this process? PROCESS INPUTS: What triggers the process? What inputs are required? Where do the inputs come from? Are they received in a timely manner? Are they fit for purpose? PROCESS NAME/DESCRIPTION: What steps are involved in the process? What happens at each step in the process? What documents and records are generated? Is the process implemented in accordance with procedures, instructions or plans? Are controls applied as described? PROCESS OUPUTS: What is the product produced by this process? Are product measures in place to ensure that product meets requirements? How are processes measured? Are product and process measures achieved? What feedback is received from customers? INSTRUCTIONS & PROCEDURES: Review the documents that describe and control the process. Review all the important steps and activities of the process being audited. This info must be documented within the QMS. Evaluate how effectively the process flows through the steps. Do you see roadblocks or issues? SUPPORT PROCESSES: As you audit, you will see how it connects and interacts with other processes. Interactions with other processes are always important. As you audit the, you will see how it connects and interacts with other processes. Audit the relevant links to related processes and support processes. KEY PERFORMANCE INDICATORS: Review metrics and performance with Managers, Supervisors and operators. They should know how things are running, objectives, customer issues, problem areas. If they do not, the requirements were not met. Is there evidence that quality objectives and targets affected by this process are being achieved? Document Ref:

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ISO 9001:2015 Process Audit Checklist

System & Process Compliance Auditing

Process Audit Checklist

Process Definition

Audit Findings (Score ‘1’ per box) COMPLIANT Audit Evidence Ref Audit Question MAJOR N/C MINOR N/C Opportunities for Improvement (OFI) Provide suggestions for process improvement OFI Provide reference to documented information to justify the finding 1 Is the process defined and documented? Is the process owner identified? (Process map, procedure or work instruction, etc.) Is there evidence that process inputs are accurately defined and understood by all employees involved? Is there evidence that process activities are accurately defined and understood by all employees involved? Is there evidence that process outputs are accurately defined and understood by all employees involved? Are inputs defined and prioritized based on risk? 2 3 4 5 6 Document Ref:

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