QMS-FORM-09-4 Internal Audit Checklist

Internal Audit Checklist

ISO9001 Toolkit: Version 3 ©CertiKit

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Purpose of this document This is a checklist to be used as a prompter for questions during an internal audit.

Areas of the standard addressed The main areas of the ISO9001 standard addressed by this document are: •

9. Performance evaluation o 9.2 Internal audit

General guidance When conducting an internal audit it can be useful to have a list of standard questions to ask, organized according to the sections of the ISO9001 standard. This makes the audit more interesting than simply reading the requirements from a spreadsheet. It’s possible that any one audit will not cover all parts of the standard so you may need to edit this checklist to cover the areas you need. You may also like to add further questions to the lists, depending on the type of organization you are auditing.

At each stage, it is important that evidence is reviewed and recorded to prove that procedures etc. are in place.

Review frequency We would recommend that this document is reviewed annually.

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Internal Audit Checklist

Audit details Audit: Audit scope: Auditor(s): Date of audit:

4 Context of the organization 4.1 Understanding the organization and its context REF

RECOMMENDED QUESTIONS

1.

What are the internal and external issues that are relevant to the QMS?

2.

How do they affect its ability to achieve its intended outcome?

3.

What does the organization do (in broad terms) and how might errors and non-conformities affect its activities?

4.

What is the purpose of the QMS?

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AUDIT FINDINGS

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EVIDENCE REVIEWED

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4.2 Understanding the needs and expectations of interested parties REF

RECOMMENDED QUESTIONS

1.

Who are the interested parties?

2.

What are their requirements?

3.

How have their requirements been established?

4.

What are the main legal and regulatory requirements that the organization must meet?

5.

How is the understanding of these requirements kept up to date?

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AUDIT FINDINGS

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EVIDENCE REVIEWED

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4.3 Determining the scope of the QMS REF

RECOMMENDED QUESTIONS

1.

What is the scope of the QMS?

2.

How is it defined?

3.

Ae any exclusions explained?

4.

Does it consider the relevant issues and requirements?

5.

Is the scope documented?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

4.4 QMS and its processes REF

RECOMMENDED QUESTIONS

1.

How established is the QMS?

2.

How long has it been running for?

3.

How much evidence has been collected so far, for example, records?

4.

What are the processes of the QMS?

5.

How are the processes documented?

6.

How much detail is given for each process?

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5 Leadership 5.1 Leadership and commitment REF

RECOMMENDED QUESTIONS

1.

Who is defined as top management within the scope of the QMS?

2.

How does top management demonstrate leadership and commitment, in practical terms?

3.

How well are customer requirements understood?

4.

How is customer satisfaction ensured?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

5.2 Policy REF

RECOMMENDED QUESTIONS

1.

Can I review the QMS policy?

2.

Is it appropriate and does it cover the required areas?

3.

Does it include the required commitments?

4.

How has it been communicated and distributed - and to whom?

5.

When was it last reviewed?

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5.3 Organizational roles, responsibilities and authorities REF

RECOMMENDED QUESTIONS

1.

What are the roles within the QMS?

2.

Does everyone understand what their responsibilities and authorities are?

3.

Who has the responsibility and authority for conformance and reporting?

4.

Who takes the lead on customer focus?

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AUDIT FINDINGS

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EVIDENCE REVIEWED

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6 Planning 6.1 Actions to address risks and opportunities REF

RECOMMENDED QUESTIONS

AUDIT FINDINGS

1.

What are the main risks to the QMS?

2.

What actions are or have been taken to address them?

3.

How effective have these actions been?

EVIDENCE REVIEWED

6.2 Quality objectives and plans to achieve them REF

RECOMMENDED QUESTIONS

1.

Are there documented quality objectives?

2.

Do the objectives comply with section 6.2.1 a) to g)?

3.

Is there a plan to achieve the objectives?

4.

Does the plan include the who, what, when and how?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

6.3 Planning of changes REF

RECOMMENDED QUESTIONS

1.

What changes have been made to the QMS in the last 12 months?

2.

How were these changes planned and managed?

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7 Support 7.1 Resources REF

RECOMMENDED QUESTIONS

1.

How are the resources needed for the QMS determined?

2.

Are the required resources, including people, infrastructure and work environment, provided?

3.

What external resources are used?

4.

What resources are allocated to monitoring and measuring?

5.

Is there a requirement for measurement traceability and, if so, how is it achieved?

6.

What knowledge is needed within the organization, and how is it maintained?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

7.2 Competence REF

RECOMMENDED QUESTIONS

1.

Have the necessary competences been determined?

2.

How has the competence of the people involved in the QMS been established?

3.

What actions have been identified to acquire the necessary competence?

4.

Have they been completed, and is there evidence of this?

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7.3 Awareness REF

RECOMMENDED QUESTIONS

1.

What approach has been taken to providing awareness of the quality policy, contribution to the QMS and implications of not conforming?

2.

Has everyone been covered?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

7.4 Communication REF

RECOMMENDED QUESTIONS

1.

How has the need for communication been established?

2.

What regular methods are used for communication?

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7.5 Documented information REF

RECOMMENDED QUESTIONS

1.

Is all the documented information required by the standard in place?

2.

Is the level of other documentation reasonable for the size of QMS?

3.

Are appropriate documentation standards, for example, identification and format, in place?

4.

Are the standards applied in a uniform way?

5.

Are appropriate controls in place to address the activities listed in 7.5.3.2?

6.

How are documents of external origin handled?

7.

How is the documentation protected?

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EVIDENCE REVIEWED

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8 Operation 8.1 Operational planning and control REF

RECOMMENDED QUESTIONS

AUDIT FINDINGS

1.

What processes are used to meet requirements?

2.

How are the requirements for products and services determined?

3.

What level of documented information is kept about the operation of the processes?

4.

What planned changes have taken place recently, and how were they controlled?

5.

What processes are outsourced?

6.

How are they controlled?

EVIDENCE REVIEWED

8.2 Emergency preparedness and response REF

RECOMMENDED QUESTIONS

1.

What types of customer communication take place?

2.

How are applicable statutory and regulatory requirements defined?

3.

Is a review carried out to check that customer requirements can be met before a commitment to supply is given?

4.

What happens when the requirements for products and services are changed?

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AUDIT FINDINGS

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EVIDENCE REVIEWED

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8.3 Design and development of products and services REF

RECOMMENDED QUESTIONS

1.

Is there a defined design and development process?

2.

What factors are taken into account when determining the stages and controls for design and development?

3.

What information is input to the design and development process?

4.

Is this information documented?

5.

What controls are applied to the design and development process?

6.

How are the outputs of design and development evaluated?

7.

What happens when changes are made during or after design and development?

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EVIDENCE REVIEWED

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8.4 Control of externally provided processes, products and services REF

RECOMMENDED QUESTIONS

1.

What processes, products or services are externally provided?

2.

What controls are applied to these?

3.

How are external providers managed?

4.

How is it ensured that external providers deliver to requirements?

5.

What information is communicated to external providers?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

8.5 Production and service provision REF

RECOMMENDED QUESTIONS

1.

What conditions are in place to control production and service provision?

2.

Are outputs identified?

3.

How are any outputs that must be traceable controlled?

4.

How is property belonging to customers or external providers managed and protected?

5.

If outputs need to be preserved, how is this achieved?

6.

What post-delivery activities are provided?

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7.

What happens when things change during production or service provision?

8.6 Release of products and services REF

RECOMMENDED QUESTIONS

1.

How are products and services verified to ensure they meet requirements, before being released?

2.

What documented information is maintained on the release of products and services?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

8.7 Control of nonconforming outputs REF

RECOMMENDED QUESTIONS

1.

How are outputs that don’t conform to requirements identified?

2.

What happens when a nonconformity is found?

3.

What documented information is recorded about nonconformities?

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9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation REF

RECOMMENDED QUESTIONS

1.

How is it determined what should be monitored and measured?

2.

May I review evidence of monitoring and measurement?

3.

How are results reported?

4.

How is customer satisfaction monitored?

5.

What have been the recent conclusions from analysis of monitoring and measurement information?

AUDIT FINDINGS

EVIDENCE REVIEWED

AUDIT FINDINGS

EVIDENCE REVIEWED

9.2 Internal audit REF

RECOMMENDED QUESTIONS

1.

How often are internal audits carried out?

2.

Who carries them out?

3.

Are the auditors objective and impartial?

4.

May I review the most recent internal audit report?

5.

Have any nonconformities resulting from previous audits been addressed?

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6.

Does the audit programme cover the complete scope of the QMS?

9.3 Management review REF

RECOMMENDED QUESTIONS

1.

How often are management reviews carried out?

2.

Who attends them?

3.

Are they minuted?

4.

Are all areas in 9.3 .2 covered at management reviews?

5.

May I review the results of the most recent one?

6.

What outputs resulted from it?

7.

Does the management review represent a reasonable assessment of the health of the QMS?

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10 Improvement 10.1 General REF

RECOMMENDED QUESTIONS

1.

How are opportunities for improvement identified?

2.

What improvement actions have been completed recently?

3.

What effect have these improvements had on the QMS?

AUDIT FINDINGS

EVIDENCE REVIEWED

10.2 Incident, nonconformity and corrective action REF

RECOMMENDED QUESTIONS

1.

How are nonconformities identified?

2.

How are they recorded?

3.

May I review the records of a recent nonconformity?

4.

Was appropriate action taken to correct it and address the underlying causes?

5.

Was the effectiveness of the corrective action reviewed?

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10.3 Continual improvement REF

RECOMMENDED QUESTIONS

1.

What evidence of continual improvement can be demonstrated?

2.

What are the main sources of improvements?

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AUDIT FINDINGS

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EVIDENCE REVIEWED

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