Committed Managers?

It’s fair to say that when an audit has to be done of Section 5 (Management Responsibility) of ISO 9001, the question you can often be left with is how do I audit a management team?   Here is a list of audit questions to use in your organisation that will really test your ISO 9001 compliance (we have included the ISO 9001 section number in brackets as a reference).

5.1 Management Commitment

• What is the process for conducting management review? (5.6.1)
• How is the Senior Management Team involved in this process? (5.1d)
• How are action plans developed following management review? (5.6.3)
• How are the resources needed to implement actions identified? (5.6.3/5.1e)
• What is Senior Management Team’s day-to-day involvement with the quality management system? (5.1)
• Do the Senior Management Team communicate importance of customer & regulatory requirements? (5.1a)
• Check for evidence of this communication & effectiveness throughout the organization
• What benefits have been derived from the QMS?

5.2 Customer Focus

• What is the Mechanism for identifying customer requirements (7.2.1)
• What is the mechanism for keeping up to date with statutory and regulatory requirements (7.2.1 c)
• Are customer expectations and requirements are reflected in product and service specifications?
• Is the quality policy is consistent with the requirements of customers (5.3)
• Are quality objectives are consistent with customer requirements (5.4.1)
• Do the product and service specifications provide customer satisfaction (8.2.1)
• Is there an effective process for communication with the customer (7.2.3)
• Is there evidence that customer satisfaction/perception data is being analysed (8.2.1 and 8.4)

5.3 Quality Policy

• Is there a quality policy and how was it developed? (5.1b)
• Is there evidence of senior management involvement with this (5.1b)
• Is the quality policy appropriate to your organization? (5.3a)
• Does the policy relate to the objectives of your organization? (5.3a)
• Does it include a commitment to meet requirements? (5.3a/5.2)
• Is it understood throughout the business?  (5.3d)
• What is important to your customers, and how do you know? (5.3.a/5.2)
• What will be the process for reviewing the quality policy? (5.3e)

5.4 Planning

• What is the process for establishing and reviewing quality objectives? (5.3.c)
• Check to what extent the Senior Management Team top management are involved in this (5.1c)
• View the current quality objectives – How were these objectives chosen? (5.4.1)
• Check how objectives link to – quality policy (5.4.1), analysed data (8.4/8.5.1), customer requirements (5.2), management review outputs (5.6.1), related business objectives (5.3)
• How are objectives established at throughout your organization? (5.4.1)
• How are objectives measured? (5.4.1)
• Is there evidence that objectives are being achieved?  If not, has appropriate corrective action been taken? (8.5.1)

5.5 Responsibility, authority & communication

• Are responsibilities and authorities communicated through your organisation? (5.5.1)
• Is there a Quality Management Representative appointed? (5.5.2)
• Does the Quality Management Representative communicate  performance to senior management? (5.5.2 b)
• Does the Quality Management Representative promote awareness of customer requirements? (5.5.2 c)
• Do senior management communicate objectives throughout your organisation? (5.5.3)
• Do senior management communicate QMS performance? (5.5.3)

5.6 Management Review

• Does your organisation perform management reviews? (5.6.1)
• Are records of these reviews maintained? (5.6.1)
• Does the review include: results of audits, customer feedback, process performance, product performance, status of preventive & corrective actions, follow up actions, changes and recommendations for improvement (5.6.2)
• Does the review result in decisions and actions to drive improvement? (5.6.3)

Hopefully this extensive list will give you all you need to thoroughly audit this part of ISO 9001 and achieve higher levels of compliance.