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- Keshav Ram Singhal
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Sunday, December 30, 2018

QMS Audit - Closing meeting


QMS Audit - Closing meeting

Guidelines for conducting closing meeting are mentioned in clause 6.4.10 of ISO 19011:2011 standard. A closing meeting is conducted at the end of an onsite audit with an objective to present the audit findings and audit conclusions in such a manner that they are understood and acknowledged by the auditee's management.

Participants of the closing meeting: The closing meeting should be chaired by the audit team leader and attended by the following:
- audit team members,
- auditee's management,
- as applicable, personnel responsible for the functions/processes that have been audited,
- as applicable, audit client,
- as applicable, other relevant interested parties as determined by the auditee/audit client.

Introduction: The audit team leader should thank the auditee for their cooperation during the audit

Recording attendance: An attendance sheet should be retained that mentions all members present in the closing meeting.

Restate audit objectives, scope and criteria: The audit team leader should restate and confirm audit objectives, scope (auditing against ISO 9001:2015 QMS standard) and criteria of the audit during the closing meeting.

Explain situations encountered and the audit findings etc: The audit team leader should advise the situations encountered during audit, the audit findings and the method of reporting. The audit team leader should also explain that the audit only looked at a sample of the auditee's activities, therefore, the absence of recorded nonconformities does not indicate its non-existence. It may be expected that the auditee's internal performance evaluation activities will discover additional nonconformities similar to those that are found by the audit team. With regard to an action plan to address audit findings, the participants should agree on the time frame and how the audit findings should be addressed based on agreed norms. The audit team leader should also advise the degree of the effectiveness of the quality management system as per ISO 9001:2015 QMS standard in achieving the auditee's objectives, including implementation of risk-based thinking. The audit team leader should also state the familiarity of the auditee with the audit process and this will ensure communication of correct details during the closing meeting. The audit team leader should also explain (i) the possible consequences of not adequately addressing the audit findings, and (ii) related post-audit activities, such as corrective action by the auditee, review of corrective action by the audit team, addressing audit complaints, appeal process.

Audit findings and conclusions should be presented in such a manner that are understood and acknowledged by the auditee's management. if there is any difference of opinion with regard to the audit findings or conclusions between the audit team and the auditee, the same should be discussed and resolved. If difference of opinion is not resolved then the same should be recorded.

The audit team leader should conclude the closing meeting with one more thanks to all participants present in the closing meeting. Thank them for coming to the closing meeting, and also for their cooperation and assistance during the audit.

The closing meeting in an internal audit may be short and less formal, where the audit team leader may solely communicate the audit findings and audit conclusions. The closing meeting for an internal audit can be accomplished in little more than fifteen minutes. The closing meeting in an external audit should be formal as per the guidelines mentioned above, however it is suggested that such meeting should be completed within 30 -45 minutes time. It is believed that a well-organized closing meeting adds value to the audit.

Best wishes,

Keshav Ram Singhal


QMS Audit - Opening meeting


QMS Audit - Opening meeting

Guidelines for conducting an opening meeting for an audit are mentioned in clause 6.4.3 of ISO 19011:2018 standard. An opening meeting is conducted at the start of an onsite audit with the following objectives:
- confirming that all participants (audit team and auditee) agree to the audit plan,
- introducing audit team members and their roles during the audit to the auditee, and
- ensuring that all planned activities of the audit can be performed during the audit.

Who should participate in the opening meeting?: The opening meeting should be chaired by the audit team leader. Audit team members, auditee's management and, where appropriate, personnel, responsible for the functions/processes to be audited, should participate in the opening meeting.

Introduction: There should be an introduction of the audit team members and auditee present at the meeting. The roles of each team members should be communicated, as necessary, during the meeting.

Recording attendance: An attendance sheet should be retained that mentions all members present in the opening meeting.

Confirmation of audit objectives, scope and criteria: The audit team leader should state and confirm audit objectives, scope (auditing against ISO 9001:2015 QMS standard) and criteria of the audit during the opening meeting.

Confirmation of audit plan: The audit team leader should state and confirm the audit plan and other relevant arrangements including (i) date/time/place for closing meeting, (Ii) any interim meetings needed, and (iii) any changes needed.

Familiarity with the audit process: The audit team leader should state the audit process so that the auditee familiarize with the audit procedures and methods. The audit team leader should also state that the audit will be a representative sampling of evidence, not a 100 percent inspection. This should be obvious to all participants, but it is important to declare this limitation before the audit begins.

Confirmation of formal communication channels and the language: The audit team leader should state and confirm (i) the formal communication channels between the audit team and the auditee, and (ii) the language to be used during the audit.

Progress reporting: The audit team leader should state and confirm progress reporting arrangements with the auditee's management.

Confirmation of audit resources and facilities: The audit team leader should mention and confirm the adequate resources and facilities available for the audit team.

Confirmation of confidentiality and information security: The audit team leader should mention and confirm matters relating to confidentiality and information security. The audit team leader should make a general commitment to maintain confidentiality related to the evidence gathered and conclusions generated during the audit.

Confirmation of access, health and safety, security, emergency and other arrangements for the auditors: The audit team leader should mention and confirm matters relating to access, health and safety, security, emergency and other arrangements, such as, security equipment, availability of other participants including observers, guides, interpreters etc and an outline of their roles.

Confirmation of activities on site: The audit team leader should mention and confirm, as appropriate, the activities on site, which can impact the auditing.

Presentation of information: The audit team leader should consider and mention, as appropriate, presentation of information relating to the audit findings reporting methods, including ant criteria for grading, for example - minor, major, observation etc.

Opportunity to ask questions: The audit team leader should provide an opportunity to ask questions with regard to the audit during the opening meeting to the participants and provide necessary clarification on the question asked during the opening meeting. The audit team leader should conclude the opening meeting with one more thanks to all participants present in the opening meeting. Thank them for coming to the opening meeting, and also for their cooperation and assistance related to the audit.

The opening meeting in an internal audit may be short and the audit team leader may (i) communicate conducting an internal audit, and (ii) explain the nature of the audit. The opening meeting for an internal audit can be accomplished in little more than five minutes. The opening meeting in an external audit should be formal as per the guidelines mentioned above, however it is suggested that such meeting should be completed within 20 - 30 minutes time. It is believed that a well-organized opening meeting leads to a successful audit.

Best wishes,

Keshav Ram Singhal


Saturday, December 8, 2018

Short Note - ISO 19011:2018 - Guidelines for auditing management systems - Changes in the principles of auditing - Specific reference to risk-based approach


Short Note - ISO 19011:2018 - Guidelines for auditing management systems -
Changes in the principles of auditing - Specific reference to risk-based approach

The previous edition of ISO 19011:2011 had suggested taking into consideration the adoption of a risk-based approach, but it (please refer to clause 5.3.4 - ISO 19011:2011) provided limited guidelines on the matter. ISO 19011:2018 standard document has placed an improved and enhanced focus. Now adoption of risk-based approach will essentially be a critical determinant while planning, conducting and reporting of the audit. It has added a new principle 'the risk-based approach' that provide guidelines to auditors to consider risks and opportunities during auditing at every phase while planning, conducting and reporting. Clause 5.3 of ISO 19011:2018 standard document specifies guidelines for determining and evaluating audit programme risks and opportunities. It is better for an auditor to understand risks and opportunities related to the context of the auditee that may affect achievement of audit objectives. The people, involved in managing an audit, should identify and consider (i) the associated risks and opportunities, and (ii) resource requirements, when developing an audit programme. These identified risks and opportunities, and resource requirements should be communicated to the audit client so that these are addressed suitably.

Risks may be associated with: (i) planning, (ii) resources, (iii) selection of auditor(s) for the audit, (iv) communication, (v) implementation, (vi) control of documented information, (vii) monitoring the audit programme, (viii) reviewing the audit programme, (ix) improving the audit programme, (x) availability of auditee, (xi) cooperation (and coordination) of auditee, and (xii) availability of evidence to be sampled.

Opportunities may be available that can improve the audit programme. Such opportunities may relate to: (i) multiple audits in a single visit, (ii) minimizing time and distances involved in travelling of audit team members, (iii) availability of competent audit team members, and (iv) aligning audit dates with the availability of relevant key auditee.

The application of risk-based approach in auditing management systems will serve as a tool for risk prevention. It will optimize efficiency and effectiveness of the audit process and audit outcome.

Thus, the new standard (ISO 19011:2018) places improved emphasis on risks, opportunities and auditor competence.

Best wishes,

Keshav Ram Singhal


Friday, December 7, 2018

Short Note - PDCA Cycle Activities as per ISO 19011:2018 - Guidelines for auditing management systems


Short Note - PDCA Cycle Activities as per ISO 19011:2018 - Guidelines for auditing management systems

PLAN activities
- Clause 5.2 - Establishing audit programme activities
- Clause 5.3 - Determining and evaluating audit programme risks and opportunities**
- Clause 5.4 - Establishing an audit programme
- Clause 6.2 - Initiating audit
- Clause 6.3 - Preparing audit activities

** Please note that 'risk-based approach' to the principles of auditing is a new addition in ISO 19011:2018

DO activities
- Clause 5.5 - Implementing audit programme
- Clause 6.4 - Conducting audit activities
- Clause 6.5 - Preparing and distributing audit reports

CHECK activities
- Clause 5.6 - Monitoring audit programme
- Clause 6.6 - Completing audit

ACT activities
- Clause 5.7 - Reviewing and implementing audit programme
- Clause 6.7 - Conducting audit follow-up

Best wishes,

Keshav Ram Singhal



Tuesday, December 4, 2018

Short Note - Developing and implementing ISO 9001:2015 QMS in an organization


Short Note - Developing and implementing ISO 9001:2015 QMS in an organization

It is a strategic decision for an organization to adopt ISO 9001:2015 QMS standard. Once the top management of an organization takes a decision to develop and implement ISO 9001:2015, following step-by-step process may be useful:
Step 1 - Leadership and Commitment from Top Management
Step 2 - Assigning responsibilities and authorities
Step 3 - Establishing a steering committee
Step 4 - Establishing a task force
Step 5 - Appointing a QMS consultant
Step 6 - Obtaining Information about QMS and ISO 9000 Family
Step 7 - Start 'ISO 9001:2015 QMS Awareness' Programme
Step 8 - Formulate an Action Plan
Step 9 - Training and Guidance
Step 10 - Conducting Initial Status Survey
Step 11 - Establishing and Developing Quality Policy and Quality Objectives, and Creating and Updating Documented Information
Step 12 - Implementation
Step 13 - Conducting Internal Audit
Step 14 - Conducting Management Review
Step 15 - Arranging Pre-assessment Audit
Step 16 - Going for Certification

For more information on these steps, please visit my blog - Please CLICK FIRST LINK and also CLICK SECOND LINK.

Best wishes,

Keshav Ram Singhal