'Actions to Address risks and opportunities' QSP has been updated

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ISO 9001:2015 QSP 6.1-01 Actions to Address risks and opportunities has been recently updated.

We have added 8 quality system forms relevant to the procedure:

• QSF 6.1-01-01 Risk management plan
• QSF 6.1-01-02 Risk criteria
• QSF 6.1-01-03 Risk List
• QSF 6.1-01-04 Risk treatment plan {.PNG preview}
• QSF 6.1-01-05 Risk Owner to Process Owner and to Risk Manager Report on the results of monitoring and review of risk management process, including improvement proposals.{.PNG preview}
• QSF 6.1-01-06 Risk Manager to Quality Manager Current Report on the results of addressing risks and opportunities in QMS Processes.
• QSF 6.1-01-07 Risk Manager to Company Management information report on the productivity of the ‘Actions to address risks and opportunities’ Process
• QSF 6.1-01-08 Risk Manager to Company Management annual report on the results of Risk Management Plan implementation and proposals to increase the effectiveness of the ‘Actions to address risks and opportunities’ Process. 

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Other ISO 9001:2015 Documents and Templates 

How and when to use Audit checklist?

Question: 
1. How and when to use Audit checklist? 

  Answer:
1.1 Internal auditors training 
When utilized for internal auditors training, our ISO 9001:2015 Audit checklist:

• provides a complete understanding of how to verify compliance with the requirements of all ISO 9001:2015 clauses;
• can be used as practice for internal auditors workshops. 

1.2 Mandatory ISO 9001:2015 staff training 
When conducting the mandatory ISO 9001:2015 staff training Audit checklist:

• Facilitates understanding of ISO 9001:2015 requirements;
• Allows every employee to check his/her activity performance in compliance with the new requirements of ISO 9001: 2015. 

1.3 QMS transition to the ISO 9001:2015 version 

Use Audit checklist as a guide in the QMS transition to the ISO 9001:2015 version applying ‘fill the gap’ methodology in four phases:

1. Conduct internal audit based on our 9001:2015 Audit checklist. 
2. Formalize the identified nonconformities, including a complete noncompliance with the requirements, in the form of a Program. 
3. Implement the Program. 
4. Conduct recurrent audit using 9001:2015 Audit checklist. 

1.4 Internal audits (Process audits)
When conducting internal audits, Audit checklist ensures:

• detailed verification of each requirements of ISO 9001:2015;
• the issues that could not be verified during current internal audit to be planned for the next internal audit and thus provides the completeness of all ISO 9001:2015 requirements verification;
• compensation for the lack of experience of novice auditors. 

Question: 
2. We are already certified to ISO 9001:2008 version. Are there any specific ways to utilize the Audit Checklist?

 Answer: 
2.1 Our ISO 9001:2015 Audit checklist can be used for QMS self-assessment for compliance with the new version of ISO 9001:2015 (see 1.3).
2.2 Use our ISO 9001:2015 Audit checklist for internal auditors’ professional development (see 1.1.).
2.3 Use of Audit checklist for internal audits is a good practice, proven over many years of experience (see 1.4.).

Question: 
3. Does ISO 9001:2015 Audit checklist cover ISO 9001:2015 conformance and performance audits?

 Answer: 
Yes, ISO 9001:2015 Audit Checklist completely covers ISO 9001:2015 conformance and performance audit.

Implementation of ISO 9001:2015 clause 4.1

How do you prove you meet the requirements of Clause 4.1 of ISO 9001:2015?

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues. ISO 9001:2015 Cl.4.1

Information monitoring and internal and external issues components analysis are carried out in the QMS processes.

1) ‘Marketing’ process. 
Information about external issues includes results of the analysis of

• political and legal issues,
• economic issues,
• demographic issues, 
• environmental issues, 
• cultural and scientific issues, 
• information from consumers,
• information from competitors, 
• information from external providers, 
• information from contact audiences,
• information from marketing intermediaries. 

Information about internal issues includes results of the analysis of

• corporate level strategy, 
• business level strategy, 
• functional level strategies, 
• adequacy of resources. 

Information to understand the context of the organization is a part of ‘Marketing’ report for management review, as well as a part of the database to obtain and maintain organizational knowledge relevant to marketing activity.

 2) ‘Control of personnel’ process - information and analysis of the of internal issues components, relevant to the status, tasks and perspectives of the personnel development.

3) ‘Design and development’ process information and analysis of the of internal issues components, relevant to perspective development.

Summarizing of information from QMS processes information (mentioned above) and general analysis of internal and external issues is carried out in the ‘Management Review’ process.

The best practice of creation and transfer of information on internal and external issues is the development of the ‘Control of organizational knowledge’ QMS process.

Description of activity of monitoring and review of information relevant to the internal and external issues is given in the corresponding QMS documented procedures of relevant processes and in the Quality manual, including section 4.1.

Other ISO 9001:2015 Documents and Templates 

Quality System Forms

The Quality manual and the documented procedures regulate the activities necessary and sufficient to meet all the requirements of ISO 9001:2015. This is the main purpose of the procedures.

Quality system forms are created by the decision of the Organization.

We have updated some of our procedures with the Quality System Form templates.
 QSP 7.1-01 Control of personnel:

• Annual training plan 
• Training efficiency evaluation sheet
• Talent search form 

QSP 7.5-01 Control of documented information

• Master List of Documents 
• Master List of Records 

QSP 8.7-01 Control of nonconforming outputs

• Nonconformity protocol 
• Hold Tag 

QSP 9.3-01 Management Review

• MR meeting agenda
• MR meeting minutes

QSP 10.2-01 Corrective actions

• CAR form
• CAR list

System audit vs. Technical audit

Question: 
Can we conclude that System audit can/may include Technical audit since technical expert may be required during a System audit (1st, 2nd or 3rd party) as per ISO 19011?

Technical Audit is an audit performed by an auditor, engineer or subject matter expert. 
Technical audit covers the technical aspects of the project implemented in the organization 

System Audit

1st Party - An internal audit that an organization performs on itself. 
2nd Party - An external audit that an organization performs on a supplier of goods or services. 
3rd Party - An external audit that is conducted by an independent organization upon another organization. 

 Answer: 
1. Planning, conducting, analysis and improvement activities of Technical audit can be a part of the Internal audits program (1st party).
2. Results of Technical audit should be taken into account when planning the scope of the 2st party audit.
3. Technical audit can not change the 3st party audits program including certification, as they are carried out by specialists of independent organization per their own programs.

Related materials

• Internal Audit quality system procedure
• ISO 9001:2015 Documents and templates