Friday, July 14, 2017

Format of QMS Documented information: Electronic or Printed?

Should the final draft of the Quality manual and procedures be printed?
What happens if we choose to keep the printed copies?

According to the requirements of ISO 9001:2015 (cl. 7.5.2.b) the Organization chooses the documented information format (electronic or printed(hard) copy).

Is it more difficult to manage a hard copy of the Manual, including making changes.

On the other hand, it is a common practice to have a hard copy of the Manual for familiarization and training purposes. In this case, such a copy is not supposed to be managed, and it will not be updated when changes are made.

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Wednesday, July 12, 2017

Quality Management Principles


ISO 9001:2015 - the most widely used ISO standard in the world - is based on a number of quality management principles including: strong customer focus, leadership, engagement of people, the process approach, continual improvement, evidence-based decision making, and relationship management.

ISO publication Quality Management Principles gives an overview of the ISO 9001:2015 QMP.



The seven quality management principles are :
  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision making
  • Relationship management
Publication contains the description of the principle, the explanation of the principle importance, the examples of benefits for the Organization, as well as the examples of typical actions that could be taken based on the principle to improve the Organization’s performance.

Access the full publication Quality Management Principles


A collection of ISO 9001:2015 Documents and Templates

ISO 9001:2015 Quality Manual temporary price reduction!

ISO 9001:2015 Quality System Procedures

Monday, July 10, 2017

Remote co-authoring of QMS documented information

In our modern world is not uncommon when two or more geographically distributed teams would want to work on the QMS documented information together.

Can the documents like Manuals and procedures be placed in the cloud where all responsible team members can contribute to it? 
How do others handle these kinds of situations?

It is a possible practice to co-author QMS documented information remotely. 

We offer a couple of simple tips to smooth the process:
  • Assign a Team leader who has the most experience in the QMS development. 
  • Make changes to the documented information having the ‘Track changes’ option ON. 
  • Team leader is solely responsible for accepting the changes and finalizing the document. 
This is a good resource on remote collaboration and co-authoring of MS Office documents.

All QMS documents and templates we carry are suitable for remote co-authoring.

Note: When setting up the co-authoring environment pay close attention to the access configuration and information security of the solution.

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Thursday, June 29, 2017

Integrated system (IMS) vs. Quality and Environment separately

Some of the benefits of having an Integrated system (IMS) vs. Quality and Environment separately include
  • IMS is easier to control because Organization’s management system is essentially a ONE system. It could comply with several Standards and in this sense, is called integrated
  • Duplication of processes is eliminated.
  • Documented information volume is decreased and thus its management is simplified
  • Certification, oversight and internal audits are significantly simplified as a result of the possibility of conducting a combined audit (simultaneous audit of several systems).
  • This all above results into saving recourses on maintaining the Integrated system in operating condition.
Our Integrated Management System Manual Template is fully aligned with the requirements of ISO 9001:2015 and ISO 14001:2015 standards.
Manual gives detailed description of the IMS processes and their interaction. (Click to download a sample IMS processes interaction diagram)
The depth of the description is enough for the Organization to decide that this IMS Manual is the only IMS document, which summarizes all mandatory Procedures as well as the procedures that regulate processes in accordance with the existing good practices.

This could be a rational decision of the Organization that provides services for small and mid-size manufacturing companies.

See the IMS section on our website for information about the template.

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Friday, June 2, 2017

Tips for staff undergoing an ISO 9001:2015 audit

What tips do you provide your front-line staff who are going to be interviewed for either an internal or external ISO 9001:2015 audit?

If the personnel already has experience of passing the ISO 9001:2008 certification audit, give them the following advice:

1. Employees should prepare the answers to the following auditor’s questions:
1.1. Risk based thinking (cl.4.4.1.f, cl.6.1):
  • Demonstrate examples of risk assessment (identification, analysis, evaluation) in the activities that you are performing (in the Process).
  • Demonstrate examples of risk treatment.
  • What projects to improve QMS (to enhance desirable effects or to prevent undesired effects) were initiated as a result of Risk treatment.
Note: An example of a methodology for addressing risks and opportunities

1.2. Organizational knowledge (cl.7.1.6):
  • How do you access the knowledge of the Organization?
  • Demonstrate examples of using the Organization's knowledge in the activities that you are doing (in the Process).
Note: you can find examples of arranging the control of Organizational knowledge activities in the ISO 9001:2015 Quality Manual

2. Managers should prepare the answers to the following auditors questions:
2.1 Context of the Organization (cl.4.1):
  • Where do you get information about the external and internal context of the organization?
  • Provide examples of use of information about the external and internal context of the organization when making decisions.
Note: the examples of gathering, transfer, and use of information about the external and internal context of the organization can be found in ISO 9001:2015 Quality Manual

2.2. Understanding the needs and expectations of interested parties (cl.4.2):
  • Who are the interested parties?
  • Give examples of considering the requirements of interested parties in your activities.
Note: the examples of gathering, transfer, and use of information about the needs and expectations of interested parties can be found in ISO 9001:2015 Quality Manual

3. Production personnel should prepare answers to such questions of auditors (cl.8.5.1.g):
  • Give an example of human error prevention activities in your processes.

Thursday, May 18, 2017

Customer communication - contingency actions requirements

IS0 9001:2015
Clause 8.2.1 Customer communication
Communication with customers shall include:
• e) establishing specific requirements for contingency actions, when relevant.


How do you establish SPECIFIC requirements with regard to CONTINGENCIES?

One of the options for meeting this requirement is inclusion of ‘Force Majeure Actions’ section in the consumer contracts.
An example of such a section can have the following form:
In the event of force majeure, neither party shall be liable for failure to fulfill its obligations or delay in performance under the Contract.

Force majeure circumstances are:
  • a natural disaster,
  • a strike at one of the parties’ organization,
  • government body’s restrictions,
  • as well as other circumstances of force majeure that make the performance of obligations of one of the parties impossible.
After the termination of force-majeure circumstances, the contractual relationship is renewed. Force Majeure automatically extends the term of performance of obligations under this Contract. If the force majeure lasts more than six (6) months, either party may terminate this Contract. The party for which the impossibility of fulfilling the obligations under the Contract on the above grounds was created is obliged to notify the other party within 10 (ten) days of the occurrence of these circumstances.
In case such Party does not notify another Party within the period specified above, it shall be deprived of the right to refer to these circumstances in the future. Chamber of Commerce certificate is the Evidence of validity of force majeure.

ISO 9001:2015 Quality System Procedure Contract Analysis

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Friday, May 5, 2017

Environmental Targets

What sort of EMS targets could be set, when preparing for ISO 14001 certification when the Organization has very little environmental impact? (i.e. - A small office with very little environmental impact 

The traditional wording of environmental targets for the office are:

1. Reduce the power consumption by at least 6%.
2. Reduce the heat consumption by at least 8%.
3. Reduce consumption of consumables related to office activities:
     3.1. Paper - no less than 12%.
     3.2. Printer cartridges - no less than 20%.
4. Organize separate disposal of drinking cups, wrapping paper and pizza boxes after lunch.


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