Auditing for control and improvement

When developing and implementing a QMS, quality managers often ask themselves these questions:

• Is this procedure mandatory? 
• Do I need to maintain those records?
• What are the documents required by ISO 9001?

The new version of ISO 9001:2015 does not make the life of quality manager any easier stating that is it up to the Organization to choose what document should be considered mandatory.

It is manager's job to establish and implement controls and ensure there is continual improvement. In the absence of specific guidance in performance standards (required procedures, records, or schedules) it is essential that management be able to demonstrate conformance to requirements.
It is especially important when preparing for the audit (both internal and external).

It is a good practice to maintain Quality Manual and Quality Standard procedures as documented information.

More on Auditing for control and improvement - in the corresponding article by J.P.Russel


ISO 9001:2015 Documents and Templates collection

Implementing 14001 within existing 9001

When implementing 14001 within existing 9001 should both systems - QMS and EMS be implemented as separate ones with separate documentation, or may EMS be included as one of QMS processes? 

For example, may I have one internal audit procedure, internal audit plan and carried out integrated internal audit for both QMS AND EMS?
Have one Management Review for both systems?
Can I just build one system describing both standards?
What is the common practice for integrated systems – how do you do it? 
(We are planning to implement 27 001 and 20 000 eventually as well…)


Integration of standard management systems, including 9001 and 14001 is not only possible, but also necessary!

The most recent versions of Management Standards have identical structure namely for the integration purposes.
All these makes the integration fairly simple.

While integrating, ‘including EMS as one of QMS processes’ is not the best approach.

It is better to build one system describing both standards.

A good practice is to build integrated systems in two phases:
1) Build an ISO 9001 QMS as a base
2) Build the integrated system using the ‘Fill the gaps’ method

In this case, gaps - are the distinctive sections of the ‘Integrated Management System Manual in compliance with ISO 9001: 2015 and ISO 14001: 2015’ and the expediency of developing additional processes can be summarized in the table:

Further, ISO 27 001, 20 000 systems could be added on.

ISO 9001:2015 Quality Manual Template

ISO 9001:2015 Documents and Templates Collection

Digital Transformation in Quality Management

Emerging digital technologies, increasing competition and changing customer demands put extra pressure on the businesses. In order to survive in the digital age, companies have to adapt to the changes and modify their operations through digital transformation.

While adapting new elements of digitization, the organization should bear in mind that that in order to achieve financial success, the investment into the digital transformation has to be combined with the clear vision of the process, careful coordination, engagement, and leadership.

For more digital transformation information, its benefits, potential pitfalls and ways to reach the competitive advantage, refer to The Advantages of Digital Maturity

ISO 9001:2015 does not directly require the organization to undergo digital transformation, though some of  ISO 9001:2015 requirements are aligned with it.

MIT Sloan School of Management identifies 9 areas of digital transformation. Let’s review them with regards to the ISO 9001:2015 clauses.

Customer focus 
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: 
a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met; 
b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; 
c) the focus on enhancing customer satisfaction is maintained 
ISO 9001:2015 cl.5.1.2 

Digitally transforming Customer Experience is the most visible and beneficial part of the Digital transformation.
1. Customer Understanding. It is a good practice to

• Leverage social media to understand the roots of customer dissatisfaction
• Build online communities to promote brands
• Use Analytic's capability to improve portfolios 

2. Top-Line Growth

• Enhance sales with use of digital presentations and customer Analytic's data 

3. Customer touch points. Create digital solutions that will leverage expert communities, resolve customer complaints quicker and overall improve customer service.

Process approach 
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. 
 ISO 9001:2014 Cl.0.3.1 

Benefits from Transforming Operational Processes are less visible in comparison to transforming the Customer experience and require more investment.

4. Process Digitization. Through automation of production processes, the Organization can improve product quality (avoid human error). The personnel, freed from the repetitive production jobs, can focus on RnD processes.

5. Worker Enablement

• Remote/virtual collaboration; ability to work from anywhere 
• Creating organization wide knowledge banks (7.1.6 Organizational knowledge) 

6. Performance Management 

• The detailed information gathered from the transaction processing system allow management decision s to be made on the real data – versus the assumptions. 
• Virtual collaboration enables better input into the processes, that will lead to the better risk and opportunities assessment 

Digital transformation also Transforms Business Models of the Organizations. They can benefit from pursuing new digital directions of business development or digitally modifying the existing ones.

 7. Digitally Modified Businesses

• Outsourcing of customer service and post-delivery activity 

8. New Digital Businesses will tackle customer needs that were overseen before.

9. Digital Globalization

• Global shared services promote efficiency and reduce risk. 

Digital transformation provides opportunity for the Organization to improve quality of product/services through the way individuals work and collaborate, the way business processes are executed and in the way a company understands and serves customers.

ISO 9001:2015 Documents and Templates collection.

What did ISO 9001:2015 teach you?

What are the new things - which you ignored about your Quality Management System - did/does the new edition of ISO 9001:2015 teach you?


Our experience in consulting the transition of the organizations to the new version of ISO 9001:2015 showed that the main «new things that were previously ignored» are the following four.

1. System-level analysis of internal and external context of the Organization. 
   1.1 Gathering information and analysis of the Context components in the following processes: ‘Management review’, ‘Marketing’, ‘Control of personnel’, ‘Design and development or products and (or) services’, ‘Production and service provision’, ‘Control of documented information’.
   1.2 Distribution of information about the context internally in the Organization within the framework of control of organizational knowledge and documented information
   1.3 Use of information about the context in QMS processes when planning and making management decisions.

The most interesting positive practice was the wording of certain quality objectives, based on the context changes through the application of QFD - matrices.

2. Actions to address risks and opportunities. 

On the very first stage the positive outcomes are, at minimum:

• Management decisions multi-variance (management started reviewing all possible variants and estimating risks);
• Forward thinking about the consequences (this was not a mass phenomenon earlier). 

3. Analysis of needs and expectations of interested parties (other than consumers and suppliers). 
A good practice here is to:

• Define processes, where the needs of each interested party is monitored and analyzed, and clearly determine the requirements information format;
• Create the shareholders interests balance table (shareholder’s interest – Organization’s interest), at least in a simplified format. 

4. Viewing Organizational knowledge as an important resource. 

A good practice is to define in the QMS:

• The nature of knowledge;
• Information media; 
• Processes- suppliers of the information – for each knowledge category;
• Level of employees’ access;
• Responsible for information updates. 

You may find it useful to implement all theses in the QSP format.

We have implemented the mentioned above (with the exception of the QFD - matrices) in the

• ISO 9001:2015 Quality Manual (2nd edition)
• QSP 6.1 Actions to address risks and opportunities 
• QSP 7.4 Control of organizational knowledge