ISO 9001:2015 Documented Information

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2016 World Conference on Quality and Improvement May 16-18 Milwaukee, WI
ISO/TS 16949 Automotive QMS Internal Auditor Training 
June 1-2 Chandler, AZ See Details Below      

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Our newsletters provide information on business management systems and process improvement methods. These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a subject of interest for a future newsletter? Please let us know.

ISO 9001:2015 Documented Information
  Close up on a file tab with the word ISO 9001 focus on the main text and blur effect. Concept image for illustration of Quality Standards

ISO 9001:2015 allows an organization flexibility to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

In our last newsletter, we covered the topic of is the standard truly driving minimal documentation given the fuller context of the requirements and the need to establish effectiveness, planned activities and planned results? This included the question “Do you really think organizations are going to discard their existing QMS documentation?”

The responses we received were overwhelming for maintaining current documentation, including procedures. Many see this also as an opportunity to improve leadership involvement with the extended requirements, and to perform a critical review of their documented system to ensure content value and improved employee process understanding.
“We have been using all our procedures effectively for over 10 years being ISO 9001 certified. Why would we get rid of them, it would create less understanding and more problems.”  
“We’re keeping our Quality Manual.  Our customers and future customers are still going to ask for it, and we use it for new employee QMS training.”          


A key documented information objective in the revision of the ISO 9000 series of standards is:
  • to define the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities.

ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.” 

All the documented information that forms part of the QMS has to be controlled in accordance with clause 7.5 Documented information.


Documented information can refer to:

a) Documented information needed to be maintained by the organization for the purposes of establishing a QMS (high level  documents). These include:
  • The scope of the quality management system (clause 4.3)
  • Documented information necessary to support the operation of processes (clause 4.4)
  • The quality policy and quality objectives (clause 5 and 6.2)
  • This documented information is subject to the requirements of clause 7.5 
b) Documented information maintained by the organization for the purpose of communicating the information necessary for the organization to operate (lower level, specific documents).  Examples of documents that can add value to a QMS may include:


Process maps and flowcharts Procedures Work and/or test instructions
Specifications Production schedules Test and inspection plans
Quality manual Strategic plans Forms
Organizational charts Approved supplier list Internal communications


c)Documented information needed to be retained by the organization for the purpose of providing evidence of result achieved (records). Examples of these include:
  • Evidence of fitness for purpose of monitoring and measuring resources (clause
  • Results of the review and new requirements for the products and services (clause 8.2.3)
  • Design and development changes, including the results of the review and the authorization of the changes and necessary actions (clause 8.3.6)
  • Results of the review of changes for production or service provision, the persons authorizing the change, and necessary actions taken (clause 8.5.6).

Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and services and quality management system. Where they exists, all such records are also subject to the requirements clause 7.5.

To claim conformity with ISO 9001:2015, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.3 of ISO 9000:2015 defines “objective evidence” as “data supporting the existence or verity of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”

Objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001:2015.

Have Questions?, Contact Us. We are here to support you with all  your ISO 9001:2015 transition needs.


Types Of Lean Methods


Lean is an organizational improvement philosophy and set of methods that can be used in any manufacturing or service sector. Our experience leading lean, 5S and kaizen events has shown us that any organization can produce measurable improvement with these simple methods and tools. Lean enables organizations to work more effectively and efficiently by identifying and eliminating waste in processes.

Lean methods vary considerably in function, level of effort, and complexity. They can range from quick fix actions your organization can implement regularly with minimal effort or team participation, to week-long events that require more in-depth planning, participation and a variety of formal tools.

Designed to reduce waste and improve efficiency, Lean methods can be used for a variety of purposes-from making your own working environment less cluttered, think 5S to designing and implementing faster and less complex ways of delivering your customer services.
Let’s take a high level look at the different types of Lean methods we have had success with that can be used effectively.
Simple, Structured Methods for Workplace Improvements
Lean methods, including 5S, standard work, and visual controls, are relatively easy to implement, but provide some defined structure for process improvements. These can be thought of as “daily Lean” methods, since they can be implemented at any time to facilitate continuous improvement, either during or outside Lean events.
For example, the 5S method can help to de-clutter and organize a workspace, making it more efficient. Standard work helps to ensure that improvements are documented and made common practice for process owners . Standardized work answers the 5W+1H of a process – the who, what, when, where, why, and how.

Event-Based Improvement Methods

Several Lean methods are implemented as “improvement events” lasting anywhere from a half-day to five days, or more. Two common types of Lean events are kaizen events and value stream mapping. These team-based methods are very powerful methods for driving improvement in processes. Although the intense period of activity in an event is focused in a few days, keep in mind that events require substantial preparation and follow-up work to be proven successful. 

Finding the Method Right for Your Improvement Goals

Before choosing a method, it can be helpful to have a sense of the initial scope of your project so you can more readily identify the method that is best suited for your needs. It is important to match your goals to the function of method, as well as to the level of resources required. Choose a method that is best suited for your problem, and the outcomes you are hoping to achieve.

Question: What type of problem do you have?   Answer: I don’t know, what’s a simple method?


Process Walk 
A process walk, also referred to as a waste walk, is a rapid technique to help you identify wastes in your everyday operations. A cross-functional team of employees walks through the work area over a short period of time, identifying opportunities to reduce waste and introduce improvements as they progress. Improvements can usually be implemented rapidly, resulting in quick gains. This method can help to engage employees in spotting waste in their day-to-day activities after the initial treasure hunt or process walk.

Typical Duration: A process walk is usually conducted in one day or less.

Identify the employees who are involved with the process. Have the group walk through the workplace with clipboards, while team members write down wastes as they identify them. Some questions to ask during the walk include:
* What inputs and outputs do you see in the process?
* Where do the outputs go?
* What is the typical process time?
* How many items are currently waiting to be processed?
* What causes delays or problems?
* What wastes do you observe, and what causes them?

Looking to implement lean methods and more information on common manufacturing or service environment wastes? Contact us for more details.  

Global State of Quality Reports


Effective and successful supply chains rely on meaningful metrics, and require open and honest relationships between suppliers and customers, according to a new 2016 Spotlight Report released by American Society o Quality (ASQ) as part of its Global State of Quality 2 Research.
ASQ also published a Spotlight Report on the role of big data in quality, featuring interviews with IBM Watson and Watson Health, and Hewlett Packard Enterprise Co. You can use the reports to learn how to implement measurements into your supply chain or how to leverage big data to improve organizational performance.

Top responses – Question Results: Quality is mainly a:

  • Method to manage organization-wide performance: 24%
  • Continuous improvement activity: 37%
Both reports are available at the ASQ Website.


Records Management in the Digital Age
Your records management strategy has to take into account the big picture. This involves understanding the context you operate in, the nature of the business you do and the risks and requirements associated with that business.

The good news is that it’s possible to design systems and apply rules so that the records are made and kept properly – whether they are data, documents or even social media content – and result in a host of business-enhancing benefits.


The creation and management of records has always been important – from ancient times to today. The key reasons for keeping records have not changed: accountability, efficient business, protection of rights and entitlements and the ability to reconstruct the past. Now, the rapidly changing digital and online world has simply introduced additional reasons to create, capture and manage records well: the shift to data-driven business, open government initiatives, shared and collaborative services, greater emphasis on corporate responsibility and more

ISO 15489-1 establishes the core concepts and principles for the design, implementation and management of policy, information systems and processes allowing people, organizations, governments, private enterprises and collaborative coalitions to:

  • Create and capture records to meet requirements for evidence of business activity.
  • Take appropriate action to protect the authenticity, reliability, integrity and useability of records, as well as their business context, and to identify requirements for their management over time.


By taking a principles-based approach, ISO 15489-1 allows for flexibility in implementation while retaining strong direction on what those implementations should be achieving.
For more information on ISO 15489-1:2016 and benefits, visit the ISO Website.




In the News

June 2016 – ISO/TS 16949 Automotive QMS Internal Auditor Course  
Date: June 1-2, 2016
Location: Hyatt Place 3535 W. Chandler Boulevard Chandler, AZ.
Click Here  for Course Description, registration and payment. Contact us with any questions and for group discounts.  
Students receive a comprehensive binder and a certificate of training completion.  Lunch is provided.  If interested in onsite group internal auditor team training, let us know.
U.S. Employee Engagement Reaches New High  
The percentage of U.S. workers whom Gallup considers “engaged” in their jobs averaged 34.1% in March, the highest level since Gallup began tracking U.S. workplace engagement daily in January 2011.

The March 2016 employee engagement average is based on Gallup Daily tracking interviews conducted with 7,194 U.S. adults working for an employer.

Engaged employees are involved in, enthusiastic about and committed to their work. Gallup’s extensive research shows that employee engagement is strongly connected to business outcomes essential to an organization’s financial success, such as productivity, profitability and customer engagement.
For more information on the study visit the Gallup Website.


Training Courses
Don’t see a course or schedule that fits your needs?  Contact us.
AS9100 Aviation, Space and Defense 
If your company is certified to the AS9100C Standard, you’re most likely aware that April 2016 was projected as the release date of the new revision.  Based on this newsletter distribution date, the revision has not yet been released. When released, we will keep you informed through our blog and future newsletter content.
Some reminders:
    • Current AS 9100C organizations will have until Sept 2018  to transition to their AS9100 Certifications.
    • Current AS9100 companies must also communicate to their certification body their transition plans NLT January 2017.
    • All recertification and surveillance audits past June 2017 will be performed to AS9100D.

Best Regards,

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642



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