ISO 9001:2015 Documented Information Requirements

ISO documentation practices, requirements


I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document?


Thank you for the question.

To begin with, the new ISO 9001:2015 standard does not present a requirement for a Quality Manual. Those requirements are now part of Clause 4.3 and 4.4 of the new standard. That information “shall” be maintained as documented information.

You would be wise to 1] Acquire a copy of the 9001:2015 standard if you haven’t already done so. 2] Check in for information explaining the new terminology related to the standard. 3] Consider pursuing the services of a quality consultant for thorough guidance.


Bud Salsbury
ASQ Senior Member, CQT, CQI

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Value Stream Mapping

Certification, ISO 9001


We produce plastic fittings and pipes. We only have one process: only one machine is needed to produce a product.  Can we still benefit from Value Stream Mapping? If yes, could you please explain how?


Thank you for your question.  Value Stream Mapping (VSM) can benefit organizations of any size.  The fundamental question you want to answer is: How quickly can I receive an order, build it, and be paid for it?    This is “order-to-cash”.  Along the way, we look primarily at two things – how quickly and smoothly can I get a build order to flow through my factory, and how do I minimize raw material inventory and work-in-process inventory during that process?

Value stream mapping can benefit your organization by answering some of the following questions…. How long do I wait for raw material (e.g., am I buying from down the street, or does it take months to arrive from China)?  How long is a customer order in hand before I start up my machines to produce it? How long is my machine set-up?  How long does work in process sit between machines?  How long does material sit in the back of the plant before it is shipped?   How long does it take me to get paid?    Value stream mapping can help to answer these questions and challenge your organization to continuously shrink these times.     I had one client who got very good at this.  They insisted on payment from key customers within 30 days, and had payments terms of 60 days with their suppliers.    In many cases, they were paid for their products before they even had to pay for their raw materials.  That’s lean!


Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.

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ISO 9001: 2015 Deliverables and Processes

About ASQ's Ask the Standards Expert program and blog


Under the revised ISO 9001: 2015 standard, what do you see as the key deliverables and processes owned by the Quality manager or QA department?


A project or process is made up of primary components aimed toward successful completion of the project/process objectives.  Those individual components are the deliverables.

In other words; you have Inputs and Outputs. An Output is a deliverable resulting from the process (Input).

The old aphorism “Everyone is responsible for quality” is strongly encouraged throughout ISO 9001:2015. Therefore, with the adage of Risk Based Thinking to the new standard, the Quality manager and the QA department would be responsible for the deliverables of their department and its processes. They would also be responsible for discerning any risks to the company’s goals and objectives.

Bud Salsbury
ASQ Senior Member, CQT, CQI

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ISO 9001: 2015 Design and Development Clause

Prepare for ISO 9001: 2015


We are service providers in NDT and inspection field. I want to know how to implement the design and development clause from ISO 9001: 2015.


There are two ways to approach this:

One is to use the process developed in ISO 9001:2008, 7.1 where you probably have a “quality plan” for the execution of the service delivery (ISO 9001:2015, 8.1).

The second approach is to design the process itself (ISO 9001:2015, 8.3).  That involves these activities:

• Development of a design plan
Who will do what when with what?
Necessary control points
• Identification of customer requirements as inputs, along with inputs from similar previous service offerings
• Identify any special service characteristics, such as safety issues, regulatory compliance
Consequences of failure
• Identify products/services to be purchased/outsourced
• Documentation of these inputs
• Preparation of an output in a format appropriate to the organization
• A comparison of the outputs with the input requirements and an approval, if required
Outputs should include process monitoring and measuring requirements
• Outputs can include verification, design review and validation*
• A mechanism to handle process design changes

George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner
Global Certification-USA
Dayton, OH

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Inspection Sample Size

Analysis, Statistics, Control Charts, Statistical Methods, Audit, Auditing


  1. The customer expects certain levels of inspection: pull 157 bottles for visual testing, but then they also want 20 pulled for dimensional testing. Can’t the 20 additional bottles be a subset of the original testing sample?
  1. When calculating the lot, do you pull the samples before or after your calculations? Do the samples get included in the produced quantity or not?  For example: If the customer orders 10,000 bottles and the level 2 inspection pulls 200 bottles that drops the total shipped to the customer to 9,800 pieces.  If 10,200 bottles are produced then the inspection level increases so that 315 bottles need to be pulled for testing.  What is the correct sample size and production number?


Here are the responses to your questions:

  1. Yes since the first inspection is visual, you can use a subset for the additional testing.
  1. The lot size is 10,000. You should be putting the samples back into the lot if they are not destroyed by the testing. You send what is contracted for.  You are sampling with replacement.

Jim Bossert

SVP Process Design Manger, Process Optimization
Bank of America
Fort Worth, TX

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Sampling and Daylight Savings Time

Pharmaceutical sampling


We are wondering if there is any generally accepted procedure to account for seemingly duplicate sample times when operating over the time period when clocks ‘fall back’ one hour for the end of daylight savings time? Our standard practice is to analyze a chemistry sample every half hour, so we foresee two each of the 01:00, 01:30 & 02:00 AM samples this next Sunday morning. Please advise on any generally accepted practice to account for such seemingly duplicate samples.


I do not know an industry accepted standard for this yet.

If used for control charting, just plot as normal, noting when the sample was taken. For the second 2:30am sample, just note it was after the time change… continue monitoring the process as normal.

If used for lot sampling, analyze the results as normal.

If doing a daily average, then adjust the calculation for the two extra samples, i.e. divide by 26 instead of 24.

At most it may require a slight change to calculations based on the number of samples, otherwise it’s just not a big issue that may require at most a comment or note about the seemingly duplicate sample times or two missing times (in spring).



Fred Schenkelberg
Reliability Engineering and Management Consultant
FMS Reliability
(408) 710-8248

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