Welcome to April, 2016 edition of Carnival of Quality Management Articles and Blogs.

We commenced the familiarizing ourselves with the changes in the Revision of ISO 9001 (:2015) with the December, 2015 episode of our blog carnival. Then, in the January 2016 episode, we took up Process Approach in the 2015 revision of the standard, as our first topic. In February, 2016, we had taken up first part of Risk-Based Thinking that primarily addressed the concept as has been taken up in ISO 9001: 2015, followed by Risk-Based Thinking, in the general perspective in March, 2016,

Now, in this month’s episode we will take a look at the subject that aims to align the organization’s QMS with the Context of the Organization.

Context of the Organization & ISO 9001:2015Kevin Gholston

According to the Merriam Webster Dictionary the word “context” has the following meaning:

context
noun con·text \ˈkän-ˌtekst\

The words that are used with a certain word or phrase and that help to explain its meaning; the situation in which something happens; the group of conditions that exist where and when something happens

Full Definition of CONTEXT

1:  the parts of a discourse that surround a word or passage and can throw light on its meaning
2:  the interrelated conditions in which something exists or occurs

Context-of-the-Organization-Overview

What is the Context of the Organization? – Itay Abuhav –

The context of the organization, in the ISO 9001:2015 is the set of functions, processes, inputs and outputs and limitations that creates the business environment of an organization. It is how business entities (functions or subsystems –intern or external) of an organization relate together and how the information travels through these elements.

The context of the organization is shaped through the integration of the business entities. The ISO 9001:2008 expresses it with the words” the relation and sequences between the main processes” (Chapter 4.1,b) and requires for example a diagram that describes those relations.

Context of the Organization

How to identify the context of the organization in ISO 9001:2015 – Strahinja Stojanovic

Context of the organization is a new requirement in ISO 9001, stating an organization must consider both the internal and external issues that can impact its strategic objectives and the planning of the QMS. It pretty much changes the concept and application of clause 4. Requirements regarding the context of the organization do sound a little bit vague, so what does this clause actually require?

Clause 4 of ISO 9001:2015, Context of the organization, requires the organization to evaluate itself and its context. This means that you need to define influences of various elements on the organization and how they reflect on the QMS, the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organization, markets, customers, etc. It is also a means to detect risks and opportunities regarding the business context.

Where to start?

First, you need to determine which of the new requirements are already met in your existing documentation, because some of the requirements related to the Quality Manual in ISO 9001:2008 are now transferred into this new clause

To determine external context, you should consider issues arising from its social, technological, environmental, ethical, political, legal, and economic environment. Examples of external context may include:

  • government regulations and changes in the law
  • economic shifts in the organization’s market
  • the organization’s competition
  • events that may affect corporate image
  • changes in technology

Basically, all this information is in the heads of the CEO and other members of management, but it was never put on paper; the best way to gather it is by organizing some brainstorming. Systematization of all this information can be very valuable and demonstrate where you stand as an organization.

ISO 9001:2015 Revision Explained: ‘Context of the Organisation’ – by Alastair Atcheson

While there is no prescribed method of determining the context of the organisation in relation to the ISO 9001, a simple and pragmatic approach to understanding your organisation’s context consists of four steps:

  1. Identify the internal issues that can affect your organisation’s products, services, investments and interested parties.
  2. Identify the external issues that can affect your organisation’s products, services, investments and interested parties.
  3. Identify who are the interested parties and what are their requirements.
  4. Institute a system for regular review and monitoring of the internal issues, external issues and interested parties as identified above.

Internal issues can include the organization’s

  • regulatory requirements
  • strategies to achieve its policies and objectives
  • relationship with its staff and stakeholders, including partners and suppliers
  • resources and knowledge (e.g. capital, people, processes and technologies)
  • internal risk appetite
  • assets
  • product or service
  • Standards, guidelines and models adopted by the organisation
  • information systems

ISO 9001:2008 vs. ISO 9001:2015 – Context of the Organization By Itay Abuhav

With the ISO 9001:2008 it is necessary to evaluate whether the organization’s quality management system follows the general requirements. Wr.t. the ISO 9001:2015 and the requirements of  context of the organization – the organization shall analyze which issues (external as well as internal) that may affect its QMS or already have an effect.

Context-of-the-Organization - tongue in cheek view

Context of the Organization” and the Power of SWOT Analysis

ISO9001-2015_at__a_glance-CLAUSE4_SWOT

We will take up, “Interested Parties”, one of the vital considerations for understanding the ‘Context of the Organization’, in our May, 2016 episode.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice blog-column, has presented a roundtable discussion on the Voice of CustomerWhat exactly should voice of the customer mean to the quality professional? How important is it? What are the best ways to gather it?.  Luciana Paulise discusses some new tool to capture the voice of the customer. Pam Schodt considers the best way to gather VoC standards is through face-to-face meeting followed up by written and verified specifications. To Dr, Suresh Gettala, key is to hear from horse’s mouth and not to surmise about what the customer wants. Luigi Sille attaches equal importance to data gathering its use

We now watch the latest ASQ TV  episodes:

  • Metrics for Management – Tim Adams, Engineering Assurance Specialist, NASA, spent a few minutes with ASQ TV to talk about some of the main ideas of his 2015 ASQ World Conference on Quality and Improvement presentation. In this interview, Adams discusses some of the finer points of identifying and using metrics.
  • Benchmarking – Today, we’ll learn the basics of benchmarking, review the recommended six phases of a successful benchmarking process, and finally, we’ll get reacquainted with one vital ingredient in benchmarking: metrics.
  • The Torque Chain of Quality Large – For more information go to www.srtorque.com   Daily torque testing is becoming more common place because it makes good business sense. But is daily testing error proofing? No, and far from it. …. If your torque wrench is out of spec, using a torque wrench to prevent errors only leads to a false sense of security. What if the torque tester you are using is out of spec and you don’t know it?   This video and the subsequent series take you through every link in the chain of quality in order to help you understand all the places where the wheels can fall off. Specifically it takes a look at the places we tend to overlook or take for granted.

In Jim L. Smith’s Jim’s Gems for the month of March, 2016, we have –

Jim's Gems♦ Integrate DFSS with Existing Design Processes – Many organizations make a mistake when trying to replace their design process with Design for Six Sigma. DFSS was never intended to completely replace an organization’s existing design process.

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites, and have the copyrights for the respective images.