Context of the Organization

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 Management System, AS9100 Aviation, Space and Defense, TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards, and more!

Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

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Context of the Organization
One of the major changes as a new requirement of the ISO 9001:2015 standard, including further quality system standards, is to Understand the Organization and its Content. We often still find today companies that are struggling with how to address this requirement. The requirement states that the organization will determine external and internal issues that are relevant to its purpose and its strategic direction, and that affect its ability to achieve the intended result(s) of its quality management system.

This includes the organization will monitor and review information about these external and internal issues. For the purpose of effective planning all organizations need to understand (1) its current status, (2) what it wants to achieve and when, and (3) its strategy on how to achieve it. If you don’t have a clear starting point, it will be difficult for your organization to achieve the desired destination for growth and sustainability.

There are a number of effective methods and supporting techniques for organizations to analyze their context. It will be very useful to retain documented information to help understand the rationale and level of understanding that challenges all companies. The information which may be helpful in this process can include:

  • Business plans
  • Review of strategic initiatives
  • Competitor analysis
  • Reports from business sectors
  • SWOT analysis
  • Minutes of Meetings
  • Action lists
  • Spreadsheets
  • External service provider reports
This process is the responsibility of the organization’s top management. It should be evident whether top management has adequately considered their organization’s context. The evidence of this may be adequately demonstrated by showing how the review outputs became the inputs into the planning process. The output from this activity should also be evident in the determined risks and opportunities regarding 6.1 Actions to address risks and opportunities requirement.
Along with organizational context, management also has to understand and determine how the organization decides on the requirements of interested parties which are relevant for the quality management system. Areas of consideration could be the range of interested parties considered, criteria to select relevant interested parties, and aspects to select relevant requirements. Examples of relevant interested parties are given in ISO 9000:2015, definition 3.2.3, and clarification related to these requirements is provided in ISO 9001:2015, Annex A, clause A.3.
The relevant requirements of those relevant interested parties should be evident as inputs into the planning process, as potential risks and opportunities. For example this could be defined from:
  • meeting minutes
  • program management interactions with customers
  • spreadsheets and databases
  • Sales and marketing personnel
  • external documentation
Specific methods that management personnel use to monitor and review information on the interested parties and their relevant requirements must be demonstrated. Establishing a solid foundation for shared understanding of an organizations purpose, strategic direction, interested parties, risks and opportunities will require a continuous active role within the leadership team and the quality group. Moving quality out of the quality department has now expanded more than ever before within quality systems compliance and effectiveness.
Occupational Health and Safety Metrics
According to the International Labor Organization, some 2.78 million people die as a result of work-related accidents or illness each year, on top of the hundreds of millions who suffer with injuries. The cost to all of society, therefore, is huge, giving rise to relevant laws and significant investments made in occupational health and safety. But how do you know such measures work and how well your staff are actually doing?

A new ISO document for occupational health and safety metrics has just been published. ISO/TS 24179, Human resource management – Occupational health and safety metrics, is the first of a large series of technical specifications (TS) and guidance documents to provide comparable measures for internal and external reporting in human resource management. It specifically relates to occupational health and safety data and highlights any issues that should be considered when interpreting it. This in turn, will not only help with decisions on appropriate interventions, but is also useful when reporting these to external stakeholders, such as regulators and investors.

The working group is currently in the process of developing specifications that cover around 70 different metrics, such as those for productivity, costs, recruitment, mobility and turnover. These will be useful tools for organizations to improve productivity, meet regulatory requirements and have a clearer picture of their performance across many areas in order to make the most effective decisions for the company and its employees.

ISO/TS 24179, Human Resource Management – Occupational Health and Safety Metrics can be purchased at the ANSI Webstore.

Common Symptoms Risk Management
Risks are also often managed centrally through management team channels. Organizations commonly lack the insight, scope and flexibility to handle risks that occur at a grass-roots level, where the work gets done. Decisions to prevent and mitigate risk can sometimes be delayed as employees do not have the capability to assess risk, or the time to define and reduce the risk. 
The following are common symptoms which could highlight to you that your approach to risk management could be improved:
  1. Uncertainty – the organization struggles to collect the right, or enough information about its risks. Checks are too infrequent, must be recurring and beyond annually. The scope of information about the organizations risk is narrow.
  2. Complexity – the organization is collecting enormous amounts of information about risk to the low level weeds areas. Decision makers cannot interpret the information. Opportunities are overlooked.
  3. Ambiguity – the organization is not able to formulate the correct questions in order to understand its risk. Additional information is useless because risk is not understood or documented effectively, and is some cases not documented at all.
  4. Lack of Common Language- there are multiple interpretations of risk between individuals across the organization. Risk management is mutually exclusive or in conflict. A power struggle usually ensues between individuals with conflicting views and beliefs.
  5. Silo mentality (larger organizations) – different departments resist communicating information about risks across the organization. This typically leads to a condition of both uncertainty and not my problem mentality.
Defining, mitigating and eliminating operational risk factors requires a holistic team approach. Get your employees at all levels involved!  
World Quality Day 2020
World Quality Day will be celebrated on November 12, 2020. It is a worldwide opportunity to shine the spotlight on individuals, teams and organizations that are deeply invested in creating and improving customer value.

In a world of ever-increasing customer expectations, competition and technological change, businesses are striving to be seen as ‘partners’ in the eyes of their stakeholders.

The quality profession supports businesses to develop a customer-centric quality culture that will help them to:
  • Recognize that it is the customer, not the company, that defines what quality means
  • Understand product and service quality through their customers eyes
  • Share their quality performance with customers
  • Collaborate with customers to improve product/service quality and resolve problems
World Quality Day gives us the opportunity to highlight how quality can help to create customer-focused organizations. Visit the World Quality Day Website for more information via videos, informing everyone of your plans, and a toolkit filled with resources. 
In The News
ISO 9001 User Survey 2020
The committee responsible for the development of the international standard, ISO 9001:2015—”Quality management systems—Requirements,” has announced a user survey to gather information on the value of ISO 9001:2015.

According to a press release from ISO/Technical Committee 176/Subcommittee 2, ISO 9001:2015 is currently undergoing a formal “systematic review” that is due to close on Dec. 2, 2020.

Following the review, ISO/TC 176/SC2 will have up to six months in which to decide whether the standard should be “confirmed” (i.e., left unchanged), be revised or amended, or be withdrawn.

The goal is to capture:
• Data on the value to organizations of implementing a quality management system in with the requirements of the current 2015 edition of ISO 9001
• Data on its advantages and disadvantages
• User opinions on how to ensure this standard remains relevant in the future

In addition, ISO/TC 176 has been giving consideration to “future concepts” for quality. SC2 would like to test the acceptability of such concepts with users, for potential inclusion in a future edition of ISO 9001.

The committee invites all categories of users of ISO 9001 from all over the world to participate in a global survey about ISO 9001’s future. For your convenience, the survey has been developed in 13 languages on SurveyMonkey; choose the language that is most convenient for you using the language link in the upper right corner of the survey page. 

Training Courses
Due to COVID-19 Virus course scheduling is currently suspended. Let us know if you have a future onsite Year 2020 training need, we can deliver. Stay Safe.

All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.

Remote Versus Virtual Audits  
With the current business environment, Virtual and/or Remote Auditing is currently the norm. “Auditing of a virtual location is sometimes referred to as virtual auditing.” ISO 19011. Remote auditing use techniques such as interactive web-based collaboration, web meetings, teleconferences and/or electronic verification of the client’s processes. Remote audits refer to the use of ICT to gather information, interview an auditee, when “face-to-face” methods are not possible or desired.

There is much discussion lately around the future and validity of virtual certification body auditing, whether conducting a surveillance audit, or initial certification audit. We have found through our reading solid arguments on both sides of the perceived value. If virtual auditing does become the new normal, the value to the client can definitely include less travel cost. We have a number of clients that have told us this cost has not incur this year. It will be interesting to see what the end result will be down the road, and whether this process will actually produce effective compliance and robust objective evidence needs for certified companies, customers, and certification bodies.

ISO 9001 Auditing Practices Group Guidance on: REMOTE AUDITS

Best regards,
Walter Tighe and SES Team  

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