Knowledge of the Organization

 

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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.

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Knowledge of the Organization

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Organizational Knowledge is a resource needed for any successful organization to support its business strategy, to obtain business objectives, maintain personnel competencies and conformity of products and services.  It is now addressed in an explicit way for the first time in the 2015 edition of ISO 9001.

Many organizations have already initiated systematic approaches to knowledge management and have mature approaches, while others will be taking their first steps or just beginning to consider this issue.

Organizational Knowledge is the specific knowledge of the organization, coming either from its collective experience or from the individual experience of its personnel. In an explicit or implicit way this knowledge is, or can be, used to attain the organization’s objectives. Organizational knowledge in the persons of the organization, may be recorded for example in documented information, imbedded in the processes, products and services of the organization.

Examples can include documented information regarding a process, product or service specifications, work instructions, experience of people related to processes and operations, knowledge of the technologies and infrastructures relevant for the organization.

The needs for knowledge and knowledge management vary considerably according to an organization’s context, the sector it operates in, and the competitiveness of its markets. While some organizations operate at the so called frontiers of knowledge, where they are in competition for knowledge with other organizations, others operate in relatively stable environments.

The requirements for organizational knowledge in the context of a QMS can be summarized by the knowledge needed for the operation of QMS processes and to achieve conformity of products and services. Organizations need consider internal and external sources, such as:
  • learning from failures, near miss situations and successes;
  • gathering knowledge from customers, suppliers and partners;
  • capturing knowledge (tacit and explicit) that exists within the organization, e.g. through mentoring, succession planning;
  • sharing organizational knowledge with relevant interested parties to ensure sustainability of the organization;
  • updating the necessary organizational knowledge based on the result of improvements.
  • Knowledge coming from conferences, networking, seminars, or other external events.
ISO 9001:2015 requirement 7.1.6 Organizational Knowledge is much more than maintaining training records. Specifics do require addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

 

Internal Audit Objective Evidence

  

 

 

 

 

 

 

 

 

According to the definition, an audit is a “process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled”.

 

That means that the competent auditor will prepare for the audit in order to know what kind of evidence he or she needs to look for, and will be able to seek out that evidence rather than requiring the auditee to “give up their own evidence sample”. 

The competent auditor will take care of the following aspects during the audit planning:

a) Comprehend the auditee’s structure, business and management practices.
b) Understand the auditee’s processes
c) Risk based thinking relevant to the industry sector or specific to the organization
d) Pre-evaluation of statutory and regulatory requirements
e) Consider the effect of the audit activities on the auditee’s processes
f) Identify possible audit evidence to look for in the audit work documents
g) Adequate time allocation
maintain personnel competencies and conformity of products and services.

During the audit  execution, it is the auditor who has to evaluate compliance or noncompliance based on the audit evidence collected. That means that if the auditor is not capable of finding evidence of conformity it should not necessarily be taken to infer that the auditee does not comply with the audit criteria.

  
During the audit, the auditor should always keep in mind the definition of “audit evidence” and the principle of an “evidence-based approach”.
 
Objective evidence, as defined in ISO 9000, is “data supporting the existence or verity of something. Objective evidence can be obtained through observation, measurement, test, or by other means. Objective evidence for the purpose of audit generally consists of records, statements of fact or other information which are relevant to the audit criteria and verifiable.” 

Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process.
 
Audit evidence should be verifiable. It will in general be based on samples of the information available since an audit is conducted during a finite period of time and with specific resources. An appropriate use of sampling should be applied, since this is closely related to the confidence that can be placed in the audit conclusions.
 
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.

Looking to improve your internal audit process? We deliver onsite and offsite auditor training. Contact us for information and to discuss  how we can help your organization with all your transition and implementation assistance needs.

 

ISO Systems Continue Global Growth

The 2015 results of the ISO Survey have just been released, showing the number of certifications to ISO management system standards continues to rise worldwide.

According to the results of the survey, a total of 1,519,952 valid certificates were reported worldwide in 2015 across nine management system standards, compared to 1,476,504 the previous year – an increase of 3 %.

ISO’s most widely used management system standards, ISO 9001 for quality management and ISO 14001 for environmental management, remain popular with  1,033,936 and 319,324 certificates respectively.

The ISO Survey is an annual survey of valid certifications to our management system standards issued by accredited certification bodies worldwide. It is the most comprehensive overview of certifications to these standards currently available. ISO does not perform certification, therefore these results rely on the responses of some of the world’s largest certification bodies.

 

View the executive summary and full results on the ISO Survey Page.

 

TL 9000:2016 Requirements Handbook
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The Integrated Global Quality (IGQ) Working Group has recently completed content changes on a new revision of the TL 9000 Requirements Handbook, TL 9000:2016 (R6). This will be the first industry specific standard published which incorporates ISO 9001:2015.

The TL 9000:2016 (R6) Requirements Handbook is now released and in effective. QuEST Forum has established a two-year transition deadline which coincides with ISO 9001:2015’s transition deadline.

 

TL 9000 is the telecommunications industry’s System Requirements. This includes all of the requirements of ISO 9001, plus industry-specific requirements for hardware, software, and services. The goal of these added requirements is continual improvement and two-way customer communication in the telecommunications industry, resulting in potential cost savings for suppliers and service providers, and improved service to end users of telecommunications services.

For more information and to purchase the TL 9000:2016 Requirements Handbook (R6) visit the QuEST Forum Website.

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In the News
 

Guidelines for the Application of ISO 9001:2015
       

ISO/TS 9002, Guidelines for the application of ISO 9001:2015, gives clause-by-clause guidance and examples to enable users, regardless of the size of the organization, to implement their own quality management system.

The new technical specification will complement ISO 9001:2015, ISO’s most widely used International Standard, which provides the requirements for a quality management system. Since ISO 9001 is designed to be applicable to all kinds of organizations, irrespective of size or context, its requirements are broad.
ISO/TS 9002 provides guidance supported by in-depth explanations and examples to help organizations fully benefit from the implementation of their own quality management system.

ISO/TS 9002 is available for purchase from the ISO Store.

 

ACSI: Higher Satisfaction for Nondurable Goods
 

The American Customer Satisfaction Index as measured by the ACSI is comprised of food manufacturing, personal care and cleaning products, soft drinks, breweries, apparel, and athletic shoes. According to ACSI data collected during the third quarter of 2016, customer satisfaction with consumer nondurable products as a whole rose to an ACSI score of 82.1 on a 100-point scale.

The “ACSI Nondurable Products Report 2016” on food, soft drinks, beer, personal care and cleaning items, apparel, and athletic shoes is based on interviews with 5,607 customers, chosen at random and contacted via email between Sept. 19-30, 2016. Customers are asked to evaluate their experiences with recently purchased products of the largest manufacturers in terms of market share, plus an aggregate category consisting of “all other”-and thus smaller-companies in these industries.
To view further information on changing consumer trends and scores, visit the ACSI Website.

 

Training Courses
 
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.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 
Quick Poll Results 
What is the greatest benefit of effective benchmarking?
#1- 51% Shows organizations what areas, systems or processes they should improve on
#2- 27% Provides a comparison with other competitors
#3- 10% Allows organizations to see and share best practices
#4- 10% Gathers data that can help create useful metrics
Source: Quality Progress Magazine

Evaluating how well your company is doing is much more than looking at whether or not you made a profit this month or this quarter. You need a way to measure your business’s performance in key areas and to identify areas that can be improved. For starters, you can compare current and past performance to identify trends. Another approach: Compare key metrics with those of successful firm of a similar size. The data and insights gained from this type of performance benchmarking exercise can be invaluable.

Best Regards,

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

 

 

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