Monday, October 30, 2017

ISO 45001:2018 Transition Gap Analysis

In anticipation of the ISO 45001:2018 updates, we introduce new product - ISO 45001:2018 Transition Gap Analysis with the guidelines for transition.

The comparison materials are presented in a table format, containing ISO 45001:2018 Clauses, corresponding OHSAS 18001:2007 and ISO 9001:2015 clauses, content of changes and recommended actions to transfer the OH&S to the new version (if changes are present).

The product features
  • Traditional clauses conformity table of OHSAS 18001:2007 and New versions of ISO 45001:2018 and ISO 9001:2015.
  • Analysis of changes.
  • Implementation recommendations for each change.
  • Easy to use table format
  • Printable PDF
  • 28 pages
For a limited in October/November 2017 we offer this document as a free download. Visit our website to claim your copy.

Friday, October 27, 2017

ISO 9001/14001/45001 Requirements Comparison

The most recent versions of ISO Management Standards (ISO 9001:2015, ISO 14001:2015, ISO 45001:2018) have identical structure.

This can be very useful when building an Integrated Management System taking into account several standards requirements.

All three international standards mentioned above contain the following clauses:

  • Context of the organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement
Having so much in common it is clear that IMS minimizes the duplication of a number of key clauses (Risks, Communication, Nonconformity and corrective actions, Continual improvement, etc.). Simplified documentation helps make better choices and allows almost real-time decisions.

Download ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 Requirements Comparison in PDF format and use it as reference materials (or in staff/auditors' training).

Check out our Integrated Management System Manual templates, Procedures and Methodical materials.

Wednesday, October 4, 2017

A system audit vs. a process audit

ISO 9001:2015 defines a System as a set of interrelated processes.
While a Process is a set of interrelated or interacting activities, which transforms inputs into outputs.

When auditing, it is important to deeply understand the difference between the two and the moment when a group of processes become a system. Conducting system and process audits at the same time could be confusing and ineffective.

On the document triangle below the first two levels describe the System in a whole, while the two bottom levels describe the process.

System audits start from the top moving down into details, while the process audits start from the bottom of the document pyramid.

To summarize from the auditing perspective:
  • A system audit is an audit of a system or subsystem against system requirements. (conformity or nonconformity of the system).
  • A process audit is an audit of individual processes against predetermined process steps or activities. (inefficiencies and areas for improvement).

More information in Which is it – a system or process audit? by J.P.Russel 

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Friday, September 29, 2017

QMS Questions answered: Audit frequencies

Within the QMS system the core business processes and the supporting 9001 standard requirements procedures/processes have been identified and separated with the specific intent of auditing them at different intervals within the 3-year cycle.

For example, the core business processes will be audited either weekly/monthly/quarterly/bi-annually/annually and the supporting 9001 standard requirements procedures/processes will be audited once within the 3-year cycle because the risk of change is considered low.

Should the auditing of the standard requirements take place each year within a 3-year cycle?

The periodicity of internal audits is not regulated by the requirements of ISO 9001:2015.

Therefore, any audit cycle is acceptable. However, the frequency greater than 1 year may cause difficulties in conducting annual supervisory audits to prove that the QMS is maintained.

A good and most common practice is to audit every process once a year.

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Monday, September 11, 2017

Nonconformity Management

What are the major changes to the nonconformity management procedure according to the new version of ISO 9001:2015 (vs. ISO 9001:2008)?

The answers to this question can be found in ISO 9001:2015 Transition Gap Analysis Transition Guidelines.

Nonconforming process outputs, products or services are the object of control (ISO 9001:2008 defined nonconforming products as an object of control).

Thus, the requirements where extended:
‘The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction (vs. ‘to eliminate the detected nonconformity’ in ISO 9001:2008 cl.8.3. a);
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession: (In ISO 9001:2008 this was worded as follows: ‘by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer’ (cl.8.3. b)).

Conformity to the requirements shall be verified when nonconforming outputs are corrected.’
ISO 9001:2015 Cl.8.7.1

ISO 9001:2015 provides more details regarding retaining of documented information (records) that:
‘a) describes the nonconformity;
b) describes the actions taken;
c) describes any concessions obtained;
d) identifies the authority deciding the action in respect of the nonconformity.’

Purchase ISO 9001:2015 Transition Gap Analysis Transition Guidelines - over 50% off in September/October 2017.

Thursday, September 7, 2017

Contract Review Metrics

What factors can be used to measure the effectiveness of the Contract review process?

Some suggest to use a quote-hit ratio to obtain a metric on the percentage of orders obtained from quotes. Not in all companies this would be an effective or accurate method, since many quotes are done verbally or through e-mails.

Are there any other ways to determine effectiveness in this process?

There is a universal and well-proven method for any QMS process effectiveness evaluation – the Expert Evaluation.
Each of the 5-7 experts evaluates the effectiveness, for example, on a 10-point scale. The maximum and minimum ratings are discarded and the arithmetic mean is determined.

The main thing is the awareness of experts, as well as disinterest in obtaining certain result. This ensures objectivity.

To evaluate the effectiveness of Contract analysis, the following criteria can also be used:
  • the time taken to sign the contract;
  • the ratio of contracts completed in time to the total number of contracts signed;
  • the number of customer complaints (an absolute value or in relation to the total number of contracts) - this criterion is applicable to several processes, including Production and service provision process.
Have a QMS related question? Get it answered by an expert!

Wednesday, August 30, 2017

ISO/DIS 45001:2017 OH&S management system manual template

We have added a new product to our Management System Documents and Templates collection: ISO/DIS 45001:2017 OH&S Manual Template.

The proposed OH&S Manual is written in sufficient detail. This allows you to use it to solve the following tasks:
  • OH&S Management system audit and certification.
  • Understanding of how the OH&S management system operates by senior leadership and personnel.
  • Personnel training. Practice shows that the OH&S Management System Manual is often the only source of knowledge about the operation of the OH&S management system for certain categories of personnel, including senior leadership.
  • The organization may find feasible to make the OH&S Management System Manual the only documented procedure for the OH&S management system. The proposed OH&S management system manual allows this.
  • The OH&S management system manual can be provided to interested parties to demonstrate the effectiveness of the organization's OH&S management system.
Section on addressing risks and opportunities were developed considering the requirements of ISO 31000:2009 Risk management. This facilitates the task of risk management integration with other standard management systems, including ISO 9001:2015 and ISO 14001:2015.

  • OH&S Manual Template is based on Plan-Do-Check-Act model
  • The following standards are referenced:
  • Draft International Standard ISO/DIS 45001.2:2017 Occupational health and safety management systems — Requirements with guidance for use
  • International Standard ISO 9000:2015 Quality management systems- Fundamentals and vocabulary
  • Document is easy to customize in Microsoft Word - no special software required!
  • User-friendly format and professional layout - reviewed and approved by experienced auditors.
Included in the package:
  • 100 pages MS Word document
  • Diagrams and models
  • Type of delivery: Instant download

Download the 16-page pdf preview of the ISO/DIS 45001:2017 OH&S Manual Template.
The preview contains the following sections:
  • 4.2 Understanding the needs and expectations of workers and other interested parties
  • 4.3 Determining the Scope of the OH&S Management System
  • 4.4. OH&S Management System
  • 5.4 Consultation and participation of workers
For more information about the OH&S manual template and to find out most up to date pricing information - please visit our website at 

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