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.’

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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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Friday, August 18, 2017

Clause 6.1 Actions to address risks and opportunities QnA

Is it possible to have two phase of Risk Based Thinking implementation in ISO 9001:2015?

I noticed that in clause 6.1, they mention the relation between this clause and clause 4.1 and 4.2, which is a new requirement, where organization shall identify the interested parties (either internal and external) and address the risk and opportunity. However, in the same clause of 6.1, they mention that the risk/opportunity addressed must be proportionate to product conformity, which still need us to do risk assessment to manufacturing process of product.

As to summarize, the two phase will be like:
Phase 1: Address Risk/Opportunity for Interested Parties
Phase 2: Risk Assessment towards process.

The first paragraph of ISO 9001 Clause 6.1 is talking about a mandatory set of requirements that must be taken into account in any QMS planning, namely:
  • internal and external context of the organization (cl.4.1);
  • needs and expectations (balance of interests) of interested parties (cl.4.2);
  • identification of risks and opportunities, which are discussed further in clause 6.1.
This does NOT mean that the requirements of cl.6.1 should be applied to 4.1 and 4.2.

This should be interpreted in a way that the requirements of clause 6.1 are applied Together with clauses 4.1 and 4.2 in achieving planning objectives.

As for addressing of risks and opportunities, these requirements are applicable to all QMS processes (cl 4.4).

Wednesday, August 16, 2017

Why should you prefer an Integrated management system (IMS) or not?

With more ISO standards being drafted on a common framework, it is more straightforward to integrate them.

More people find using IMS very beneficial because it helps avoid redundancy of efforts and makes management system truly agile and effective.

Pros of the IMS:
  • Using 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.

Cons of the IMS:
  • Difficult to find truly integrated Auditors. QMS auditors often have little to no training in EMS and Safety. You may need to keep internal audit teams separate or plan on getting them additional training on the basics in OSHA and Environmental systems above and beyond the standards.
Choosing to build an IMS should never be driven by desire for certification.
If the management decides to integrate all or some of the aspects described in the different ISO standards into their vision and objectives, it is their strategic decision. 

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Friday, July 14, 2017

Format of QMS Documented information: Electronic or Printed?

Should the final draft of the Quality manual and procedures be printed?
What happens if we choose to keep the printed copies?

According to the requirements of ISO 9001:2015 (cl. 7.5.2.b) the Organization chooses the documented information format (electronic or printed(hard) copy).

Is it more difficult to manage a hard copy of the Manual, including making changes.

On the other hand, it is a common practice to have a hard copy of the Manual for familiarization and training purposes. In this case, such a copy is not supposed to be managed, and it will not be updated when changes are made.

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Wednesday, July 12, 2017

Quality Management Principles

ISO 9001:2015 - the most widely used ISO standard in the world - is based on a number of quality management principles including: strong customer focus, leadership, engagement of people, the process approach, continual improvement, evidence-based decision making, and relationship management.

ISO publication Quality Management Principles gives an overview of the ISO 9001:2015 QMP.

The seven quality management principles are :
  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision making
  • Relationship management
Publication contains the description of the principle, the explanation of the principle importance, the examples of benefits for the Organization, as well as the examples of typical actions that could be taken based on the principle to improve the Organization’s performance.

Access the full publication Quality Management Principles

A collection of ISO 9001:2015 Documents and Templates

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ISO 9001:2015 Quality System Procedures