How to implement the Check phase (performance evaluation) in the QMS according to ISO 9001:2015
Mark Hammar
Performance evaluation has been an important part of ISO 9001 for many years, and this importance is highlighted in the new...
Performance evaluation has been an important part of ISO 9001 for many years, and this importance is highlighted in the new version, ISO 9001:2015, by having an entire main clause dedicated to this topic. Performance evaluation...
How to determine interested parties and their requirements according to ISO 9001:2015
With the amount of emphasis put on relevant interested parties in the release of ISO 9001:2015, it is important to...
With the amount of emphasis put on relevant interested parties in the release of ISO 9001:2015, it is important to better understand what this means. It may not be easy to know who the interested...
ISO 9001:2015 clause 8.5 Product realization – Practical examples for compliance
ISO 9001:2015 includes some changes in product realization, but what are some practical examples of how these requirements can be implemented?...
ISO 9001:2015 includes some changes in product realization, but what are some practical examples of how these requirements can be implemented? Section 8.5 of the new standard discusses the requirements for product and service provision, and...
Methodology for ISO 9001 Risk Analysis
Risk analysis is one of the biggest expected additions to the ISO 9001 standard, and has been included in all...
Risk analysis is one of the biggest expected additions to the ISO 9001 standard, and has been included in all of the drafts of ISO 9001:2015 that have been circulated. Risk analysis is the important...
Would hospitals benefit from ISO 9001?
John Nolan
ISO 9001 is a universally used quality management standard, adopted by organizations all over the world to standardize and improve...
ISO 9001 is a universally used quality management standard, adopted by organizations all over the world to standardize and improve the service given to customers. The standard is used across all sectors of business, but...
What clauses can be excluded in ISO 9001:2015?
The draft of the new version of ISO 9001 has completely removed the word “exclusions” from the text of the requirements...
The draft of the new version of ISO 9001 has completely removed the word “exclusions” from the text of the requirements document, and many people have wondered if this is an indication that you can no...
New approach to document and record control in ISO 9001:2015
There is a lot of talk going around about how documented information is changing in the new version of ISO...
There is a lot of talk going around about how documented information is changing in the new version of ISO 9001. Can we get rid of our documented procedures? What about documents or records –...
How to structure work instructions in the ISO 9001 QMS
Knowing when to write work instructions and what to put into them are often struggles that hinder people from implementing...
Knowing when to write work instructions and what to put into them are often struggles that hinder people from implementing a quality management system (QMS). Since ISO 9001 does not specify how you must structure...
How to deal with nonconformities in an ISO 9001 certification audit
Many companies going for an ISO 9001 certification audit wonder what will happen if the auditors find something wrong in the...
Many companies going for an ISO 9001 certification audit wonder what will happen if the auditors find something wrong in the audit. Will they just leave in the middle of the audit? Will they refuse to...
ISO 9001 requirements
Updated: December 22, 2023. If you’re planning to comply with ISO 9001, you probably do not know how the standard...
Updated: December 22, 2023. If you’re planning to comply with ISO 9001, you probably do not know how the standard is structured and what it requires to implement a QMS. Read further to learn more....
ISO 9001 vs. Six Sigma: How they compare and how they are different
Have you considered adding Six Sigma methodologies as a way of focusing the improvement activities in your quality management system?...
Have you considered adding Six Sigma methodologies as a way of focusing the improvement activities in your quality management system? If so, yours is one of several companies that see the benefits of process improvement...
Quality Certification
Strahinja Stojanovic
Quality Certification is a general term that is used for two main things: certifying the knowledge of individuals, and certifying a...
Quality Certification is a general term that is used for two main things: certifying the knowledge of individuals, and certifying a company’s system of quality management. Quality certifications for individuals can be granted through organizations such...
ISO 9001 internal auditor training: Is it for me?
Since the internal audit is one of the most important tools for driving improvement in an ISO 9001 quality management...
Since the internal audit is one of the most important tools for driving improvement in an ISO 9001 quality management system (QMS), it is vital that you have internal auditors who have the skills needed...
ISO 9001 awareness training material: How to create it, what it should contain
When you are implementing ISO 9001, it is critical that everyone knows what you are doing and why. ISO 9001...
When you are implementing ISO 9001, it is critical that everyone knows what you are doing and why. ISO 9001 may start from the top management, but it is crucial to have all employees on...
How to make your QMS successful with ISO 9004
Ana Meskovska
For many companies, getting an ISO 9001 certificate is the main goal; however, implementing a Quality Management System represents only...
For many companies, getting an ISO 9001 certificate is the main goal; however, implementing a Quality Management System represents only the beginning of the story. Continual improvement is one of the key principles of ISO...
Should universities implement ISO 9001?
Although ISO 9001 is applicable for all organizations, the ISO (International Organization for Standardization) strategic plan 2011-2015 failed to identify education...
Although ISO 9001 is applicable for all organizations, the ISO (International Organization for Standardization) strategic plan 2011-2015 failed to identify education as a sector where ISO standards provide benefits. Aware of this problem, ISO published IWA...
GM ignition switch recall vs. sunroof recall: An ISO 9001 case study
Product recalls are something we have become used to in our society. As I argued in my article Does a...
Product recalls are something we have become used to in our society. As I argued in my article Does a QMS ensure 100% quality?, product recalls do not mean that there is a complete failure...
How links between processes can increase level of quality
ISO 9001 is based on seven quality management principles, and the process approach is one of the most important. By...
ISO 9001 is based on seven quality management principles, and the process approach is one of the most important. By focusing on managing and improving processes, a quality management system (QMS) based on ISO 9001...
What is an acceptable exclusion in Clause 7 of ISO 9001?
Section 4.2.2 of ISO 9001 allows for the inclusion in the quality manual of details and justification for any exclusion as...
Section 4.2.2 of ISO 9001 allows for the inclusion in the quality manual of details and justification for any exclusion as part of the scope of the Quality Management System (QMS). But what is an acceptable...
Writing a good QMS internal audit report
In ISO 9001, the process for internal audits is one of the most important ways for you to ensure that...
In ISO 9001, the process for internal audits is one of the most important ways for you to ensure that your quality management system (QMS) is functioning properly and efficiently, but what is the role...
