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ISO 9001:2015 best practices, templates, procedures, questions and answers.
Interesting updates on ISO management system standards, quality, business sustainability, corporate and social responsibility, innovation and more.
Online learning for certified professionals news.
2020-02-10 00:17
Making sure that people have the right competence contributes to the organization’s sustained success.ISO 9001:2015 set requirements for definition and provision of competence.Recently… Read More
2020-02-09 23:55
In December 2019 ISO published new standard ISO/TS 26030 Social responsibility and sustainable development – Guidance on using ISO 26000:2010 in the food chain.The food and a… Read More
2018-11-16 23:26
The ISO 9000 family standards addresses different aspects of quality management. It is true to say that ISO 9001 is the most popular standard in the world. According to ISO.org, there are 'o… Read More
2018-11-06 16:37
Following the recent release of the ISO 50001:2018 – Energy Management System standard, we have updated our Energy Management System Manual Template to fully comply with the updated re… Read More
2018-07-16 21:32
In June 2018 ISO published the new edition of ISO 22000:2018 - Food safety management systems — Requirements for any organization in the food chain.The new edition brings clarity of un… Read More
2018-06-28 20:21
Following the release of the first international standard for occupational health and safety (ISO 45001:2018) in May 2018 ISO release a new technical specification (ISO/IEC TS 17021-10) that… Read More
2018-06-10 23:58
We have added an MSP to our ISO 14001:2015 documents and templates collection: MSP 6.1.2.Control of Environmental Aspects.The main purpose of the Procedure is to:establish a procedure for th… Read More
2018-05-30 16:49
We are announcing new product - ISO 22000:2018 FSMS Manual Template.Use the Manual for:FSMS audit and certification. Understanding of how the Food safety management system operates by s… Read More
2018-05-09 16:36
ISO 41001, Facility management – Management systems – Requirements with guidance for use was published on April 28, 2018.The new management system standard constitutes a benchmar… Read More
2018-04-25 20:37
Health and safety is one of the major concerns of the businesses.To prevent even more deaths and injuries - ISO 45001 sets standards to protect workers worldwide.Following the release of the… Read More
2018-03-13 16:07
ISO announced the publication of the first International Standard for occupational health and safety - ISO 45001:2018.What are the major differences between OHSAS 18001 and ISO 45001?ISO 450… Read More
2018-02-20 16:40
The new version of ISO 31000:2018 Risk Management Standard has been published on February 15th 2018.It is now available in English and French on ISO website and ISO's member bodies.You can a… Read More
2018-02-16 16:00
What are the ISO 9001:2015 guidelines regarding the intellectual property? ISO 9001:2015 Cl. 7.1.6 Control of organizational knowledge is aimed at:Defining knowledge necessary to operat… Read More
2018-02-08 18:59
Is risk understood and when appropriate, communicated throughout your Organization?The requirements of ISO 9001:2015 states that “the organization shall determine the internal and… Read More
2018-02-02 22:14
Something went wrong in the process. How to clearly identify what exactly is the root cause of the issue to prevent it from happening in the future?Let's look at the example.A wrong product… Read More
2017-12-22 17:30
New article by Tara Callinan 'How AI, Machine Learning and Automation will Impact Business in 2018 and Beyond' gives an overview of what technology trends to watch for and how they will impa… Read More
2017-11-27 19:12
Can we assume that ISO 9001-2015 can be used as a Business management system? In which case that can be possible?ISO 9001:2015, like the earlier versions of the Standard, was created precise… Read More
2017-11-20 21:59
Introducing new product - ISO 45001 Audit checklist.42 pages editable MS Word document with detailed explanations, auditor tips and recommendations - our ISO 45001 Audit checklist can be uti… Read More
2017-10-30 23:45
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… Read More
2017-10-27 20:25
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… Read More
2017-10-04 21:40
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 i… Read More
2017-09-29 22:05
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 t… Read More
2017-09-11 18:57
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 9001:2… Read More
2017-09-07 22:44
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 quote… Read More
2017-08-30 18:44
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 det… Read More
2017-08-18 23:50
Question: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 a… Read More
2017-08-16 17:48
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 eff… Read More
2017-07-14 21:19
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 O… Read More
2017-07-12 17:02
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… Read More
2017-07-10 21:13
In our modern world is not uncommon when two or more geographically distributed teams would want to work on the QMS documented information together.Can the documents like Manuals and procedu… Read More
2017-06-30 00:11
Some of the benefits of having an Integrated system (IMS) vs. Quality and Environment separately include IMS is easier to control because Organization’s management system is essentiall… Read More
2017-06-03 02:43
What tips do you provide your front-line staff who are going to be interviewed for either an internal or external ISO 9001:2015 audit?If the personnel already has experience of passing the I… Read More
2017-05-19 01:41
IS0 9001:2015Clause 8.2.1 Customer communicationCommunication with customers shall include: • e) establishing specific requirements for contingency actions, when relevant. How do you es… Read More
2017-05-05 18:23
What sort of EMS targets could be set, when preparing for ISO 14001 certification when the Organization has very little environmental impact? (i.e. - A small office with very little environm… Read More
2017-04-29 02:13
Which does ISO 9001 emphasize more, the Management of Quality or the Quality of Management?The majority of newbies who just become familiarizing themselves with ISO 9001 international standa… Read More
2017-04-18 19:49
Can we merge Risk Management for QMS and EMS? If yes what is the common criteria? Integration of Risk Management for QMS and EMS is highly advisable. A unified methodolo… Read More
2017-04-10 22:45
CBG inc. launches new product - ISO 14001:2015 EMS Manual Template.The proposed EMS Manual is written in sufficient detail. This allows you to use it to solve the following tasks:EMS Audits… Read More
2017-04-07 01:16
QMS objectives will vary from Organization to Organization but are some of the more common objectives professionals see?Do they scores on customer feedback surveys, lack of complaints measur… Read More
2017-04-03 17:25
Does ISO 9001:2015 require Quality Manual to contain brief information of the Organization? The structure of documented information as per ISO 9001: 2015 (cl 7.5.1) does not contain req… Read More
2017-03-22 04:07
When developing and implementing a QMS, quality managers often ask themselves these questions:Is this procedure mandatory? Do I need to maintain those records?What are the documents req… Read More
2017-03-10 20:07
When implementing 14001 within existing 9001 should both systems - QMS and EMS be implemented as separate ones with separate documentation, or may EMS be included as one of QMS processes?&nb&hell…Read More
2017-03-09 20:58
Emerging digital technologies, increasing competition and changing customer demands put extra pressure on the businesses. In order to survive in the digital age, companies have to adapt to t… Read More
2017-03-04 19:28
What are the new things - which you ignored about your Quality Management System - did/does the new edition of ISO 9001:2015 teach you?Our experience in consulting the transition of the orga… Read More
2017-02-17 03:13
Are there any key points to remember in transitioning from ISO 9001:2008 to ISO 9001:2015 especially when it comes to documentation?For the key points to remember in transitioning from ISO 9… Read More
2017-02-12 20:04
We have incorporated 12 months’ experience of SO 9001:2015 compliant QMS operation, took into consideration the ISO 9002:2016 requirements and offer the 2nd edition of Quality Manual t… Read More
2017-02-09 19:00
One of the requirements of the new version of ISO 9001 Standard is that there should be a plan to achieve quality objectives.How would/have you come up with a plan for achieving quality obje… Read More
2017-02-03 21:18
As far as I know ISO 9001:2015 do not mandates a specific numbering system for control documents.Is it true that the organization is left open to adopt one that suits it's organizational nee… Read More
2017-01-31 16:33
How are actions to address risks and opportunities planned ? There are two approaches to the planning of actions to address risks and opportunities.The choice depends ofthe size of the… Read More
2017-01-26 02:04
When a company is transitioning from the 2008 version of ISO 9001 to the 2015, which version must the company comply with? For example:A company has an existing ISO 9001:2008 certification… Read More
2017-01-23 00:13
We are stuck on getting 'Organizational Knowledge' element off the ground. We know what is required and have the intellectual resources to do it. Any ideas on where to start?I've got the ass… Read More
2016-11-22 22:27
Recently ISO has published a new document that is intended to help users with Quality management system implementation: ISO/TS 9002, Guidelines for the application of ISO 9001:2015.The new d… Read More
2016-11-16 02:48
What was the rational behind TC 176 changing from Control of Monitoring and Measuring Devices to Monitoring and Measuring Resources?It is obvious, that TC 176 made the change to the ISO 9001… Read More
2016-11-13 16:56
We have added a new Procedure to our ISO 9001:2015 QSP collection: Control of Infrastructure.This QSP regulates the execution of ‘Control of Infrastructure’ process as part of Or… Read More
2016-11-12 02:01
Question: 1. Which ISO 9001:2015 clause refers to the change management in the Process ? Answer: Speaking about ISO 9001:2015 clauses that refer to the Change in process, fi… Read More
2016-10-29 05:26
ISO has released the 2015 Survey report, that provides data on the total certifications to ISO 9001, ISO 14001 and other management standards across the world.A free copy can be downloaded… Read More
2016-10-21 13:11
We listen to our customers' feedback and continuously improve our products.ISO 9001:2015 QSP 8.2-02 Contract Analysis has been recently updated.We have added 8 quality system forms relevant… Read More
2016-09-27 17:08
We listen to our customers' feedback and continuously improve our products.ISO 9001:2015 QSP 6.1-01 Actions to Address risks and opportunities has been recently updated.We have added 8 quali… Read More
2016-09-24 03:08
Question: 1. How and when to use Audit checklist? Answer: 1.1 Internal auditors training When utilized for internal auditors training, our ISO 9001:2015 Audit checklis… Read More
2016-09-21 04:18
How do you prove you meet the requirements of Clause 4.1 of ISO 9001:2015?The organization shall determine external and internal issues that are relevant to its purpose and its strategic… Read More
2016-09-14 00:10
The Quality manual and the documented procedures regulate the activities necessary and sufficient to meet all the requirements of ISO 9001:2015. This is the main purpose of the procedures.Qu… Read More
2016-09-07 23:44
Question: Can we conclude that System audit can/may include Technical audit since technical expert may be required during a System audit (1st, 2nd or 3rd party) as per ISO 19011?Techni… Read More
2016-09-01 01:00
Question: Some of the current controls we have are "Customer requirements", PFMEAs, DFMEAs, Six Sigma, etc. Would those count as being part of the COTO? We also go over these… Read More
2016-08-30 23:23
'The organization shall retain documented information that:a) describes the nonconformity;b) describes the actions taken;c) describes the concessions obtained;d) identifies the authority dec… Read More
2016-08-30 01:37
How to address ISO 9001:2015 clause 6.3 (Planning of changes)?Could you provide risks and opportunities examples or references for small companies?Planning of changes (cl.6.3 in ISO 9001:201… Read More
2016-08-17 22:21
Q: I'm putting together a quality risk register for our business and looking for some examples other people have used for their definitions of 'high', 'moderate' and 'slight' risk. For… Read More
2016-08-11 13:00
Can a company afford errors in our highly competitive world?'A company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a compa… Read More
2016-08-09 18:20
The execution of ISO 9001:2015 ‘Control of Monitoring and Measuring Resources’ process includes definition of the requirements, ensuring availability and maintenance of the… Read More
2016-07-27 16:00
What are the important steps to start implementing Risk management in the QMS?It is important to accept that the main task of the initial implementation of risk management in the QMS - makin… Read More
2016-07-25 18:20
Control of nonconformities in provision of services often causes additional questions. The new documented procedure QSP 8.7-02 regulates the execution of ‘Control of nonconformit… Read More
2016-07-22 16:13
The organization shall ensure that relevant persons doing work under the organization’s control are aware of:c) their contribution to the effectiveness of the quality management sy… Read More
2016-07-20 00:09
This Methodical Manual summarizes 15 years of field risk management experience at the workplace.For the organization, the regulatory framework for actions to address risks and opportunities… Read More
2016-07-15 02:37
Procedures vs. Work InstructionsI was recently working with a process owner to modify one of his procedures.And part of the conversation was that, in my opinion, his procedure looked more li… Read More
2016-07-09 21:58
Marketing Quality System Procedure regulates the operation of the ‘Marketing’ process in compliance with ISO 9001:2015. The QSP ensures relationship with other QMS processes and… Read More
2016-06-27 23:24
If a Company is ISO 9001 certified, is it mandatory for the Supplier of the materials to have the ISO 9001 in place or the Company’s certification is sufficient.There are three availab… Read More
2016-06-17 15:41
ISO 9001:2015 requires to determine objects for monitoring and measuring to determine the performance and effectiveness of the QMS.The term Key Performance Indicator (KPI) refers to the chos… Read More
2016-06-14 19:26
New quality system procedure has been added to the ISO 9001:2015 documents and templates collection - Control of Organizational Knowledge.QSP describes the organization activity to implement… Read More
2016-06-11 01:19
ISO 9001:2015 requires the identification of external and internal issues. The standard gives several examples of external issues, however is very "light" on internal issue examples.&n&hell…Read More
2016-06-11 00:05
What is the Difference in Risk definition between ISO 9001:2015 and ISO 31000?The key difference of ISO 31000:2009 is that the Standard defines the requirements for Risk management as a Syst… Read More
2016-06-03 01:01
Control of externally provided processes, products and services quality system procedure requirements apply to the activities of the purchases department, as well as the ‘Production&rs&hell…Read More
2016-06-03 00:52
Contract Analysis is one of the QMS processes related to the Customers.ISO 9001:2015 defines the requirements to the Contract analysis in sub clauses of 8.2 Requirements for products and Ser… Read More
2016-05-12 01:19
Q: ISO 9001:2015, does it require a documented risk register? Will it become a requirement, indirectly? I plan to identify and review all risks and opportunities in the MRM but sti… Read More
2016-05-10 18:55
Our ISO 9001:2015 Quality System Procedures collection was updated with the Control of Personnel Procedure. The key personnel competence requirements of ISO 9001:2015 are implemented in this… Read More
2016-05-04 20:21
The revised version of ISO 9001:2015 requirements sometimes are confusing, especially regarding the 'documented information'.What is documented information? What documented information is ma… Read More
2016-05-04 20:13
Why the 'Control of documented information QSP' does not contain any forms?The 'Control of Documented information’ Procedure (that you hav… Read More
2016-04-28 18:53
International standard ISO 9001:2015 (as well as the earlier versions of the 9001) does not contain any requirements to such an evaluation procedure, thus it is beneficial to use a good prod… Read More
2016-04-21 04:08
Service Provision procedure reflects completion of all the requirements of ISO 9001:2015 concerning the provision of services or production of goods. We recommend this procedure for organiza… Read More
2016-04-17 19:57
Question: We are doing internal audit (Gap analysis) for ISO 9001:2015 Certification (transition from 2008 to 2015 version).What Processes and Systems should we have in place to ensure… Read More
2016-04-08 01:29
A saying 'The devil is in the detail' is 100% applicable to the QMS transition to the new version of ISO 9001:2015.The requirements wording of the Standard is often confusing while the decis… Read More
2016-04-02 00:55
Internal audits can help identify issues in a company's QMS. Addressing these issues can increase efficiency, save money and make the final product better for the customer.A company may also… Read More
2016-03-12 00:34
Building a Quality Management System (QMS) can be divided into 3 phases.QMS Development Phase includes the following activities:- Initial audit of the organization- Evaluation of existing ma… Read More
2016-03-10 02:35
We've added a new document to our ISO 9001:2015 Documents and Templates collection. ISO 9001:2015 Audit Checklist The Checklist contains explanations and recommendations that:… Read More
2016-03-07 17:58
What is the best way to prepare for an audit?What practices to use to make it more efficient? Auditing has been around for a long time but those questions are still being asked.In his articl… Read More
2016-03-04 21:26
Following the revision of ISO 14001, the newly revised ISO 14004:2016 Environmental management systems -- General guidelines on implementation has been published.Dr Anne-Marie Warris, Chair… Read More
2016-01-27 23:34
Product, process, and service audits focus on defect reduction or prevention and are conducted more often, than System Audits.ISO 9001:2015 clause 8.4.2 Type and Extent of Control states:"Th… Read More
2016-01-20 01:09
Oxebridge has launched an online survey to gauge early user feedback on the new ISO 9001:2015 standard. The intent is to collect data on early opinions on the new ISO 9001 standard from th… Read More
2016-01-06 02:03
We put together a collection of Business Process Improvement Tools in a form of a presentation that you can download free from our site.Those tools can be used by quality professionals, Lean… Read More
2015-12-30 02:21
Looking for re-certification? Need CEU credits?We've updated our course catalog - added new classes and discounted old ones.Download your copy of the catalog for details.Project Management:… Read More
2015-12-18 23:22
We created a new QMS Transition Workshop that will help youBetter understand the ISO 9001:2015 RequirementsUse this knowledge in the Staff and Internal Auditors training. Plan and carry… Read More
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