Clause 7.3 Awareness (secrets revealed)
Are you confused about the requirements of clause 7.3 awareness? If so, then continue reading the secrets to this requirement.
Clause 7.3 Awareness (secrets revealed) Read More »
Clause 7.4 Communication Requirements (explained)
Are you confused about the ISO 9001:2015 Clause 7.4 Communication Requirements? If so, then all will be revealed in this detailed article
Clause 7.4 Communication Requirements (explained) Read More »
Clause 7.5 Documents & Records (secrets explained)
The terms “document” and “record” are frequently used interchangeably however, they refer to two distinct concepts. Not only are they distinct, but so are the controls used to manage them
Clause 7.5 Documents & Records (secrets explained) Read More »
Clause 8.1 Operational Planning and Control (secrets)
Do you have detailed plans for the production and provision of your products and services? I hope so! Have those plans been effectively implemented and monitored for effectiveness
Clause 8.1 Operational Planning and Control (secrets) Read More »
Clause 8.2 Requirements for Products and Services
Are you communicating with your customers? Is this communication on a random basis or is it controlled by a process? Have roles, responsibilities and authorities been assigned concerning customer communication?
Clause 8.2 Requirements for Products and Services Read More »
Clause 8.2.2 Determining the Requirements for Products and Services
So far as determining the requirements for products and services, you are primarily looking for breaks in information flow, faults in form capture and human error. When examining your processes, try also to build checkpoints that will occur immediately after any identified areas of possible we.
Clause 8.2.2 Determining the Requirements for Products and Services Read More »
Clause 8.2.3 Review of Requirements for Products and Services (secrets)
Do you have a process for reviwing the customers’ product or service requirements? Are you confident you are meeting your legal requirements? These are requirements of clause 8.2.3
Clause 8.2.3 Review of Requirements for Products and Services (secrets) Read More »
Clause 8.3 Design and Development of Products and Services
If you fail to get the design and development planning and review processes correct, you will be spending lots of extra time and money! This article details in plain English what the various clauses of 8.3 design and development mean and how important it is to get them right.
Clause 8.3 Design and Development of Products and Services Read More »
Clause 8.4 Control of Externally Provided Processes, Products and Services
Are you purchasing product or services from an external provider? If yes, then you are required by ISO 9001:2015 to have an extent of control over their product or service provision. Read how in this article that explains clause 8.4 in detail.
Clause 8.4 Control of Externally Provided Processes, Products and Services Read More »
Clause 8.5 Production and Service Provision (secrets)
How do you control the production of products or implement service delivery so that non-conforming outputs can be irradiated? Is this even possible? I’ve demystified the requirements of clause 8.5 ‘Production and Service Provision’ in this detailed and informative article.
Clause 8.5 Production and Service Provision (secrets) Read More »
Clause 8.5.2 Identification and Traceability (revealed)
Are you confused about the requirements of clause 8.5.2 Identification and Traceability in ISO 9001:2015? What about clause 8.5.3 and your responsibility for handling property that belongs to the customer including their personal data? Read my article that explains these requirements in plain English.
Clause 8.5.2 Identification and Traceability (revealed) Read More »
Clause 8.5.4 Preservation (secrets)
How do you manage your product or service preservation? Do you understand the concept of post-delivery activities according to the requirements of clause 8.5.5 of ISO 9001:2015? If this all sounds like tech speak then read my article that explains these requirements in simple terms.
Clause 8.5.4 Preservation (secrets) Read More »
Clause 8.5.6 Control of Changes (explained)
So, you are reading clause 8.5.6 of ISO 9001:2015 and wondering what the difference is between this clause requirement and that for clause 6.3 requirements. There are subtle but important differences and working as an auditor, I’ve often had to award non-conformances because of this misunderstanding. Don’t let that happen to you, read my detailed article to put your mind at rest.
Clause 8.5.6 Control of Changes (explained) Read More »
Clause 8.6 Release of Products and Services (explained)
So, your products have been manufactured or your service has been designed and is ready for delivery, but do you have a process for the final release? What are the final release requirements for products and services according to ISO 9001:2015? Are there any legal requirements to consider? For the answers to these questions and more, read my detailed article that describes the requirements of clause 8.6 of ISO 9001:2015 in plain English.
Clause 8.6 Release of Products and Services (explained) Read More »
Clause 8.7 Control of Non-conforming Outputs (secrets)
So, you have products that don’t quite match the design requirements or the requirements of the customer. Or, maybe you have delivered a service and have received a customer complaint. In ISO terms these are referred to as non-conforming outputs. How do you identify and control your non-conforming outputs? What are the requirements of ISO 9001:2015 regarding the retention of records that describe non-conforming outputs? For the answer to these questions and more, read my detailed article.
Clause 8.7 Control of Non-conforming Outputs (secrets) Read More »