5.5.3 is about Internal communication and here a SOP not required by the standard. All that is required is communication proceses are established, and effectiveness of the quality management system is communicated.
Does a process require an SOP? we have a requirement in our QMS and ISO 13485 to communicate the effectiveness of the QMS at least monthly to management. We conduct weekly management meetings without formal documentation. Reviewing data from the last several years these meetings have occurred...
...from your calibration process. Capture the identify of the person approving the records, and make sure his authority for such approving is documented as in Responsibility and authority (5.5.1).
Juat a bit of processinteractions in verification of purchased products.....you are good :agree:
If that's his genuine view (that ISO 9001 is a disappointment), then it seems like a great opportunity for you - you get to pick and choose what elements you want from 9001 and use your creativity and skills to add in other new and novel elements, and create a QM that is both better than 9001...
I completely understand. Believe he can't grasp the concept, we try several times (directly and indirectly) but no luck. I told him that ISO is just a facilitator, a systematic-process approach designed to facilitate that world-class quality and that the QM is just basically a documented...
Just because the standard calls it a process does not mean that it is a process of the QMS
Please see
4.4 Quality management system and its processes
4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed...
The only direct risk as i can think of is if you are forced into a common QMS structure. That you need to adopt to a QMS that does not fit your sites glove. Also interactions & responsibilities between the sites need to be clear from all sides.
If one site in a corporate scheme enters the...
Qualygirl,
First pioneered in the deployment or swim-lane format by Myron Tribus to illustrate the essentials of any industrial processes.
Swim-lane representations of processes show the interactions of activities (work) and the entity, department or person doing the work as necessary to...
This reminds me of the well-known opinion rendered by SCOTUS Justice Potter Stewart in a pornography case:
I think most of us know a process when we see one, and whether or not some "activity" is part of some larger entity or stands by itself. That doesn't get TC176 off the hook, of course...
One might say the same of change management, or risks and opportunities, as they are not written as topics, but rather as threads that re-appear in the standard.
As for ISO 9001, the organization has a few to consider regarding their "processes"
0.1 General-The process approach enables an...
If you depict processinteractions using a deployment (swim lane) flowchart you can dedicate lanes to internal and external organizations thereby showing their interactions.
If anyone has experience with this particular TIR, I'm curious to read your opinions. Independent of the TIR content, my suspicion is that the development team has its own ideas of what Agile development means.
The original Agile manifesto included, I believe this statement:
For medical...
I’m trying to implement a more robust and well-defined procedure at my company for risk management activities per ISO 14971, and I’m having a lot of trouble coming up with methods that are effective, efficient, and consistent. I was hoping some of the people here might have some insights.
My...
@John Broomfield
@John C. Abnet
Thank you very much for the details in your replies. I am currently very new to my current position. And the previous QM left there QMS in shambles. So I have been trying to inundate myself in learning the ISO req. I have currently created a Sequence and...
1st - the requirement stems from this within the 9001:2015 Standard.......... "4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this...
Aphel,
Scope the system, determine the stakeholders and synthesize the organization’s global purpose or mission.
My experience taught me to seek understanding of job titles and their roles, authorities and responsibilities. Chances are that these are not yet standardized. Then pay attention...
I will preface this by stating that i am by no means an expert on AS9100 but I'm in a similar situation. I work in a company that has less than 50 employees. we have well established processes, and well established quality control and glowing reviews from all of our customers. But we are not yet...
First some context:
I have no quality management experience. I'm a lowly inspector who has been charged with significant responsibility for the last 8 or so months:, assisting our quality manager with assessing our QMS after our prior manager retired last year. I'm a smart dude and my boss...
Hi, It's been a while since I have been to the site and scanning some of the topics I came across yours and thought I'd respond. I have been a QMS auditor for about 6 years now. I perform certification, supplier and internal audits. I have never encountered any issues during audits...
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