Various

V

Vash Stampede

#1
1. Almost 90% of our procedures is referenced to the old standard. Our specs was paraphrased using ISO9001:1994. Do we need to revise or update all specs affected since we are converting to ISO9001:2000 this year? :confused:

2. How do we document quality objectives? Is this a part of management review? :confused:

3. What does the "Use of Competence" Versus "Qualified" Means? :frust:

4. What is the main focus of preventive action? Do we need to track all nonconformity history, in order for us to define the real root cause of the problem? :confused:

Any feedback would be appreciated.
Thanks in advance.

Vash
 
Elsmar Forum Sponsor
#2
Hi Vash,

Here are my views:

1. You’ll need to go through your system to see if your procedures cover the requirements in ISO9001:2000 (gap analysis). Then you update or write new procedures as needed. There is no need to update procedures that are still valid.

2. How you document your objectives is largely up to you. I suggest a procedure that describes how you establish, follow up, report and review your objectives. The ***DEAD LINK REMOVED*** SMART model that Jim Wade among others talk about is a good way to set them up. You will definitely have to deal with objectives in the MR.

3. Where did you find the term "Use of Competence"? :confused: I can't find it. I find the word qualified in ISO9001:1994, but not in the 2000 version, so I think that's one thing less to worry about. Anyway, english is not my native lingo...

4. The focus of preventive ation is quite literally on figuring out what may go wrong and do something about it before it happens. I would think that applying FMEA to your processes would be a good idea.

/Claes
 
Last edited:
J

Jimmy Olson

#3
All good points Claes.

The only thing I can think of related to competence is ensuring the personnel are competent. If this is what you are referring to Vash, then you determine the competence and the criteria. You can show competence by training or experience or several other factors.

If this isn't what you were referring to and I'm way off track, sorry :p If you are referring to something else, let us know and I'm sure someone will step in to help.
 
V

Vash Stampede

#4
Hi Claes,

I got Competence in 6.2.2 which was "Competence, Awareness and Training" and under that clause 6.2.2 (a), I'm sorry if I got the term"use of competence" instead of "competence" :ko:

Hi Richard,

Your right, I'm referring on how to ensure that personnel are competent. We had training with a written and actual examination, with 100% efficiency. I don't know whether that would be enough. When we speak of competence, isn't it, about Skills and Knowledge?

Best regards,
Vash
 
J

Jimmy Olson

#5
Hi Vash,

It seems like "Competence" covers a pretty wide spectrum. During our audit we were asked about one person operating a machine. We showed that he had been trained by the machine manufacturer when it had been installed, and that was enough to satisfy the requirements.

I don't think it really matters how it's done, as long as you can show that people know what they're doing. I hope this helps and doesn't create more confusion. :D
 
#6
Vash Stampede said:

Hi Claes,

I got Competence in 6.2.2 which was "Competence, Awareness and Training" and under that clause 6.2.2 (a), I'm sorry if I got the term"use of competence" instead of "competence" :ko:
---X---
No worries Vash,

You just managed confuse me a bit, that's all... not a new experience for me, I assure you. It happens a lot :vfunny:

/Claes
 
Thread starter Similar threads Forum Replies Date
A We're currently looking for any studies performed on various PPE materials Qualification and Validation (including 21 CFR Part 11) 1
GreatNate Various Audit Templates - Canned forms and templates Document Control Systems, Procedures, Forms and Templates 9
Q Applicable Medical Device Wifi regulations for various Countries Other Medical Device Regulations World-Wide 7
Marc Where do you buy your ISO and other various standards? Various Other Specifications, Standards, and related Requirements 3
K Where does the FDA post its various compliance dates? US Food and Drug Administration (FDA) 2
S Employee Training Matrix - Keeping track of employee training on various SOPs ISO 13485:2016 - Medical Device Quality Management Systems 4
M Calibration of Thread Plugs and Ring Gages - Various Thread Standards General Measurement Device and Calibration Topics 3
B TS16949 Section 8.2.2.3 Product Audit - Requirements for various Customers IATF 16949 - Automotive Quality Systems Standard 10
M Electrical and Electromechanical Product CE Compliance with various Directives CE Marking (Conformité Européene) / CB Scheme 22
S Retention time requirement for various for quality records Records and Data - Quality, Legal and Other Evidence 1
L BS EN 60601 or IEC 60601 or GB9706 - Our product is going to various markets ISO 13485:2016 - Medical Device Quality Management Systems 4
D Lesser expensive to calibrate various test weights General Measurement Device and Calibration Topics 5
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D Different kinds of Risk Analysis for various Hazards ISO 14971 - Medical Device Risk Management 3
S Medical Device Registration in various African countries Other Medical Device Regulations World-Wide 4
A Risk Assessment Considerations for various Activities Occupational Health & Safety Management Standards 10
H 87% Confidence Level for the Product Quality Control for Various Products Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
M Where to buy various VDA Sandards VDA Standards - Germany's Automotive Standards 1
N What is a good % tolerance for various QC Tests? General Measurement Device and Calibration Topics 2
T Auditing software/app for various devices/OS After Work and Weekend Discussion Topics 2
A How to handle the various Document Revisions Document Control Systems, Procedures, Forms and Templates 2
C Differences in Medical Device Approvals in various countries (US, EU, Japan) Other Medical Device Regulations World-Wide 1
A Internal Audits of various Processes such as Support Processes IATF 16949 - Automotive Quality Systems Standard 8
N Standard Calibration Procedures for various Measurement Devices General Measurement Device and Calibration Topics 3
W Digital Multi-Meter Calibration Procedure for various Meter Brands and Functions General Measurement Device and Calibration Topics 7
C Building a Dimensional Metrology Laboratory to Inspect various Physical Measurements General Measurement Device and Calibration Topics 2
T Employee Access to various Documents of our QMS System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J Equipment for Cleaning various materials over a Wide Area Manufacturing and Related Processes 5
P Import and Border Control of Medical Devices in various countries Other Medical Device Regulations World-Wide 1
G Various ?QMS? packages on the market - Which software package? Quality Assurance and Compliance Software Tools and Solutions 35
C Template to capture various Customer Turnaround time? Quality Tools, Improvement and Analysis 3
Sidney Vianna ISO Video (mentions various standards) for Business and Government ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
Q How should I Keep my various types of records .. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M To Calibrate or Not to Calibrate various Weight Scales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
Q Nonconformance partially applied to a company with various products? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Auditing various industries reference book recommendations wanted Book, Video, Blog and Web Site Reviews and Recommendations 6
somashekar ISO 9001 Clause 5.5.1 Responsibility and Authority - Application in various companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Export - We would like to sell our products to various United States installations US Food and Drug Administration (FDA) 5
S Methods for determining Supplier Capacity in various industries Supplier Quality Assurance and other Supplier Issues 13
L ISO 13485 - Overwhelmed by various Medical Device standards ISO 13485:2016 - Medical Device Quality Management Systems 2
T Determination of UMDNS Code for various types of Contact Lens ISO 13485:2016 - Medical Device Quality Management Systems 4
D Electronic Gauge Measuring Various Heights and Lengths - Your Opinion On our problem Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
L Quality Objectives - How various device companies handle "Quality Objectives" ISO 13485:2016 - Medical Device Quality Management Systems 9
A Quality Tools: When to use various quality tools? Quality Tools, Improvement and Analysis 4
5 Thousands of part numbers and various items - PPAP questions APQP and PPAP 9
B What do you think about ISO 9001:2008? - Interested in various points of view. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
I Various Processes - "Management", "planning" & "feedback", oh my! Document Control Systems, Procedures, Forms and Templates 5
B Control of various Ink Stamps such as Acceptance, Document Status, etc. Document Control Systems, Procedures, Forms and Templates 3
Hershal Management Review under various standards Management Review Meetings and related Processes 1
P Medical Device Regulatory Requirements - Various Countries Other ISO and International Standards and European Regulations 3

Similar threads

Top Bottom