Summary of Changes in ISO 9001:2000

L

lmfoong

#1
Changes to ISO 9001:2000

I seek to obtain advice pertaining to the any significant changes in the revision of ISO 9001:2000 in the following areas :-
1) Involvement of top management
2) Measurement of customer satisfaction and dissatisfaction
3) Continual improvement

------------------
Thanks and Best Regards

lmfoong
 
Elsmar Forum Sponsor
A

Andy Bassett

#3
Ill avoid the specifics, but tell you my take on the three points mentioned.

1) Involvement of top management.
I beleive that the new standard strengthens the requirements for management involvement. I understand that they now have to set clear targets for the system and measure them and follow them. Before you could of scraped by with a Quality Policy.
2) Measurement of customer satisfaction and dissatisfaction.
I now understnad that this is a requirement.
3) Continual improvement.
This should automatically come about becuase you are required to measure your processes.

The general discussion is that all this SHOULD have been done before. This is true, but i beleive many companies with the certificate were not doing this.

Regards
------------------
Andy B
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Some thoughts:
******************

From: ISO Standards Discussion
Date: Mon, 9 Oct 2000 13:21:07 -0500
Subject: Re: Q: ISO 9000:1994 Vs. ISO 90002000 /van Putten/Paten

From: "Mike Paten"

Dirk,

I have used Figure 1 of ISO 9001:2000 (the "Process-Based Quality Management System") to depict how the new standard focuses on both "compliance" and "improvement". The following narrative explains:

Assuming that what you "Say You Do" meets the intent of the standards, both the 1994 and 2000 versions require you to "Do What you Say" (implement) and "Prove It" (demonstrate compliance).

The biggest change for 2000 is that you also must "Improve It".

In order to improve you must have "baseline" measures to gage improvement against. Therefore we must develop at least one key performance measure for each of the key QMS processes (or elements) - then we must gather our baseline data and set goals or objectives for improvement based on current performance - then we must take action to improve the processes most in need of improvement - then we must take a look at measureable results to see if actions taken achieved the desired results. Classic stuff.

I advocate that at least two key measures be easily established for each QMS process or element: 1) at least one measure of (in)effectiveness - i.e. something that measures whether (or not) you achieved the overall objective or desired outcome of a particular process; and 2) at least one measure of (in)efficiency - i.e. something that measures how well (or poorly) resources were utilized to achieve the results measured in 1). For example

Clause 6.2.2: Training Processes: Key measures of effectiveness: % employees fully trained and qualified and/or % corrective actions resulting from a lack of training. Key measures of efficiency: % of training completed rated by attendees as marginally satisfactory or worse.

Clause 7.2: Customer Related Processes. Key measures of effectiveness: % customer satisfacation and/or the # of customer complaints. Key measures of efficency: resources dedicated to customer related processes and/or resources devoted to investigating/resolving customer complaints.

Clause 7.3: Design Control Processes. Key measure(s) of effectiveness: Product/Service Performance Measures. Key measures of efficiency: resources devoted to design function and/or resources devoted to design changes resulting from product failures reported from the field.

Clause 7.4: Purchasing Control Processes: Key measures of effectiveness: Supplier performance measures and/or the # corrective actions resulting from incorrect, misidentified or poor quality purhased material. Key measures of efficiency: Resources involved in processing returns and/or supplier corrective actions.

Clause 7.5: Operations Control Processes: Key measures of effectiveness: Product / Service Quality Measures. Key measures of efficiency: defect rate, % scrap, rework, equipment downtime; inventory accuracy, % operations where work instructions or automated process controls are in place.

In any case, these measures should be easy to come up and track. Like most of what ISO has always required - it's not rocket science - just good, down to earth common sense stuff.

Best of luck in the "Move from Conformance to Performance"

Mike Paten
 
Thread starter Similar threads Forum Replies Date
J Does anyone have a summary of changes made to ISO 11137-2? Other Medical Device Related Standards 3
E Is there a summary of changes from a withdrawn ISO standard to the current version Other ISO and International Standards and European Regulations 5
Marc Summary of ISO 9001:2000 and ISO 9001:2008 Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 166
K Draft ISO 9001:2008 (Feb 08 version) & Summary of Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 60
Marc Summary of Differences and Changes - ISO 9001:1994 and ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
M MDR Clinical Evaluation & investigation (SUMMARY of changes) EU Medical Device Regulations 2
B Has anyone seen a Summary of AS9100C Changes yet? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
Watchcat DE NOVO SUMMARY - IVDs and Radiology Devices, 2015-2018 Other US Medical Device Regulations 2
Watchcat De novo Summary (ODE 2015-2018) Other US Medical Device Regulations 2
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
M Informational US FDA – MDR Data Files – Alternative Summary Report Data Since 1999 Available Medical Device and FDA Regulations and Standards News 0
M Informational EU – Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) – Summary records Medical Device and FDA Regulations and Standards News 0
A Minitab 18: How to automate GRR Summary Table save Reliability Analysis - Predictions, Testing and Standards 1
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
T Executive summary for Traditional 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Summary of safety and clinical performance (SSCP) EU Medical Device Regulations 1
D MDR and Summary Technical Documentation Files EU Medical Device Regulations 13
S 510(k) statement or 510(k) summary ? US Food and Drug Administration (FDA) 2
shimonv Summary of FDA Guidance on “Medical Device Accessories” (Dec 2016) Other US Medical Device Regulations 1
L A "good" non-parametric test summary? Statistical Analysis Tools, Techniques and SPC 0
R 510(k) Executive Summary vs 510(k) Summary - Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L ISO 9001:2015 Correlation Matrix & Change Summary ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
S Internal Audit Findings Summary Rewrite by an Auditee ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S RAPS Article on STED (Summary Technical Documents) Other Medical Device Regulations World-Wide 1
R What should be the content or elements of an MDR Evaluation Summary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Are Control Plans "Summary Documents" not meant to replace Work Instructions? IATF 16949 - Automotive Quality Systems Standard 3
K Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary: Other US Medical Device Regulations 12
R Summary / Checklist for ANSI Z80.1 and ANSI Z80.3 Other Medical Device Related Standards 2
C Training Planning - Using Summary Sheet for Documenting Training Activities Training - Internal, External, Online and Distance Learning 3
K Clinical Evaluation Report Article Summary Requirements EU Medical Device Regulations 5
S Internal ISO 9001:2008 Audit Summary Report wanted General Auditing Discussions 4
Rameshwar25 Acceptance Criteria for Attribute MSA Study Effectiveness Summary Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
E STED (Summary Technical Document) and CSDT Differences Other Medical Device Regulations World-Wide 6
R CAPA 4-panel or 4-pane for Executive Summary Presentation Nonconformance and Corrective Action 3
S AIAG MSA 4th Edition Summary APQP and PPAP 4
N Audit Summary Report - Need template example and help Internal Auditing 3
Q Adding ISO13485 to existing AS9100 QMS - Summary of the differences ISO 13485:2016 - Medical Device Quality Management Systems 9
C Product Quality Planning Summary and Sign Off Sheet APQP and PPAP 3
B Requirements Summary - Part 21g / Part 21j and Part 145 and DAOS EASA and JAA Aviation Standards and Requirements 4
Q ISO 13485 vs. 21 CFR Part 820 Management Summary wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
E Declarations of conformity and summary reports 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Audit Summary Report - Nonconformance Aging Analysis Nonconformance and Corrective Action 10
R FDA 510(k) Summary and FDA 510(k) Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
M FDA 510(k) Summary and FDA 510(k) Statement Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S How to develop a Quality Cost Summary Report Quality Manager and Management Related Issues 4
Le Chiffre Health Canada to accept Summary Technical Documentation (STED) for Class III & IV ISO 13485:2016 - Medical Device Quality Management Systems 1
SteveK EU Medical Device Regulations - Summary Report EU Medical Device Regulations 2

Similar threads

Top Bottom