ISO 10007 - Configuration Management Requirements

L

Lorenzo

#1
Looking for quick help in understanding "Configuration Management", what in general is required. We are being required as a supplier to have an AS 9100 compliant system, at this time. I am ordering the ISO 10007 for future reference, but don't yet have.
 
Elsmar Forum Sponsor
#2
The requirement states that the config mgmt system must be "appropriate to the product" which seems to be somewhat open to interpretation by the auditor. Our system is quite complex as are our products. We also develop software for airborne systems so the config mgmt of that process is done in accordance with RTCA DO-178B. We use some fairly elaborate software tools to manage configuration during the software development/lifecycle because the task is so complex. We have never had a registrar/auditor write an observation against our system so I must conclude that it is somewhere in the adequacy ballpark relative to our products.

I don't have much knowledge of other systems and have not read 10007 so maybe somebody who is more "worldly" can enlighten us.
 
A

ARUMPLE

#3
Reference - 4.3 Config. management.
When you receive the guide ISO 10007, you will find the "key elements", to document within your QMS manual. I don't remember exactly how many, but you should see them in several areas.

Best regards
 
R

Raptorwild

#4
Re: Configuration Management

Hello All!

Would anyone out there like to share how they meet the requirement for clause 4.3 Configuration Management?

I ask this because our QM has a section stating the following below, and would like some feedback on wether you all feel it is adequate.

4.3 Configuration Management
Maricopa Controls Inc. has established, documented and maintains a Configuration Management process to ensure that our products continue to function safely and reliably when individual components are changed.
This is achieved through the use of a Product Matrix, located on the Server and in the Blue Books listed by Part Number.

We have no seperate process for CM at this time, our CM is broken down by part number.

Thanks Paula :)
 
Q

QualityPhD

#5
CM and 10007

When looking at configuration management the standard defines configuration as the functional and physical characterisitcs of a product as defined in technical documents and is achieved on the product.

Looking at the configuration of the product first identify the configuration item, whether it is a part or an assembly. From that point, usually an engineering drawing, look to how the organization documents and justifies changes to the product, evaluates the risk of the change, shows evidence that the change of the configuration has been approved (usu. and ECN) and that the change has been implemented (changed production orders) or a process deviation or waiver has been received.

Structure of CM is normally acheived in the project design phase and includes all the functional or performance characteristics of the product that are to be maintained throughout the life cycle of the product.

Configuration identification should include such things as a listing of the technical specifications used, the numbering system that will identify the specification, drawing or any changes, how serial numbers or other traceability will be addresses and the proper procedure or tech. specs required for release of the product.

Hope this is of some assistance to you.

Ann Morgan
 
R

Raptorwild

#6
QualityPhD said:
When looking at configuration management the standard defines configuration as the functional and physical characterisitcs of a product as defined in technical documents and is achieved on the product.

Looking at the configuration of the product first identify the configuration item, whether it is a part or an assembly. From that point, usually an engineering drawing, look to how the organization documents and justifies changes to the product, evaluates the risk of the change, shows evidence that the change of the configuration has been approved (usu. and ECN) and that the change has been implemented (changed production orders) or a process deviation or waiver has been received.

Structure of CM is normally acheived in the project design phase and includes all the functional or performance characteristics of the product that are to be maintained throughout the life cycle of the product.

Configuration identification should include such things as a listing of the technical specifications used, the numbering system that will identify the specification, drawing or any changes, how serial numbers or other traceability will be addresses and the proper procedure or tech. specs required for release of the product.

Hope this is of some assistance to you.

Ann Morgan
:thanx: Ann,
This is right on with what I was thinking and is verifiable during an audit and also during everyday operations. Great Response! :bigwave: Paula
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#7
Raptorwild said:
...Would anyone out there like to share how they meet the requirement for clause 4.3 Configuration Management?...
This is something I've been wondering about for us. We manufacture products in accordance with someone else's configuration management plan - we're not design responsible. So I think our procedures need to address cmp's as they pertain to us - like change control/contract review and document control, etc. In the same manner that we control and use technical orders and repair manuals given to us by some of our customers (customer specific requirements).

I'm also not sure about configuration audits - who does them? The design responsible function who created the CMP? Or is it our final product inspection? 10007 says "A CA may be required for the formal acceptance of a configuration item."

What do you guys think?
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
I got this in my personal e-mail so I guess someone pushed the wrong button:

The organization shall establish, document and maintain a configuration "management process", "appropriate to the product":.
****
Sounds a little confusing, almost describes why we need a change process.

I do not see the whole, so its inadequate. looking for something in other processes. What's the QMS scope, and its exclusions, if any?

Phillip
 
N

nodakbil

#9
I am also waiting on my copy of ISO 10007 for clarification on configuration management. I am curious if this affects products which are altered per OEM (bulletins), FAA (AD's), and/or customer requirements (PMA manufacturing)?
As an aerospace rework facility we continually update products per customer request and FAA mandate. This usually is accompanied by a part number and/or change letter/number change. We also provide a number of FAA/DER internal repairs. Would this procedure only include those internal processes, or will it need to include the additional requirements?
 

howste

Thaumaturge
Super Moderator
#10
It should include whatever processes you use to control the configuration of product. This would apply to both internal and external requirements. Here are a few quotes from ISO 10007 that may be helpful:
5.1
The configuration management process should focus on customer requirements for the product and should take into account the context in which it will be performed.
5.4.1
After the initial release of product configuration information, all changes should be controlled. The potential impact of a change, customer requirements and the configuration baseline will affect the degree of control needed to process a proposed change or concession.
A.3
The configuration management plan should detail the configuration management policies that have been agreed with the customer or suppliers.
 
Thread starter Similar threads Forum Replies Date
K Example of ISO 10007 - Configuration Management Plan AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
B Configuration Management and ISO 10007 (again) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
L Configuration Management, Need to review ISO 10007, anybody have one? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S ISO 10007 Standard for Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 0
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
C ISO 639-1 Languages Other Medical Device Related Standards 0
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 17021-1:2015 toolkit General Auditing Discussions 2
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 3
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom