Small Companies and the ISO 9001 Management Representative

B

Bob the QE

#1
I have taken 3 larger organizations through the ISO registration process and one through AS9100 and I am now working with a very small org. (about 11 people) on their ISO project. Since I have worked with larger org's it was never a problem identifying the ISO rep as a top management with the independence needed. However, in this smaller company I am finding it much more difficult to do this as the owner who is the president, engineer manager, sales manager and quality manager realy does not have the personnel to meet the ISO rep requirements. I come from a sister company and am only acting as tghe project coordinator. Has any one worked with such small companies and if so how did you meet the ISO rep requirements.

Thanks inadvance
 
Elsmar Forum Sponsor

Stijloor

Leader
Super Moderator
#2
Re: Small Companies and the ISO Rep

One of my ISO 9001 Clients is a small family business. Five people in all. The VP of Operations is also the Management Representative. All personnel have different roles and responsibilities that are well-defined. It's like a play where all actors play different roles..:)

Stijloor.
 

SteelMaiden

Super Moderator
Trusted Information Resource
#3
Re: Small Companies and the ISO Rep

The only thing that is required is that the rep reports to top management, and that top management has given that person the responsibility and authority to act as management rep. The rep does not have to be a manager, just someone the management listens to and accepts as the person who can give the correct guidance in matters QMS related.

I've usually had another job besides my Mgt. Rep. responsibilities. It was just known that if those responsibilities had to take a priority back seat for MR duties, they would.
 
#5
Re: Small Companies and the ISO Rep

However, in this smaller company I am finding it much more difficult to do this as the owner who is the president, engineer manager, sales manager and quality manager really does not have the personnel to meet the ISO rep requirements. I come from a sister company and am only acting as the project coordinator. Has any one worked with such small companies and if so how did you meet the ISO rep requirements.
What's so burdensome that they can't fulfill this requirement? It's only a job done about 4 times a year for about a day at a time - IF they learn what to do to be effective...:mg:
 

SteelMaiden

Super Moderator
Trusted Information Resource
#6
Re: Small Companies and the ISO Rep

While I wouldn't go so far as to say it is an unimportant job performed 4 times per year..... really, there is very little there that can't be done as added duties to another job, especially if that job has anything to do with customer satisfaction, or a quality function.
 

Le Chiffre

Quite Involved in Discussions
#7
Re: Small Companies and the ISO Rep

It's certainly achievable in a small company. The issue that Bob has hit is that the Quality Manager is also the owner, president, engineering manager, and sales manager. The standard states that the QM has to be appointed by top management and the QM must report to top management which taken literally may cause some auditors to object. Thinking about the purpose of this wording in the standard, makes you realize that:
a) the job function is performed - top management have the responsibility to assign resources, and
b) issues found by the QM must be brought to the attention of top management.

Neither of which cause a problem if the Quality Manager and "top management" are one and the same person.
 

jerry_Malaysia

Quite Involved in Discussions
#8
Re: Small Companies and the ISO Rep

It's certainly achievable in a small company. The issue that Bob has hit is that the Quality Manager is also the owner, president, engineering manager, and sales manager. The standard states that the QM has to be appointed by top management and the QM must report to top management which taken literally may cause some auditors to object. Thinking about the purpose of this wording in the standard, makes you realize that:
a) the job function is performed - top management have the responsibility to assign resources, and
b) issues found by the QM must be brought to the attention of top management.

Neither of which cause a problem if the Quality Manager and "top management" are one and the same person.
But the standard does not specify "Quality Manager shall be the MR". So, the owner can assign a clerk to be the MR and still fulfill all the requirements.;)
 

Stijloor

Leader
Super Moderator
#9
Re: Small Companies and the ISO Rep

But the standard does not specify "Quality Manager shall be the MR". So, the owner can assign a clerk to be the MR and still fulfill all the requirements.;)
Well....

What does the Standard say?

Top management shall appoint a member of the organization's management who, irrespective of other responsibilities, shall have responsibility and authority that includes <snip>
Stijloor.
 

Marc

Fully vaccinated are you?
Leader
#10
But the standard does not specify "Quality Manager shall be the MR". So, the owner can assign a clerk to be the MR and still fulfill all the requirements.;)
The *important* part is that who ever is the Management Representative know and understand ISO 9001 requirements. Someone in the company has to know and understand the standard and how it relates to their company and company systems.

Yes, a clerk could technically be 'assigned' to be management representative, but if the clerk doesn't know and understand the requirements of the standard, who will? How will the clerk know what the responsibilities of a management representative are?
 
Thread starter Similar threads Forum Replies Date
B Case Study - Implementation of ISO 9001:2008 in Small Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Y How can Small Companies afford and meet the needs of ISO 9001 accreditation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
Marc ISO 14001 EMS - Objectives and Targets in Small Service Companies Service Industry Specific Topics 8
Q ISO 9000 and TQM (Total Quality Management) in Small Companies Preventive Action and Continuous Improvement 11
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
E CAPA Management Software Tool Recommendations for Small Companies Quality Assurance and Compliance Software Tools and Solutions 3
D Documentation Control Software for small companies on a Budget Quality Assurance and Compliance Software Tools and Solutions 10
N Nonconforming Material (NCM) Control in very Small Manufacturing Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Do auditors make concessions for smaller companies - AS9100 Small Company Questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L Is Six Sigma Valuable to Small Companies of 50 People or Less? Six Sigma 7
A Is it really useful to implement EN 9100 in small companies (3 people)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Is Six Sigma 'achieveable' for every company? What about SMALL companies? Six Sigma 8
Marc Calibration Issues for Small Companies - Common Sense Calibration General Measurement Device and Calibration Topics 1
N Writing Risk Management procedure for small manufacturing and we don't know where to start. Manufacturing and Related Processes 9
G Suggestions for environmental compliance with small machinists? REACH and RoHS Conversations 1
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
D Calibration of Small Scales General Measurement Device and Calibration Topics 32
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
Proud Liberal Small radius with tight tolerance on a torus General Measurement Device and Calibration Topics 4
shimonv Worthwhileness for a small startups to apply for EUA (Emergency Use Authorization) for COVID-19 US Food and Drug Administration (FDA) 17
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J SPC - Stamping parts - Small batch size Statistical Analysis Tools, Techniques and SPC 6
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 18
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Gauge Study for Small Lots Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
Nicole Desouza ISO / AS Certification - Small business with less than 100 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
R Inventory management for a small startup device company Other Medical Device Related Standards 1
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
E Question on GD&T added to print - Positional callout for the small holes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
Ed Panek Small Medical Device company - Bring production in-house ISO 13485:2016 - Medical Device Quality Management Systems 1
K Small Sample - Lower Limit Probability Statistical Analysis Tools, Techniques and SPC 0
Z Best Practices - small volume medical device tube cutting (0.020" to 0.080" OD)? Manufacturing and Related Processes 3
leftoverture REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
Tagin Measuring supplier quality with small quantities Statistical Analysis Tools, Techniques and SPC 10
apestate Inexpensive Gage Blocks for small aerospace startup shop General Measurement Device and Calibration Topics 1
I DOE: High variance and small effects in Minitab Using Minitab Software 1
E Small one man shop with QMS (shoptech e2) | AS9100 cert help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 46
M AS9100 - Where to start - Small company (10 employees) and I am the Quality Dept. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
B ISO 9001:2015 for a Small Machine Shop need Resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6

Similar threads

Top Bottom