Integrated Quality System Manual for ISO 9001 - ISO 17025

L

Libnani

#1
Hello

I had been asked by one of our clients about the following issue :

He is manufacturer of electrical equipments certified ISO 9001 and the same time he prepares his laboratory (used usually for testing of the final product) to be accredited according to ISO 17025 .

He asks if he could issue one quality manual by modifying the existing quality manual ISO 9001 to include the ISO 17025 requirements ?

and if the external audit could be done by the same organism which gives him the certification ISO 9001 and the accreditation ISO 17025 (to lower his cost)

thank you for your help because i couldn't answer him .
 
Elsmar Forum Sponsor
M

Mr Niceguy

#3
You could have one manual. If the Quality Manager was the same person for 9001 and 17025 perhaps that's the way it would go. My experience however is different. I manage the 17025 accreditation within a larger 9001 certified organisation managed by someone else. The manuals are substantially separate but I refer quite a lot to the 9001 manual. For example I don't have a separate complaints procedure and our audit teams are linked. My 17025 manual is quite specific in a narrow field and mirrors the standard to a large extent because that's the way the accreditation body wanted it. Our 9001 manual does not mirror the standard. It's structured in the way which suits the diversity of our business and the certification body is happy with it. Therefore it would not be easy or desirable for us to merge the two.

As for joint assessment I don't see how it's possible. The AB accredits and the CB certifies (and the AB accredits the CB to certify). To make things easier for the 17025 AB to write a positive finding on 17025:2005 4.2.2 e (continuous improvement) I show them all previous findings of the 9001 CB and our corrective actions.
 
L

Libnani

#4
Dear Marc

in your previous thread you refer to a file named QS-Req.pdf which is " simple example of Larry Gradin's suggested matrix " but i didn't find it in the free files directory !:confused:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
I haven't look back through the discussion thread to see in context what was said. The matrix was only an example of how to take 2 or more standards (and other requirements as applicable) and align them. Its a standard matrix - Nothing new.

The thought is that you can take any two or more standards (and other requirements as applicable) and align them including mapping the requirements to the company's documentation. This can be done with ISO 9001 and ISO 17025 just as it was done in the old matrix with QS-9000, etc.

Now - How you want to structure your quality manual is another topic. The last revision to ISO 9001 changed how many companies write their quality manuals.

None the less, when I did implementations I always set up a cross reference matrix like the one cited and did a gap analysis using it and from it derived the road map for the implementation. Part of this was because many companies already had some, if not most, of the required systems in place which is the reason for colums for company documentation. It was also an 'auditor friendly' document. Even now with the 'no check list method', this type of matrix is excellent for showing where each requirement is met in the company's systems / documentation.

If I was doing a quality manual today, I'd read through QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do? because it has a lot of good discussion on how different companies structure their quality manuals.

The bottom line is you can easily write a quality manual which addresses both ISO 9001 and ISO 17025. See this recent discussion thread: ISO 9001:2000 and ISO 17025 combined Quality Manual needed (see post 3 in the thread).
 
P

politech

#8
I have read the related threads on this topic and my question is: What quality manual contents are absolutely essential to satisfy the 17025 standard?
I am preparing the current company wide 9000/17025 (and other Nadcap rqmts) manual for integration with 14000. It is too large and structured around the old 1994 standard and has much duplication with their tier2. I want to restructure and streamline this manual but I am only just becoming familiar with 17025. Can I satisfy most of the requirements in the Tier 2 documents? From what I have read the quality manual is only required to have:
a) Quality Policy (which includes a list of items from 4.2.2)
b) Reference to Supporting Procedures (4.2.5)
c) Outline the structure of the management system (4.2.5)
d) The roles and responsibilities of technical management/quality manager (4.2.6)

Is this correct?

Thank you.
 
Thread starter Similar threads Forum Replies Date
T Guidance - Setting up an integrated quality & environmental management system Career and Occupation Discussions 12
Marc Integrated Quality, Safety and Environmental System management - The Future? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Integrated Quality Manual ISO 13485:2003 ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 6
E Integrated Standards Quality Manual Structured According to Clauses is better? Quality Manager and Management Related Issues 3
C Integrated Quality EHS&S (ISO 9001:2000 and RC14001) Manual for comment Miscellaneous Environmental Standards and EMS Related Discussions 6
D Integrated ISO 9001 Quality Policy and ISO 14001 Environmental Policy ISO 14001:2015 Specific Discussions 12
A Quality Manual for ISO 9001 integrated with AAALAC (Animal care program) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
A 60601-1 : Integrated Dry ECG Electrodes = 2 Patient connections inside 1 applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A 60601-1-2 : Integrated Dry Electrodes = PATIENT COUPLED PORT? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Management Review (integrated system) Management Review Meetings and related Processes 17
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G IMS (Integrated Management System) 9001, 14001 & 45001- Request Assistance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
U Imagine a technology which is an artificial muscle and is integrated into textiles... Coffee Break and Water Cooler Discussions 1
M Interview question - IMS (Integrated Management Systems) a necessity or an ISO mistake? ISO 14001:2015 Specific Discussions 10
E Scales integrated in medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Efficacy of Q-Das system integrated with PC-DMIS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
A Integrated risk and opportunities evalution template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
T From certified QMS to certified integrated MS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Integration of Information Security in an existent Integrated Management System IEC 27001 - Information Security Management Systems (ISMS) 4
G Integrated ISO EHSQ Multi-Site Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Integrated Phased Processes - AS9100D cl. 8.1 Operational Planning - Clarification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
S Sample document for integrated ISO 20000 & ISO 27001 Other ISO and International Standards and European Regulations 3
W ISO 9001, ISO 14001 and 18001 Integrated Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G What to do and prepare for an Integrated Management Systems Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M IMS - Integrated ISO9001, ISO14001 & OHSAS 18001 Internal Audit Checklist Internal Auditing 3
S ISO 9001, ISO 17020 and ISO 3834 Joint (Integrated) QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S GDPMD integrated with ISO9001 Other Medical Device and Orthopedic Related Topics 3
D IMS (Integrated Management Systems) for 6 standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Integrated 9001, 14001, 18001 Management Review Meeting and Minutes Management Review Meetings and related Processes 10
B FMEA example for Cokemaking Process at a integrated Iron and Steelmaking Plant IATF 16949 - Automotive Quality Systems Standard 3
A Measureables to Monitor an Integrated Management System Capability IATF 16949 - Automotive Quality Systems Standard 3
G Integrated Systems Audit Mandays Duration - IAF Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Standalone Corrective Action Procedure or Integrated Nonconformance and Corrective Action 5
S Critique of an IMS (Integrated Management Systems) Manual Misc. Quality Assurance and Business Systems Related Topics 1
Claes Gefvenberg IMS (Integrated Management System) Audited for a week... Other ISO and International Standards and European Regulations 10
H Integrated Manual for ISO 9001:2008 and API Q1, Eighth Edition. Oil and Gas Industry Standards and Regulations 6
S Can the Integrated Test be linked to Software Requirements? IEC 62304 - Medical Device Software Life Cycle Processes 13
J Site Visit - Implementing an integrated management system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B How the indicator is integrated with other activities in the procedure? Customer Complaints 6
V Internal Audit of Integrated Management System Miscellaneous Environmental Standards and EMS Related Discussions 2
J Integrated Management System - Anyone with experience dealing with ISOQAR? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Open letter to inform our Vendors we are setting up an Integrated (QHSE) System Miscellaneous Environmental Standards and EMS Related Discussions 5
I Integrated Management System - Nonconforming Service/Product Defects ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H ISO 26000 ... THE integrated management system? Various Other Specifications, Standards, and related Requirements 8
A Internal Audit for an Integrated Management System (IMS)? Internal Auditing 17
L Calibration Procedure for an IC (Integrated Circuit) Test Socket Calibration and Metrology Software and Hardware 6
A Evaluating an Integrated Management System - Dissertation Topic ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom