Documents required to display/keep during ISO 9000 Audit in EPCC firm

K

katchani

#1
Dear All,

I am working in an Oil&Gas EPCC (Engineering,Procurement,construction& Commissioning)firm. Could you please give me the list of documents required to display/keep in our office during ISO 9000 Audit.
 
Elsmar Forum Sponsor
S

samsung

#2
Re: Documents required to display/keep during ISO 9000 Audit in EPC firm

Dear All,

I am working in an Oil&Gas EPCC (Engineering,Procurement,construction& Commissioning)firm. Could you please give me the list of documents required to display/keep in our office during ISO 9000 Audit.
As a minimum, you would require QMS Policy, Objectives, Manual, atleast 6 of the mandatory procedures (Doc control, record control, Internal Audit, Control on NC product, CA & PA) and mandatory records (list posted by Howste).

In addition there are various threads available in this forum. Use the 'search' button to look for those resources.

Thanks.
 

harry

Super Moderator
#3
Re: Documents required to display/keep during ISO 9000 Audit in EPC firm

Dear All,

I am working in an Oil&Gas EPCC (Engineering,Procurement,construction& Commissioning)firm. Could you please give me the list of documents required to display/keep in our office during ISO 9000 Audit.
Not being picky but ISO 9000 as a family refers to the whole set of 3 documents viz: ISO 9000, 9001 & 9004 and on its own refers to a standard - Quality management systems - Fundamentals and vocabulary. Of which the only certifiable (and hence the related audit) standard is ISO 9001.

You talk about an audit - which means your QMS documentation should be completed and ready. Hence, the list of documents required to 'display/keep in your office' during the audit (apart from your QMS documents) are all those related to and referenced or specified in your system.
 
S

samsung

#4
Re: Documents required to display/keep during ISO 9000 Audit in EPC firm

Additionally, you may also have a look at the following guidance from ISO 9000:2005

2.7 Documentation
2.7.1 Value of documentation

Documentation enables communication of intent and consistency of action. Its use contributes to

a) achievement of conformity to customer requirements and quality improvement,

b) provision of appropriate training,

c) repeatability and traceability,

d) provision of objective evidence, and

e) evaluation of the effectiveness and continuing suitability of the quality management system.

Generation of documentation should not be an end in itself but should be a value-adding activity.

2.7.2 Types of document used in quality management systems
The following types of document are used in quality management systems:

a) documents that provide consistent information, both internally and externally, about the organization's quality management system; such documents are referred to as quality manuals;

b) documents that describe how the quality management system is applied to a specific product, project or contract; such documents are referred to as quality plans;

c) documents stating requirements; such documents are referred to as specifications;

d) documents stating recommendations or suggestions; such documents are referred to as guidelines;

e) documents that provide information about how to perform activities and processes consistently; such documents can include documented procedures, work instructions and drawings;

f) documents that provide objective evidence of activities performed or results achieved; such documents are referred to as records.
 
K

katchani

#5
Hi Harry,

We are expecting an audit based on ISO 9001 from our client(One of the major oil baron in the world) in our central work shop and site. Unfortunately, even a single paper not available at our workshop and site office pertaining to our project(new project) !!! So my newly joined QA/QC manager(for site activity) told me to prepare a list of documents required for client audit(As per ISO 9001),so that he can arrange it from our head office.I am new to ISO 9001 and have no idea about what are all the documents required to satisfy our client.It will be highly helpful,if you could give some advise on this matter.

Thanks
 
Last edited by a moderator:

harry

Super Moderator
#6
.................. Unfortunately, even a single paper not available at our workshop and site office pertaining to our project(new project) !!! So my newly joined QA/QC manager(for site activity) told me to prepare a list of documents required for client audit(As per ISO 9001),so that he can arrange it from our head office. .....................................
You have to understand that an audit is not a paper show but a process to obtain evidence and evaluating the extent to which your system is performing. It means you need to implement it, let it run and generate the necessary evidence or records for you or your client to make an evaluation.

If its me, I'd rather inform (and apologized) the client that I am not ready than to let them come in and form a negative impression of your organization because you are not ready.
 
K

katchani

#7
Hi Harry,

I asked for the list of documents required.Be precise in your reply. Philosophy never work in these kind of situations.EPCC is massive compared to small scale manufacturing and service industry.It will be highly helpful if you could give a template/list on the same.

Thanks
 
S

samsung

#8
As Harry has rightly pointed out, you haven't so far 'established' a formal management system (set up a system in a place and make it stable there). In order for a system to be audited, first it has to be 'established' and for that matter, it needs to be conceived, designed, constructed, installed & commissioned and finally weaved into the core business activities.
 

harry

Super Moderator
#9
Hi Harry,

I asked for the list of documents required.Be precise in your reply. Philosophy never work in these kind of situations.EPCC is massive compared to small scale manufacturing and service industry.It will be highly helpful if you could give a template/list on the same.

Thanks
I think you are not being rational or reasonable. It is precisely because you are involved with massive projects made complicated due to various reasons like customer/contract requirements, process differences that nobody can tell you exactly what is required but only yourself. As I mentioned in post #2. the details are be in your QMS documents.
 
K

katchani

#10
Hi Samsung,

Our company is doing multi million dollar heavy engineering projects in many part of the world.As you know QMS is not a major issue for us(as you know with out the ISO certificate we cannot bag much contracts from reputed clients) and we have ISO 9001 certification too.Many projects are running many places in our country as well.But in this particular project no document at all.That is why I asked such a query.If you have experience in EPC ,you can imagine the situation.Otherwise leave it as it is.

"Helping hand is better than praying lips"

Thanks
 
Thread starter Similar threads Forum Replies Date
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
C Defining Approvals Required for Design Control Documents ISO 13485:2016 - Medical Device Quality Management Systems 6
Marc IAF Mandatory Documents (MD Series) - Required to be used by certification bodies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
F The depth of the required Design Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Which documents are required for a class I medical device listing US Food and Drug Administration (FDA) 4
S Clarification in organizing required documents for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 6
H Is "Master Documents and Records list" required per ISO 9001 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
drgnrider Informational Required Documents/Records in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 49
x-files Documents required by the quality management system shall be controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Minimum documents required by AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
N What Documents are Required for each ISO 9001 Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Rookie to the ISO 9001:2008 World - Required Procedures and Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M AS9100 Clause 4.2.3 requirements - Documents required by the QMS shall be Controlled AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
T Control of Safety Documents Required? ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R What Documents are required for Application of Brazilian INMETRO IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
W Electronic Distribution of Controlled Documents: Validation required? Qualification and Validation (including 21 CFR Part 11) 5
J ISO 9001:2008 Clause 4.2.3 - What are the required documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
C ISO 3834-2 references ISO 3834-5 for the list of documents required for conformity Other ISO and International Standards and European Regulations 1
M All Internally Generated Documents ? Required to be Controlled or Not All? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
C Control of Documents - Is a unique format required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Required documents for Class III Medical Device in Yemen Other Medical Device Regulations World-Wide 3
M List of documents required for engineering service project (CAD/CAM) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
V What documents are required for Education and Training in AS9100 Internal Auditing 3
A Documents required for ISO 17020 vs. ISO 9001? General Measurement Device and Calibration Topics 10
P Required Documents and Document Control in Human Resources for ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 5
P New product Design & Development for automotive requirements - Documents required Design and Development of Products and Processes 4
T Using References - Required in Quality Documents? Document Control Systems, Procedures, Forms and Templates 2
R Documents required for certification process - AS/EN/JISQ9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E New and revised documents - Acknowledgement of distribution required? Document Control Systems, Procedures, Forms and Templates 3
E Level 3 PPAP with only a few of the required documents? APQP and PPAP 3
O What are typical records of different documents required by ISO9001? Records and Data - Quality, Legal and Other Evidence 2
R TS16949 Grandfather documents - Control Plans - Required or not based upon date FMEA and Control Plans 4
L ISO 14001 4.4.4 d) - What exactly are the documents and records required by ISO 14001 ISO 14001:2015 Specific Discussions 3
Howard Atkins TS 16949 Clause 4.2.1 - Required Documents IATF 16949 - Automotive Quality Systems Standard 15
G Control of External Documents - Which documents are required to be controlled? IATF 16949 - Automotive Quality Systems Standard 10
C How long we're required to keep supplier and our PPAP documents? Supplier Quality Assurance and other Supplier Issues 1
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 5
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 18
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
D DQ documents of new equipment - Function specification Qualification and Validation (including 21 CFR Part 11) 0
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Mandatory documents vs shall "something" but without mandatory documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17

Similar threads

Top Bottom