Management System Manual 31.000.001E NS-EN ISO 9001:2008 Quality Management System

Document name
Management System Manual
Document number
31.000.001E
Scope
NS-EN ISO 9001:2008 Quality Management System
NS-EN ISO 14001:2004 Environmental Management System
C
08.01.2014 Changed in accordance with internal audit
Guro
Ingelin
Rolf
B
26.03.2012 Changed some referance
Christian
Rolf
Torstein
A
13.10.2011 Issued for EPTEC release
Christian
Ulf
Torstein
Author
Review
QA Approved
Rev.
Issue date
Reason for issue
Replacement for:
Additional information (if applicable):
Total number of pages:
12
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TABLE OF CONTENTS
1.
2.
3.
4.
5.
Introduction ................................................................................................................................................ 3
Scope ......................................................................................................................................................... 4
Normative References ............................................................................................................................... 4
Terms and Definitions ................................................................................................................................ 4
Management system ................................................................................................................................. 5
5.1
General Requirements ..................................................................................................................... 5
5.2
Documentation ................................................................................................................................. 6
5.3
Control of Documents ...................................................................................................................... 6
5.4
Control of Records ........................................................................................................................... 6
6. Management responsibility ........................................................................................................................ 6
6.1
Management Commitment ............................................................................................................... 6
6.2
Quality Policy and Customer Focus ................................................................................................. 7
6.3
Environmental Policy and Objectives ............................................................................................... 7
6.4
Quality Objectives and Environmental Targets ................................................................................ 7
6.5
Responsibility, Authority and Communication .................................................................................. 8
6.6
Management Review ....................................................................................................................... 8
7. Resource Management ............................................................................................................................. 8
7.1
Provision of Resources .................................................................................................................... 8
7.2
Human Resources............................................................................................................................ 8
7.3
Infrastructure and Work Environment .............................................................................................. 9
8. Project execution ....................................................................................................................................... 9
8.1
Planning process .............................................................................................................................. 9
8.2
Identification and Follow-up of Environmental Aspects ................................................................... 9
8.3
Operational Control in the EMS ....................................................................................................... 9
8.4
Customer-related Processes ............................................................................................................ 9
8.5
Design and Development: Planning, Input and Output ................................................................. 10
8.6
Engineering and construction ......................................................................................................... 10
8.7
Procurement ................................................................................................................................... 10
8.8
Production and Service Provision .................................................................................................. 10
8.9
Calibration and Control of Tools and Measuring Equipment ......................................................... 10
9. Monitoring, Measurement, Analysis, Improvement ................................................................................. 11
9.1
General ........................................................................................................................................... 11
9.2
Customer Satisfaction .................................................................................................................... 11
9.3
Monitoring and Measurement of Operations with Significant Environmental Aspects .................. 11
9.4
Internal Audit .................................................................................................................................. 11
9.5
Control of Non-Conformities ........................................................................................................... 11
9.6
Analysis of Data ............................................................................................................................. 12
9.7
Corrective Action and Preventive Action ........................................................................................ 12
10.
References ......................................................................................................................................... 12
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1. INTRODUCTION
The EPTEC Group consists of the parent company EPTEC - Energy & Process Technic AS and its daughter
companies EPTEC Energi AS and EPTEC Kuldeteknikk AS.
We are an engineering company with a great many years of experience within energy and process technologies, including rotating equipment, refrigeration and air conditioning. Our main activities have traditionally
been in the general industry - industry related to infrastructure and the process industry. In addition, with
CIAT as a partner we have chosen to expand our marketing strategy to include areas for the marine industry,
and oil and gas.
Our competitive strength consists of high engineer competence, technological skill as well our experience in
handling of complex projects. We are using environmental concepts with low energy consumption, low noise
execution and refrigerants with low global warming potential. Environmental energy systems will be the focus
in future and we are working intensively with modern heat pump technology that can utilize natural energy
sources even with low temperatures.
EPTEC recognizes its responsibility towards quality and environmental requirements. In order to live up to its
promise of high quality and environmentally responsible products EPTEC has appropriately documented and
implemented a Management System following the ISO 9001:2008 QMS Standard as well as the ISO
14001:2004 Standard for Environmental Management Systems.
This Management System Manual is designed to give a comprehensive overview of what specific assurance
and control mechanisms have been implemented. It is not only meant to be an information source to our customers, suppliers and employees but also to relevant authorities and other interested stakeholders of ours.
EPTEC Energi AS can be contacted via below details:
E-mail: eptec@eptec.no
Website: www.eptec.no
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2. SCOPE
The scope of EPTEC’s Management System certificate for ISO 9001:2008 QMS and ISO 14001:2004 Environmental Management System covers project engineering and management, sales, service and installation
of energy and process systems as well as project- and construction management. Above activities are performed for customers in the Oil & Gas industry, building/construction and general industry.
The requirements of ISO 9001:2008 and ISO 14001:2004 are complied with by EPTEC’s management system (certificate number 965, Teknologisk Institutt).
3. NORMATIVE REFERENCES
ISO 9000:2005 makes integral part of this manual and is related to the ISO terminology used.
EU Directive 94/9/EC is complied with, e.g. with regard to minimum storage time of documentation and records generated in connection with EPTEC’s products and services.
“Teknologisk Institutt” in Oslo/Norway is EPTEC’s current certification body for both ISO 9001 and ISO
14001.
4. TERMS AND DEFINITIONS
EMS
EPTEC
HSE
MS
NC
QA
QMS
Environmental Management System
EPTEC Energi AS
Health, Safety and Environment
Management System
Non-conformity
Quality Assurance
Quality Management System
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5. MANAGEMENT SYSTEM
5.1
General Requirements
EPTEC generates product and service value by running three main processes (in grey). Each is related to
and depending on specific client projects. Management as well as procurement processes support the main
processes (in white). Quality and Environment processes (dotted) embrace all of above mentioned processes and are thereby integral part of them. All processes have specific controls imposed on them to secure
compliance with customer, statutory and regulatory requirements.
Process ownership has been assigned to the respective departments. The interfaces between the main processes are managed by defined hand-over routines. Among other, yearly management reviews and internal
audits evaluate process effectiveness and suitability. Output from such review is used to continually improve
those processes and keep the quality system updated in accordance with EPTEC’s and its customers’ as
well as regulatory and statutory requirements.
The scope of EPTEC’s Environmental Management System (EMS) includes all activities that relate to the
relevant legal requirements and that show significant environmental aspects. Environmental aspects shall
hereby always be such ones that can be identified and influenced by EPTEC (ref. 21.000.101 Prosedyre for
identifisering og rangering av miljøaspekter).
Quality and Environment processes
Owned by: Quality Rep.
Management processes
Main process:
Inquiry and Offer
Main process:
Project Management
Main process:
Service and Spare Parts
Supporting process:
Procurement
Figure A: EPTEC’s business processes
The success of company quality policy, and therefore the success of the company, requires on awareness
on the part of every individual, in every department at every level of his own contribution to quality and his
individual responsibility for it.
It is vital that all stakeholders understand that responsibility for quality and environmental aspects is not a
specialized function within our company. Respective responsibility rests with each employee and is ensured
via introduction and re-training.
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Documentation
EPTEC intends to set up and use the manual at hand as a high-level description of its Management System
(MS). It shall act as its “entry door”, provide a quick and comprehensive overview and lead to relevant documentation and established processes. Every main process as well as the supporting processes have their
respective descriptions and rely on dedicated documentation.
EPTEC’s MS includes procedures, checklists and guidelines. Procedures and checklists are must-follow
work instructions, whereas guidelines help keeping a certain process within an allowed frame. Checklists
help ensure that product and services comply with their pre-defined quality specification.
5.3
Control of Documents
The purpose of document and data control is to ensure that all documentation related to the MS is reviewed
and approved by authorized personnel before release. Another purpose is to ensure that only formally released documents are available for use and that obsolete documents are withdrawn from use. However,
their availability for history purpose is secured.
All released documents are available via our online system called “IK-Sentral”. MS-related documents are
easily identifiable, searchable and downloadable. IK-Sentral also secures adequate access rights and controls document editing and releasing authority.
The QA Representative at EPTEC has the overall responsibility for document control. He shall be consulted
when needed with regards to document numbering, layout, distribution, editing and updating of documents.
A respective documented procedure has been established to control this MS process (31.000.100 Dokumentstyring).
5.4
Control of Records
EPTEC has procedures and systems in place to ensure that records are established and maintained to provide evidence of conformity to customer, regulatory and statutory requirements and of the effective functioning of the Management System.
Minimum record storage time is in accordance with EU Directive 94/9/EC (10 years after last day of production of product), unless otherwise stated in contracts /agreements with individual customers. Back-up routines to secure record/document availability and retrieval are in place for EPTEC’s IT systems.
The following, non-extensive list shows an overview of controlled documentation and records:
 Documentation of the quality system
 QA notification, internal and external audit reports and management reviews
 Product documentation
 Construction, design and testing documentation regarding customer projects
 Identification (serial numbers) of products supplied
 Information on delivered products and services: what, who, when, where, etc.
 Service and maintenance documentation
 Documentation showing actions taken towards customers and resp. authorities in case of nonconforming products
 Documentation of corrective & preventive actions taken
6. MANAGEMENT RESPONSIBILITY
6.1
Management Commitment
EPTEC’s management is not only dedicated to satisfying customer requirements towards its products and
services. It also commits to statutory and regulatory requirements on both quality and environmental product
aspects. Specifically regarding potential environmental impact of its products EPTEC is committed to prevent
pollution.
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EPTEC management further commits itself to continuously improving quality, consistency and cost effectiveness of its products and processes. A system for registering and solving detected non-conformances but
also for following up improvement suggestions is in place. The manual at hand shows the importance of
such MS, internally as well as to external stakeholders.
6.2
Quality Policy and Customer Focus
Delivering excellent product and service quality to all its customers worldwide is self-evident to EPTEC. Customer requirements and satisfaction are gathered and measured (31.000.300 Prosedyre for måling av
kundetilfredshet). Policy and customer satisfaction make also part of the periodical management review.
In more detail the EPTEC’s quality policy looks as follows:
 To supply goods and services meeting customers quality requirements
 To ensure that equipment is installed and commissioned satisfactorily
 To deliver effective after-sales service
 To maintain and develop our knowledge of the market in order to provide the best possible service to
customers
 To safeguard and enhance company reputation for quality
We also aim to establish and maintain good relations with partners for manufacture of products and systems
included in our scope of supply. This, taken together with our own design, engineering, commissioning, servicing, and coordinating activities, will ensure the highest possible quality content in deliveries from EPTEC.
6.3
Environmental Policy and Objectives
EPTEC’s policy and objectives to prevent or reduce adverse environmental impact are shaped as follows:
- To focus on and maintain continuous awareness of potential pollution risk in all our activities
- To follow up current and implement new environmental regulation/legislation fast and targeted
- To use processes, practices, techniques and materials to avoid, reduce or control creation and
emission of any type of pollutant or waste
- To specifically establish and maintain procedures for emergency situations where pollution is an immediate threat or where a pollution incident has taken place already
We recognize that successful implementation of above policies demands qualified personnel, the provision
of adequate resources and orderly methods of work.
This manual and its related procedures and other supporting documents are meant to assist us in our work
and will be used
 as a reference for company policies and procedures
 as a basis for evaluating and improving current practices
 to encourage continuity of practice when personnel changes
 to introduce EPTEC’s quality and environmental policies and objectives to new employees
6.4
Quality Objectives and Environmental Targets
Delivery time
Products
Spare parts
Service
- contract
- emergency
Product guarantee cost
Incorrect deliveries
HMS objectives
Goal
95% in time
95% in time
Definition
delivery time +/- 2 days
delivery time +/- 2 days
90% in time
+/- 2 weeks
100% in time
agreed date
Guarantee cost less than 2% of total product sales
Less than 1% of total deliveries
no serious injuries
less than 1 accident / year with medical treatment or sick leave
less than 3% sick leave
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Environmental targets
Customer satisfaction objectives
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Reduce release of greenhouse gasses by minimizing leakages of
traditional refrigerant and by increased use of natural refrigerants
with low global warming potential.
Targets:
- at least 20% equipment with natural refrigerants like Ammonia or
CO2
- report every release of refrigerant
95% satisfied customers acc. to 31.000.300 «Prosedyre for måling
av kundetilfredshet».
Responsibility, Authority and Communication
EPTEC management has delegated responsibility and authority to a dedicated Quality Representative. The
Quality Representative is responsible for
 establishing and maintaining EPTEC’s Management System covering both ISO 9001 and ISO 14001
requirements
 verifying that the requirements of the system are met regarding both quality and environmental aspects
 identifying risks, issues and recommending solutions, together with all other employees
 reporting performance of the MS to EPTEC management
He also takes steps to have requirements, effectiveness and suitability of the Management System communicated internally with respective focus towards and between all hierarchies in the organization.
With regard to the organization’s environmental aspects and their significance EPTEC maintains a transparent communication approach. EPTEC’s website offers information in both English and Norwegian to all interested external parties. Receipt, documentation and response to external inquiries concerning our EMS are
either treated in the project organization or via our management. This depends on the character and source
of the communication.
6.6
Management Review
EPTEC’s management shall review the MS once a year to ensure its continuing suitability, adequacy and
effectiveness (31.000.200 Ledelsens gjennomgang og internrevisjon). Both quality and environmental aspects shall be part of the review. The review shall comply with the resp. requirements in the ISO 9001 and
ISO 14001 standards and take into account as a minimum the input and output requirements as stated in
those standards. Management Review Meetings are always documented and followed up closely.
7. RESOURCE MANAGEMENT
7.1
Provision of Resources
EPTEC depends on the adequate provision of resources to run its business. It therefore continuously evaluates the resource situation (a.o. management meetings and management review) and takes necessary actions when indicated. This includes financial resources which are planned for in yearly budgets.
7.2
Human Resources
EPTEC recognizes the importance of competent, qualified, and trained personnel for the success of the
company's operations. New employees are to be familiarized with the EPTEC organization, its policies, routines and the quality and environmental system. Continuous internal training for new products is provided. As
the need arises employees attend dedicated internal and/or external training courses. (11.000.001 Personalhåndbok).
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Minimum annually, at formal employee talks, current competence level and need for training is discussed,
documented and followed up thereafter.
7.3
Infrastructure and Work Environment
EPTEC continuously determines, provides and maintains the infrastructure needed to achieve conformity to
product and environmental requirements (e.g. work space, utilities, process equipment and supporting services like IT).
EPTEC has further established and implemented “Health, Safety & Environment” (HSE) procedures according to local laws and regulations (21.000.001 HMS-manual for EPTEC Energi AS). A dedicated HSE responsible is in place.
8. PROJECT EXECUTION
8.1
Planning process
Quality objectives and requirements for our products have been clearly determined. Processes serving this
purpose have been put in place, e.g. product and construction/design documentation which is used as
standard in all projects. Necessary records have been determined and are constantly improved. Requirements regarding verification, monitoring, inspection, and testing to ensure desired product quality and acceptance of it have been defined.
8.2
Identification and Follow-up of Environmental Aspects
EPTEC has implemented and maintains procedures to adequately identify significant environmental aspects
of its activities and products. At the same time it is regularly evaluated and determined what effects those
aspects have or can have on the environment (see 61.000.029 Prosedyre for risikovurdering i prosjekt and
31.000.200 Ledelsens gjennomgang og internrevisjon).
Output from such analyzes is further used to establish, implement and maintain emergency preparedness
and response.
8.3
Operational Control in the EMS
With respect to identified environmental aspects and EPTEC’s environmental policy, objectives and targets,
control in day-to-day operations is essential. Respective processes have been identified and are planned for
in written by taking into account above environmental aspects. Where relevant, this is also communicated to
our suppliers and contractors.
8.4
Customer-related Processes
Winning and constantly satisfying our customers, starts with determining their requirements. Client communication processes (clarifications, offers, feedback, complaints, etc.) are cared for in the respective processowning departments (31.000.300 Prosedyre for måling av kundetilfredshet). Further, customer requirements
and contracts go through standard review processes. This ensures that deviations are kept at a minimum,
both before and after contract commitment (ref. 61.000.001 Prosedyre for prosjektgjennomføring). Respective records are kept for each project.
EPTEC further secures adequate knowledge of statutory and regulatory requirements by closely following up
the respective rules, laws and guidelines (31.000.004 Myndighetskrav). This counts for requirements both in
the area of product quality as well as environmental aspects.
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Design and Development: Planning, Input and Output
While EPTEC does not have processes linked to research or development of its products it still performs activities that refer to design and construction of component systems. Such systems are assembled from various third-party components.
Establishing a project organisation ensures appropriate control of interfaces and effective communication.
Further, during progress on the project, suitable information is generated and collected to enable verification
of the product against its initial specification. Such information also includes data required by the procurement and service functions to plan and perform their related activities.
8.6
Engineering and construction
Potential design changes are handled and agreed on via variation order requests (ref. 61.000.001 Prosedyre
for prosjektgjennomføring).
Validation of a finished project is normally done with factory/site acceptance tests. Respective commissioning and test procedures have been established and are to be followed strictly by EPTEC personnel.
8.7
Procurement
The capabilities of our suppliers make an obvious and important contribution to the products and services
supplied by EPTEC. It is therefore essential that we select suppliers who are able to meet specified requirements (42.000.001 Prosedyre for leverandørgodkjennelse). Purchase requirements are determined and
communicated very clearly and unambiguously (41.000.001 Prosedyre for innkjøp og lagerføring).
A yearly approval routine for key suppliers supports EPTEC in securing component quality (checklist in
42.000.001 Prosedyre for leverandørgodkjennelse). Additionally, purchased goods and accompanying documentation undergo incoming inspection and verification activities before storage or use in a client project
(41.000.004 Prosedyre for inngangskontroll, vareinspeksjon og varemottak).
8.8
Production and Service Provision
EPTEC shall provide products and services under controlled conditions. This includes provision of adequate
documentation, including relevant procedures.
Deficiencies in product or service provision should be avoided or detected before delivery. Therefore, procedures and routines are provided for in such a way that planned results are achieved acc. to specification. In
case of non-conformity after delivery, respective measures have been established and implemented
(31.000.002 Prosedyre for avvikshåndtering).
8.9
Calibration and Control of Tools and Measuring Equipment
Appropriate testing and calibration of tools and measurement equipment secure correct product acceptance.
Equipment shall therefore be calibrated in accordance with applicable statutory regulations and company
requirements. Respective measurement uncertainties shall be known and be complying with requirements.
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9. MONITORING, MEASUREMENT, ANALYSIS, IMPROVEMENT
9.1
General
EPTEC is committed to continually improve its product and services quality. Respective processes are in
place to ensure continued conformity with customer, statutory and regulatory requirements. The effectiveness and suitability of the MS is regularly under scrutiny in order to continuously improve it. Management
review and internal audits are examples for this.
9.2
Customer Satisfaction
Project-based customer satisfaction surveys are in use to keep track of our client satisfaction level. Those
surveys reflect EPTEC's performance (31.000.300 Prosedyre for måling av kundetilfredshet). This procedure
lays out how the satisfaction measurement is to be done and how responsibilities are distributed.
Analysis of actual output data from those measurements are done continuously as well as in the annual
management review. The QA Representative together with the project engineers is responsible for initiating,
monitoring and communicating necessary improvements.
9.3
Monitoring and Measurement of Operations with Significant Environmental Aspects
EPTEC monitors and measures the key characteristics of its operations that can have a significant environmental impact. This is in most cases concerning the performance of our products and less our production
operations themselves. Relevant controls are established in the final product testing before delivery.
9.4
Internal Audit
EPTEC performs annual internal audits to determine whether the MS complies with the resp. standards, internal requirements and the planned way of product and service realization. The focus for internal audits is
normally derived from changes in product, MS and/or other areas which had shown critical issues. The evaluation of compliance with applicable legal requirements makes standard part of such audit. (31.000.200
Ledelsens gjennomgang og internrevisjon).
Internal audits can be carried out by EPTEC internal personnel who can act independently and objectively
towards the audited areas. The auditor shall have competence for performing audits. Respective audit reports shall be distributed to EPTEC’s management. The QA Representative takes responsibility for having
non-conformances analyzed and corrective and/or preventive actions proposed.
9.5
Control of Non-Conformities
EPTEC has established a system for detecting, registering and following up non-conformances (NC). Registration and follow-up of both NC’s and improvement proposals is handled in a dedicated online system called
“IK-Sentral”. A respective procedure is in place and describes process flow and responsibilities (31.000.002
Prosedyre for avvikshåndtering).
The QA Representative is responsible for initiating follow-up with internal and external customers as well as
authorities, where necessary.
EPTEC’s NC procedure secures among other that
 all detected non-conformances are reported and documented
 a risk analysis is performed in case the NC is estimated critical
 effective corrective/preventive actions are taken to eliminate the NC and its root cause
 non-conforming products are separated from others if detected before delivery
 corrective action (incl. risk analysis if necessary) is taken for non-conformities detected after delivery
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use, release or acceptance of non-conforming product is only authorized under concession of the
notified body and/or the customer
Improvement proposals are reviewed and put into action where reasonable
Analysis of Data
EPTEC has determined what data needs to be collected and analyzed for the QMS to be evaluated on effectiveness and suitability. Such analysis shall at a minimum cover the following:
 Conformity of product/services/processes to their pre-defined specifications
 Characteristics and trends of processes and products, incl. opportunities for preventive action
 Customer satisfaction
 Supplier quality
It is the QA Representative’s responsibility to periodically perform such analysis of the trends derived from
NC data. Serious negative trends shall be brought up immediately with the responsible personnel and
EPTEC management.
9.7
Corrective Action and Preventive Action
Corrective and preventive actions are handled acc. to a defined (31.000.002 Prosedyre for avvikshåndtering). The purpose of this routine is to ensure that the causes of non-conformances are identified and that reoccurrence of the same non-conformances is avoided (root-cause elimination).
Procedures for corrective actions include:
 Review of non-conformances and cause determination
 Need for preventive action in order to avoid recurrence
 Record-keeping
 Review of effectiveness of the corrective actions taken
Procedures for preventive actions include:
 Determination of potential non-conformances and their causes
 Evaluation of need for action to prevent non-conformity occurrence
 Determination and implementation of action
 Record-keeping
 Review of effectiveness of preventive actions taken
The QA Representative is in charge of maintaining the processes reg. non-conformities, corrective and preventive actions.
10. REFERENCES
11.000.001 Personalhåndbok
21.000.001 HMS-manual for EPTEC Energi AS
21.000.101 Prosedyre for identifisering og rangering av miljøaspekter
31.000.002 Prosedyre for avvikshåndtering
31.000.004 Myndighetskrav
31.000.100 Dokumentstyring
31.000.200 Ledelsens gjennomgang og internrevisjon
31.000.300 Prosedyre for måling av kundetilfredshet
41.000.001 Prosedyre for innkjøp og lagerføring
41.000.004 Prosedyre for inngangskontroll, vareinspeksjon og varemottak
42.000.001 Prosedyre for leverandørgodkjennelse
61.000.001 Prosedyre for prosjektgjennomføring
61.000.029 Prosedyre for risikovurdering i prosjekt
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