Quality Manual: Pylon Electronics Inc
Quality Manual: Pylon Electronics Inc
Quality Manual: Pylon Electronics Inc
QUALITY MANUAL
REVISION 28
© 1995, 2019 Pylon Electronics Inc., 147 Colonnade Road., Ottawa, Ontario K2E 7L9
TABLE OF CONTENTS
LIST OF FIGURES
1.1 Purpose
The purpose of this Quality Manual is to define the quality system for Pylon Electronics
Inc., Pylon Atlantic – A Division of Pylon Electronics Inc., and Pylon Acquisitions Ltd.,
which includes Wescan Calibration and JEM Precision Ltd. hereafter referred to as Pylon
which has offices at the following addresses:
1.2 Scope
This document is applicable to all of Pylon’s calibration and repair services with the
exception of the following exclusion:
1) The Instrumentation Division products and services because this division is not
included in our scope.
This manual and all referenced procedures and work instructions shall be periodically
reviewed and revised, as necessary, to ensure continuing suitability and compliance with the
applicable requirements. All revisions shall be made in accordance with Pylon procedure
D009 - Documentation Control Procedure.
The cognizant Manager(s) are responsible for the review. All new revisions shall receive the
approval of the appropriate management levels.
Any individual may request a change to any part of the Quality Manual, referenced
procedures and work instructions. All requests shall be addressed to the cognizant
Manager(s).
EFFECTIVE
REV DATE REASON FOR RE-ISSUE
1 Sep 1995 First Version
2 Oct 1995 Corrected nonconformances noted during Registrar's review.
3 Jan 1996 Corrected concerns noted during implementation audits.
4 Jan 1997 Revised Organization Chart & responsibilities to match actual
organization.
5 Jan 1997 Revised Paragraph 20 to address KPMG Nonconformance 046-
NC-A1-02.
6 Jan 1998 Revised document to reflect new organizational structure and to
add Mississauga operation.
7 Mar 1998 Revised Paragraph 2.1 to address KPMG Concern 046.2-CN-
DR2-01.
8 Sep 1998 Revised to include ISO/IEC Guide 25 requirements.
9 Jun 1999 Revised to address NRC Level 1 Requirement (Quality Policy)
and NRC Level 2 Requirement (Designates).
10 Sep 1999 Revised to address NRC Level 1 and 2 Requirements found
during the quality system audit.
11 Feb 2001 Revised to remove references to the distribution and avionics
processes and incorporate organizational changes.
12 Oct 2001 Revised to incorporate ISO/IEC 17025 requirements.
13 Jul 2003 Complete re-write to incorporate ISO 9001:2000 requirements.
14 Sep 2003 Revised to address BSI nonconformance on the sequence and
interaction of the quality management processes that was raised
during the ISO 9000:2000 upgrade documentation review. Also
renumbered and moved the figures.
15 Sep 2004 Revised the quality policy to more accurately meet the ISO
9000:2000 requirements.
16 Jun 2005 Deleted D005 references and added ISO 10005:2004 reference.
Updated Mississauga organization chart.
17 Dec 2005 Revised organization to add Pylon Atlantic and show new
organization. Revised the quality policy to redefine the
objectives. Minor updates and corrections to clarify the intent.
18 May 2006 Revised to update ISO/IEC 17025 reference, update
Mississauga & Dartmouth organization charts, address NRC
requirement 1.1 f), and make minor corrections.
19 Aug 2006 Revised to update corporate re-organization due to sale of
Power Group and new Mississauga address. Updated Figure 1.
20 Feb 2007 Revised quality policy to meet the requirements of para 4.2.2 e)
of ISO/IEC 17025:2005.
21 Jan 2009 Revised to update procedure title references, organization charts
and make other minor revisions.
1.5 Approvals
Position Name
Corporate Quality Assurance Manager Lydia Robinson
General Manager - Ottawa Jim Mullins
General Manager - Mississauga Jim Mullins
General Manager - Dartmouth Jarett Grant
Vice-President Jim Mullins
Operations Manager - Edmonton Cathy Schultz
Operations Manager - Calgary Michelle Habkirk
Operations Manager - Richmond Michelle Habkirk
1.6 Responsibility
All departments within Pylon are responsible for ensuring that the procedures described
herein are followed.
The Corporate Quality Assurance Manager is responsible for this document. Any requests
for change shall be addressed to the Corporate Quality Assurance Manager. Incomplete or
ambiguous documentation shall be brought to the attention of the Corporate Quality
Assurance Manager for resolution.
Throughout this document and the various referenced documents, only the position that has
the main responsibility for the task is provided. However, the term “or designate” is implied
in every case. A designate is defined as a person who can perform the tasks because of
education, training, experience and/or background. In the event that a suitable designate is
not available, the matter shall be referred to the next level of management for resolution.
2.1 Impartiality
2.1.1 Pylon’s activities shall be undertaken impartially and structured and managed so as to
safeguard impartiality.
2.1.3 Pylon shall be responsible for the impartiality of its laboratory activities and shall not allow
commercial, financial or other pressure to compromise impartiality.
2.1.4 Pylon shall identify risks to its impartiality on an on-going basis. This shall include those
risks that arise from its activities, or from its relationships, or from the relationship of its
personnel. However, such relationships do not necessarily present Pylon with a risk to
impartiality.
2.1.5 If a risk to impartiality is identified, Pylon shall be able to demonstrate how it eliminates or
minimizes such risk.
2.2.1 Pylon shall be responsible, through legally enforceable commitments, for the management
of all information obtained or created during the performance of Pylon’s activities. Pylon
shall inform the customer in advance of the information it intends to place in the public
domain. Except for information that the customer makes publicly available, or when agreed
between Pylon and the customer (e.g. for the purpose of responding to complaints), all other
information is considered proprietary information and shall be regarded as confidential.
2.2.3 Information about the customer obtained from sources other than the customer (e.g.
complainant, regulators) shall be confidential between the customer and Pylon. The
provider(source) of this information shall be confidential to Pylon and shall not be shared
with the customer, unless agreed by the source.
2.2.4 Personnel, including any committee members, contractors, personnel of external bodies, or
individuals acting on the laboratory’s behalf, shall keep confidential all information obtained
or created during the performance of Pylon’s activities, except where required by law.
3.1 Pylon is a legal entity that is legally responsible for its laboratory activities.
3.2 Pylon shall and has identified management that has overall responsibility for the laboratory.
3.3 Pylon performs two types of calibrations- accredited and non-accredited calibrations.
Accredited calibration shall be performed in accordance with ISO/IEC 17025:2017 and each
laboratory location's capabilities are listed on their respective scopes of accreditation.
3.4 Pylon’s activities shall be carried out in such a way as to meet the requirements of this
document, Pylon’s customers, regulatory authorities and organizations providing
recognition. This shall include Pylon’s activities performed in all its permanent facilities, at
sites away from its permanent facilities, in associated temporary or mobile facilities or at a
customer’s facility.
a) defined the organization and management structure of the laboratory, and the
relationships between management, technical operations and support services.
Top management shall ensure that responsibilities and authorities are defined and
communicated within Pylon. The following provides an overview of the organization,
responsibilities, and authorities.
All top management, Technical Managers and Supervisors, and the 17025 Technical
Authorities are responsible for ensuring compliance with ISO/IEC 17025:2005.
In the event that a key Manager, a key Supervisor or a 17025 Technical Authority is absent,
a qualified deputy may be nominated and identified in advance of the absence in order to
maintain continuity. The identity of the deputy shall be disseminated to the cognizant
managers.
• Direct and control the management system of the Calibration Division at the
highest level. This includes, in addition, the authority to provide, direct and
control the laboratory resources (persons and material) necessary to conduct and
maintain the testing activities on the scope of accreditation and maintaining
Pylon's commitment to quality.
• Approve the addition of new staff or reallocation of existing staff.
• Approve the addition or replacement of the most expensive equipment used by the
lab to conduct testing on the scope by either procuring new funds or authorizing
the reallocation of existing funds.
The Corporate Controller is responsible for all accounting functions within the organization.
Accounting is responsible for all the accounting functions required by Pylon. This includes
accounts receivable, accounts payable, and payroll.
The Corporate Quality Assurance Manager is responsible for the overall direction of Pylon's
quality system. This includes setting policy and providing guidance to the Quality
Assurance Managers.
The General Manager is responsible for the day to day administrative operation of the lab
including the monitoring of the quality status in consultation with the Quality Assurance
Manager.
Under the direction of the Corporate Quality Assurance Manager, the Quality Assurance
Manager is responsible for implementing and enforcing the quality system in the lab.
a) ensuring that processes needed for the quality management system are
established, implemented and maintained,
b) reporting to top management on the performance of the quality management
system and any need for improvement,
c) ensuring the promotion of awareness of customer requirements throughout the
organization,
d) initiating actions to prevent the occurrence of any nonconformity’s relating to the
product, process, and quality system,
e) identifying and recording any problems relating to the product, process, and quality
system,
f) initiating, recommending, or providing solutions through designated channels,
g) verifying the implementation of solutions,
h) controlling further processing, delivery, or installation of nonconforming equipment
until the deficiency or unsatisfactory condition has been corrected, and
i) liaison with external parties on matters relating to the quality management system.
The Logistics Manager is responsible for the Traffic and Material Control in the labs with
these sections.
The Traffic section is responsible for receiving all material including customer equipment
for repair or calibration and parts. The Traffic section is also responsible for packing and
shipping all deliverables including subcontracted equipment. In addition, the Traffic section
is responsible for scheduling customer equipment pick-ups and deliveries in company
vehicles, maintaining control of GFE (Government Furnished Equipment), maintaining
database records, and creating work orders.
The Material Control section is responsible for material purchasing and material control
including inventory management, which ensures that only quality products and services are
procured from qualified suppliers.
Purchasing is the focal point for all suppliers and no commitment shall be made to a supplier
by anyone, except Purchasing.
Purchasing is also responsible for including the quality requirements specified by Quality
Assurance in all purchase orders and contracts negotiated with suppliers. Quality Assurance
will be notified of the need for evaluating suppliers when new or second sources are being
considered.
The Technical Manager is responsible for the day-to-day operations of the respective
calibration labs, to ensure that the outgoing equipment conforms to all quality requirements.
The Technical Manager is also responsible for the calibration and repair processes and for
coordinating with customers concerning any problems or ambiguities with contract work, in
cooperation with the Quality Assurance Manager, the Operations Managers, the General
Managers, and the Vice President.
At location’s where Pylon has Operations Managers, the Operations Manager is responsible
for day-to-day operations of non-technical areas of Pylon’s business such as Material
Control, Traffic, QC, Accounting and depending on the facility can also be responsible for
the sales team.
The Operations Manager is also responsible for coordinating with customers concerning any
problems or ambiguities with contract work, in cooperation with the Quality Assurance
Manager, the Technical Managers, the General Managers, and the Vice President.
3.5.1.1.9 Sales
The sales team consists of Customer Service Representatives and Technical Sales
Representatives.
The Customer Service Representatives are responsible for coordinating all calibration/repair
contracts with commercial customers including coordinating equipment pick-up and
delivery. The Customer Service Representatives are also responsible for coordinating with
commercial customers concerning any problems or ambiguities with contract work, in
cooperation with the Quality Assurance Manager, the General Managers, and the Vice
President.
The Technical Representatives are responsible for all commercial sales contacts. This
includes visiting customers and potential customers to obtain feedback on the services that
are provided or could be provided. They are also responsible for coordinating quotes to
commercial customers with the Customer Service Representatives.
The 17025 Technical Authorities are the Technical Authorities for all 17025 parameters
within their areas of expertise (i.e., electrical or physical properties) for which Pylon
becomes accredited.
The Lab Supervisors are responsible for day-to-day operation of the electrical and physical
calibration labs. The duties include supervising lab technical personnel, performing in-house
and insitu calibrations, monitoring standards and their performance and providing sales
assistance for quoting.
The Lab Supervisors report to the Technical Manager for the day-to-day operation of the lab
including administrative and technical issues.
Each manager is an approved signatory for the area of responsibility. The managers are
responsible for identifying approved signatories within their department, when appropriate
and required.
Figure 9 indicates the sequence and interaction of Pylon's core and support processes.
b) identification of deviations from the management system or from the procedures for
performing laboratory activities;
4.1 General
Pylon shall have available the personnel, facilities, equipment, systems and support services
necessary to manage and perform its laboratory activities.
4.2 Personnel
4.2.1 All personnel of the laboratory, either internal or external, that could influence the
laboratory activities shall and will act impartially, be competent and work in accordance
with Pylon’s management system.
4.2.2 Pylon shall and has documented the competence requirements for each function influencing
the results of Pylon’s activities, including requirements for education, qualification, training,
technical knowledge, skills and experience.
4.2.3 Pylon shall ensure that personnel have the competence to perform laboratory
activities for which they are responsible and to evaluate the significance of deviations.
4.2.4 The management of Pylon shall communicate to personnel their duties, responsibilities,
and authorities.
b) selection of personnel;
c) training of personnel;
d) supervision of personnel;
e) authorization of personnel;
4.2.6 Pylon shall authorize personnel to perform specific laboratory activities, including, but
not limited to, the following:
4.3.1 The facilities and environmental conditions shall be suitable for Pylon’s activities and
shall not adversely affect the validity of results.
4.3.2 The requirements for facilities and environmental conditions necessary for the
performance of Pylon’s activities shall be documented.
4.3.3 Pylon shall monitor, control and record environmental conditions in accordance with
relevant specifications, methods or procedures or where they influence the validity of the
results.
4.3.4 Measures to control facilities shall be implemented, monitored, and periodically reviewed
and shall include, but not be limited to:
4.4 Equipment
4.4.1 Pylon shall have access to equipment including, but not limited to, measuring
instruments, software, measurement standards, reference materials, reference data,
reagents, consumables or auxiliary apparatus which are required for the correct
performance of Pylon’s activities and which can influence the result.
4.4.2 When Pylon uses equipment outside its permanent control, it shall ensure that the
requirements for equipment of this document are met.
4.4.3 Pylon shall have a procedure for handling, transport, storage, use and planned
maintenance of equipment to ensure proper functions and to prevent contamination or
deterioration.
4.4.4 Pylon shall verify that equipment conforms with specified requirements before being
placed or returned into service.
4.4.5 The equipment used for measurement shall be capable of achieving the measurement of
accuracy and/or measurement uncertainty required to provide a valid result.
4.4.7 Pylon shall establish a calibration programme, which shall be reviewed and adjusted as
necessary in order to maintain confidence in the status of calibration.
4.4.8 All equipment requiring calibration or which has a defined period of validity shall be
labelled, coded or otherwise identified to allow the user of the equipment to readily
identify the status of calibration or period of validity.
4.4.9 Equipment that has been subjected to overloading or mishandling, gives questionable
results, or has been shown to be defective or outside specified requirements, shall be
taken out of service. It shall be isolated to prevent its use or clearly labelled or marked as
being out of service until it has been verified to perform correctly. Pylon shall
examine the effect of the defect or deviation from specified requirements and shall
initiate management of nonconforming work procedure.
4.4.11 When calibration and reference material data include reference values or correction
factors, Pylon shall ensure that reference values and correction factors are updated and
implemented, as appropriate, to meet specified requirements.
4.4.12 Pylon shall take practicable measures to prevent unintended adjustments of equipment
from invalidating results.
4.4.13 Records shall be retained for equipment which can influence Pylon’s activities. The
records shall include the following, where applicable:
b) the manufacturer’s name, type identification, and serial number or other unique
identification;
e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due
date of the next calibration or the calibration interval;
g) the maintenance plan and maintenance carried out to date, where relevant to the
performance of the equipment;
h) details of any damage, malfunction, modification to, or repair of, the equipment.
4.5.1 Pylon shall establish and maintain metrological traceability of its measurement results by
means of a documented unbroken chain of calibrations, each contributing to the
measurement uncertainty, linking them to an appropriate reference.
4.5.2 Pylon shall ensure that measurement results are traceable to the International System of
Units(SI) through:
4.5.3 When metrological traceability to the SI units is not technically possible, Pylon shall
demonstrate metrological traceability to an appropriate reference, e.g.:
4.6.1 Pylon shall ensure that only suitable externally provided products and services that affect
laboratory activities are used, when such products and services:
b) are provided, in part or in full, directly to the customer by Pylon, as received from the
external provider;
b) defining the criteria for evaluation, selection, monitoring of performance and re-
evaluation of the external providers;
d) taking any actions arising from evaluations, monitoring of performance and re-
evaluations of the external providers.
d) activities that Pylon, or its customers, intends to perform at the new external provider’s
premises
5.1.1 Pylon shall have a procedure for the review of requests, tenders and contracts. The
procedure shall ensure that:
c) where external providers are used, the requirements of 4.6 are applied and Pylon advises
the customer of the specific laboratory activities to be performed by the external provider
and gains the customer’s approval;
d) the appropriate methods or procedures are selected and are capable of meeting the
customers’ requirements.
5.1.2 Pylon shall inform the customer when the method requested by the customer is considered
to be inappropriate or out of date.
5.1.3 When the customer requests a statement of conformity to a specification or standard for the
test or calibration (e.g. pass/fail, in-tolerance/out-of-tolerance), the specification or standard
and the decision rule shall be clearly defined. Unless inherent in the requested specification
or standard, the decision rule shall be communicated to, and agreed with, the customer.
5.1.4 Any differences between the request or tender and the contract shall be resolved before
laboratory activities commence. Each contract shall be acceptable both to Pylon and the
customer. Deviations requested by the customer shall not impact the integrity of Pylon or
the validity of results.
5.1.5 The customer shall be informed of any deviation from the contract.
5.1.6 If a contract is amended after work has commenced, the contract review shall be repeated
and any amendments shall be communicated to all affected personnel.
5.1.7 Pylon shall cooperate with customers or their representatives in clarifying the customer’s
request and in monitoring Pylon’s performance in relation to the work performed.
5.2.1.1 Pylon shall use appropriate methods and procedures for all laboratory activities and, where,
appropriate, for evaluation of the measurement uncertainty as well as statistical techniques
for analysis of data.
5.2.1.2 All methods, procedures and supporting documentation, such as instructions, standards,
manuals and reference data relevant to Pylon’s activities, shall be kept up to date and shall
be made readily available to personnel.
5.2.1.3 Pylon shall ensure that it uses the latest valid version of a method unless it is not appropriate
or possible to do so. When necessary, the application of the method shall be supplemented
with additional details to ensure consistent application.
5.2.1.4 When the customer does not specify the method to be used, Pylon shall select an appropriate
method and inform the customer of the method chosen. Methods published either in
international, regional or national standards, or by reputable technical organizations, or in
relevant scientific texts or journals, or as specified by the manufacturer of the equipment are
recommended. Laboratory-developed or modified methods can also be used.
5.2.1.5 Pylon shall verify that it can properly perform methods before introducing them by ensuring
that it can achieve the required performance. Records of the verification shall be retained.
If the method is revised by the issuing body, verification shall be repeated to the extent
necessary.
5.2.1.6 When method development is required, this shall be a planned activity and shall be assigned
to competent personnel equipped with adequate resources. As method development
proceeds, periodic review shall be carries out to confirm that the needs of the customer are
still being fulfilled. Any modifications to the development plan shall be approved and
authorized.
5.2.1.7 Deviations from methods for all Pylon activities shall only occur if the deviation has been
documented, technically justified, authorized, and accepted by the customer.
5.2.2.1 Pylon shall validate non-standard methods, laboratory-developed methods and standard
methods used outside their intended scope of otherwise modified. The validation shall be as
extensive as is necessary to meet the needs of the given application or field of application.
5.2.2.3 The performance characteristics of validated methods as assessed for the intended use, shall
be relevant to the customer’s needs and consistent with specified requirements.
d) results obtained;
e) a statement on the validity of the method, detailing its fitness for the intended use.
5.3 Sampling
5.4.1 Pylon shall have a procedure for the transportation, receipt, handling, protection, storage,
retention, and disposal or return of test or calibration items, including all provisions
necessary to protect the integrity of the test or calibration item, and to protect the interests of
the Pylon and the customer. Precautions shall be taken to avoid deterioration,
contamination, loss or damage to the item during the handling, transporting, storing/waiting,
and preparation for testing or calibration. Handling instructions provided with item shall be
followed.
5.4.2 Pylon shall have a system for the unambiguous identification of test or calibration items.
The identification shall be retained while the item is under the responsibility of Pylon. The
system shall ensure that items will not be confused physically or when referred to in records
or other documents. The system shall, if appropriate, accommodate a sub-division of an
item or groups of items and the transfer of items.
5.4.3 Upon receipt of the test or calibration item, deviations from specified conditions shall be
recorded. When there is doubt about the suitability of an item for test or calibration, or
when an item does not conform to the description provided, Pylon shall consult the customer
for further instructions before proceeding and shall record the results of this consultation.
When the customer requires the item to be tested or calibrated acknowledging a deviation
from specified conditions, Pylon shall include a disclaimer in the report indicating which
results may be affected by the deviation.
5.5.1 Pylon shall ensure that technical records for each laboratory activity contain the results,
report and sufficient information to facilitate, if possible, identification of factors affecting
the measurement results and its associated measurement uncertainty and enable the
repetition of the laboratory activity under conditions as close as possible to the original. The
technical records shall include the date and identity of personnel responsible for each
laboratory activity and for checking data and results. Original observations, data and
calculations shall be recorded at the time they are made and shall be identifiable with the
specific task.
5.5.2 Pylon shall ensure that amendments to technical records can be tracked to previous versions
or to original observations. Both the original and amended data and files shall be kept,
including the date of alteration, an indication of the altered aspects and the personnel
responsible for the alterations.
5.6.1 Pylon shall identify the contributions to measurement uncertainty. When evaluating
measurement uncertainty all contributions which are of significance, including those arising
from sampling, shall be taken into account using appropriate methods of analysis.
5.6.2 When Pylon is performing calibrations, including on its own equipment, it shall evaluate the
measurement uncertainty for all calibrations.
5.6.3 If Pylon is performing testing, it shall evaluate measurement uncertainty. Where the test
method precludes rigorous evaluation of measurement uncertainty, an estimation shall be
made based on an understanding of the theoretical principles or practical experience of the
performance of the method.
5.7.1 Pylon shall have a procedure for monitoring the validity of results. The resulting data shall
be recorded in such a way that trends are detectable and, where practicable, statistical
techniques shall be applied to review the results. The monitoring shall be planned and
reviewed and shall include, where appropriate, but not be limited to:
b) use of alternative instrumentation that has been calibrated to provide traceable results;
j) intralaboratory comparisons;
5.7.2 Pylon shall monitor its performance by comparison with results of other laboratories, where
available and appropriate. This monitoring shall be planned and reviewed and shall include,
but not be limited to, either or both of the following:
5.7.3 Data from monitoring activities shall be analysed and used to control and, if applicable,
improve Pylon’s activities. If the results of the analysis of data from monitoring activities
are found to be outside pre-defined criteria, appropriate action shall be taken to prevent
incorrect results from being reported.
5.8.1 General
5.8.1.2 The results shall be provided accurately, clearly, unambiguously and objectively, usually in
a report (e.g. test report or a calibration certificate or report of sampling) and shall include
all the information agreed with the customer and necessary for the interpretation of the
results and all information required by the method used. All issued reports shall be retained
as technical records.
5.8.1.3 When agreed with the customer, the results may be reported in a simplified way. Any
information listed in 5.8.2 to 5.8.7 that is not reported to the customer shall be readily
available.
5.8.2.1 Each report shall include at least the following information, unless Pylon has valid reasons
for not doing so, thereby minimizing any possibility or misunderstanding or misuse:
d) unique identification that all its components are recognized as a portion of a complete
report and a clear identification of the end;
g) a description, unambiguous identification, and, when necessary, the condition of the item;
h) the date of receipt of the test or calibration item(s), or the date of sampling, where this is
critical to the validity and application of the results;
k) a statement to the effect that the results relate only to the items tested or calibrated;
5.8.2.2 Pylon shall be responsible for all the information provided in the report, except when the
information is provided by the customer. Data provided by a customer shall be clearly
identified. In addition, a disclaimer shall be put on the report when the information is
supplied by the customer and can affect the validity of results.
5.8.4.1 In addition to the requirements listed in 5.8.2, calibration certificates shall include the
following:
a) the measurement uncertainty of the measurement result presented in the same unit as
that of the measurand or in a term relative to the measurand (e.g. percent);
b) the conditions (e.g. environmental) under which the calibrations were made that have
an influence on the measurement results;
5.8.4.2 A calibration certificate or calibration label shall not contain any recommendation on the
calibration interval except where this has been agreed with the customer.
5.8.6.2 Pylon shall report on the statement of conformity, such that the statement clearly
identifies:
5.8.7.1 When opinions and interpretations are expressed, Pylon shall ensure that only personnel
authorized for the expression of opinions and interpretations release the respective
statement. Pylon shall document the basis upon which the opinions and interpretations
have been made.
5.8.7.2 The opinions and interpretations expressed in reports shall be based on the results
obtained from the tested or calibrated item and shall be clearly identified as such.
5.8.7.3 When opinions and interpretations are directly communicated by dialogue with the
customer, a record of the dialogue shall be retained.
5.8.8.1 When an issued report needs to be changed, amended or re-issued any change of
information shall be clearly identified and, when appropriate, the reason for the change
included in the report.
5.8.8.2 Amendments to a report after issue shall be made only in the form of a further
document, or data transfer, which includes the statement “Amendment to Report, serial
number…[or as otherwise identified]”, or an equivalent form of wording.
5.8.8.3 When it is necessary to issue a complete new report, this shall be uniquely identified and
shall contain a reference to the original that it replaces.
5.9 Complaints
5.9.1 Pylon shall have a documented process to receive, evaluate and make decisions on
complaints.
5.9.2 A description of the handling process for complaints shall be available to any
interested party on request. Upon receipt of a complaint, Pylon shall confirm whether the
complaint relates to laboratory activities that it is responsible for and, if so, shall deal
with it. Pylon shall be responsible for all decisions at all levels of the handling process
for complaints.
5.9.3 The process for handling complaints shall include at least the following elements and
methods:
a) description of the process for receiving, validating, investigating the complaint, and
deciding what actions are to be taken in response to it;
5.9.4 The laboratory receiving the complaint shall be responsible for gathering and verifying
all necessary information to validate the complaint.
5.9.5 Whenever possible, Pylon shall acknowledge receipt of the complaint, and provide the
complainant with progress reports and the outcome.
5.9.6 The outcomes to be communicated to the complainant shall be made by, or reviewed and
approved by, individual(s) not involved in the original laboratory activities in questions.
5.9.7 Whenever possible, Pylon shall give formal notice of the end of the complaint handling
to the complainant.
5.10.1 Pylon shall have a procedure that shall be implemented when any aspect of its laboratory
activities or results of this work do not conform to its own procedures or the agreed
requirements of the customer (e.g. equipment or environmental conditions are out of
specified limits, results of monitoring fails to meet specified criteria). The procedure
shall ensure that:
a) the responsibilities and authorities for the management of nonconforming work are
defined;
5.10.2 Pylon shall retain records of nonconforming work and actions as specified in 5.10.1, b) to
f).
5.10.3 Where the evaluation indicated that the nonconforming work could recur, or that there is
doubt about the conformity laboratory’s operations with its own management system,
Pylon shall implement corrective action.
5.11.1 Pylon shall have access to the data and information needed to perform laboratory
activities.
5.11.2 Pylon’s laboratory information management system(s) used for the collection,
processing, recording, reporting, storage or retrieval of data shall be validated for
functionality, including the proper functioning of interfaces within the laboratory
information management systems(s) by Pylon before introduction. Whenever there are
any changes, including laboratory software configuration or modification to commercial
off-the-shelf software, they shall be authorized, documented, and validated before
implementation.
d) be maintained in a manner that ensures the integrity of the data and information;
e) include recording system failures and the appropriate immediate and corrective
actions.
5.11.4 When a laboratory information management system is managed and maintained off-site
or through an external provider, Pylon shall ensure that the provider or operator of the
system complies with all applicable requirements of this document.
5.11.5 Pylon shall ensure that instructions, manuals and reference data relevant to the laboratory
information management system(s) are made readily available to personnel.
5.11.6 Calculations and data transfers shall be checked in an appropriate and systematic manner.
6.1 Options
6.1.1 General
6.1.2 Option A
-control or records
-improvement
-corrective action
-internal audits
-management review
6.1.3 Option B
6.2.1 Pylon’s management shall and has established, documented and maintained policies and
objectives for the fulfilment of the purposes of this quality manual and shall ensure that
policies and objectives are acknowledged and implemented at all levels of Pylon’s
organization.
6.2.2 The policies and objectives shall and do address, amongst other things, the competence,
impartiality and consistent operation of Pylon’s laboratories.
6.2.3 Pylon’s management shall provide evidence of commitment to the development and
implementation of the management system and to continually improving its
effectiveness.
6.2.4 All documentation, processes, systems, and records related to the fulfilment of the
requirements of this document shall be included in, referenced from, or linked to the
management system.
6.2.5 All personnel involved in Pylon’s activities shall have access to the parts of the
management system documentation and related information that are applicable to their
responsibilities.
6.3.1 Pylon shall control the documents (internal and external) that relate to the fulfilment of
this document.
6.4.1 Pylon shall establish and retain legible records to demonstrate fulfillment of the
requirements in this document.
6.4.2 Pylon shall implement the controls needed for the identification, storage, protection,
back-up, archive, retrieval, retention time, and disposal of its records. Pylon shall retain
records for a period consistent with its contractual and legal obligations. Access to these
records shall be consistent with the confidentiality commitments and records shall be
readily available.
6.5.1 Pylon shall consider the risk and opportunities associated with Pylon’s activities in order
to:
a) give assurance the management system can achieve its intended results;
d) achieve improvement.
b) how to:
6.5.3 Actions taken to address risks and opportunities shall be proportional to the potential
impact on the validity of laboratory results.
6.6.1 Pylon shall identify and select opportunities for improvement and implement any actions.
6.6.2 Pylon shall seek feedback, both positive and negative, from its customers. The feedback
shall be analysed and used to improve the management system, laboratory activities, and
customer service.
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order
that is does not recur or occur elsewhere, by:
6.7.2 Corrective actions shall be appropriate to the effects of the nonconformities encountered.
6.8.1 Pylon shall conduct internal audits at planned intervals to provide information on whether
the management system:
a) conforms to:
- Pylon’s own requirements for its managements system, including the laboratory
activities;
a) plan, establish, implement and maintain an audit programme including the frequency,
methods, responsibilities, planning requirements and reporting, which shall take into
consideration the importance of the laboratory activities concerned, changes affecting the
laboratory, and the results of previous audits;
c) ensure that the results of the audits are reported to the relevant management;
e) retain records as evidence of the implementation of the audit programme and the audit
results.
6.9.1 Pylon management shall review its management system at planned intervals, in order to
ensure its continuing suitability, adequacy and effectiveness, including the stated policies
and objectives relate to the fulfilment of this document.
6.9.2 The inputs to management review shall be recorded and shall include information related
to the following:
a) changes in internal and external issues that are relevant to the laboratory;
b) fulfilment of objectives;
f) corrective actions;
h) changes in the volume and type of the work or in the range of laboratory activities;
j) complaints
l) adequacy of resources;
6.9.3 The outputs from the management review shall record all decisions and actions related to
at least: