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8.1 Options
8.1.1
General
The laboratory shall establish, document,
implement and maintain
a management system that is capable
of supporting and demonstrating the consistent achievement of the requirements
of this document and assuring the quality of the laboratory results. In
addition to meeting the requirements of Clauses 4 to 7, the laboratory shall implement a management system
in accordance with Option A or Option B.
NOTE See Annex B for more information.
As a minimum, the management system of the laboratory shall address the following:
— management system documentation (see 8.2);
— control
of management system documents (see 8.3);
— control of records (see 8.4);
— actions to address risks and opportunities (see 8.5);
— improvement (see 8.6);
— corrective actions
(see 8.7);
— internal audits (see 8.8);
— management reviews
(see 8.9).
A laboratory that has established and maintains a
management system, in accordance with the requirements of ISO 9001, and that is
capable of supporting and demonstrating the consistent fulfilment of the requirements of Clauses 4 to 7,
also fulfils at least the intent of the management system requirements
specified in 8.2 to 8.9.
8.2 Management system
documentation (Option A)
8.2.1 Laboratory management shall establish, document,
and maintain policies
and objectives for the fulfilment of the purposes of this
document and shall ensure that the policies and objectives are acknowledged and
implemented at all levels of the laboratory organization.
The laboratory documents its operational policies and objectives in
its Quality Manual. Notably, the Quality Policy Statement includes the overall
objectives; these are approved and applied at all organizational levels of the
laboratory; they were reviewed during management audits; and they were issued
by the laboratory management (see 8.2.2).
8.2.2 The
policies and objectives shall address the competence, impartiality and
consistent operation of the laboratory.
The laboratory guarantees the provision of accurate and timely
analytical services that consistently meet or exceed clients' stated or implied
expectations through their daily interactions. The laboratory is committed to
providing clients with the best laboratory testing services to help them meet
their regulatory needs (see Appendix 19: Quality Policy and Objectives).
8.2.3 Laboratory
management shall provide evidence of commitment to the development and
implementation of the management system and to continually improving its
effectiveness.
The laboratory's quality manual outlines the organizational structure
of the documentation used and details the supporting actions, including
technical procedures, to ensure the management system remains up-to-date and
its effectiveness continuously improved. The laboratory's quality management
system consists of three levels of documentation: (1) the quality manual; (2)
protocols, procedures, and forms; and (3) records.
8.2.4 All
documentation, processes, systems, records, related to the fulfilment of the
requirements of this document shall be included in, referenced from, or linked
to the management system.
The Quality Manual includes the following records and documents, each
in a separate section:
- Organizational Structure (Item 5.5)
- Copy of the Laboratory Quality Policy Statement (8.2.2)
- Resources and Management Review (Items 6.2, 6.3.3, 6.6.2, 6.4.13,
8.6.1, and 8.9)
- Job Description (Item 5.5)
- Test Reports (Item 7.8.3)
- List of Authorized Signatures in the Laboratory (Section 5.7)
- Scope of Testing in the Laboratory (Item 1.0)
- Equipment Inventory Records and Calibration Status Indicators (Items
6.4.13)
- List of Reference Standards (Item 6.5)
- Quality Control Plan (Items 6.4.4 and 5.3)
- Preventive Action Records (Item 8.6.1) Customer Complaints File
(Item 7.9)
- Review Schedule and Records (Item 8.8)
- Procurement (Items 6.6.1)
- Training Records (Item 6.6.3)
- List of Main Documents (Item 8.3.2)
- Confidentiality Agreements (Item 4.2)
- Contract Review (Item 7.1)
- Verification of Test Methods (Item 7.2.2.4)
- Laboratory and Authority or Organization Chart (Item 6.5).
8.2.5 All
personnel involved in laboratory activities shall have access to the parts of
the management system documentation and related information that are applicable
to their responsibilities.
The Quality Control Manager establishes and
maintains the laboratory's Quality Management System (QMS) and applies it to
all specified tests and activities conducted within the laboratory. The QMS
manager ensures the quality of results by documenting all policies, protocols,
procedures, forms, and instructions. To guarantee the quality of testing and
calibration processes, the QMS manager sends copies of all QMS documents to the
individuals responsible for the system and holds meetings with them to explain
and discuss them. Furthermore, through the strict application of the laboratory
management system, the QMS manager ensures that all services provided by the
laboratory to the client are performed and delivered in accordance with ISO
17025 requirements and its specific requirements (Quality Control Unit).
8.3 Control of management system
documents (Option A)
8.3.1 The laboratory shall control the documents (internal and external) that relate to the fulfilment of this document.
NOTE
In this context, “documents” can be policy statements, procedures,
specifications, manufacturer’s instructions,
calibration tables, charts,
text books, posters,
notices, memoranda, drawings, plans, etc. These
can be on various media, such as hard copy or digital.
The laboratory uses the general procedure GP17 to manage all quality
management system documentation, both internally generated and from external
sources (see Appendix 18: General Procedures and Forms Guide). Regulations,
standards, other standard documents, tests, drawings, specifications,
instructions, and manuals are examples of externally generated documents.
Documents include, among other things, policy statements, procedures,
specifications, diagrams, references, labels, notices, memos, software,
drawings, and plans, as they contain information or instructions. Documents may
be paper, electronic, photographic, or written. Quality manuals, standard
operating procedures, test methods, forms, and standards are the documents
under control.
8.3.2 The laboratory shall ensure that:
a)
documents are approved for adequacy prior to issue by authorized personnel;
b)
documents are periodically reviewed, and updated as necessary;
c)
changes and the current revision
status of documents
are identified;
d)
relevant versions of applicable documents are available at
points of use and, where necessary, their distribution is controlled;
e)
documents are uniquely
identified;
f)
the unintended use of obsolete
documents is prevented, and suitable identification is applied to them if they are retained for any
purpose.
The laboratory maintains a master list that identifies the current
review status and document distribution within the quality management system,
including the date of document review (see Appendix 20: Master List). Formally,
documents are reviewed as needed to ensure their continued compliance with ISO
17025 and ISO 9001 requirements. The master list displays the current status of
all controlled documents. Each document on the master list must include the
following information:
- Title.
- Rev. No./Date of Last Rev.
- Issue/Last Revised Date.
- Status (Current, Outdated, Unused, or Assigned).
- Distribution List (Version Number).
- All Quality Management System documents are identified by:
- Issue Date and/or Rev. No.
- Page Number.
- Total Number of Pages (e.g., Page 5 of 5).
- Issuing Authority (i.e., Approval Signature).
External documents must be in their most recent version.
Laboratory documents are approved by the Laboratory Manager before
being issued to ensure their adequacy. The GP17 document control procedure
ensures the following:
- Provision of approved copies of appropriate documents at all
locations where operations necessary for the efficient operation of the
laboratory are carried out.
The following are the names of those with the authority to prepare,
review, approve, and issue various documents at different levels:
|
Level |
Description |
Responsible for Preparation |
Responsible for Review |
Responsible for Approval |
|
1 |
Quality System Manual |
|
|
|
|
2 |
Procedures and Forms |
|
|
|
|
3 |
Records |
|
|
|
- Review documents as necessary to ensure their continued relevance
and compliance with applicable requirements.
- Promptly remove invalid or obsolete documents from all issuing or
using points to ensure they are not misused.
- Appropriately mark obsolete documents retained for legal or
knowledge preservation purposes (e.g., stamped "Old" and dated).
A description of the quality system control procedure is found in the
Quality Manual (8.4).
8.4 Control of records (Option
A)
8.4.1 The laboratory shall establish and retain legible
records to demonstrate fulfilment of the requirements in this document.
The laboratory communicates details of document changes to all
relevant parties, highlighting current changes with bold, italics, and an
underlined letter.
If a document is to be reviewed, the Quality Control Manager reviews
it and obtains approval from the appropriate authorities. The laboratory
supervisor reviews any document changes with the appropriate authority and
decides whether to approve or reject the change. The laboratory supervisor is
the source of any document changes.
8.4.2 The
laboratory shall implement the controls needed for the identification, storage,
protection, back-up, archive, retrieval, retention time, and disposal of its records.
The laboratory shall retain records for a period consistent with its
contractual obligations. Access to these records shall be consistent with the
confidentiality commitments, and records shall be readily available.
NOTE Additional requirements regarding technical
records are given in 7.5.
The laboratory periodically updates its documents
as policies and procedures evolve, requiring new or updated documentation. The
nature of the change is clearly defined within the document itself, and
handwritten modifications are not permitted. Changes to documents undergo the
same level of review and approval as the original document. Revised documents
are retained in the records, and the laboratory records the date of the
revision at the end of each document. Protocols, forms, and standard operating
procedures are reviewed as needed. Procedure GP17 is used for any document
changes. Outdated documents are clearly marked as obsolete, their use is
prohibited, and they are retained only for archival purposes in controlled
computer systems. The responsibility for modifying any document(s) rests with
the Quality Control Unit.
8.5 Actions to address risks and opportunities (Option A)
8.5.1 The laboratory shall
consider the risks and opportunities
associated with the laboratory activities in order to:
a)
give assurance that the management system achieves its intended results;
b)
enhance opportunities to achieve the purpose and objectives of the laboratory;
c)
prevent, or reduce, undesired impacts and potential
failures in the laboratory activities;
d)
achieve improvement.
8.5.2 The laboratory shall plan:
a)
actions to address these risks and opportunities;
b)
how to:
—
integrate and implement
these actions into its management system;
—
evaluate the effectiveness of these actions.
NOTE Although this document specifies that
the laboratory plans actions to address risks, there is no requirement for
formal methods for risk management or a documented risk management process.
Laboratories can decide whether or not to develop a more extensive risk
management methodology than is required by this document, e.g. through the
application of other guidance or standards.
8.5.3 Actions taken to address
risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.
NOTE 1 Options to address risks can include
identifying and avoiding threats, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or
consequences, sharing the risk, or retaining risk by informed decision.
NOTE 2 Opportunities can lead to
expanding the scope of the laboratory activities, addressing new customers,
using new technology and other possibilities to address customer needs.
The laboratory implements a risk plan that considers the risks and
opportunities associated with its activities. The risk plan ensures that the
management system achieves its intended outcomes, maximizes opportunities to
fulfill the laboratory's purpose and objectives, prevents or minimizes
undesirable impacts and potential failures in laboratory activities, and
achieves continuous improvement.
8.6.1 The
laboratory shall identify and select opportunities for improvement and
implement any necessary actions.
NOTE
Opportunities for improvement can be identified through the review of the operational procedures, the use of the policies,
overall objectives, audit results, corrective actions, management review,
suggestions from personnel, risk assessment, analysis of data, and proficiency
testing results.
The laboratory continuously improves the effectiveness of its
laboratory management system through the use of the Quality Policy and Quality
Objectives (see Appendix 19: Approved Quality Policy and Quality Objectives),
audit results (Appendix 20: Internal Audit File), data analysis (see Appendix
21), corrective actions (Appendix 22: Corrective Actions), the complaints file
(see Appendix 17), and management review (Appendix 23: Management Review). The
Management Review Manager is responsible for assessing service improvement
opportunities, and the laboratory technical managers are responsible for
implementing improvements after verification, as outlined in Section 7.7 of
this manual. The laboratory utilizes management review processes to evaluate
and improve its quality system, including corrective and preventive actions.
8.6.2 The laboratory 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.
NOTE
Examples of the types of feedback include customer satisfaction surveys, communication records
and review of reports with customers.
Opportunities to improve processes and equipment are identified by
incorporating feedback from customer satisfaction surveys (Appendix 11: Records
Files: Customer Satisfaction Survey Log) and reviewing test reports with
customers. Feedback from these sources is used to improve the quality
management system, testing activities, and customer service. The technical
manager is responsible for obtaining customer feedback using form FT.43.0 and
for maintaining the feedback data in the complaint file (Appendix 17).
8.7 Corrective actions
(Option A)
8.7.1 When a nonconformity occurs,
the laboratory shall:
a)
react to the nonconformity and, as applicable:
— take action to control and correct it;
— address the consequences;
b)
evaluate the need for action
to eliminate the cause(s) of the nonconformity, in order that it does not
recur or occur elsewhere, by:
— reviewing and analysing the nonconformity;
— determining the causes of the nonconformity;
— determining if similar nonconformities exist, or could potentially occur;
c)
implement any action
needed;
d)
review the effectiveness of any corrective action taken;
e)
update risks and opportunities determined
during planning, if necessary;
f)
make changes to the management
system, if necessary.
Corrective actions arise from customer feedback, internal feedback,
and internal and external audits. The general procedure GP19 is used to
implement corrective action for any non-conformity, deviation from policies and
procedures in the quality management system, or technical processes. After the
corrective action(s) are implemented, the laboratory monitors the results to
ensure that the actions taken were effective in addressing the identified
problem. The general procedure form FGP07 is used to examine, analyze, and
document corrective actions and to implement the required changes to
operational procedures. The general procedure form FGP08 is used to document
changes resulting from corrective action. The laboratory identifies any
opportunities for improvement and potential sources of nonconformity (see
Appendix 10: Protocols File: Nonconformity Protocol), either technically or in
conjunction with the quality management system. It then develops action plans
to capitalize on these opportunities for improvement and address potential
sources of nonconformity. The laboratory implements and monitors the
implementation of these plans to capitalize on the improvement opportunities
and minimize the likelihood of nonconformity. The Quality Control Manager is
the employee responsible for identifying nonconformity, taking effective action
to address it, and determining preventative measures to avoid its recurrence.
The general procedure GP19 is used to implement the required improvement
opportunities and to avoid potential sources of nonconformity.
8.7.2 Corrective actions
shall be appropriate to the effects
of the nonconformities encountered.
The quality control manager implements the required improvement
opportunities and prevents potential sources of nonconformity to ensure that
corrective actions are appropriate to the impact of the nonconformities
encountered.
8.7.3 The laboratory shall retain records
as evidence of:
a)
the nature of the nonconformities, cause(s) and any subsequent actions taken;
b)
the results of any corrective
action.
The laboratory maintains a record of non-conformities (see Appendix
11: Record File: Non-Conformity Record), including the reasons and any
subsequent actions taken.
8.8 Internal audits
(Option A)
8.8.1
The laboratory shall conduct
internal audits at planned intervals to provide information on whether the
management system:
a)
conforms to:
—
the laboratory’s own requirements for its management system, including the laboratory activities;
—
the requirements of this document;
b)
is effectively implemented and maintained.
The internal audit program includes periodic
audits conducted according to a schedule (Appendix 19: Internal Audit File).
All elements of the Quality Manual are audited annually, and the laboratory
provides all relevant laboratory records to the staff conducting the internal
audit. The laboratory conducts these audits to verify that laboratory
operations are carried out in accordance with the requirements of this Quality
Manual.
8.8.2
The laboratory shall:
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;
b)
define the audit criteria and scope for each audit;
c)
ensure that the results of the audits are reported
to relevant management;
d)
implement appropriate correction and corrective actions
without undue delay;
e)
retain records as evidence of the implementation of the audit programme and the audit results.
NOTE
ISO 19011 provides guidance for internal audits.
Internal auditing encompasses the quality
management system, processes, procedures, services, reports, corrective
actions, and customer suggestions.
Audits are conducted using a pre-established
checklist to minimize the likelihood of overlooking any details during the
review. The audit process is monitored to ensure that corrective actions are
recorded and that the actions taken are effective. The Quality Control Manager
is responsible for developing and scheduling audits according to management
requirements. They are also responsible for ensuring that audit results are
communicated to the laboratory or relevant department, implementing corrective
actions and appropriate adjustments without undue delay, and maintaining
records as evidence of audit program implementation and audit results. The
laboratory uses the general procedure GP21 and the general procedure forms
FGP09, FGP10, FGP11, and FGP13 to manage the internal audit process.
8.9 Management reviews
(Option A)
8.9.1
The laboratory 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 related to the
fulfilment of this document.
Senior management periodically (at least annually) and according to a
pre-defined schedule, conducts a review of the laboratory's quality management
system and testing and calibration activities to ensure their continued
suitability and effectiveness and to introduce any necessary changes or
improvements using the General Procedure GP16. The review considers the
suitability of policies and procedures; quality reports and technical managers;
the results of recent internal reviews; corrective and preventive actions;
evaluations by external bodies; the results of interlaboratory comparisons or
proficiency tests; changes in the volume and type of work performed; customer
feedback, including complaints and customer satisfaction surveys; improvement
recommendations; and other relevant factors, such as quality control
activities, resources, and staff training. The laboratory's Quality Control
Manager uses the General Procedure GP16 and the General Procedure Form FGP01
for management review.
8.9.2
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;
c)
suitability of policies and procedures;
d)
status of actions from previous management reviews;
e)
outcome of recent internal audits;
f)
corrective actions;
g)
assessments by external
bodies;
h)
changes in the volume and type of the work or in the range of laboratory activities;
i)
customer and personnel
feedback;
j)
complaints;
k)
effectiveness of any implemented improvements;
l)
adequacy of resources;
m)
results of risk identification;
n)
outcomes of the assurance of the validity
of results; and
o)
other relevant factors,
such as monitoring activities and training.
The Laboratory Quality Control Manager uses the
General Procedure GP16 and the General Procedure Form FGP01 for management
audits, which are conducted periodically (at least annually) according to a
predetermined schedule. The audit considers: the adequacy of policies and
procedures; reports from administrative and supervisory personnel; the results
of recent internal audits; corrective and preventive actions; evaluations by
external bodies; the results of interlaboratory comparisons or proficiency
tests; changes in the volume and type of work performed; customer feedback,
including complaints and customer satisfaction surveys; recommendations for
improvement; and any other relevant factors, such as quality control activities,
resources, and staff training. The audit results are used in planning
(objectives, goals, and work plans) for the laboratory in the following year.
8.9.3 The outputs from the management review shall record all decisions and actions related to at least:
a)
the effectiveness of the management system and its processes;
b)
improvement of the laboratory activities related to the fulfilment of the requirements of this document;
c)
provision of required
resources;
d)
any need for change.
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