Checklist ISO 15378:2011 (DIN EN ISO 15378:2012)
Ref.No: ______Organization: ______
Audit period / date / Name of lead auditor / Signature of lead auditorInstructions for using the DQS-audit checklist
1.Normative references and identification
The ordered QM-elements from the standard are preceded by numbers. The additional requirements of ISO 15378:2011 are post-positioned.Special additional questions from Annex A of the standard can be found at the end of this checklist and only need to be answered if they are applicable
2.Application of the assessment checklist
The checklist serves for the evaluation of audit results. Every audit requirement should be evaluated separately. The applicability of Annex A (normative) for the organization is to be determined at the beginning of the audit.
The evaluation of the documentation and implementation of a standard’s requirement should be documented in the following way:
1 = fulfilled2 = partially fulfilled, still acceptable3 = partially fulfilled, not acceptable
4 = not fulfilledna = not applicable0 = not audited
Auditor remarks:
ISO 15378:2011 / DIN EN ISO 15378:2012 / Additional requirements for ISO:9001 / Assessment4 Quality management system
4.1 General requirements
4.1-1 / Has the organization established and documented a quality management system that fulfils the requirements of ISO 15378?
4.1-2 / Does the organization implement, maintain and continually improve the effectiveness of this QM-system?
4.1-3 / Has the organization determined the processes necessary for the QM-system and its application in the whole organization?
4.1-4 / Has the organization determined the sequence and interaction of these processes?
4.1-5 / Has the organization determined criteria and methods needed to ensure that both the operation and control of these processes are effective?
4.1-6 / Does the organization ensure the availability of resources and information necessary to support the operation and monitoring of these processes?
4.1-7 / Are these processes monitored, measured and analyzed?
4.1-8 / Are actions necessary to achieve planned results and continual improvement of these processes implemented?
4.1-9 / Does the organization manage these processes in accordance with the requirements of ISO 9001:2008?
4.1-10 / Does the organization ensure control over outsourced processes that affect product conformity with requirements?
4.1-11 / Is the control of such outsourced processes identified within the quality management system?
4.1-12 / Does the overall policy describe the intentions and approach to assurance of product quality? / 4.1 g)
4.2 Documentation requirements
4.2.1 General
Does the quality management documentation include…
4.2-1 / a)documented statements of a quality policy and quality objectives?
4.2-2 / b)a quality manual?
4.2-3 / c)documented procedures required by ISO 9001:2008?
4.2-4 / d)documents needed by the organization to ensure the effective planning, operation and control of its processes?
4.2-5 / e)records required by ISO 15378?
4.2-6 / f)the documented overall policy of the organization, its intentions and approach for validation? / 4.2.1.1
4.2.2 Quality manual
4.2-8 / Has the organization established and maintained a quality manual?
Does the quality manual include…
4.2-9 / a)the scope of the quality management system, including details of and justification for any exclusions?
4.2-10 / b)documented procedures for the quality management system, or reference to them?
4.2-11 / c)a description of the interaction between the processes of the quality management system?
4.2-12 / d)the extent to which this international standard is applicable to Your processes? / 4.2.2.1
4.2-13 / e)the structure of the documentation used in the quality management system? / 4.2.2.2
4.2.3 Control of documents
4.2-14 / Are the documents required by the quality management system controlled?
4.2-15 / Are records controlled according to the requirements given in 4.2.4 “Control of records” of the standard?
4.2-16 / Is a documented procedure established to define the controls needed for…
4.2-17 / a)approving documents for adequacy prior to issue?
4.2-18 / b)reviewing and updating as necessary and re-approving documents?
4.2-19 / c)ensuring that changes and the current revision status of documents are identified?
4.2-20 / d)ensuring the prevention of unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?
4.2-21 / e)ensuring that documents remain legible and readily identifiable?
4.2-22 / f)ensuring that documents of external origin are identified and their distribution controlled?
4.2-23 / g)ensuring the prevention of unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?
4.2-24 / Does the organization ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions? / 4.2.3.1
4.2-25 / Has the organization defined the period for which at least one copy of obsolete, controlled documents is to be retained? / 4.2.3.2
4.2-26 / If electronic signatures are used on documents, are the documents controlled to provide equivalent security to that given by a hand-written signature? / 4.2.3.3
4.2-27 / Do controlled documents include a unique identification?
Do controlled documents contain a unique identification on each page (eg documents /-number, issue and page number)? / 4.2.3.4
4.2.4 Control of records
4.2-27 / Are records established and maintained to provide evidence of conformity to requirements and to the effective operation of the quality management system?
4.2-28 / Are the records maintained so as to be legible, readily identifiable and retrievable?
4.2-29 / Is a documented procedure established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records?
4.2-30 / Are electronic records subject to the same controls as those required for other records (See 4.2.4 and 7.5.2.9)? / 4.2.4.1
4.2-31 / Are entries in records
- clear and indelible?
- made directly after performing the activity (in the order performed)?
- dated and initialed or signed by the person making the entry?
- with corrections dated and initialed or signed and, where appropriate, explained?
4.2-32 / Does the organization define the quality critical processes and parameters where a double check is necessary for the release of a batch? If either check is carried out electronically, is this clearly defined? / 4.2.4.3
4.2-33 / Is each quality critical stage and parameter in production and control processes identified and double-checked? / 4.2.4.4
4.2-34 / For each batch of primary packaging material, does the organization establish and maintain a record that proves traceability and identifies the quantity manufactured and quantity approved for distribution? / 4.2.4.5
4.2-35 / Has the organization defined those parameters of the batch documentation that need to be verified? / 4.2.4.6
4.2-36 / Is the batch documentation verified and approved? / 4.2.4.7
4.2-37 / Are all manufacturing, control, testing, distribution and investigation records retained:
for at least five years after the date of manufacture, or
as agreed with the customer, or
for at least one year after the expiration date of the primary packaging material assigned by the organization, unless agreed otherwise with the customer? / 4.2.4.8
5 Management responsibility
5.1 Management commitment
Does top management provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by…
5.1-1 / a)communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements?
5.1-2 / b)establishing the quality policy?
5.1-3 / c)ensuring that quality objectives are established?
5.1-4 / d)conducting management reviews?
5.1-5 / e)ensuring the availability of resources?
5.2 Customer focus
5.2 / Does top management ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction?
5.2.1 Customer audits
5.2-2 / Does the organization permit the customers or their representatives to conduct audits to review the quality management system? / 5.2.1
5.3 Quality policy
Does top management ensure, that the quality policy…
5.3-1 / a)is appropriate to the purpose of the organization?
5.3-2 / b)includes a commitment to comply with the requirements and continually improve the effectiveness of the QM system?
5.3-3 / c)provides a framework for establishing and reviewing quality objectives?
5.3-4 / d)is communicated and understood within the organization?
5.3-5 / e)is reviewed for continuing suitability?
5.4 Planning
5.4.1 Quality objectives
5.4-1 / Does top management ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization?
5.4-2 / Are the quality objectives measurable and consistent with the quality policy?
5.4.2 Quality management system planning
Does top management ensure that...
5.4-3 / a)the planning of the quality management system is carried out in order to meet the requirements given in 4.1 “General requirements” as well as the quality objectives?
5.4-4 / b)the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5-1 / Does top management ensure that the responsibilities and authorities are defined and communicated within the organization?
5.5-2 / Does the organization maintain a current record of signatures of responsible persons? / 5.5.1.1
5.5-3 / Do quality units with responsibility for quality critical decisions have the authority to make these decisions independently from production? / 5.5.1.2
5.5.2 Management representative
Has top management appointed a member of management whohas responsibility and authority that includes:
5.5-4 / a)ensuring that processes needed for the quality management system are established, implemented and maintained?
5.5-5 / b)reporting to top management on the performance of the quality management system and any need for improvement?
5.5-6 / c)ensuring the promotion of awareness of customer requirements throughout the organization?
5.5.3 Internal communication
5.5-7 / Has top management ensured that appropriate communication processes are established within the organization?
5.5-8 / Does top management ensure that communication regarding the effectiveness of the QM-system takes place?
5.5-9 / Are Good Manufacturing Practices (GMP) in this international standard and requirements stated by laws and regulations communicated, as appropriate, to each level of the organization? / 5.5.3.1
5.5-10 / Is top management notified of quality critical situations in a timely manner? / 5.5.3.2
5.6 Management review
5.6.1 General
5.6-1 / Does top management review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?
5.6-2 / Does this review include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and the quality objectives?
5.6-3 / Are records from management reviews maintained?
5.6.2 Review input
Does the input to management review include information on…
5.6-4 / a)results of audits?
5.6-5 / b)customer feedback?
5.6-6 / c)process performance and product conformity?
5.6-7 / d)status of preventive and corrective actions?
5.6-8 / e)follow-up actions from previous management reviews?
5.6-9 / f)changes that could affect the quality management system?
5.6-10 / g)recommendations for improvement?
5.6.3 Review output
Does the output from the management review include any actions and decisions related to:
5.6-11 / a)improvement of the effectiveness of the quality management system and its processes?
5.6-12 / b)improvement of product related to customer requirements?
5.6-13 / c)resource needs?
6 Resource management
6.1 Provision of resources
Does the organization determine and provide the resources needed to…
6.1-1 / a)implement and maintain the quality management system and continually improve its effectiveness?
6.1-2 / b)enhance customer satisfaction by meeting the customer requirements?
6.2 Human resources
6.2.1 General
6.2-1 / Are the personnel performing work affecting product quality competent on the basis of appropriate education, training, skills and experience?
6.2.2 Competence, awareness and training
6.2-2 / a)Has the organization determined the necessary competence or personnel performing work affecting product quality?
6.2-3 / b)Does the organization provide training to satisfy these needs or take other actions to provide the necessary competence?
6.2-4 / c)Does the organization evaluate the effectiveness of actions taken?
6.2-5 / d)Does the organization ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives?
6.2-6 / e)Does the organization maintain appropriate records of education, training, skills and experience?
6.2.2.1 GMP training
6.2-7 / Is addition training conducted regularly and include awareness of applicable GMP and all procedures and policies that affect product quality and the quality management system? Does thins training include:
a)the risk of contamination and cross-contamination?
b)the potential hazard to end user/patient if product is contaminated?
c)the impact of any deviations from specified procedures, processes or specifications on customer’s product quality or the end user? / 6.2.2.1.1
6.2-8 / Is particular attention given to training of the personnel involved with the manufacture of sterile components or components to be subsequently sterilized? / 6.2.2.1.2
.2-9 / Is specific training on microbiological and particulate contamination and the potential risk to the patient of such contamination provided? / 6.2.2.1.3
6.2-10 / Is additional refresher training carried out at defined intervals? / 6.2.2.1.4
6.2-11 / Are temporary personnel trained or under supervision of a trained person? / 6.2.2.2
6.2-12 / Where consultants are employed to advise on quality matters, are records of their qualifications and type of service(s) provided maintained? / 6.2.2.3
6.3 Infrastructure
6.3-1 / Has the organization determined, provided and maintained the infrastructure needed to achieve conformity to product requirements?
Does it include, as applicable...
6.3-2 / a)buildings, workspace and associated utilities?
6.3-3 / b)process equipment (both hardware and software)?
6.3-4 / c)supporting services (such as transport and communication)?
6.4 Work environment
6.4-1 / Has the organization determined and managed the work environment needed to achieve conformity to product requirements?
6.4-2 / Has the organization established documented requirements for health, cleanliness, clothing and access control of personnel, if contact between such personnel and the primary packaging material or work environment could adversely affect the quality of the primary packaging material? / 6.4.1.1
6.4-3 / If work conditions can have an adverse effect on primary packaging material quality, has the organization defined the appropriate work environment conditions and established a system for their effective monitoring and control? / 6.4.1.2
6.4-4 / If appropriate, are special conditions established and documented for the control of contaminated or potentially contaminated primary packaging material to prevent contamination of other primary packaging material, the work environment or personnel? / 6.4.1.3
6.4.2 / Classification of clean areas/cleanrooms / 6.4.2
Are clean areas/cleanrooms classified according to ISO 14644-1 and monitored/operated according to ISO 14644-2, ISO 14644-3 and ISO 14644-5 or equivalent? / 6.4.2
6.4.3 / Risk control of contamination / 6.4.3
Has the organization determined and controlled the risks that may result in contamination of primary packaging materials, for example:
a)personal hygiene and health?
b)personal clothing, jeweler including piercing and make-up?
c)smoking, eating, chewing, drinking and personal medication?
d)handling and disposal of waste?
e)microbiological contamination? / 6.4.3
6.4.4 Pest control
Is an effective, documented pest control program implemented and maintained? / 6.4.4
6.4.5 Utilities (ancillary services)
Are all utilities (e.g. air, gases, steam water) assessed for their potential impact on the quality of the primary packaging materials and any associated risks? Are records of the assessments maintained? (see 4.2.4) / 6.4.5.1
Are appropriate ventilation and exhaust systems provided, where necessary, to minimize contamination? Is particular attention given to recirculation systems? / 6.4.5.2
If water comes into direct contact with the primary packaging material, or its starting material or is used for cleaning the equipment in contact with the product, it its quality determined and controlled? / 6.4.5.3
6.5 Maintenance activities
Has the organization established documented requirements for maintenance activities (e.g. production processes, systems and equipment), when such activities or lack thereof may affect product quality? / 6.5.1
Are records of such maintenance activities maintained (see 4.2.4)? / 6.5.2
Has the organization ensured that the infrastructure is managed, operated, cleaned and, where appropriate, maintained in accordance with GMP and to avoid product contamination (including control of particulate matter and microbiological control where applicable)? / 6.5.3
Do computerized systems that may impact upon primary packaging material quality have sufficient controls for installation, operation, maintenance, modification and security? / 6.5.4
Is a set of technical documentation for quality critical equipment and installations maintained? / 6.5.5
7 Product realization
7.1 Planning of product realization
7.1-1 / Does the organization plan and develop the processes needed for product realization? / 4.2.3
7.1-2 / Is the planning of product realization consistent with the requirements of other processes of the quality management system?
In planning product realization, has the organization determined the following, as appropriate:
7.1-3 / a)Quality objectives and requirements for the product?
7.1-4 / b)The need to establish processes, documents, and provide resources specific to the product?
7.1-5 / c)Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance?
7.1-6 / d)Records needed to provide evidence that the realization processes and resulting product meet requirements
7.1-7 / Is the output of this planning in a form suitable for the organization’s method of operations?
7.1-8 / Does product realization planning consider the requirement for consistent processing of primary packaging materials?
Does planning also take account of the need for taking and retaining samples in appropriate conditions? / 7.1.1
7.1-9 / Does the organization ensure that risk management processes are included in the planning and implemented throughout product realization?
Are records maintained? / 7.1.2
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
Does the organization determine…
7.2-1 / a)requirements specified by the customer, including the requirements for delivery and post-delivery activities?
7.2-2 / b)requirements not stated by the customer but necessary for specified or intended use, where known?
7.2-3 / c)statutory and regulatory requirements related to the products?
7.2-4 / d)any additional requirements determined by the organization?
7.2-5 / Are requirements related to the product, including changes requiring notification, determined and documented? / 7.2.1.1
7.2-6 / Are customer requirements to avoid unauthorized use of waste primary packaging material (including samples, print media, and labels) determined and documented? / 7.2.1.2
7.2.2 Review of requirements related to the product
7.2-7 / Does the organization review the requirements related to the product?
7.2-8 / Is this review conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders)?
Does this review ensure that ...