Professional Documents
Culture Documents
Audit Checklist Questions
Audit Checklist Questions
Audit Checklist Questions
Were external and internal issues relevant to the organization identified? How and what record
will evidence such? Is the record updated, as necessary? (*hint – Business Model Canvas and/or
SOAR Analysis)
4.1
Natukoy mo na ba ang mga external at internal na issues na makakaapekto sa inyong
organisasyon? Paano at saan eto naisulat? Eto ba ay updated? (*pahiwatig – Business Model
Canvas at/o SOAR Analysis)
Were you able to identify your process’ stakeholders AND their needs and expectations? Is the
document updated as necessary? (*hint –Stakeholders Analysis)
4.2
Natukoy mo na ba ang inyong process' stakeholders at ang kani-kanilang pangangailangan at
inaasahan? Nababago ba ang mga dokumento kung kinakailangan? (*pahiwatig -Stakeholders
Analysis)
Aside from the identified external and internal issues and stakeholder analysis, was the scope of
the QMS determined and discussed in any document? Where? e.g. types of products and
services covered; any clause exclusions, etc.
4.3
Maliban sa mga natukoy na external and internal issues at stakeholder analysis, natukoy at
naisulat din ba ang scope ng QMS? Saan ito nakasulat? (halimbawa: mga nasakop na products at
services, mga clause exclusions, etc.)
Was there a documented business process chart? Is this updated? Are these processes defined
in the Management System Manual?
4.4.1
Meron bang nakasulat na business process chart? Updated ba ito? Nakasulat ba ito sa
Management System Manual?
Is the implementation of your process evidenced by required documented information as
dictated by your process’ procedures? (*hint – check the implementation of all procedures
related to the process being audited)
4.4.2
May kaukulang documented information (halimbawa: process procedure) ba ang pagsasagawa
ng inyong proseso o trabaho? (*pahiwatig - pakicheck ang aktwal na pagsagawa ng procedures,
nasusunod ba ang lahat na nakasulat dito)
Does the top management exhibit its leadership through the following?
- taking accountability in implementing effective QMS
- Quality Policy and corresponding objectives/targets set are well communicated
- promoting risk-based thinking
- ensuring that necessary resources are provided
- promoting improvement of processes
5.1.1
Naipapakita ba ng top management ang kanilang leadership sa pamamagitan ng mga
sumusunod:
- pagiging accountable sa pagpatupad ng isang maayos na QMS
- pag communicate ng Quality Policy at kaukulang objectives/targets
- pagtaguyod ng risk-based thinking
- pagbigay ng mga kinakailangang resources
- pagtaguyod ng magandang pagbabago sa mga proseso
5.1.2 Top management must ensure:
- customer and applicable statutory and regulatory requirements are consistently
complied with
- relevant risks and opportunities are determined and addressed by the organization
- maintained customer satisfaction
Kung may mga pagbabago sa proseso (e.g. new service, new technology, new product, etc.),
nasisiguro ba na ang mga sumusunod na documented information ay napag-aralan sa mga
kinakailangang baguhin?:
- Risk Register
- apektadong system procedures (o kinakailangan bang gumawa ng bagong system
procedure)
- SRDSs
- Table of Organization
Are needed resources of the process being audited identified? Where? (*hint – SRDS, SQOT
and/or any document identifying planning of needed materials/services)
7.1.1
Natukoy ba ang mga kailangan na resources sa proseso? Saan? (*pahiwatig – SRDS, SQOT o
kahit anong document na nagtutukoy ng pagpaplano ng mga kailangang materyales at serbisyo.
Are the people involved in the process being audited competent/knowledgeable of their
assigned responsibilities? If there are weaknesses or gaps, are these being addressed thru
trainings or orientations?
7.1.2
Ang mga tao ba na kasama sa proseso ay may kakayahan o kaalaman sa kanilang mga
responsibilidad? Kung may mga pagkukulang, eto ba ay nasosolusyunan sa pamamagitan ng
mga training o orientation?
For the process being audited, are needed infrastructures provided AND maintained? (*hint –
when we talk about ‘maintained’, look for any preventive maintenance activities)
Are non-calibrated and/or damaged measuring equipment labeled to avoid accidental use of
such?
Ang mga non-calibrated at mga sira na gamit panukat ay may label ba para maiwasan ang
aksidenteng pag gamit nito?
If there are weaknesses or gaps, are these being addressed thru trainings or orientations or
conferences?
Are there any knowledge necessary to keep up with the changing needs and trends? (e.g. new
technology, new law, realizations from other partners in the industry, etc.)
7.1.6
Natukoy ba ang minimum na kaalaman sa kahit anong trabaho sa proseso? (halimbawa: drayber
– kailangan ay marunong magbasa at umintindi ng mga palatandaan or signs sa daan.
How do you ensure that persons working within your process are competent on the basis of
appropriate education, training, or experience?
When there are training/awareness needs, how do you ensure that these are addressed? (*hint
– possible actions may include provision of training to, mentoring of, the re-assignment of the
employee, or contracting of competent persons)
When trainings or awareness sessions are given to those who need it, how is effectiveness of
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such action evaluated?
Paano mo natitiyak na ang mga tao sa proseso na ito ay may kakayahan base sa nararapat na
edukasyon, training, o karanasan?
Kapag ang training o awareness ay naibigay sa mga may kailangan nito, paano nasusuri kung eto
ba ay effective?
All members of the organization (including those that are outsourced, should be aware of the
following):
- Quality Policy
- relevant quality objectives and targets
- their contribution to and the implications of not conforming with the QMS
requirements
7.3
Ang lahat ng miyembro ng organisasyon (kasama ang mga tagalabas na mangagawa) ay dapat
alam ang mga sumusunod:
- Quality Policy
- May kaugnayan na quality objectives and targets
- Ang kanilang kontribusyon at implikasyon ng hindi pagsunod sa QMS requirements
All relevant internal AND external communications within the process would have to ensure
that the following are determined:
- on what it will communicate
- when to communicate
- with whom to communicate
- how to communicate
- who communicates
7.4
Kailangan na natukoy ang mga sumusunod sa lahat ng may importansya na internal and external
na komunikasyon sa proseso:
- Ano ang nais na ipaalam
- Kailan ito ipapaalam
- Kanino ito ipapaalam
- Paano ito ipapaalam
- Sino ang magpapaalam
7.5.1 The following general documented information requirements would have to be available with
the process:
- Quality Policy
- System Procedures Manual
- Risk Register
- SRDS
- Objectives and Targets
- Documented Information Management Table
- Masterlist of External Documented Information
- Corrective Action Report
ISO Clause Question/s
Ang mga sumusunod na general documented information requirements ay kailangan na
mayroon sa proseso:
- Quality Policy
- System Procedures Manual
- Risk Register
- SRDS
- Objectives and Targets
- Documented Information Management Table
- Masterlist of External Documented Information
- Corrective Action Report
Relevant documented information would have to ensure that the following are considered:
- appropriate identification (e.g. title, date, author)
- appropriate format (e.g. language, software version)
- appropriate media (e.g. paper, electronic)
- appropriate review and approval
7.5.2
Kailangan masigurado na ang mga sumusunod ay maconsider sa mga may kaugnayan na
documented information:
- Naaangkop na identipikasyon (e.g. title, date, author)
- Naaangkop na format (e.g. lenggwahe, software version)
- Naaangkop na media (papel, electronic)
- Naaangkop na pag-review at pag-apruba
Required documented information of the process would always have to be available and
suitable for use. It should also be adequately protected from loss of confidentiality, improper
use, or loss of integrity (e.g. no tampered documents, etc.)
7.5.3.1
Ang mga required na documented information ng proseso ay kailangan laging nandyan at
maaaring gamitin. Ito ay kailangan din protektado sa pagkawala ng confidentiality, sa maling
paggamit, o pagkawala ng integridad (halimbawa: walang pinakielaman na dokumento, atbp)
7.5.3.2 Are distribution of manuals and forms controlled? How?
Whenever there are needed revisions, are the old/superseded documents retrieved effectively?
How?
Is the storage method of any documented information appropriate to ensure that the
documented information is preserved?
Are retention periods of ‘records’ defined and followed? How are lapsed records disposed?
Are external references relevant to the process controlled? How? (e.g. Standards, Equipment
Manuals, Books, Government Memorandums, etc..)
Kapag mayroon kailangan baguhin sa dokumento, ang mga luma ba na dokumento ay nabawi ng
maayos? Paano?
Does the process have any outsourced services? If yes, how is it controlled? See questions under
8.4.1 to 8.4.3
8.1
Nagawa ba ng proseso kung ano ang naiplano? (halimbawa: ano ang nakasulat sa SQOT o
SRDS?)
Ang proseso ba ay may mga serbisyo na kinukuha sa labas? Kung oo, paano ito kontrolado?
Tignan ang mga tanong sa iababa ng 8.4.1 haggang 8.4.3
Any of the following issues would have to be relayed properly to the customer (with proper
documentation):
- providing any information related to the organization’s product/service
- handling client inquiry
- preparation of contracts (or handling orders) and any changes to such
- anything related to client feedback and/or complaint
- handling any property that is owned by the customer
- any changes that will arise from relevant contingency actions
8.2.1
Ang mga sumusunod na issue ay kailangan na ipaalam ng maayos sa customer (nararapat na
may tamang dokumentasyon):
- pagbigay ng impomasyon na may kaugnayan sa produkto o serbisyo ng organisasyon
- pag-handle ng mga tanong ng client (o client inquiry)
- paghanda ng mga kontrata (at paghawak ng orders) at kahit anong pagbabago
- kahit anong may kaugnayan sa reaksyon at reklamo ng client
- paghawak ng kahit anong gamit na pagmamay-ari ng customer
- kahit anong pagbabago na mangagaling sa mga contingency na aksyon
How do you ensure that all applicable statutory and regulatory requirements applicable to the
company are complied with in a timely manner?
8.2.2
Paano mo natitiyak na ang mga naaangkop na statutory at regulatory na requirements sa
kumpanya ay nagagawa o nasusunod sa tamang panahon?
Before committing to supply products/services to a customer, does the organization review the
following?
- requirements specified by the customer (are the requirements documented?)
- requirements not stated by the customer but necessary (are these documented?)
- applicable statutory and regulatory requirements
- contract or order requirements differing from previously expressed (are these
resolved?)
8.2.3.1
8.2.3.2 Bago mag-commit na magbigay ng produkto o serbisyo sa customer, ang organisasyon ba ay
naaaral ang mga sumusunod?
- Mga requirements na tinukoy ng customer (nakadokumento ba ang requirements?)
- Mga requirements na hindi natukoy ng customer ngunit kailangan (eto ba ay
nakadokumento?)
- Naaangkop na statutory at regulatory requirements
- Kontrata o order requirement na nagpapaiba sa naunang natukoy (eto ba ay
nasolusyonan?)
8.2.4 Are relevant persons informed of any changes generated from the previous questions in 8.2.3.1
and 8.2.3.2
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Naipapaalam ba sa mga tao ang kahit anong pagbabago sa naunang tanong sa 8.2.3.1 at
8.2.3.2?
Is there a system procedure created to capture design activities?
8.3.1
Meron bang proseso na nagawa para sa mga gawain sa pagdisenyo ng produkto o serbisyo ng
organisasyon?
Are design planning activities captured in a documented information? Where? Are the following
evident in this documented information (*Note: only when applicable)?
- the nature, duration and complexity of the design and development activities
- the required process stages, including applicable design and development reviews
- the required design and development verification and validation activities
- the responsibilities and authorities involved in the design and development process
- the internal and external resource needs for the design and development of products
and services
- the need to control interfaces between persons involved in the design and
development process
- the need for involvement of customers and users in the design and development
process
- the requirements for subsequent provision of products and services
- the level of control expected for the design and development process by customers
and other
8.3.2 - relevant interested parties
During the design of service/s, are there controls in place to ensure that (*Note: only when
applicable):
- the results to be achieved are defined
- reviews are conducted to evaluate the ability of the results of design and development
to meet requirements
- verification activities are conducted to ensure that the design and development
outputs meet the input requirements
- validation activities are conducted to ensure that the resulting products and services
meet the requirements for the specified application or intended use;
- any necessary actions are taken on problems determined during the reviews, or
verification and validation activities
8.3.4
Habang nagdidisensyo ng produkto o serbisyo, mayroon bang mga controls para siguraduhin
ang mga sumusunod: (*tandaan: kapag naaangkop lamang)
- ang resulta na kailangan makamit ay natukoy
- mga pag-aaral para masuri ang kalidad ng resulta ng design and development na
magawa ang requirements
- ginawa ang mga gawain sa pagberipika para masigurado na ang produkto at serbisyo ay
nakamit ang requirements para sa natukoy na application o tamang gamit;
- Ang mga nararapat na aksyon ay nagawa sa mga problema na natukoy habang pinag-
aaralan o verification and validation activities
Do the outputs of the designed service/s meet the following? (*Note: only when applicable)
- meet the input requirements
- are adequate for the subsequent processes for the provision of products and services
- include or reference monitoring and measuring requirements, as appropriate, and
acceptance criteria
- specify the characteristics of the products and services that are essential for their
intended purpose and their safe and proper provision.
8.3.5
Nakamit ba ang mga sumusunod ng output ng nadisenyo na produkto o serbisyo? (*tandaan:
kapag naaangkop lamang)
- nakamit ang input requirements
- naaangkop sa susunod na proseso sa paggawa ng product at serbisyo
- may kasama na requirements sa pagsukat at pagsubaybay kung naaangkop, at
acceptance criteria
For the designed services, were the following recorded? Where? (*Note: only when applicable)
- design and development changes
- the results of reviews
- the authorization of the changes
- the actions taken to prevent adverse impacts
8.3.6 Para sa mga nadisensyo na produkto o serbisyo , ang mga sumusunod ba ay natatala? Saan?
(*note: kung naaangkop lamang)
- pagbabago sa design at development
- resulta ng pag-aaral
- pag otorisa ng mga nabago
- mga aksyon para maiwasan ang hindi magandang epekto
8.4.1 For any externally provided processes, products and services, do you ensure that they undergo:
- accreditation procedure
- evaluation procedure
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Para sa mga externally provided na proseso, produkto, at serbisyo, tinitiyak mo ba na sila ay
dumadaan sa:
- proseso ng akreditasyon
- proseso ng pagsusuri o pag-evaluate ng kanilang performance
For any externally provided processes, products and services, how are performance of such
monitored? How do you ensure that the efficiency of such are closely controlled to ensure that
it will not affect the management system of your company?
8.4.2
Para sa mga externally provided na proseso, produkto, at serbisyo, paano nasusubaybayan ang
performance nila? Paano mo natitiyak na ang efficiency ay kontrolado para matiyak na hindi ito
makakaapekto sa management system ng kumpanya?
How do you ensure that you are effectively and clearly communicating your requirements to
your external providers? (e.g. clear instructions in the Purchase Order, Contracts, etc.)
8.4.3
Paano mo natitiyak na ang mga requirements ay epektibo at malinaw mong napapaalam sa
iyong external providers? (halimbawa: malinaw na instruction sa Purchase Order, Contracts, at
iba pa)
Are the following provided and/or available and/or implemented in the process being audited?
- The characteristics of the products to be produced; or the services to be provided; or
the activities to be performed
- Plans related to the process (ex: Preventive Maintenance Program, Internal Audit
Schedule, Annual Training Program, etc.)
- Implementation of actions to prevent human error
- Any necessary tests to be conducted (e.g. test runs of equipment repaired)
- Inspection prior to release of products or services
8.5.1
Ang mga sumusunod ba ay mayroon, naibigay, o nagawa ng proseso?
- mga katangian ng produkto na ginawa; o serbisyo na naibigay, o mga aktibidad na
ginawa
- plano na may kaugnayan sa proseso (halimbawa: preventive maintenance program,
Internal Audit Schedule, Annual Training Program, etc.)
- Paggawa ng mga aksyon para maiwasan ang pagkakamali ng tao
- Kahit anong nararapat na pagsusuri na isasagawa (halimbawa: test run ng equipment
na naayos)
- Inspeksyon bago irelease ang produkto o serbisyo
Do any product/service outputs have unique identification for traceability purposes? (e.g.
Contract numbers, Job Order numbers, etc.).
8.5.2
Ang mga product.service outputs ba ay may kakaibang pagkikilanlan para sa layuning
pagbabakas (Halimbawa: contract numbers, job order numbers, etc.)
Do any property belonging to customers OR external providers well taken cared of? For any
damages or loss of property, was the incident documented and communicated to the customer/
external provider? (*hint: property may include materials, components, tools and equipment,
premises, intellectual property and personal data)
8.5.3
Ang mga gamit na pagmamay-ari ba ng customer o external provider ay maayos na naaalagaan?
Sa bawat danyos o pagkawala ng gamit, ang insidente ba ay nadokumento at napaalam sa
customer/external provider? (*pahiwatig: Ang mga gamit na ito ay maaaring materyales,
components, gamit, lugar, intellectual property at personal na datos.
Any outputs during production or service provision must be preserved to the extent necessary.
8.5.4
Ang mga outputs habang paggawa ng produkto o serbisyo ay kailangan na naiingatan hanggang
sa lawak ng pangangailangan?
8.5.5 Post-delivery requirements would have to be complied with. (*note: Post-delivery requirements
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would include any of the following: warranty provisions, contractual obligations such as
maintenance services, and supplementary services such as recycling or disposal).
Any relevant nonconformities would have to be dealt with in one or more of the following ways:
- correction
- segregation, containment, return or suspension of provision of product/service
- informing the customer
- obtaining authorization for acceptance under concession
The issues seen in 8.7.1 would have to be properly documented to reflect the following:
- description of the nonconformity
- actions taken
- concessions obtained
- identification of the authority deciding the action in respect of the nonconformity
8.7.2
Ang mga issues na nakita sa 8.7.1 ay kailangang maayos na madokumento para maipakita ang
mga sumusunod:
- Paglalarawan ng nonconformity
- Mga ginawang aksyon
- Nakuha na konsesyon
- Pagkikilanlan ng may otoridad na magdedesisyon sa aksyon ng nonconformity.
All set objectives and targets (and its SRDS’) would have to be monitored and evaluated.
9.1.1
Lahat ng natakdang objectives and targets (at SRDS’) ay kailangan na nasusubaybayan at
nasusuri.
9.1.2 How are customer perception (satisfaction) measured? How is it documented? (*note:
customer perception is not just limited to the use of customer survey forms)
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Paano nasusukat ang satispaksyon ng customer? Paano ito nadodokumento? (*note ang
persepsyon ng customer ay hindi nalilimitahan sa pag gamit ng customer survey forms lamang).
Does the process being audited analyze its recorded data to evaluate its contribution to the
following areas:
- conformity of products or services
- the degree of customer satisfaction
- the performance and effectiveness of the QMS
- the effectiveness of actions taken to address risks and opportunities
- the performance of external providers
9.1.3
Ang mga datos ba na natala o na-generate ng proseso ay nasusuri upang malaman ang
kontribusyon nito sa mga sumusunod:
- conformity ng produkto o serbisyo
- antas ng satispaksyon ng customer
- performance at effectiveness ng QMS
- effectiveness ng aksyon na ginawa para ma-address ang risk at oportunidad
- performance ng mga external providers
How often is internal audit being conducted? Is it being conducted as scheduled?
9.2.1
Gaano kadalas isinasagawa ang internal audit? Eto ba ay nagagawa ng base sa schedule?
Is Audit Plan prepared to reflect the assigned auditors? Are audit checklists and reports
prepared? When planning, are importance of the processes considered?
Are results of the audit reported to the management? Correction and Corrective Actions to any
findings are taken without undue delay?
May nagawa ba na audit plan upang ipakita ang mga nakatalaga na auditors? Ang mga audit
9.2.2
checklist at reports ba ay nagawa? Sa pagpaplano, kinokonsider ba ang kahalagahan ng mga
proseso?
Ang mga auditors ba ay pinili para masigurado na ang makikita ay base sa katotohanan at hindi
sa emosyon, at para masigurado na ang pagtrato ay pare-pareho sa lahat?
Ang resulta ng audit ba ay ipinapaalam sa management? Ang Correction and Corrective Actions
ba sa mga nakita ay nagawa sa tamang panahon ng hindi naaantala?
Were all required agenda (letters a to f in 9.3.2) discussed and reflected in the Management
Review minutes?
9.3.2
Ang mga kailanganang pag-usapan na agenda (letters a to f ng 9.3.2) ay natalakay at nakasama
ba sa Management Review minutes?
9.3.3 Did the Management Review minutes include needed outputs such as decisions and actions
related to any of the following:
- opportunities for improvement
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- any need for changes to the QMS
- resource needs
Nakalagay ba sa Management Review minutes ang mga kailangan na output tulad ng mga
desisyon at aksyon na may kaugnayan sa mga sumusunod?
- Oportunidad sa pagimprove
- Mga kailangan na pagbabago sa QMS
- Mga kailangan na resources
Any notable identified opportunities to improve/enhance customer satisfaction? (*Examples of
improvement includes: correction, corrective action, continual improvement, breakthrough
change, innovation and re-organization)
10.1
May mga nakita bang mga oportunidad para maimprove o mapaunlad ang satispaksyon ng
customer? (*halimbawa ng improvement ay: correction, corrective action, continual
improvement, breakthrough changes, inobasyon, at pag re-organisasyon)
For any nonconformities identified in the process, the following would have to be documented:
- correction
- determining the cause
- implement action needed to address the cause
- update of Risk Register (if necessary)
10.2.1
Sa bawat nonconformities na natukoy sa proseso, ang mga sumusunod ay dapat na
nakadokumento:
- Pagwawasto
- pagtukoy ng dahilan
- Pagsagawa ng kailangang aksyon para masolusyonan ang dahilan.
- Update ang risk register (kung kailangan)
There should be a documented evidence that the actions have been really implemented for the
nonconformities identified in Clause 10.2.1.
10.2.2
Mayroon dapat nakadokumento na ebidensya na ang aksyon ay naipatupad para sa natukoy na
nonconformities sa clause 10.2.1.
Any other noted areas that could further be improved?
10.3
Mayroon bang nakikita na maaari pang maimprove sa ino-audit na proseso?