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In this presentation, Charles highlights the changes to the TS16949 Rules Document and the affect on the certificate holders. The presentation is followed by a very informative FAQ session which can be found at the end of the ISO/TS 16949 webinar here - http://ul-dqsusa.com/information-center/recorded-webinars/amendment-isots-164949-rules-document-4th-edition-training/
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In this presentation, Charles highlights the changes to the TS16949 Rules Document and the affect on the certificate holders. The presentation is followed by a very informative FAQ session which can be found at the end of the ISO/TS 16949 webinar here - http://ul-dqsusa.com/information-center/recorded-webinars/amendment-isots-164949-rules-document-4th-edition-training/
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Dear quality professionals, just in case you have not already done so for yourself, I am sharing a helpful sheet listing the new numeric structure for the emerging automotive standard. As I’m sure you are aware, there are differences between TS structure and IATF, something to keep in mind when auditing and addressing transition and corrective action. Applying IATF changes now, will confidently make it easier for all to save time effort and resources during this transition as well as current corrective actions as opposed to restarting in a year from now. Enjoy!
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ISO 9001-2015 IATF 16949-2016 Numeric Structure Ramona Kellner
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PECB Webinar: Proposed changes for medical device quality management systems ...PECB
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1. APLAC TC 006
Issue No. 1 Issue Date: 07/04 Page 1 of 9
GUIDANCE NOTES ON ISO/IEC 17020
2. APLAC Guidance Notes on ISO/IEC 17020 –
APLAC TC 006
Issue No. 1 Issue Date: 07/04 Page 2 of 9
PURPOSE
This document provides guidance notes additional to the ILAC/IAF guidance
document on accreditation of inspection bodies. It is intended primarily to assist
inspection bodies to understand issues that will be examined by accreditation bodies
during assessments. It is to be used in conjunction with the ILAC/IAF document.
The commentary and interpretative material is numbered with the relevant clause
number of the standard, e.g. 12.2(1) is commentary number 1 on the requirements of
clause 12.2 of ISO/IEC 17020:1998.
AUTHORSHIP
This document was produced by the APLAC Technical Committee.
COPYRIGHT
The copyright of this document is held by APLAC. APLAC publications may not be
copied for sale by an individual or body other than APLAC member organisations.
FURTHER INFORMATION
For further information about this document, contact the APLAC Secretariat at:
NATA
71-73 Flemington Road
North Melbourne VIC 3051
Australia
Tel: +61 3 9329 1633
Fax: +61 3 9326 5148
email: aplac@nata.asn.au
Website: www.aplac.org
3. APLAC Guidance Notes on ISO/IEC 17020 –
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Issue No. 1 Issue Date: 07/04 Page 3 of 9
TABLE OF CONTENTS
Page
Purpose 2
Authorship 2
Copyright 2
Further Information 2
1. Scope 4
2. Definitions 4
3. Administration Requirements 4
4. Independence, Impartiality and Integrity 4
6. Organization and Management 5
7. Quality System 5
8. Personnel 6
9. Facilities and Equipment 6
10. Inspection Methods and Procedures 7
12. Records 7
13. Inspection Reports and Inspection Certificates 8
14. Sub-contracting 8
15. Complaints and Appeals 9
References 9
4. APLAC Guidance Notes on ISO/IEC 17020 –
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Issue No. 1 Issue Date: 07/04 Page 4 of 9
1 SCOPE
1.4(1) In cases of ambiguity, final determination of whether a particular activity
may be included in the scope of accreditation as an inspection activity
should be made by the accreditation body, taking into account accepted
international practice where relevant.
2 DEFINITIONS
2.1(1) For professional judgement to be exercised the staff member responsible
for the inspection, referred to in clause 8.2 of ISO/IEC 17020, should
personally perform the inspection or effectively supervise the inspection.
3 ADMINISTRATIVE REQUIREMENTS
3.5(1) The conditions referred to in this clause of ISO/IEC 17020 are contractual
conditions not physical conditions at inspection sites. Items which are
commonly included in conditions of contract include:
access to documented inspection history
responsibility for safe site access
timely availability of key client personnel
preparation of items for inspection
response to adverse weather conditions
level of reporting
terms of payment
level of liability insurance, etc.
3.5(2) In the case of Type C inspection bodies the conditions of contract should
include a clear statement of the activities that prevent it being classified as
a Type A inspection body.
4 INDEPENDENCE, IMPARTIALITY AND INTEGRITY
4.1(1) An effective procedure normally requires personnel to report and record
any incidents of undue pressure they experience.
4.1(2) Undue pressure on personnel may be brought to bear through financial,
marketing, customer relations and personal matters, as well as by other
technical or non-technical considerations.
4.2.3(1) In the case of type C inspection bodies, contractual conditions should
include a clear statement summarising the interests or activities of the
inspection body or associated bodies that resulted in the type C
classification. This statement should be sufficiently explicit to enable
potential clients to make informed decisions on the adequacy of the level of
independence offered.
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6 ORGANIZATION AND MANAGEMENT
6.2(1) Details of personal or position responsibilities should be included in the
quality system documentation. This may cover clerical staff as well as
management, technical and inspection personnel.
6.3(1) Functions of the technical manager may include, but not be limited to,
authorisation of inspection methods, and technical support for inspectors.
7 QUALITY SYSTEM
7.1(1) Policy statements are intended to demonstrate senior management
commitment to the quality system. Objectives should include measurable
targets, which are reviewed at least annually. Training records should
include details of extent to which familiarity with the quality system that has
been assessed.
7.5(1) In cases where an inspection body has a number of offices in different
locations, responsibility for the practical maintenance of the quality system
should be assigned to a named individual in each office.
7.6(1) The document control system shall be documented. A statement that
documents will be controlled is not sufficient.
7.6a)(1) There must be a clear and authoritative means for all employees to identify
the current authorised version of any controlled document.
7.6a)(2) Effective systems must be in place to ensure that each relevant employee
has been made aware of and understands updates to any document which
could affect the conduct, outcome, recording or reporting of an inspection.
7.6b)(1) It must always be possible to identify the individual who is responsible for
the technical validity of any specific technical document.
7.7(1) Internal audits cannot be considered to meet the requirements of ISO/IEC
17020 unless there is evidence of effective corrective action following
identification of any non-compliances.
7.8(1) Feedback includes internal feedback for the purposes of improvement, as
well as complaints and preventive action.
7.8(2) Procedures for feedback and corrective action should normally include but
not be limited to the following constituents:
description of the issue
investigation of the cause
description of immediate action taken
description of corrective action to be taken to prevent recurrence
identification of the person responsible for corrective action
target date for completion of corrective action
monitoring of progress of corrective action
sign off of completed corrective action.
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Records of feedback and corrective action should be kept.
7.9(1) An important aspect of management review is the identification of trends in
all forms of feedback that may indicate areas of the quality system that
would benefit from review. This aspect of management review need not be
carried out more than once a year unless there are large volumes of
feedback suggesting an urgent need for review.
7.9(2) The outcome of a management review should include the setting of
objectives for the coming period, proposed improvements to the quality
system or an explicit statement that no improvements are required.
8 PERSONNEL
8.2(1) For professional judgement to be exercised the staff member responsible
for inspection, referred to in clause 8.2 of ISO/IEC 17020, should
personally perform the inspection or effectively supervise the inspection.
8.4(1) All stages of training, such as those detailed in clause 8.3 of ISO/IEC
17020, should be recorded.
Note: Training records do not establish competence. They are a
statement that the management considers the individual to be competent
to perform specific inspection tasks and, where relevant, to use specific
equipment.
Note: Training records should detail competence levels assessed in all
relevant technical and administrative areas and should be reviewed
regularly (normally annually).
8.6(1) In cases where it is impossible to separate remuneration from the number
of inspections done, eg. in very small inspection bodies, other means, such
as recording the duration of inspections, should be established to ensure
that the quality of inspections is not compromised by financial
considerations.
9 FACILITIES AND EQUIPMENT
9.7(1) The definition of measurement traceability given in ILAC P10:2002 should
be applied in understanding this clause.
9.7(2) Where accuracy requirements permit calibrations of working instruments to
be performed in-house, traceability to national standards should be
assured by the use of reference standards of measurement for which the
inspection body holds current traceable calibration certificates. The
calibration certificate should detail an uncertainty of measurement that is
appropriate for the equipment that is to be calibrated from the reference
standard. For further information on uncertainty of measurement see
ISO/IEC 17025, clause 5.4.6, and EA-4/02, “Expressions of the Uncertainty
of Measurements in Calibration”.
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9.9(1) Records of in-service checks on equipment should be maintained.
9.10(1) In situations where non-certified reference materials are used, inspection
reports should clearly state that the stated conclusion on conformity was
based on uncertified reference materials.
9.13a)(1) In-house developed software such as spreadsheet programs shall be
validated before use. Validation may be accomplished by processing a
known data set and performing equivalent processing manually or by other
means. The extent of the known data set should be such that all possible
outcomes of the software manipulation can be adequately checked.
Software should be protected from unauthorised alteration. Unauthorised
alteration may be detected by processing the known data set periodically.
Records of software validations and any necessary periodic checks should
be maintained.
9.13a)(2) All software, including proprietary products, should be controlled in an
equivalent way to hard-copy documents. Records of version numbers and
dates when each version was brought into or taken out of service should
be maintained.
9.13d)(1) Where electronic records are the primary storage medium, appropriate
methods such as regular backups and offsite safekeeping of backups
should be implemented. The frequency of backups should be set to
reduce the risk of loss to an acceptable level.
10 INSPECTION METHODS AND PROCEDURES
10.3(1) All non-standard methods should be authorised by the technical manager
or another technically qualified person. Non-standard methods should be
documented, retained and referenced in relevant reports.
10.7(1) Checking points should be identified in operating procedures. The extent
of checking should also be defined, e.g. checks for completeness, for
technical consistency or typographical errors.
10.7(2) There should be documentary evidence that checks have been done.
This evidence should include the identity of the checker and the date of the
check.
10.7(3) An inspection body that performs large numbers of routine inspections may
perform less than 100% checking. In such cases justification of the
sampling method and sample size should be documented.
12 RECORDS
12.2(1) Inspection records should be detailed and comprehensive. Satisfactory
evaluation of the inspection may require more than the following types of
information to be recorded:
client instructions
details of job review
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details of the items inspected
inspection conditions
information provided by the client
identity of the person who performed the inspection
equipment used
equipment verification records
the inspection procedures used
inspection observations
conformity decisions (with supporting justification)
aspects not inspected, with reasons given, e.g. lack of safe access.
Additional information requirements should be considered at the times of
the inspection and subsequent reporting.
13 INSPECTION REPORTS AND INSPECTION CERTIFICATES
13.2(1) Accreditation cannot normally be claimed for an inspection report that
relies upon material provided by a subcontractor that does not have
demonstrated competence as required by clause 14.2 of ISO/IEC 17020.
Where regulations or other authoritative requirements stipulate that a
report must include a claim of accreditation, all information, critical to the
inspection decision, provided by a body that does not have demonstrated
competence, should be clearly identified as such.
14 SUBCONTRACTING
14.2(1) To maintain consistent standards of assessment of competence (as
required by international MRAs among accreditation bodies), where the
assessment of a subcontractor is carried out by an inspection body, it
should be able to be demonstrated that the assessment team is technically
competent and knowledgeable in the application of ISO/IEC 17020 or
ISO/IEC 17025, as appropriate, and that the assessing body complies with
the requirements of ISO/IEC 17011.
14.4(1) Clause 14.4 refers to work outside the accredited scope of the inspection
body, the results of which have a critical influence on conformity decisions
in the inspection body’s reports or certificates.
14.4(2) Inspection reports that rely on data or services not covered by a scope of
accreditation for their conclusions cannot include any reference to
accreditation except under the circumstances outlined in clause 14.4c of
the ILAC/IAF guidance document on ISO/IEC 17020.
14.4(3) When an endorsed inspection report or certificate is required by
regulations and no providers of demonstrated competence are available for
a particular supporting service, the report or certificate shall state
prominently that the conformity decision is made in good faith, based on
information of unknown reliability, and that the conformity decision is not
covered by an accreditation. The report or certificate should clearly identify
9. APLAC Guidance Notes on ISO/IEC 17020 –
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which information is of unproven reliability. The inspection body shall take
full responsibility for the conformity decision irrespective of the source of
any information required to support the decision.
15 COMPLAINTS AND APPEALS
15.1(1) Complaints should include all feedback from dissatisfied clients, regulators
or other stakeholders, however received.
REFERENCES
1. ILAC P10:2002 ILAC Policy on Traceability of Measurement Results
2. ISO/IEC 17025:1999 General requirements for the competence of testing and
calibration laboratories
3. EA-4/02:1999 Expressions of the Uncertainty of Measurements in Calibration
4. ISO/IEC 17011:2004 General requirements for accreditation bodies
accrediting conformity assessment bodies