Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact

#1
Hello Everyone,
In my calibration laboratory, checks like intermediate checks, replicate calibration and recalibration of retained items are to be carried out as per Clause 7.7 of ISO/IEC 17025:2017. What I need to know is whether the artefact against which my working standard must be checked, should be chosen on the basis of specific requirements such as higher / lower accuracy / resolution, etc. compared to my working standard (the one I am using to routinely calibrate calibration items / UUC received from customers)?

Thanks in advance.
Peace.
Richie Rich
 
Elsmar Forum Sponsor

dwperron

Trusted Information Resource
#2
Your artifact needs to be of a known value for it to accomplish the purpose of an intermediate check. If you don't know the value of your artifact it tells you nothing about your standard.

Intermediate checks primarily look for drift in your standards, so accuracy and resolution for the artifact are less important that the stability. But then again, stability normally goes along with accuracy and resolution.
 
Thread starter Similar threads Forum Replies Date
B IEC 60601-1 Clause 14.8 - Architecture IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
somashekar Justification for Non-applicable clause at Stage 2, in clause 4. ISO 13485:2016 - Medical Device Quality Management Systems 11
T API SPEC Q1 Clause 5.6.1.2.C).2) First Article Oil and Gas Industry Standards and Regulations 16
A ISO Clause 4.1/4.2 & 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P Maximum Mains Voltage (clause 8.5.3) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S IATF 16949 - Summary at a glance Clause wise - changes from ISO TS IATF 16949 - Automotive Quality Systems Standard 4
A ISO 14001:2015 clause 4.4 ISO 14001:2015 Specific Discussions 2
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
D PSW with waiver statement (hold harmless clause) IATF 16949 - Automotive Quality Systems Standard 3
Ashland78 MSA clause or wording needed. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A 60601-1 clause 8.11.3.6 Test Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S MSA clause 7.1.5.1.1 - Statistical studies on counting weight scale Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Thee Bouyyy Internal NCR - API Q1 5.4.2b - API 16C Clause 4.1.3 Internal Auditing 9
L ISO 45001:2018 - Clause 5.4: Consultation and Participation of Workers Process Maps, Process Mapping and Turtle Diagrams 1
V Clause 7.1.3.1 Plant, facility, and equipment planning Lean in Manufacturing and Service Industries 0
J Aluminum anodization as MOP insulation? Clause 8.5.1.1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
R AS5553 Clause 3.1.7 f - "Implement a returns process....." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
M IATF16949 Clause 9.1.2.1e - Customer notification related IATF 16949 - Automotive Quality Systems Standard 4
N 60601-2-2 Ed 6 Clause 201.8.8.3.102 - HF instrument leakage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
H AS9100D clause 8.5.1 f) & 8.5.1 g) - Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
SANTHSH API Spec. Q1 clause 5.6.1.2 On site evaluation Oil and Gas Industry Standards and Regulations 10
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
lanley liao How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
lanley liao How to understand the term 3.1.21 'Servicing' and the clause 5.7.1.2 'Servicing' of API Spec Q1? Oil and Gas Industry Standards and Regulations 19
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
A ISO 41001:2018 - Clause No.8 Operations Part Quality Management System (QMS) Manuals 2
L AS5553 Clause 3.1.7 e "Control packaging material ..................reused" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
R What is meant by Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT (clause no 4.9) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom